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Abstract Background Transforaminal epidural injections with steroids (TESI) are increasingly being used in patients sciatica. The STAR (steroids against radiculopathy)-trial aimed to evaluate the (cost-) effectiveness of TESI in patients with acute sciatica (

Background: Transforaminal epidural injections with steroids (TESI) are increasingly being used in patients sciatica. The STAR (steroids against radiculopathy)-trial aimed to evaluate the (cost-) effectiveness of TESI in patients with acute sciatica (< 8 weeks). This article contains the economic evaluation of the STAR-trial. Methods: Participants were randomized to one of three study arms: Usual Care (UC), that is oral pain medication with or without physiotherapy, n = 45); intervention group 1: UC and transforaminal epidural steroid injection (TESI) 1 ml of 0.5% Levobupivacaine and 1 ml of 40 mg/ml Methylprednisolone and intervention group 2: UC and transforaminal epidural injection (TEI) with 1 ml of 0,5% Levobupivacaine and 1 ml of 0.9% NaCl (n = 50). The primary effect measure was health-related quality of life. Secondary outcomes were pain, functioning, and recovery. Costs were measured from a societal perspective, meaning that all costs were included, irrespective of who paid or benefited. Missing data were imputed using multiple imputation, and bootstrapping was used to estimate statistical uncertainty. Results: None of the between-group differences in effects were statistically significant for any of the outcomes (QALY, back pain, leg pain, functioning, and global perceived effect) at the 26-weeks follow-up. The adjusted mean difference in total societal costs was €1718 (95% confidence interval [CI]: − 3020 to 6052) for comparison 1 (intervention group 1 versus usual care), €1640 (95%CI: − 3354 to 6106) for comparison 2 (intervention group 1 versus intervention group 2), and €770 (95%CI: − 3758 to 5702) for comparison 3 (intervention group 2 versus usual care). Except for the intervention costs, none of the aggregate and disaggregate cost differences were statistically significant. The maximum probability of all interventions being cost-effective compared to the control was low (< 0.7) for all effect measures. Conclusion: These results suggest that adding TESI (or TEI) to usual care is not cost-effective compared to usual care in patients with acute sciatica (< 8 weeks) from a societal perspective in a Dutch healthcare setting. Trial registration: Dutch National trial register: NTR4457 (March, 6th, 2014). [ABSTRACT FROM AUTHOR]

Background: Individuals with wrist osteoarthritis (OA) can suffer from pain, muscular weakness, and impaired motion of the wrist, which can reduce the quality of life. While there is strong evidence that all patients with OA should receive first-line treatment with education and exercises, this approach has not yet been proposed for individuals with wrist OA. Therefore, this trial aimed to evaluate the effectiveness of a first line neuromuscular joint-protective exercise therapy program compared to a training program with range of motion (ROM) exercises in patients with wrist OA. Methods: In this randomized controlled trial (RCT), 48 patients with symptomatic and radiographically confirmed wrist OA were randomly allocated to a 12-week self-management program with either a neuromuscular joint-protective exercise therapy program (intervention group) or a training program with ROM exercises only (control group). Our primary outcome measure was the Patient-Rated Wrist Evaluation (PRWE) with secondary outcome measures of grip strength, range of wrist motion, the Numerical Pain Rating, Scale (NPRS), the Disabilities of the Arm, Shoulder, and Hand (DASH) and the Generalized Self-Efficacy Scale (GSES). The outcome measures were evaluated by a blinded assessor at baseline and 12 weeks. Between-groups differences were analyzed using the Mann–Whitney U test and within-group differences were analyzed with the Wilcoxon signed-rank test. Results: A total of 41 participants were analyzed at 12 weeks. There were no significant differences in PRWE between the groups at 12 weeks (p = 0.27). However, DASH improved significantly in the intervention group compared to the control group (p = 0.02) and NPRS on load within the intervention group (p = 0.006). The difference in DASH should be interpreted with caution since it could be due to a non-significant increase (worsening) from baseline in the control group in combination with a non-significant decrease (improvement) in the intervention group. Conclusions: This RCT showed that the novel neuromuscular joint-protective exercise therapy program was not superior in reducing pain and improving function compared to a training program with ROM exercises at 12 weeks. Future research is warranted to evaluate the effectiveness of forthcoming exercise therapy treatment programs for patients with wrist OA. Trial registration: ClinicalTrials.gov, NCT05367817. Retrospectively registered on 10/05/2022. https://clinicaltrials.gov. [ABSTRACT FROM AUTHOR]

Abstract Background New-onset neurological symptoms such as numbness and pain in lower extremities might appear immediately after conventional lumbar interbody fusion (LIF) surgery performed in patients with lumbar spinal stenosis. Methods and analysis This is a multicenter, randomized, open-label, parallel-group, active-controlled trial investigating the clinical outcomes of modified LIF sequence versus conventional LIF sequence in treating patients with lumbar spinal stenosis. A total of 254 eligible patients will be enrolled and randomized in a 1:1 ratio to either modified LIF sequence or conventional LIF sequence group. The primary outcome measure is the perioperative incidence of new-onset lower extremity neurological symptoms, including new adverse events of pain, numbness, and foot drop of any severity. Important secondary endpoints include visual analogue scale (VAS) pain score and lumbar Japanese Orthopaedic Association (JOA) recovery rate. Other safety endpoints will also be evaluated. The safety set used for safety data analysis by the actual surgical treatment received and the full analysis set for baseline and efficacy data analyses according to the intent-to-treat principle will be established as the two analysis populations in the study. Conclusion This study is designed to investigate the clinical outcomes of modified LIF sequences in patients with lumbar spinal stenosis. It aims to provide clinical evidence that the modified “fixation-fusion” sequence of LIF surgery is effective in treating lumbar spinal stenosis. Trial registration http://www.chictr.org.cn/index.aspx ID: ChiCTR2100048507.

Background: New-onset neurological symptoms such as numbness and pain in lower extremities might appear immediately after conventional lumbar interbody fusion (LIF) surgery performed in patients with lumbar spinal stenosis. Methods and analysis: This is a multicenter, randomized, open-label, parallel-group, active-controlled trial investigating the clinical outcomes of modified LIF sequence versus conventional LIF sequence in treating patients with lumbar spinal stenosis. A total of 254 eligible patients will be enrolled and randomized in a 1:1 ratio to either modified LIF sequence or conventional LIF sequence group. The primary outcome measure is the perioperative incidence of new-onset lower extremity neurological symptoms, including new adverse events of pain, numbness, and foot drop of any severity. Important secondary endpoints include visual analogue scale (VAS) pain score and lumbar Japanese Orthopaedic Association (JOA) recovery rate. Other safety endpoints will also be evaluated. The safety set used for safety data analysis by the actual surgical treatment received and the full analysis set for baseline and efficacy data analyses according to the intent-to-treat principle will be established as the two analysis populations in the study. Conclusion: This study is designed to investigate the clinical outcomes of modified LIF sequences in patients with lumbar spinal stenosis. It aims to provide clinical evidence that the modified "fixation-fusion" sequence of LIF surgery is effective in treating lumbar spinal stenosis. Trial registration: http://www.chictr.org.cn/index.aspx ID: ChiCTR2100048507. [ABSTRACT FROM AUTHOR]

Abstract Background Patients with rheumatoid arthritis (RA) are prone to muscle atrophy due to inflammatory cytokines and corticosteroid use and immobility due to joint pain and deformity. Although resistance training is effective and safe in reversing muscle atrophy in RA, some patients are unable to perform a conventional high-load exercise program due to disease-related limitations. This study aims to examine the efficacy of individualized exercise therapy on physical function in elderly patients with RA who are at a high risk for sarcopenia. Methods This study is a single-center, parallel-group, two-arm, healthcare provider- and outcome assessor-blinded, superiority randomized controlled trial with a 1:1 allocation ratio. A total of 160 participants with RA between 60 and 85 years of age with a positive screening test for sarcopenia will be included. The intervention group will receive nutritional guidance and a four-month individualized exercise program in addition to the usual treatment. The control group will receive nutritional guidance in addition to the usual care. The primary endpoint will be physical function assessed using the Short Physical Performance Battery (SPPB) at 4 months. The data on outcome measures will be collected at baseline and at the two- and four-month follow-ups. Linear mixed-effects models for repeated measures will be conducted using the modified intention-to-treat analysis population. Discussion This study will provide evidence on whether a personalized exercise program can improve physical function and quality of life in elderly patients with RA. Some limitations include limited generalizability due to the single-center study and lack of blinding of the patients to the intervention assignment because of the nature of the exercise. Physical therapists may use this knowledge in their daily practice to improve RA treatment. Tailored exercise may enhance the health outcomes of the RA population and contribute to a reduction in healthcare costs. Trial registration The study protocol was retrospectively registered at the University hospital Medical Information Network-Clinical Trial Repository (UMIN-CTR) (registration number: UMIN000044930, https://www.umin.ac.jp/ctr/index-j.htm ) on January 4, 2022.

Background: Patients with rheumatoid arthritis (RA) are prone to muscle atrophy due to inflammatory cytokines and corticosteroid use and immobility due to joint pain and deformity. Although resistance training is effective and safe in reversing muscle atrophy in RA, some patients are unable to perform a conventional high-load exercise program due to disease-related limitations. This study aims to examine the efficacy of individualized exercise therapy on physical function in elderly patients with RA who are at a high risk for sarcopenia. Methods: This study is a single-center, parallel-group, two-arm, healthcare provider- and outcome assessor-blinded, superiority randomized controlled trial with a 1:1 allocation ratio. A total of 160 participants with RA between 60 and 85 years of age with a positive screening test for sarcopenia will be included. The intervention group will receive nutritional guidance and a four-month individualized exercise program in addition to the usual treatment. The control group will receive nutritional guidance in addition to the usual care. The primary endpoint will be physical function assessed using the Short Physical Performance Battery (SPPB) at 4 months. The data on outcome measures will be collected at baseline and at the two- and four-month follow-ups. Linear mixed-effects models for repeated measures will be conducted using the modified intention-to-treat analysis population. Discussion: This study will provide evidence on whether a personalized exercise program can improve physical function and quality of life in elderly patients with RA. Some limitations include limited generalizability due to the single-center study and lack of blinding of the patients to the intervention assignment because of the nature of the exercise. Physical therapists may use this knowledge in their daily practice to improve RA treatment. Tailored exercise may enhance the health outcomes of the RA population and contribute to a reduction in healthcare costs. Trial registration: The study protocol was retrospectively registered at the University hospital Medical Information Network-Clinical Trial Repository (UMIN-CTR) (registration number: UMIN000044930, https://www.umin.ac.jp/ctr/index-j.htm) on January 4, 2022. [ABSTRACT FROM AUTHOR]

