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Background: Obsessive-compulsive disorder (OCD) is a prevalent and burdensome mental health condition, often resistant to conventional treatments. Agomelatine (Valdoxan), a compound acting on serotonin and melatonin systems, has shown promise in treating those with treatment-resistant OCD based on anecdotal reports and case studies. Methods: A randomized, double-blind controlled trial was conducted with 60 patients diagnosed with treatment-resistant OCD. Participants were randomized into an intervention group (receiving agomelatine 50 mg/day) and a control group (receiving placebo). OCD symptoms were assessed using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) over a 12-week period. Results: There were no significant differences in age, gender, or baseline Y-BOCS scores between intervention and control groups. Agomelatine did not demonstrate a significant improvement in OCD symptoms compared to placebo. Adverse events were comparable between groups, and liver enzyme levels remained within the normal range. Conclusion: This study, while not confirming superior efficacy compared to placebo, underscores the need for continued investigation into agomelatine's potential for treating specific subgroups of OCD patients, underscoring the need for more comprehensive and well-controlled trials in the future. [ABSTRACT FROM AUTHOR]

Purpose: Depressive symptoms are prevalent among Chinese adolescents. However, there is a lack of effective prevention programs to reduce depressive symptoms. Methods: A pilot cluster randomized controlled trial was implemented in a sample of senior secondary school adolescents. Participants in the intervention group (N = 148) received a 6-week universal prevention course, whereas the control group (N = 131) received a routine course focusing on career development. Results: The linear mixed models showed that the group × time interaction was significant for depressive symptoms measured by DASS-21 (F (2, 550) = 5.72, p =.003) and marginally significant for that measured by SMFQ (F (2, 549) = 2.41, p =.09). Likewise, the level of anxiety and stress were significantly reduced after the program, but not maintained in the follow-up. Conclusions: This pilot study showed that a universal prevention program is promising in reducing adolescent depressive symptoms. [ABSTRACT FROM AUTHOR]

Chinese immigrant survivors of men's violence experience both significant mental health impacts from abuse and barriers to formal services. Therefore, we examined the preliminary efficacy of an innovative mobile-based empowerment-based intervention (self-compassion, health, and empowerment; SHE) that specifically focuses on abused Chinese immigrant women in the US. This pilot study used a two-arm randomized controlled design with repeated measures. A convenience sample (N = 50) of Chinese immigrant women who experienced past year intimate partner violence (IPV) were recruited online and randomly assigned to the intervention or control group (25 per group). We assessed IPV exposure, safety behaviors, depressive symptoms, anxiety symptoms, post-traumatic stress disorder (PTSD) symptoms, and self-compassion at baseline, post-intervention, and 8-week follow-up. Of 95 eligible participants, 50 (52.6%) agreed to participate and completed baseline data collection; intervention completion rate was 64%. We found a significant group and time interaction for self-judgment (a self-compassion component), with a significant reduction seen in the intervention group compared to the control group. Despite no other significant group differences observed over time, the intervention group showed consistent trends toward improvements in most outcome measures, including specific types of IPV (i.e., negotiation, psychological aggression, and sexual coercion), depressive and PTSD symptoms, self-compassion, and certain components of self-compassion (i.e., isolation and over-identification) when compared to the control group. Our findings suggest that the SHE intervention shows promise in improving the mental health well-being of Chinese immigrant survivors. However, a fully powered randomized controlled trial is warranted to determine its efficacy. Our intervention has the potential to be translated in the Chinese immigrant populations with the necessary organizational support. [ABSTRACT FROM AUTHOR]