Abstract Aims Dupuytren’s contracture (DC) is a chronic debilitating fibroproliferative disorder. Common treatment options include collagenase clostridium histolyticum injections (CI), percutaneous needle fasciotomy (NF) and limited fasciectomy (LF). Superiority of one specific treatment remains controversial. This study aims to assess the short-term efficacy and safety of CI, NF, and LF for the treatment of DC. Methods We included randomized controlled trials of CI compared with placebo, NF and LF for patients with DC. PubMed, Embase and the Cochrane Library were searched from inception to August 2021. Contracture reduction rates in treated joints (within 0–5° of full extension within 30 days), relative reduction in total passive extension deficit (TPED), occurrence of one or more adverse events and number of treatment-related adverse events per patient were the outcomes of interest. The Cochrane risk-of-bias tool was employed for quality assessment of the studies. A network meta-analysis was performed using MetaXL. Results Nine studies met our inclusion criteria (n = 903). Overall, risk bias was mixed and mostly low. Short term TPED reduction achieved with LF was superior compared to CI and NF. Although CI achieved greater TPED reduction compared to NF, it was associated with the highest risk of overall adverse effects. The analyzed data was limited to a maximum three-year follow-up period and therefore insufficient for long-term outcome evaluation. Conclusions In DC, LF may be able to provide patients with severe disease, superior flexion contracture release postoperatively. CI is a valid treatment alternative to NF, however the higher risk of overall adverse effects must be considered. The quality-of-evidence is limited due to short-term follow-up periods and a lack of standardized definitions of complications and adverse events.

Abstract Trial design The prospective randomized controlled trial. Background This study compares outcomes in terms of early postoperative anterior wrist pain and time to return to work or activities of daily living of patients who underwent carpal tunnel syndrome (CTS) release with short incision and those who had minimally invasive surgery (MIS) with CTS kits. Methods A total of 24 patients diagnosed with primary CTS confirmed with electrodiagnosis at an academic university hospital were randomly assigned into one of two groups of 12 patients each: a short incision group and an MIS with tool-kit group using computer-generated block randomization (block of four). Sequentially numbered, opaque, sealed envelopes were used in the allocation concealment process. In the short incision group, skin was incised longitudinally from Kaplan’s line to the area distal to transverse wrist crease (2.5–4.0 cm) while in the tool-kit group, an incision of less than 2.5 cm. was made using special MIS-CTS kits. Primary outcomes evaluated include visual analogue scale (VAS) measurement of pain intensity in the anterior carpal area both while at rest and while conducting daily activities at the 2nd week postoperatively as well as the time to return to activities of daily living and work. Improvement in the Michigan hand questionnaire (MHQ) score, a secondary outcome, was also measured at the 2nd week postoperatively. Patients, allocator and outcome assessor were blinded. Results Demographic data, including preoperative electrodiagnostic severity and occupation, were similar in the two groups. There were no significant differences in terms of VAS of the early postoperative anterior carpal area at rest (p > 0.99), while conducting daily activities (p = 0.89) and time to return to activities of daily living (p = 0.46) and work (p = 0.24). The MHQ score improvement at the 2nd week postoperatively showed no significant difference between the groups (p = 0.95). The MIS wound length in the tool-kit group was significantly shorter than in the short incision group (1.95 vs 2.92 cm, p

Background: Hip fractures are common in elderly patients. The surgery is usually delayed due to underlying conditions, and pain control is crucial while the patient is cleared for surgery. In this randomized controlled trial (RCT) study, we hypothesized that the application of skin traction in patients with intertrochanteric fracture does not significantly change the Visual Analogue Score (VAS) of pain. Methods: This is a prospective, single institution, parallel randomized controlled trial. Two hundred and twenty-nine patients with isolated intertrochanteric fractures were enrolled in the study. Patients with neurologic issues, drug addiction, scars or swelling, or vascular issues at the site of skin traction application were excluded from the study. Patients were divided into two groups: group A included 97 patients, and group B included 95 patients. Skin traction was applied for group A, while only a soft pillow was put beneath the patients' knees in the other group. The VAS score was measured after the diagnosis, two hours before the operation, and 24 h after the surgery. The morphine dosage administered per day was documented for both groups. Results: After excluding patients with postoperative delirium, 154 patients (55 males and 99 females) with isolated intertrochanteric fractures (69 right-sided and 85 left-sided), and a mean age of 70 ± 10 remained in the study. There were no significant differences between the two groups regarding age, gender, and mean time from injury to admission (P >.05). The mean VAS score measures and morphine dosage administered per day were not significantly different between the two groups (P >.05). Both groups experienced significant pain relief 24 h postoperatively (P <.001). Conclusion: Pre-operative skin traction application affected neither the patients' VAS scores nor the mean morphine dosage per day in patients with isolated intertrochanteric fractures. Our data does not support the routine application of pre-operative skin traction in patients with intertrochanteric fractures. Trial registration: The project was registered in the Iranian Registry of Clinical Trials (registration reference: IRCT20180729040636N3, registration date: 01/07/2020). Level of evidence: 1. [ABSTRACT FROM AUTHOR]

Abstract Background Osteoarthritis (OA) is the most common joint disease, and is most frequently seen in the knees. However, there is no effective therapy to relieve the progression of knee OA. Metformin is a safe, well-tolerated oral medication that is extensively used as first-line therapy for type 2 diabetes. Previous observational studies and basic researches suggested that metformin may have protective effects on knee OA, which needs to be verified by clinical trials. This study, therefore, aims to examine the effects of metformin versus placebo on knee cartilage volume loss and knee symptoms in overweight knee OA patients by a randomized controlled trial over 24 months. Methods This protocol describes a multicenter, randomized, double-blind, and placebo-controlled clinical trial aiming to recruit 262 overweight knee OA patients. Participants will be randomly allocated to the two arms of the study, receiving metformin hydrochloride sustained-release tablets or identical inert placebo for 24 months (start from 0.5 g/day for the first 2 weeks, and increase to 1 g/day for the second 2 weeks, and further increase to 2 g/day for the remaining period if tolerated). Primary outcomes will be changes in tibiofemoral cartilage volume and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score over 24 months. Secondary outcomes will be changes in visual analogue scale (VAS) knee pain, tibiofemoral cartilage defects, effusion-synovitis volume, and tibiofemoral bone marrow lesions maximum size over 24 months. The primary analyses will be intention-to-treat analyses of primary and secondary outcomes. Per-protocol analyses will be performed as the secondary analyses. Discussion If metformin is proved to slow knee cartilage volume loss and to relieve knee symptoms among overweight knee OA patients, it will have the potential to become a disease modifying drug for knee OA. Metformin is a convenient intervention with low cost, and its potential effects on slowing down the structural progression and relieving the symptoms of knee OA would effectively reduce the disease burden worldwide. Trial registration ClinicalTrials. gov NCT05034029 . Registered on 30 Sept 2021.

Aims: Dupuytren's contracture (DC) is a chronic debilitating fibroproliferative disorder. Common treatment options include collagenase clostridium histolyticum injections (CI), percutaneous needle fasciotomy (NF) and limited fasciectomy (LF). Superiority of one specific treatment remains controversial. This study aims to assess the short-term efficacy and safety of CI, NF, and LF for the treatment of DC.Methods: We included randomized controlled trials of CI compared with placebo, NF and LF for patients with DC. PubMed, Embase and the Cochrane Library were searched from inception to August 2021. Contracture reduction rates in treated joints (within 0-5° of full extension within 30 days), relative reduction in total passive extension deficit (TPED), occurrence of one or more adverse events and number of treatment-related adverse events per patient were the outcomes of interest. The Cochrane risk-of-bias tool was employed for quality assessment of the studies. A network meta-analysis was performed using MetaXL.Results: Nine studies met our inclusion criteria (n = 903). Overall, risk bias was mixed and mostly low. Short term TPED reduction achieved with LF was superior compared to CI and NF. Although CI achieved greater TPED reduction compared to NF, it was associated with the highest risk of overall adverse effects. The analyzed data was limited to a maximum three-year follow-up period and therefore insufficient for long-term outcome evaluation.Conclusions: In DC, LF may be able to provide patients with severe disease, superior flexion contracture release postoperatively. CI is a valid treatment alternative to NF, however the higher risk of overall adverse effects must be considered. The quality-of-evidence is limited due to short-term follow-up periods and a lack of standardized definitions of complications and adverse events. [ABSTRACT FROM AUTHOR]

Abstract Background To investigate the analgesic effect of perioperative use of duloxetine in patients received total knee arthroplasty (TKA). Method This prospective randomized, double-blind, placebo-controlled trial study was registered in the Chinese Clinical Trial Registry (ChiCTR2000033910). 100 patients were finally enrolled. The hospital pharmacy prepared small capsules containing either duloxetine or starch (placebo) which were all identical in appearance and weight (50:50). The 100 enrolled patients were given a capsule (containing either 60 mg duloxetine or 60 mg placebo) every night before sleep since preoperative day 2 till postoperative day 14 (17 days in all) by a nurse who were not involved in this trial. Other perioperative managements were the same in the two groups. The primary outcome was the VAS score, including rVAS (visual analogue scale at rest) and aVAS (visual analogue scale upon ambulation) throughout the perioperative period. The secondary outcomes included opioid consumption, range of motion, including both active range of motion (aROM) and passive range of motion (pROM) and adverse events. The patients were followed up everyday until 7 days after TKA, afterwards, they were followed up at the time of 3 weeks and 3 months after TKA. Result rVAS in duloxetine group were significantly less than placebo group throughout the postoperative period: 4.7 ± 2.3 vs 5.9 ± 2.6 (P = 0.016) at 24 h postoperative; 2.1 ± 1.6 vs 2.8 ± 1.7 (P = 0.037) at 7 days postoperative. In terms of aVAS, similarly, duloxetine group had less aVAS than placebo group throughout the postoperative period: 6.2 ± 2.1 vs 7.1 ± 2.2 (P = 0.039) at 24 h postoperative; 3.3 ± 1.7 vs 4.1 ± 2.0 (P = 0.034) at 7 days postoperative. Patients in duloxetine group consumed significantly less opioids per day than the placebo group: 24.2 ± 10.1 g vs 28.5 ± 8.3 g (P = 0.022) at 24 h postoperative; 2.7 ± 2.5 g vs 4.1 ± 2.6 g (P = 0.007) at 7 days postoperative. aROM in duloxetine group were significantly better than placebo group until postoperative day 6, the aROM became comparable between the two groups: 110.2 ± 9.9° in duloxetine group vs 107.5 ± 11.5° in control group (P = 0.211). In terms of pROM, duloxetine group had significantly better pROM until postoperative day 5, the pROM became comparable between the two groups: 103.8 ± 12.1° in duloxetine group vs 99.5 ± 10.8° in control group (P = 0.064). No significant difference was found between the two groups in the rates of dizziness, bleeding, sweating, fatigue and dryness of mouth. In the placebo group, more patients got nausea/vomiting and constipation (P

Background: Multidisciplinary rehabilitation is recommended to reduce sickness absence and disability in patients with subacute or chronic low back pain (LBP). This study aimed to investigate whether a 12-week coordinated work oriented multidisciplinary rehabilitation intervention was effective on return to work and number of days off work during one-year follow-up when compared to usual care.Methods: This study is a randomized controlled trial comparing the effectiveness of a 12-week multidisciplinary vocational rehabilitation program in addition to usual treatment. 770 patients with LBP, who were sick-listed, or at risk of being sick-listed were included in the study. The primary outcome was number of days off work due to LBP. The secondary outcomes were disability, health-related quality of life, pain, psychological distress and fear avoidance behavior. Data were collected at baseline, at the end of treatment, and at 6- and 12-months follow-up. Analyses were carried out according to the "intention-to-treat" principles.Results: A significant decrease in the number of patients who were on sick-leave was found in both groups at the end of treatment and at 6- and 12-months follow-up. Additionally, disability, pain, health related quality of life, psychological distress, and fear avoidance beliefs improved in both groups. No statistically significant differences were found between the groups on any of the outcomes.Conclusions: The coordinated multidisciplinary intervention had no additional effect on sickness absence, disability, pain, or health related quality of life as compared with that of usual care.Trial Registration: This study was retrospectively registered in ClinicalTrials.gov (registration ID: NCT01690234). The study was approved by The Danish Regional Ethics Committee (file no: H-C-2008-112) as well as registered at and approved by the Danish Data Protection Agency. [ABSTRACT FROM AUTHOR]

Trial Design: The prospective randomized controlled trial.Background: This study compares outcomes in terms of early postoperative anterior wrist pain and time to return to work or activities of daily living of patients who underwent carpal tunnel syndrome (CTS) release with short incision and those who had minimally invasive surgery (MIS) with CTS kits.Methods: A total of 24 patients diagnosed with primary CTS confirmed with electrodiagnosis at an academic university hospital were randomly assigned into one of two groups of 12 patients each: a short incision group and an MIS with tool-kit group using computer-generated block randomization (block of four). Sequentially numbered, opaque, sealed envelopes were used in the allocation concealment process. In the short incision group, skin was incised longitudinally from Kaplan's line to the area distal to transverse wrist crease (2.5-4.0 cm) while in the tool-kit group, an incision of less than 2.5 cm. was made using special MIS-CTS kits. Primary outcomes evaluated include visual analogue scale (VAS) measurement of pain intensity in the anterior carpal area both while at rest and while conducting daily activities at the 2nd week postoperatively as well as the time to return to activities of daily living and work. Improvement in the Michigan hand questionnaire (MHQ) score, a secondary outcome, was also measured at the 2nd week postoperatively. Patients, allocator and outcome assessor were blinded.Results: Demographic data, including preoperative electrodiagnostic severity and occupation, were similar in the two groups. There were no significant differences in terms of VAS of the early postoperative anterior carpal area at rest (p > 0.99), while conducting daily activities (p = 0.89) and time to return to activities of daily living (p = 0.46) and work (p = 0.24). The MHQ score improvement at the 2nd week postoperatively showed no significant difference between the groups (p = 0.95). The MIS wound length in the tool-kit group was significantly shorter than in the short incision group (1.95 vs 2.92 cm, p < 0.01).Conclusions: There is no difference in early postoperative anterior wrist pain, time to return to work or to activities of daily living between the surgical techniques. Short incision is recommended for benefit in term of cost-effectiveness, while MIS with tool-kit could be preferred in patients who concerned in cosmetic appearance between the surgical techniques.Trial Registration: www.Clinicaltrials: in.th (TCTR20200530003). Registered 30 May 2020. [ABSTRACT FROM AUTHOR]

Abstract Background In treating patients with cervical ossification of the posterior longitudinal ligament (COPLL), a novel surgery technique - anterior controllable antedisplacement and fusion (ACAF) suggested promising clinical benefits in recent exploratory studies. Methods This is a multicentre, randomized, open-label, parallel-group, active controlled trial that will compare the clinical benefits of ACAF versus conventional posterior laminoplasty (LAMP) in severe COPLL patients. A total of 164 patients will be enrolled and randomized in a 1:1 ratio to either ACAF or LAMP group. The primary efficacy measure is cervical- Japanese Orthopaedic Association (C-JOA) recovery rate at 12 months post operation, which is to be derived by Hirabayashi’s method from JOA data (range, 0 [worst] to 17 [normal condition]). Other important secondary efficacy endpoints include visual analogue scale (VAS) pain score (range, 0 [no pain] to 10 [most severe]), 10-item neck disability index (NDI, a total range of 0 to 50 points, the highest index the worst) and 6-level Nurick disability grade (range, 0 [mild] to 5 [severe]). Safety endpoints including adverse events, perioperative complications, and adverse events of special interest will also be assessed in this study. Full analysis set for baseline and efficacy data analyses according to the intention-to-treat principle will be established as the primary analysis population. Analysis of covariance (ANCOVA) will be used to analyze the C-JOA recovery rate, with random stratification factors (if appropriate) and the treatment group as fixed factors, and the baseline level of C-JOA score as covariate. Discussion This study is designed to demonstrate the clinical benefits of ACAF as compared to conventional LAMP in COPLL patients. It will provide clinical evidence that the novel surgery technique – ACAF might be more favorable in treating patients with severe cervical ossification of the posterior longitudinal ligament. (Words: 290). Trial registration ClinicalTrials.gov number, NCT04968028 .

Background: Osteoarthritis (OA) is the most common joint disease, and is most frequently seen in the knees. However, there is no effective therapy to relieve the progression of knee OA. Metformin is a safe, well-tolerated oral medication that is extensively used as first-line therapy for type 2 diabetes. Previous observational studies and basic researches suggested that metformin may have protective effects on knee OA, which needs to be verified by clinical trials. This study, therefore, aims to examine the effects of metformin versus placebo on knee cartilage volume loss and knee symptoms in overweight knee OA patients by a randomized controlled trial over 24 months.Methods: This protocol describes a multicenter, randomized, double-blind, and placebo-controlled clinical trial aiming to recruit 262 overweight knee OA patients. Participants will be randomly allocated to the two arms of the study, receiving metformin hydrochloride sustained-release tablets or identical inert placebo for 24 months (start from 0.5 g/day for the first 2 weeks, and increase to 1 g/day for the second 2 weeks, and further increase to 2 g/day for the remaining period if tolerated). Primary outcomes will be changes in tibiofemoral cartilage volume and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score over 24 months. Secondary outcomes will be changes in visual analogue scale (VAS) knee pain, tibiofemoral cartilage defects, effusion-synovitis volume, and tibiofemoral bone marrow lesions maximum size over 24 months. The primary analyses will be intention-to-treat analyses of primary and secondary outcomes. Per-protocol analyses will be performed as the secondary analyses.Discussion: If metformin is proved to slow knee cartilage volume loss and to relieve knee symptoms among overweight knee OA patients, it will have the potential to become a disease modifying drug for knee OA. Metformin is a convenient intervention with low cost, and its potential effects on slowing down the structural progression and relieving the symptoms of knee OA would effectively reduce the disease burden worldwide.Trial Registration: ClinicalTrials. gov NCT05034029 . Registered on 30 Sept 2021. [ABSTRACT FROM AUTHOR]

Background: Musculoskeletal disorders are a leading cause of morbidity and the most prevalent source of disability among soldiers. Their high prevalence in armed forces and limited ressources have led to problems related to access to physical rehabilitation care. To increase access, supervised group-based exercise programs for the most prevalent musculoskeletal disorders (low back pain, patellofemoral pain, rotator cuff-related shoulder pain or lateral ankle sprain) have been developed at a Canadian Armed forces (CAF) base, but their effectiveness has not been evaluated. The primary objective of this randomized controlled trial is to evaluate the mid- and long-term effects of these group-based training programs on pain severity and functional limitations, in comparison with usual individual physiotherapy care. Secondary objectives include comparing both interventions in terms of health-related quality of life, pain-related fear, and patients' satisfaction.Methods: One hundred and twenty soldiers with a new medical referral for physiotherapy services for one of the four targeted musculoskeletal disorders will be consecutively recruited. They will be randomly assigned to either group-based training program or usual individual physiotherapy care, and will take part in the assigned 12-week intervention. There will be four evaluation sessions over 26 weeks (baseline, week 6, 12 and 26). At each follow-up, functional limitations, pain severity, health-related quality of life and pain-related fears will be assessed. Patients satisfaction with treatment will also be evaluated at the end of the intervention period. Either two-way repeated measures ANOVA will be used to analyse and compare the effects of the interventions.Discussion: This RCT will determine the effectiveness of group-based training programs compared to usual individual physiotherapy care. This new intervention model could represent an efficient, and more pro-active approach to manage a higher number of soldiers with musculoskeletal disorders. It could improve access to physical rehabilitation care and improve the health of soldiers.Trial Registration: ClinicalTrials.gov ( NCT05235152 ), February 11th 2022. [ABSTRACT FROM AUTHOR]

Abstract Background Increasing evidence has shown benefits of spinal manipulations in patients with patellofemoral pain syndrome (PFPS). There is scarcity regarding medium term effects of spinal manual therapy on outcome measures in PFPS patients. Therefore, the aim of the present study was to compare the effectiveness of local exercise therapy and spinal manual therapy for knee pain, function and maximum voluntary peak force (MVPF) velocity of the quadriceps in PFPS patients. Methods Forty-three patients with PFPS were randomly assigned to a local exercise or spinal manual therapy group. The local exercise group received six sessions (one session per week) of supervised training of the knee-and hip muscles with mobilization of the patellofemoral joint. The spinal manual therapy group received six interventions (one intervention per week) of high velocity low thrust manipulations at the thoracolumbar region, sacroiliac joint, and/or hip. All patients were also asked to do home exercises. Maximum, minimum and current pain were measured using the visual analogue scale. Function was assessed with the anterior knee pain scale (AKPS) and MPFV was recorded using a Biodex System 3 dynamometer. Patients were assessed before intervention, after 6 weeks of intervention and after 6 weeks of follow-up. Between-group differences at assessments were analysed by way of analysis of covariance with Bonferroni correction. Results Pain and functionality improved more following spinal manipulative therapy than local exercise therapy. After 6 weeks of intervention the between-group difference (local versus spinal) for maximal pain was 23.4 mm [95% CI: 9.3, 37.6; effect size (ES): 1.04] and − 12.4 [95% CI: − 20.2, − 4.7; ES: 1.00] for the AKPS. At 6 weeks of follow-up the between-group difference for maximal pain was 18.7 mm [95% CI: 1.4, 36.0; ES: 0.68] and − 11.5 [95% CI: − 19.9, − 3.3; ES: − 0.87] for the AKPS. Conclusions This study suggests that spinal manual therapy is more effective than local exercise therapy in improving pain and function in patients with PFPS in the medium term. We suggest for future research to investigate whether combining local exercise therapy and spinal manual therapy is more effective than either single intervention on its own. This clinical trial study was approved by the Medical Ethics Committee METC Z under registration number NL57207.096. and registered retrospectively in ClinicalTrials.gov PRS with registration ID number NCT04748692 on the 10th of February 2021.

Abstract Background Opioids continue to be the analgesic of choice for postoperative pain control following arthroscopic knee and shoulder surgery. Despite their widespread use, there are limited evidence-based clinical practice guidelines for postoperative opioid prescribing. The Non-Opioid Prescriptions after Arthroscopic Surgery in Canada (NO PAin) Trial is a randomized controlled trial (RCT) designed to determine whether a non-opioid analgesia approach to postoperative pain, compared to usual care, reduces oral morphine equivalents (OME) consumed in patients undergoing outpatient knee and shoulder arthroscopy. Methods This is a multi-centre, RCT with a target sample size of 200 patients. Adult (18+ years of age) patients undergoing outpatient knee and shoulder arthroscopy will be randomized to a non-opioid postoperative protocol (intervention) or the current standard of care (control). The intervention will consist of a standardized non-opioid analgesic prescription, a limited rescue opioid prescription, and a patient education infographic. The control is defined as the treating surgeons’ pre-trial postoperative analgesic regimen. Exclusion criteria include chronic opioid use, concomitant open surgery, contraindications to the prescribed analgesics or ongoing workers compensation/litigation. The primary outcome is OMEs consumed at 6 weeks postoperatively. Secondary outcomes will include patient-reported pain and satisfaction, quantity of OMEs prescribed, number of opioid refills, and any adverse events up to 6 weeks postoperatively. Utilizing the intention to treat principle for all analyses, independent samples t-test and presented with a p-value as well as a mean difference (MD) with 95% confidence intervals (CIs) will be performed for primary and secondary outcomes. Discussion The ongoing opioid epidemic and overprescribing of opioids in orthopaedics serve as the rationale for this trial. There is a lack of evidence upon which to develop post-operative pain management guidelines for patients undergoing arthroscopic surgery. A prospective evaluation of this relatively inexpensive intervention will demonstrate whether an explicit effort to reduce the number of opioids prescribed results in a reduction in the amount of opioids consumed and help to inform future studies and guidelines. Trial registration The NO PAin trial has been prospectively registered with clinicaltrials.gov ( NCT04566250 ).

Background: To investigate the analgesic effect of perioperative use of duloxetine in patients received total knee arthroplasty (TKA).Method: This prospective randomized, double-blind, placebo-controlled trial study was registered in the Chinese Clinical Trial Registry (ChiCTR2000033910). 100 patients were finally enrolled. The hospital pharmacy prepared small capsules containing either duloxetine or starch (placebo) which were all identical in appearance and weight (50:50). The 100 enrolled patients were given a capsule (containing either 60 mg duloxetine or 60 mg placebo) every night before sleep since preoperative day 2 till postoperative day 14 (17 days in all) by a nurse who were not involved in this trial. Other perioperative managements were the same in the two groups. The primary outcome was the VAS score, including rVAS (visual analogue scale at rest) and aVAS (visual analogue scale upon ambulation) throughout the perioperative period. The secondary outcomes included opioid consumption, range of motion, including both active range of motion (aROM) and passive range of motion (pROM) and adverse events. The patients were followed up everyday until 7 days after TKA, afterwards, they were followed up at the time of 3 weeks and 3 months after TKA.Result: rVAS in duloxetine group were significantly less than placebo group throughout the postoperative period: 4.7 ± 2.3 vs 5.9 ± 2.6 (P = 0.016) at 24 h postoperative; 2.1 ± 1.6 vs 2.8 ± 1.7 (P = 0.037) at 7 days postoperative. In terms of aVAS, similarly, duloxetine group had less aVAS than placebo group throughout the postoperative period: 6.2 ± 2.1 vs 7.1 ± 2.2 (P = 0.039) at 24 h postoperative; 3.3 ± 1.7 vs 4.1 ± 2.0 (P = 0.034) at 7 days postoperative. Patients in duloxetine group consumed significantly less opioids per day than the placebo group: 24.2 ± 10.1 g vs 28.5 ± 8.3 g (P = 0.022) at 24 h postoperative; 2.7 ± 2.5 g vs 4.1 ± 2.6 g (P = 0.007) at 7 days postoperative. aROM in duloxetine group were significantly better than placebo group until postoperative day 6, the aROM became comparable between the two groups: 110.2 ± 9.9° in duloxetine group vs 107.5 ± 11.5° in control group (P = 0.211). In terms of pROM, duloxetine group had significantly better pROM until postoperative day 5, the pROM became comparable between the two groups: 103.8 ± 12.1° in duloxetine group vs 99.5 ± 10.8° in control group (P = 0.064). No significant difference was found between the two groups in the rates of dizziness, bleeding, sweating, fatigue and dryness of mouth. In the placebo group, more patients got nausea/vomiting and constipation (P < 0.05). However, in terms of drowsiness, duloxetine group was reported higher rate (P < 0.05).Conclusion: Several other RCTs have already mentioned the analgesic effect of duloxetine, but not in the immediate postoperative period. In this study, we found duloxetine could reduce acute postoperative pain in the immediate postoperative period and decrease the opioids consumption as well as accelerating postoperative recovery, without increasing the risk of adverse medication effects in patients undergoing TKA. Duloxetine could act as a good supplement in multimodal pain management protocol for patients undergoing TKA.Trial Registration Statement: This study was registered in the Chinese Clinical Trial Registry (ChiCTR2000033910). The date of registration was 06/16/2020. [ABSTRACT FROM AUTHOR]

Abstract Background Physiotherapy is a proven effective treatment strategy after total knee and hip arthroplasty (TKA/THA), however there is considerable practice variation regarding its timing, content and duration. This study aims to compare the (cost-) effectiveness of a standardized, treat-to-target postoperative physiotherapy strategy with usual postoperative care. Methods Using a cluster randomized study design, consecutive patients scheduled for a primary TKA/THA in 18 hospitals in the Netherlands will be assigned to the treat-to-target physio therapy strategy or usual postoperative care. With the treat-to-target strategy a standardized, individually tailored, exercise program is aimed at the attainment of specific functional milestones. Assessments are done at baseline, 6 weeks and 3, 6, 9 and 12 months follow up. The primary outcome will be the Knee injury / Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS / HOOS-PS) at 3 months follow up. Secondary outcomes are the numeric rating scale for pain, the Oxford Knee and Hip Scores, performance-based test and the EuroQol 5D-5L for quality of life. Healthcare use, productivity and satisfaction with postoperative care are measured by means of questionnaires. In total, 624 patients will be needed of which 312 TKA and 312 THA patients. Discussion The study will provide evidence concerning the (cost-) effectiveness of the treat-to-target postoperative physiotherapy treatment compared to usual postoperative care. The results of this study will address an important evidence gap and will have a significant impact in daily practice of the physio therapist. Trial registration Registered in the Dutch Trial Registry on April 15, 2018. Registration number: NTR7129 .

Abstract Background The knee is symptomatically the most frequent affected joint in osteoarthritis and, in the Netherlands and other Western countries, is mainly managed by general practitioners (GPs). An intra-articular glucocorticoid injection is recommended in (inter) national guidelines for patients with knee osteoarthritis as an option for a flare of knee pain and/or for those who are not responding well to pain medication. An innovative approach that could replace the intra-articular injection is an intramuscular gluteal glucocorticoid injection. An intramuscular injection is easier to perform than an intra-articular injection with lesser risk of severe local adverse reactions. We hypothesize that intramuscular gluteal glucocorticoid injection is non-inferior in reducing knee pain compared to intra-articular glucocorticoid injection, with potentially a longer lasting effect than intra-articular injection. Methods/design The study will be a pragmatic randomized controlled non-inferiority trial with two parallel groups. A total of 140 patients aged 45 years and older with knee osteoarthritis who contacted their general practitioner and have persistent knee pain (score ≥ 3 on 0–10 numerical rating scale; 0 = no knee pain) will be included. Patients will be randomly allocated (1:1) to an injection of 40 mg triamcinolone acetonide intra-articular in the knee joint or intramuscular in the ipsilateral ventrogluteal area. The effect of treatment will be evaluated by questionnaires at 2, 4, 8, 12, and 24 weeks after injection. The primary outcome is patients’ reported severity of knee pain measured with the pain subscale of the Knee injury and Osteoarthritis Outcome Score 4 weeks after injection. Statistical analysis will be based on both the per-protocol and the intention-to-treat principle. Discussion This study will evaluate non-inferiority of intramuscular glucocorticoid injection compared to intra-articular glucocorticoid injection for knee osteoarthritis symptoms. Trial registration This trial is registered in the Dutch Trial Registry (number NTR6968) at 2018-01-22 ( https://www.trialregister.nl/trial/6784 ). Issue date: 1 October 2019. Trial sponsor Erasmus MC University Medical Center Rotterdam. PO-box 2040. 3000 CA Rotterdam. The Netherlands.

Abstract Background Endoscopic carpal tunnel release (ECTR) and open carpal tunnel release (OCTR) both have advantages and disadvantages for the treatment of carpal tunnel syndrome (CTS). We compared the effectiveness and safety of ECTR and OCTR based on evidence from a high-level randomized controlled trial. Methods We comprehensively searched PubMed, EMBASE, Cochrane Library, Web of Science, and Medline to identify relevant articles published until August 2019. Data regarding operative time, grip strength, Boston Carpal Tunnel Questionnaire scores, digital sensation, patient satisfaction, key pinch strength, return to work time, and complications were extracted and compared. All mean differences (MD) and odds ratios (OR) were expressed as ECTR relative to OCTR. Results Our meta-analysis contained twenty-eight studies. ECTR was associated with significantly higher satisfaction rates (MD, 3.13; 95% confidence interval [CI], 1.43 to 4.82; P = 0.0003), greater key pinch strengths (MD, 0.79 kg; 95% CI, 0.27 to 1.32; P = 0.003), earlier return to work times (MD, − 7.25 days; 95% CI, − 14.31 to − 0.19; P = 0.04), higher transient nerve injury rates (OR, 4.87; 95% CI, 1.37 to 17.25; P = 0.01), and a lower incidence of scar-related complications (OR, 0.20; 95% CI, 0.07 to 0.59; P = 0.004). The permanent nerve injury showed no significant differences between the two methods (OR, 1.93; 95% CI, 0.58 to 6.40; P = 0.28). Conclusions Overall, evidence from randomized controlled trials indicates that ECTR results in better recovery of daily life functions compared to OCTR, as revealed by higher satisfaction rates, greater key pinch strengths, earlier return to work times, and fewer scar-related complications. Our findings suggest that patients with CTS can be effectively managed with ECTR.

Background: In treating patients with cervical ossification of the posterior longitudinal ligament (COPLL), a novel surgery technique - anterior controllable antedisplacement and fusion (ACAF) suggested promising clinical benefits in recent exploratory studies.Methods: This is a multicentre, randomized, open-label, parallel-group, active controlled trial that will compare the clinical benefits of ACAF versus conventional posterior laminoplasty (LAMP) in severe COPLL patients. A total of 164 patients will be enrolled and randomized in a 1:1 ratio to either ACAF or LAMP group. The primary efficacy measure is cervical- Japanese Orthopaedic Association (C-JOA) recovery rate at 12 months post operation, which is to be derived by Hirabayashi's method from JOA data (range, 0 [worst] to 17 [normal condition]). Other important secondary efficacy endpoints include visual analogue scale (VAS) pain score (range, 0 [no pain] to 10 [most severe]), 10-item neck disability index (NDI, a total range of 0 to 50 points, the highest index the worst) and 6-level Nurick disability grade (range, 0 [mild] to 5 [severe]). Safety endpoints including adverse events, perioperative complications, and adverse events of special interest will also be assessed in this study. Full analysis set for baseline and efficacy data analyses according to the intention-to-treat principle will be established as the primary analysis population. Analysis of covariance (ANCOVA) will be used to analyze the C-JOA recovery rate, with random stratification factors (if appropriate) and the treatment group as fixed factors, and the baseline level of C-JOA score as covariate.Discussion: This study is designed to demonstrate the clinical benefits of ACAF as compared to conventional LAMP in COPLL patients. It will provide clinical evidence that the novel surgery technique - ACAF might be more favorable in treating patients with severe cervical ossification of the posterior longitudinal ligament. (Words: 290).Trial Registration: ClinicalTrials.gov number, NCT04968028 . [ABSTRACT FROM AUTHOR]

Background: Opioids continue to be the analgesic of choice for postoperative pain control following arthroscopic knee and shoulder surgery. Despite their widespread use, there are limited evidence-based clinical practice guidelines for postoperative opioid prescribing. The Non-Opioid Prescriptions after Arthroscopic Surgery in Canada (NO PAin) Trial is a randomized controlled trial (RCT) designed to determine whether a non-opioid analgesia approach to postoperative pain, compared to usual care, reduces oral morphine equivalents (OME) consumed in patients undergoing outpatient knee and shoulder arthroscopy. Methods: This is a multi-centre, RCT with a target sample size of 200 patients. Adult (18+ years of age) patients undergoing outpatient knee and shoulder arthroscopy will be randomized to a non-opioid postoperative protocol (intervention) or the current standard of care (control). The intervention will consist of a standardized non-opioid analgesic prescription, a limited rescue opioid prescription, and a patient education infographic. The control is defined as the treating surgeons' pre-trial postoperative analgesic regimen. Exclusion criteria include chronic opioid use, concomitant open surgery, contraindications to the prescribed analgesics or ongoing workers compensation/litigation. The primary outcome is OMEs consumed at 6 weeks postoperatively. Secondary outcomes will include patient-reported pain and satisfaction, quantity of OMEs prescribed, number of opioid refills, and any adverse events up to 6 weeks postoperatively. Utilizing the intention to treat principle for all analyses, independent samples t-test and presented with a p-value as well as a mean difference (MD) with 95% confidence intervals (CIs) will be performed for primary and secondary outcomes. Discussion: The ongoing opioid epidemic and overprescribing of opioids in orthopaedics serve as the rationale for this trial. There is a lack of evidence upon which to develop post-operative pain management guidelines for patients undergoing arthroscopic surgery. A prospective evaluation of this relatively inexpensive intervention will demonstrate whether an explicit effort to reduce the number of opioids prescribed results in a reduction in the amount of opioids consumed and help to inform future studies and guidelines. Trial registration: The NO PAin trial has been prospectively registered with clinicaltrials.gov (NCT04566250). [ABSTRACT FROM AUTHOR]

Background: Opioids continue to be the analgesic of choice for postoperative pain control following arthroscopic knee and shoulder surgery. Despite their widespread use, there are limited evidence-based clinical practice guidelines for postoperative opioid prescribing. The Non-Opioid Prescriptions after Arthroscopic Surgery in Canada (NO PAin) Trial is a randomized controlled trial (RCT) designed to determine whether a non-opioid analgesia approach to postoperative pain, compared to usual care, reduces oral morphine equivalents (OME) consumed in patients undergoing outpatient knee and shoulder arthroscopy.Methods: This is a multi-centre, RCT with a target sample size of 200 patients. Adult (18+ years of age) patients undergoing outpatient knee and shoulder arthroscopy will be randomized to a non-opioid postoperative protocol (intervention) or the current standard of care (control). The intervention will consist of a standardized non-opioid analgesic prescription, a limited rescue opioid prescription, and a patient education infographic. The control is defined as the treating surgeons' pre-trial postoperative analgesic regimen. Exclusion criteria include chronic opioid use, concomitant open surgery, contraindications to the prescribed analgesics or ongoing workers compensation/litigation. The primary outcome is OMEs consumed at 6 weeks postoperatively. Secondary outcomes will include patient-reported pain and satisfaction, quantity of OMEs prescribed, number of opioid refills, and any adverse events up to 6 weeks postoperatively. Utilizing the intention to treat principle for all analyses, independent samples t-test and presented with a p-value as well as a mean difference (MD) with 95% confidence intervals (CIs) will be performed for primary and secondary outcomes.Discussion: The ongoing opioid epidemic and overprescribing of opioids in orthopaedics serve as the rationale for this trial. There is a lack of evidence upon which to develop post-operative pain management guidelines for patients undergoing arthroscopic surgery. A prospective evaluation of this relatively inexpensive intervention will demonstrate whether an explicit effort to reduce the number of opioids prescribed results in a reduction in the amount of opioids consumed and help to inform future studies and guidelines.Trial Registration: The NO PAin trial has been prospectively registered with clinicaltrials.gov ( NCT04566250 ). [ABSTRACT FROM AUTHOR]

Background: Increasing evidence has shown benefits of spinal manipulations in patients with patellofemoral pain syndrome (PFPS). There is scarcity regarding medium term effects of spinal manual therapy on outcome measures in PFPS patients. Therefore, the aim of the present study was to compare the effectiveness of local exercise therapy and spinal manual therapy for knee pain, function and maximum voluntary peak force (MVPF) velocity of the quadriceps in PFPS patients.Methods: Forty-three patients with PFPS were randomly assigned to a local exercise or spinal manual therapy group. The local exercise group received six sessions (one session per week) of supervised training of the knee-and hip muscles with mobilization of the patellofemoral joint. The spinal manual therapy group received six interventions (one intervention per week) of high velocity low thrust manipulations at the thoracolumbar region, sacroiliac joint, and/or hip. All patients were also asked to do home exercises. Maximum, minimum and current pain were measured using the visual analogue scale. Function was assessed with the anterior knee pain scale (AKPS) and MPFV was recorded using a Biodex System 3 dynamometer. Patients were assessed before intervention, after 6 weeks of intervention and after 6 weeks of follow-up. Between-group differences at assessments were analysed by way of analysis of covariance with Bonferroni correction.Results: Pain and functionality improved more following spinal manipulative therapy than local exercise therapy. After 6 weeks of intervention the between-group difference (local versus spinal) for maximal pain was 23.4 mm [95% CI: 9.3, 37.6; effect size (ES): 1.04] and - 12.4 [95% CI: - 20.2, - 4.7; ES: 1.00] for the AKPS. At 6 weeks of follow-up the between-group difference for maximal pain was 18.7 mm [95% CI: 1.4, 36.0; ES: 0.68] and - 11.5 [95% CI: - 19.9, - 3.3; ES: - 0.87] for the AKPS.Conclusions: This study suggests that spinal manual therapy is more effective than local exercise therapy in improving pain and function in patients with PFPS in the medium term. We suggest for future research to investigate whether combining local exercise therapy and spinal manual therapy is more effective than either single intervention on its own. This clinical trial study was approved by the Medical Ethics Committee METC Z under registration number NL57207.096. and registered retrospectively in ClinicalTrials.gov PRS with registration ID number NCT04748692 on the 10th of February 2021. [ABSTRACT FROM AUTHOR]

Abstract Background The efficacy of postoperative pain management is an important factor that influences the final outcome of total knee arthroplasty (TKA). Whether liposomal bupivacaine offers better efficacy compared with traditional peri-articular injection after TKA remains inconclusive. We conduct this study to compare the true efficacy of liposomal bupivacaine (LB) with traditional peri-articular injection (TPAI) following TKA. Materials and methods Randomized controlled trials (RCTs) from PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) and Web of Science were searched. Thirteen RCTs involving 1373 patients were finally included in our meta-analysis (LB = 691, TPAI = 682). The continuous and dichotomous outcome were collected in a standard form, and the data were analysed by using Review Manager 5.3 software. Finally, the results were presented in the forest plots. Result The pooled data demonstrated that the postoperative visual analogue score (VAS) in the LB group was not significantly different compared with that in the TPAI group at every time period after TKA. The liposomal bupivacaine group had significantly lower consumption of morphine equivalents 24 to 72 h postoperatively and reduced incidence of nausea and vomiting after TKA compared with the TPAI group. Finally, the length of hospital stay in the two groups was not significantly different. Conclusion Liposomal bupivacaine did not yield different results on the visual analogue scale compared with traditional peri-articular injection after total knee arthroplasty. However, liposomal bupivacaine was preferred in terms of lower consumption of morphine equivalents 24–72 h postoperatively and lower incidence of nausea and vomiting after total knee arthroplasty.

Abstract Background The etiology of non-specific low back pain (LBP) is complex and not well understood. LBP is common and causes a remarkable health burden worldwide. Leg-length discrepancy (LLD) is potentially a risk factor for development of LBP, although this relationship has been questioned. Yet only one randomized controlled study (RCT) has been performed. The objective of our study was to evaluate the effect of insoles with leg-length discrepancy (LLD) correction compared to insoles without LLD correction among meat cutters in a RCT-design. Methods The study population consisted 387 meat cutters who were over 35 years old and had been working 10 years or more. The LLD measurement was done by a laser ultrasound technique. All workers with an LLD of at least 5 mm and an LBP intensity of at least 2 on a 10-cm Visual Analog Scale were eligible. The LLD of all the participants in the intervention group was corrected 70%, which means that if the LLD was for example 10 mm the correction was 7 mm. The insoles were used at work for eight hours per day. The control group had insoles without LLD correction. The primary outcome was between-group difference in LBP intensity. Secondary outcomes included sciatic pain intensity, disability (Roland Morris), RAND-36, the Oswestry Disability Index, physician visits and days on sick leave over the first year. We used a repeated measures regression analysis with adjustments for age, gender and BMI. The hurdle model was used for days on sick leave. Results In all, 169 workers were invited and 114 (67%) responded. Of them, 42 were eligible and were randomized to the intervention (n = 20) or control group (n = 22). The workers in the intervention group had a higher improvement in LBP intensity (− 2.6; 95% confidence intervals − 3.7 – − 1.4), intensity of sciatic pain (− 2.3; − 3.4 – − 1.07) and RAND-36 physical functioning (9.6; 1.6–17.6) and a lesser likelihood of sick leaves (OR -3.7; − 7.2 - -0.2). Conclusions Correction of LLD with insoles was an effective intervention among workers with LBP and a standing job. Trial registration ISRCTN11898558. Registration date 11. Feb 2011. BioMed Central Ltd.

Abstract Background Low back pain is one of the most prevalent musculoskeletal conditions and the highest contributor to disability in the world. It is characterized by frequent relapses leading to additional care-seeking. Engagement in leisure physical activity is associated with lower recurrences and better prognosis and potentially reduced care-seeking. Our aim was to investigate the feasibility and preliminary efficacy of a patient-centred physical activity intervention, supported by health coaching and mobile health, to reduce care-seeking, pain and disability in patients with chronic low back pain after treatment discharge. Methods We conducted a pilot randomised controlled trial with blinded outcome assessment. Sixty-eight participants were recruited from four public outpatient physiotherapy departments and the general community in Sydney. The intervention group received a physical activity information booklet, plus one face-to-face and 12 telephone-based health coaching sessions. The intervention was supported by an internet-based application and an activity tracker (Fitbit). Control group (standard care) received the physical activity information booklet and advice to stay active. Feasibility measures included recruitment rate, intervention compliance, data completeness, and participant satisfaction. Primary outcomes were care-seeking, pain levels and activity limitation. Outcomes were assessed at baseline, 6-month follow-up and weekly for 6 months. Results Ninety potential participants were invited over 15 months, with 68 agreeing to take part (75%). Overall, 903 weekly questionnaires were answered by participants from a total of 1107 sent (89%). Participants were largely satisfied with the intervention (mean = 8.7 out of 10 on satisfaction scale). Intervention group participants had a 38% reduced rate of care-seeking (Incidence Rate Ratio (IRR): 0.62, 95% CI: 0.32 to 1.18, p = 0.14, using multilevel mixed-effects Poisson regression analysis) compared to standard care, although none of the estimates was statistically significant. No between groups differences were found for pain levels or activity limitation. Conclusion The health coaching physical activity approach trialed here is feasible and well accepted by participants and may reduce care-seeking in patients with low back pain after treatment discharge, although further evaluation with an adequately powered trial is needed. Trial registration Australian and New Zealand Trial Registry ACTRN12615000189527. Registered prospectively on 26–02–2015.

Abstract Background Fusion in addition to decompression has become the standard treatment for lumbar spinal stenosis with degenerative spondylolisthesis (DS). The evidence for performing fusion among these patients is conflicting and there is a need for further investigation through studies of high quality. The present protocol describes an ongoing study with the primary aim of comparing the outcome between decompression alone and decompression with instrumented fusion. The secondary aim is to investigate whether predictors can be used to choose the best treatment for an individual. The trial, named the NORDSTEN-DS trial, is one of three studies in the Norwegian Degenerative Spinal Stenosis (NORDSTEN) study. Methods The NORDSTEN-DS trial is a block-randomized, controlled, multicenter, non-inferiority study with two parallel groups. The surgeons at the 15 participating hospitals decide whether a patient is eligible or not according to the inclusion and exclusion criteria. Participating patients are randomized to either a midline preserving decompression or a decompression followed by an instrumental fusion. Primary endpoint is the percentage of patients with an improvement in Oswestry Disability Index version 2.0 of more than 30% from baseline to 2-year follow-up. Secondary outcome measurements are the Zürich Claudication Questionnaire, Numeric Rating Scale for back and leg pain, Euroqol 5 dimensions questionnaire, Global perceived effect scale, complications and several radiological parameters. Analysis and interpretation of results will also be conducted after 5 and 10 years. Conclusion The NORDSTEN/DS trial has the potential to provide Level 1 evidence of whether decompression alone should be advocated as the preferred method or not. Further on the study will investigate whether predictors exist and if they can be used to make the appropriate choice for surgical treatment for this patient group. Trial registration ClinicalTrials.gov Identifier: NCT02051374. First Posted: January 31, 2014. Last Update Posted: February 14, 2018.

Abstract Background There is a growing interest concerning the understanding of and rehabilitation of the sagittal configuration of the cervical spine as a clinical outcome. However, the literature on the topic specific to conservative treatment outcomes of patients with chronic myofascial cervical pain syndrome (CMCPS) has not adequately addressed the relationship between cervical sagittal alignment and improved pain, disability and range of motion. Methods A randomized controlled study with a 1-year follow-up. Here, 120 (76 males) patients with chronic CMCPS and defined cervical sagittal posture abnormalities were randomly assigned to the control or an intervention group. Both groups received the Integrated neuromuscular inhibition technique (INIT); additionally, the intervention group received the denneroll cervical traction device. Alignment outcomes included two measures of sagittal posture: cervical angle (CV), and shoulder angle (SH). Patient relevant outcome measures included: neck pain intensity (NRS), neck disability (NDI), pressure pain thresholds (PPT), cervical range of motion using the CROM. Measures were assessed at three intervals: baseline, 10 weeks, and 1 year after the 10 week follow up. Results After 10 weeks of treatment, between group statistical analysis, showed equal improvements for both the intervention and control groups in NRS (p = 0.36) and NDI (p = 0.09). However, at 10 weeks, there were significant differences between groups favoring the intervention group for PPT (p

Abstract Background Proximal humerus fractures are the third most common fracture in the elderly population and are expected to increase due to the aging population. Surgical fixation with locking plate technology has increased over the last decade despite a lack of proven superiority in the literature. Three previous randomized controlled trials have not shown a difference in patient-centered outcomes when comparing non-operative treatment with open reduction and internal fixation. Low patient enrollment and other methodological concerns however limit the generalizability of these conclusions and as a result, management of these fractures remains a controversy. By comparing the functional outcomes of locked plate surgical fixation versus non-operative treatment of displaced three and four-part proximal humerus fractures in the elderly population with a large scale, prospective, multi-centered randomized controlled trial, the optimal management strategy for this common injury may be determined. Methods We will conduct a prospective, single blind randomized controlled parallel arm trial to compare non-operative management of proximal humerus fractures with open reduction and internal fixation using locked plating technology. One-hundred and sixty patients > age 60 with acute 3- or 4- part proximal humerus fractures will be randomized to either open reduction and internal fixation with locked plating technology or non-operative management treatment arms. The primary outcome measure is the Constant Score at 24 months post-operative. Secondary outcome measures include the American Shoulder and Elbow Surgeon’s Score (ASES), EuroQol EQ-5D-5 L Health Questionnaire Score, short form PROMIS upper extremity score and IPAQ for the elderly score. Further outcome measures include assessment of the initial classification, displacement and angulation and the quality of surgical reduction via a standard computed tomography (CT) scan; rates of non-union, malunion, arthrosis, osteopenia or other complications including infection, nerve injury, intra-articular screw penetration, reoperation rates and hospital re-admission rates. Discussion The results of this trial will provide Level 1 evidence to guide decision-making in the treatment of proximal humerus fractures in the elderly population. Trial registration ClinicalTrials.gov NCT02362100. Registered 5 Feb 2015.

Abstract Background Knee osteoarthritis (KOA) is one of the most common chronic diseases in the elderly and is the primary cause of the loss of motor function and disability in this population. Exercise therapy is a core, basic and matureand treatment method of treating patients with KOA. Exercise therapy is “strongly recommended” or “recommended” in the diagnosis and treatment guidelines of osteoarthritis in many countries, and most scholars advocate exercise therapy as the preferred rehabilitation method for KOA patients. However, poor long-term adherence is a serious problem affecting the therapeutic effect of this mature treatment. The objective of this study was to construct a concise and practical adherence rating scale (ARS) based on the exercise therapy adherence prediction model in patients with knee osteoarthritis. Methods A binary logistic regression model was established, with the adherence of 218 cases of KOA patients as the dependent variable. The patients’ general information, exercise habits, knowledge, attitude, and exercise therapy were independent variables. The regression coefficients were assigned to various variables in the model, and the ARS was constructed accordingly. Receiver operating characteristic curves and curve fitting were used to analyse the effect of the ARS in predicting the adherence and to determine the goodness of fit for the adherence. The external validity of the ARS was examined in a randomized controlled trial. Results The construction of the adherence model and the ARS included the following variables: age (1 point), education level (1 point), degree of social support (2 points), exercise habits (3 points), knowledge of KOA prevention and treatment (2 points), degree of care needed to treat the disease (1 point), familiarity with exercise therapy (4 points) and treatment confidence (3 points). The critical value of the total score of the ARS was 6.50, with a sensitivity of 87.20% and a specificity of 76.34%. Conclusions A KOA exercise therapy adherence model and a simple and practical ARS were constructed. The ARS has good internal validity and external validity and can be used to evaluate the adherence to exercise therapy in patients with KOA.

Abstract Background In the literature, there are numerous studies that compare different surgical procedures in the treatment of distal radius fractures (DRF). It is, however, unknown whether operative treatment and better restoration of anatomy with volar locking plate yields a better functional outcome in the elderly population when compared with non-operative treatment. Methods and design This study is a prospective, randomized, controlled, multi-center trial. The purpose will be to compare the non-operative and operative treatment of initially or early malaligned distal radius fractures in patients aged 65 and older. The primary outcome in this study will be the patient rated wrist evaluation (PRWE) score measured after 1 and 2 years. Discussion We expect that initial operative treatment of a DRF with volar locking plate will not yield superior results when compared with non-operative treatment with cast immobilization in terms of functional outcome, pain, disability, quality of life, grip strength, and number of complications. Trial registration This trial is registered on clinicaltrials.gov, identifier NCT02879656, registration date 08/17/2016.

Abstract Background Work disability involves large costs to the society as well as to the individual. Work disability is common among people with chronic pain conditions, yet few effective interventions exist. Individual Placement and Support (IPS) is an evidence-based work rehabilitation model originally developed to help people with severe mental illness obtain and maintain employment. The effectiveness of IPS for patients with severe mental illness is well documented, but the model has never before been tested for patients with chronic pain. Methods/design The aim of the IPS in Pain trial is to investigate the effectiveness of IPS as an integrated part of the interdisciplinary treatment for patients with chronic pain in a hospital outpatient clinic. The study is a randomized controlled trial comparing pain treatment with integrated IPS to treatment as usual in unemployed patients suffering from various chronic pain conditions. The primary outcome of the study is labor market participation during 12 months after enrollment, and secondary outcomes include physical and mental health and well-being, collected at baseline, 6, and 12 months. Finally, there will be an additional long-term follow-up for the primary outcome, which will be collected through a brief phone interview at 24 months. Discussion The IPS in Pain trial will be the first report of the effectiveness of the IPS model of supported employment applied in an outpatient setting for chronic pain patients. It will thus provide important information about the effectiveness of repurposing IPS to a new patient group in great need of job support. Trial registration Clinicaltrials.gov: NCT02697656. Registered January 15th, 2016.

Abstract Background Recent studies have reported that radial extracorporeal shock wave therapy (rESWT) reduces pain and improves function in patients with mild to moderately severe carpal tunnel syndrome (CTS) compared to a placebo. However, most of those studies used multi-session rESWT combined with wrist support and evaluation of efficacy was limited to a maximum of 14 weeks. Methods The prospective randomized controlled trial compared efficacy in relieving pain and improving clinical function between single-dose rESWT and local corticosteroid injection (LCsI) over the mid-term (24 weeks). Twenty-five patients with mild to moderately severe CTS were randomized to receive either single-dose rESWT (n = 13) or LCsI (n = 12). Primary outcomes were evaluated using the Boston self-assessment questionnaire (BQ), while secondary outcomes used the Visual analogue scale (VAS) and electrodiagnostic parameters. Evaluations at baseline and at 1, 4, 12 and 24 weeks after treatment were performed. Results There was significantly greater improvement in symptom severity scores, functional scores and Boston questionnaire scores at weeks 12 to 24 in the rESWT group compared to the LCsI group. When compared to the baseline, there was significant reduction of VAS and functional score in the rESWT group at weeks 12 and 24. The LCsI group had no statistically significant differences in VAS reduction and functional score of the same period. Conclusions Treatment of CTS using single-dose rESWT has a carry-over effect lasting up to 24 weeks suggesting that single-dose rESWT is appropriate for treatment of mild to moderate CTS and provides longer-lasting benefits than LCsI. Trial registration ( TCTR20150709001 ). Registered 9 July 2015

Background: Physiotherapy is a proven effective treatment strategy after total knee and hip arthroplasty (TKA/THA), however there is considerable practice variation regarding its timing, content and duration. This study aims to compare the (cost-) effectiveness of a standardized, treat-to-target postoperative physiotherapy strategy with usual postoperative care.Methods: Using a cluster randomized study design, consecutive patients scheduled for a primary TKA/THA in 18 hospitals in the Netherlands will be assigned to the treat-to-target physio therapy strategy or usual postoperative care. With the treat-to-target strategy a standardized, individually tailored, exercise program is aimed at the attainment of specific functional milestones. Assessments are done at baseline, 6 weeks and 3, 6, 9 and 12 months follow up. The primary outcome will be the Knee injury / Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS / HOOS-PS) at 3 months follow up. Secondary outcomes are the numeric rating scale for pain, the Oxford Knee and Hip Scores, performance-based test and the EuroQol 5D-5L for quality of life. Healthcare use, productivity and satisfaction with postoperative care are measured by means of questionnaires. In total, 624 patients will be needed of which 312 TKA and 312 THA patients.Discussion: The study will provide evidence concerning the (cost-) effectiveness of the treat-to-target postoperative physiotherapy treatment compared to usual postoperative care. The results of this study will address an important evidence gap and will have a significant impact in daily practice of the physio therapist.Trial Registration: Registered in the Dutch Trial Registry on April 15, 2018. Registration number: NTR7129 . [ABSTRACT FROM AUTHOR]

Background: Little research exists on the effectiveness of motivational interviewing (MI) on return to work (RTW) in workers on long term sick leave. The objectives of this study protocol is to describe a randomized controlled trial (RCT) with the objectives to compare the effectiveness and cost-effectiveness of usual case management alone with usual case management plus MI or usual case management plus stratified vocational advice intervention (SVAI), on RTW among people on sick leave due to musculoskeletal (MSK) disorders.Methods: A multi-arm RCT with economic evaluation will be conducted in Norway with recruitment of 450 participants aged 18-67 years on 50-100% sick leave for > 7 weeks due to MSK disorders. Participants will be randomized to either usual case management by the Norwegian Labour and Welfare Administration (NAV) alone, usual case management by NAV plus MI, or usual case management by NAV plus SVAI. Trained caseworkers in NAV will give two MI sessions, and physiotherapists will give 1-4 SVAI sessions depending upon risk of long-term sick leave. The primary outcome is the number of sick leave days from randomization to 6 months follow-up. Secondary outcomes are number of sick leave days at 12 months follow-up, time until sustainable RTW (≥4 weeks of at least 50% of their usual working hours) at 12 months, proportions of participants receiving sick leave benefits during 12 months of follow-up, and MSK symptoms influencing health at 12 months. Cost-utility evaluated by the EuroQoL 5D-5L and cost-benefit analyses will be performed. Fidelity of the interventions will be assessed through audio-recordings of approximately 10% of the intervention sessions.Discussion: The results from this RCT will inform stakeholders involved in supporting RTW due to MSK disorders such as staff within NAV and primary health care.Trial Registration: ClinicalTrials.gov ID: NCT03871712 registered March 12th 2020. [ABSTRACT FROM AUTHOR]

Background: Non-specific neck pain and headache are major economic and individual burden in office-workers. The aim of this study is to investigate the effect of a multi-component intervention combining workstation ergonomics, health promotion information group workshops, neck exercises, and an app to enhance intervention adherence to assess possible reductions in the economic and individual burden of prevalent and incident neck pain and headache in office workers.Methods/design: This study is a stepped wedge cluster-randomized controlled trial. Eligible participants will be any office-worker aged 18-65 years from two Swiss organisations in the Cantons of Zurich and Aargau, working more than 25 h a week in predominantly sedentary office work and without serious health conditions of the neck. One hundred twenty voluntary participants will be assigned to 15 clusters which, at randomly selected time steps, switch from the control to the intervention group. The intervention will last 12 weeks and comprises workstation ergonomics, health promotion information group workshops, neck exercises and an adherence app. The primary outcome will be health-related productivity losses (presenteeism, absenteeism) using the Work Productivity and Activity Impairment Questionnaire. Secondary outcomes are neck disability and pain (measured by the Neck Disability Index, and muscle strength and endurance measures), headache (measured by the short-form headache impact test), psychosocial outcomes (e.g. job-stress index, Fear-Avoidance Beliefs Questionnaire), workplace outcomes (e.g. workstation ergonomics), adherence to intervention, and additional measures (e.g. care-seeking). Measurements will take place at baseline, 4 months, 8 months, and 12 months after commencement. Data will be analysed on an intention to treat basis and per protocol. Primary and secondary outcomes will be examined using linear mixed-effects models.Discussion: To the authors' knowledge, this study is the first that investigates the impact of a multi-component intervention combining current evidence of effective interventions with an adherence app to assess the potential benefits on productivity, prevalent and incident neck pain, and headache. The outcomes will impact the individual, their workplace, as well as private and public policy by offering evidence for treatment and prevention of neck pain and headache in office-workers.Trial Registration: ClinicalTrials.gov, NCT04169646. Registered 15 November 2019 - Retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Endoscopic carpal tunnel release (ECTR) and open carpal tunnel release (OCTR) both have advantages and disadvantages for the treatment of carpal tunnel syndrome (CTS). We compared the effectiveness and safety of ECTR and OCTR based on evidence from a high-level randomized controlled trial.Methods: We comprehensively searched PubMed, EMBASE, Cochrane Library, Web of Science, and Medline to identify relevant articles published until August 2019. Data regarding operative time, grip strength, Boston Carpal Tunnel Questionnaire scores, digital sensation, patient satisfaction, key pinch strength, return to work time, and complications were extracted and compared. All mean differences (MD) and odds ratios (OR) were expressed as ECTR relative to OCTR.Results: Our meta-analysis contained twenty-eight studies. ECTR was associated with significantly higher satisfaction rates (MD, 3.13; 95% confidence interval [CI], 1.43 to 4.82; P = 0.0003), greater key pinch strengths (MD, 0.79 kg; 95% CI, 0.27 to 1.32; P = 0.003), earlier return to work times (MD, - 7.25 days; 95% CI, - 14.31 to - 0.19; P = 0.04), higher transient nerve injury rates (OR, 4.87; 95% CI, 1.37 to 17.25; P = 0.01), and a lower incidence of scar-related complications (OR, 0.20; 95% CI, 0.07 to 0.59; P = 0.004). The permanent nerve injury showed no significant differences between the two methods (OR, 1.93; 95% CI, 0.58 to 6.40; P = 0.28).Conclusions: Overall, evidence from randomized controlled trials indicates that ECTR results in better recovery of daily life functions compared to OCTR, as revealed by higher satisfaction rates, greater key pinch strengths, earlier return to work times, and fewer scar-related complications. Our findings suggest that patients with CTS can be effectively managed with ECTR. [ABSTRACT FROM AUTHOR]

Background: The knee is symptomatically the most frequent affected joint in osteoarthritis and, in the Netherlands and other Western countries, is mainly managed by general practitioners (GPs). An intra-articular glucocorticoid injection is recommended in (inter) national guidelines for patients with knee osteoarthritis as an option for a flare of knee pain and/or for those who are not responding well to pain medication. An innovative approach that could replace the intra-articular injection is an intramuscular gluteal glucocorticoid injection. An intramuscular injection is easier to perform than an intra-articular injection with lesser risk of severe local adverse reactions. We hypothesize that intramuscular gluteal glucocorticoid injection is non-inferior in reducing knee pain compared to intra-articular glucocorticoid injection, with potentially a longer lasting effect than intra-articular injection.Methods/design: The study will be a pragmatic randomized controlled non-inferiority trial with two parallel groups. A total of 140 patients aged 45 years and older with knee osteoarthritis who contacted their general practitioner and have persistent knee pain (score ≥ 3 on 0-10 numerical rating scale; 0 = no knee pain) will be included. Patients will be randomly allocated (1:1) to an injection of 40 mg triamcinolone acetonide intra-articular in the knee joint or intramuscular in the ipsilateral ventrogluteal area. The effect of treatment will be evaluated by questionnaires at 2, 4, 8, 12, and 24 weeks after injection. The primary outcome is patients' reported severity of knee pain measured with the pain subscale of the Knee injury and Osteoarthritis Outcome Score 4 weeks after injection. Statistical analysis will be based on both the per-protocol and the intention-to-treat principle.Discussion: This study will evaluate non-inferiority of intramuscular glucocorticoid injection compared to intra-articular glucocorticoid injection for knee osteoarthritis symptoms.Trial Registration: This trial is registered in the Dutch Trial Registry (number NTR6968) at 2018-01-22 (https://www.trialregister.nl/trial/6784). Issue date: 1 October 2019.Trial Sponsor: Erasmus MC University Medical Center Rotterdam. PO-box 2040. 3000 CA Rotterdam. The Netherlands. [ABSTRACT FROM AUTHOR]

Abstract Background The promotion of physical activity is a major field in rehabilitation and health promotion but evidence is lacking on what method or strategy works best. Ensuing from this research gap, the present study compared the effectiveness of a comprehensive theory based multicomponent intervention (Movement Coaching) to a low intensity intervention in low back pain patients. Methods A monocenter randomized controlled trial with three measuring points (T0 = baseline, T1 = six month follow-up, T2 = twelve month follow-up) was conducted. N = 412 chronic low back pain patients participated. The Movement Coaching group (n = 201) received a comprehensive multicomponent intervention with small-group intervention, phone- and web 2.0-intervention. The low intensity control (n = 211) received two oral presentations that were available for download afterwards. Main outcome was total physical activity measured by Global Physical Activity Questionnaire at 12 month follow-up. Additionally, workplace, leisure time and transportation activities were compared. A split-plot anova was conducted for evaluating repeated measure effects and between group effects. Results At six and twelve month follow-up there were no statistically significant between group differences in total (T1: p = 0.79; T2: p = 0.30) as well as domain-specific physical activity (workplace (T1: p = 0.16; T2: p = 0.65), leisure time (T1: p = 0.54; T2: p = 0.89), transportation (T1: p = 0.29; T2: p = 0.77) between Movement Coaching and the control group. In both groups, workplace physical activity showed the highest proportion of total physical activity. From baseline to twelve month follow-up the results showed a decline in total physical activity (Movement Coaching: p = 0.04; control group: p = 0.50). Conclusions The comprehensive Movement Coaching intervention was not found to be more effective than a low intensity intervention in promoting total and domain-specific physical activity in chronic low back pain patients. Trial registration This study is registered at German Clinical Trials Register (DRKS)-ID: DRKS00004878 .

Abstract Background To determine effects of allogeneic human chondrocytes expressing TGF-β1 (TG-C) on structural progression of MRI features of knee osteoarthritis over a 1 year period. Methods This phase II randomized controlled trial of TG-C included patients with moderate to advanced osteoarthritis. Patients were randomized to receive an intraarticular 3:1 mixture of non-transduced allogeneic human chondrocytes and TG-C or placebo. 3 T MRI was acquired for all patients at baseline and follow-up (3, 6 and 12 months). MRIs were assessed using the WORMS system including cartilage damage, bone marrow lesions (BMLs), meniscal damage/extrusion, Hoffa-, effusion-synovitis, and osteophytes. Analyses were performed on a whole knee level, compartmental level, and subregional level. Binary logistic regression with Generalized Estimating Equation was used to compare risks of progression, adjusting for baseline age and gender. Mann − Whitney − Wilcoxon tests were used to assess differences for continuous variables. Results Fifty-seven Patients were included in the TG-C group and 29 in the placebo group. At 12 months, knees in the TG-C group showed less progression of cartilage damage compared to placebo on a whole knee level (34.6% vs. 47.9%; adjusted RR 0.7, 95%CI [0.5–1.1], p = 0.077). Less progression of Hoffa-synovitis and effusion-synovitis was observed in the TG-C group compared to placebo (9.6% vs. 21.1%, adjusted RR 0.5, 95%CI [0.2,1.2], p = 0.115). No statistically significant differences were seen for BMLs, meniscal damage and osteophytes. Conclusions Intraarticular treatment with TG-C showed fewer patients in the treated group with progression in structural OA features and other MRI-defined inflammatory markers such as Hoffa-synovitis and effusion-synovitis. However, no differences were observed in regard to progression of BMLs and meniscal damage, or hypertrophic osteophyte formation. Trial registration NCT01221441 .Registered 13th October, 2010

Abstract Background Inflammatory arthritis leads to work disability, absenteeism and presenteeism (i.e. at-work productivity loss) at high cost to individuals, employers and society. A trial of job retention vocational rehabilitation (VR) in the United States identified this helped people keep working. The effectiveness of this VR in countries with different socioeconomic policies and conditions, and its impact on absenteeism, presenteeism and health, are unknown. This feasibility study tested the acceptability of this VR, modified for the United Kingdom, compared to written advice about managing work problems. To help plan a randomized controlled trial, we tested screening, recruitment, intervention delivery, response rates, applicability of the control intervention and identified the relevant primary outcome. Methods A feasibility randomized controlled trial with rheumatoid, psoriatic or inflammatory arthritis patients randomized to receive either job retention VR or written information only (the WORK-IA trial). Following three days VR training, rheumatology occupational therapists provided individualised VR on a one to one basis. VR included work assessment, activity diaries and action planning, and (as applicable) arthritis self-management in the workplace, ergonomics, fatigue and stress management, orthoses, employment rights and support services, assistive technology, work modifications, psychological and disclosure support, workplace visits and employer liaison. Results Fifty five (10%) people were recruited from 539 screened. Follow-up response rates were acceptable at 80%. VR was delivered with fidelity. VR was more acceptable than written advice only (7.8 versus 6.7). VR took on average 4 h at a cost of £135 per person. Outcome assessment indicated VR was better than written advice in reducing presenteeism (Work Limitations Questionnaire (WLQ) change score mean: VR = −12.4 (SD 13.2); control = −2.5 (SD 15.9), absenteeism, perceived risk of job loss and improving pain and health status, indicating proof of concept. The preferred primary outcome measure was the WLQ, a presenteeism measure. Conclusions This brief job retention VR is a credible and acceptable intervention for people with inflammatory arthritis with concerns about continuing to work due to arthritis. Trial registration ISRCTN 76777720 . Registered 21.9.12.

Abstract Background Transforaminal epidural injections with steroids (TESI) are used increasingly for patients with sciatica. However there is much debate about their safety and effectiveness. It is important to identify patients that benefit most from TESI and only few trials have yet evaluated the effects in patients with acute sciatica. Methods We describe a prospective, randomized controlled trial (RCT), with the aim to evaluate the hypothesis that TESI plus Levobupivacaine (TESI-plus) added to oral pain medication is more effective compared to pain medication alone or compared to transforaminal injection with a local anesthetic of short duration among patients with acute sciatica. We will recruit a total of 264 patients with sciatica (

Abstract Background Among the working population, non-specific low-back pain and neck pain are one of the most common reasons for sickness absenteeism. The aim was to evaluate the effects of an early intervention of yoga - compared with strength training or evidence-based advice - on sickness absenteeism, sickness presenteeism, back and neck pain and disability among a working population. Methods A randomized controlled trial was conducted on 159 participants with predominantly (90%) chronic back and neck pain. After screening, the participants were randomized to kundalini yoga, strength training or evidence-based advice. Primary outcome was sickness absenteeism. Secondary outcomes were sickness presenteeism, back and neck pain and disability. Self-reported questionnaires and SMS text messages were completed at baseline, 6 weeks, 6 and 12 months. Results The results did not indicate that kundalini yoga and strength training had any statistically significant effects on the primary outcome compared with evidence-based advice. An interaction effect was found between adherence to recommendations and sickness absenteeism, indicating larger significant effects among the adherers to kundalini yoga versus evidence-based advice: RR = 0.47 (CI 0.30; 0.74, p = 0.001), strength training versus evidence-based advice: RR = 0.60 (CI 0.38; 0.96, p = 0.032). Some significant differences were also found for the secondary outcomes to the advantage of kundalini yoga and strength training. Conclusions Guided exercise in the forms of kundalini yoga or strength training does not reduce sickness absenteeism more than evidence-based advice alone. However, secondary analyses reveal that among those who pursue kundalini yoga or strength training at least two times a week, a significantly reduction in sickness absenteeism was found. Methods to increase adherence to treatment recommendations should be further developed and applied in exercise interventions. Trial Registration Clinicaltrials.gov NCT01653782, date of registration: June, 28, 2012, retrospectively registered.

Background: The efficacy of postoperative pain management is an important factor that influences the final outcome of total knee arthroplasty (TKA). Whether liposomal bupivacaine offers better efficacy compared with traditional peri-articular injection after TKA remains inconclusive. We conduct this study to compare the true efficacy of liposomal bupivacaine (LB) with traditional peri-articular injection (TPAI) following TKA.Materials and Methods: Randomized controlled trials (RCTs) from PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) and Web of Science were searched. Thirteen RCTs involving 1373 patients were finally included in our meta-analysis (LB = 691, TPAI = 682). The continuous and dichotomous outcome were collected in a standard form, and the data were analysed by using Review Manager 5.3 software. Finally, the results were presented in the forest plots.Result: The pooled data demonstrated that the postoperative visual analogue score (VAS) in the LB group was not significantly different compared with that in the TPAI group at every time period after TKA. The liposomal bupivacaine group had significantly lower consumption of morphine equivalents 24 to 72 h postoperatively and reduced incidence of nausea and vomiting after TKA compared with the TPAI group. Finally, the length of hospital stay in the two groups was not significantly different.Conclusion: Liposomal bupivacaine did not yield different results on the visual analogue scale compared with traditional peri-articular injection after total knee arthroplasty. However, liposomal bupivacaine was preferred in terms of lower consumption of morphine equivalents 24-72 h postoperatively and lower incidence of nausea and vomiting after total knee arthroplasty. [ABSTRACT FROM AUTHOR]