Background: Cannabidiol (CBD) has been shown recently to positively affect patient pain and satisfaction immediately after arthroscopic rotator cuff repair (ARCR). However, it is unclear whether the addition of CBD to a perioperative regimen could affect postoperative outcomes. Purpose: To evaluate patient-reported outcomes among patients who underwent ARCR and received buccally absorbed CBD or an identical placebo for early postoperative pain management at 1-year follow-up. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: Eligible patients had previously participated in a multicenter, placebo-controlled, randomized, double-blinded trial that evaluated the analgesic effects of CBD in the immediate postoperative period after ARCR. The experimental group received 25 mg of CBD 3 times/day if <80 kg and 50 mg of CBD 3 times/day if >80 kg for 14 days, with the control group receiving an identical placebo. The following outcomes were assessed at minimum 1-year follow-up: visual analog scale (VAS) for pain, American Shoulder and Elbow Surgeons (ASES) score, Single Assessment Numeric Evaluation (SANE), and patient satisfaction. The rates of achievement of the Patient Acceptable Symptom State (PASS) were compared based on ASES at latest follow-up. Continuous and categorical variables were compared with the Mann-Whitney U test and Fisher exact test, respectively. Results: Follow-up was obtained from 83 of 99 patients (83.8%) who completed the original trial. There were no significant differences between the CBD and control groups with respect to age, sex, body mass index, rate of concomitant procedures, or number of anchors used intraoperatively. At 1-year follow-up, there were no significant differences between the CBD and control groups in VAS pain (0.8 vs 1.2, P =.38), ASES (93.0 vs 91.1, P =.71), SANE (87.6 vs 90.1, P =.24), or satisfaction (97.4 vs 95.4, P =.41). A majority of patients achieved the PASS (81.0% [CBD] vs 77.5% [control]; P =.79). Conclusion: Perioperative use of CBD for pain control among patients undergoing ARCR did not result in any significant deficits in pain, satisfaction, or patient-reported outcomes at 1-year postoperatively compared with a placebo control group. These findings suggest that CBD can be considered in a postoperative multimodal pain management regimen without detrimental effects on outcome. Registration: NCT04672252 (ClinicalTrials.gov identifier). [ABSTRACT FROM AUTHOR]

Background: Many Gulf War (GW) Veterans report chronic symptoms including pain, fatigue, and cognitive impairment, commonly defined as Gulf War Illness (GWI). Complementary and integrative health (CIH) therapies may potentially improve multiple symptoms of GWI. Objective: To examine the effectiveness of combining 2 commonly available CIH therapies, mindfulness meditation and auricular acupuncture, in improving health-related functioning and multiple symptom domains of GWI (e.g., pain, fatigue). Methods: This study was a randomized controlled trial in which Veterans with GWI were randomly assigned to either the intervention group (n = 75), wherein they received 2 distinct CIH therapies – mindfulness meditation and auricular acupuncture, or the active control group, wherein they received a GW Health Education (GWHE) program (n = 74), each lasting 8 weeks. Self-report health measures were assessed at baseline, endpoint, and 3 month follow-up. Results: In the intention-to-treat analyses, there were significant between-group differences for mental-health related functioning, fatigue, depression symptoms, and Kansas total severity scores for symptoms in which the CIH group had improved scores for these outcomes at endpoint compared to the GWHE group (all P ≤.05). The CIH group also had significant reductions in pain interference at endpoint and follow-up compared to baseline (estimated marginal mean difference: −2.52 and −2.22, respectively; all P =.01), whereas no significant changes were observed in the GWHE group. For pain characteristics, the GWHE group had a worsening of pain at endpoint compared to baseline (estimated marginal mean difference: +2.83; P =.01), while no change was observed in the CIH group. Conclusion: Findings suggest a possible beneficial effect of combining 2 CIH therapies, mindfulness meditation and auricular acupuncture, in reducing overall symptom severity and individual symptom domains of fatigue, musculoskeletal, and mood/cognition in Veterans with GWI. Trial Registration: Clinical Trials identifier NCT02180243 [ABSTRACT FROM AUTHOR]

Objective: To test the feasibility of a telephone delivered intervention, informed by cognitive behavioural principles, for post-stroke fatigue, and estimated its effect on fatigue and other outcomes. Design: Randomised controlled parallel group trial. Setting: Three Scottish stroke services. Subjects: Stroke survivors with fatigue three months to two years post-stroke onset. Interventions: Seven telephone calls (fortnightly then a 'booster session' at 16 weeks) of a manualised intervention, plus information about fatigue, versus information only. Main measures: Feasibility of trial methods, and collected outcome measures (fatigue, mood, anxiety, social participation, quality of life, return to work) just before randomisation, at the end of treatment (four months after randomisation) and at six months after randomisation. Results: Between October 2018 and January 2020, we invited 886 stroke survivors to participate in postal screening: 188/886 (21%) returned questionnaires and consented, of whom 76/188 (40%) were eligible and returned baseline forms; 64/76 (84%) returned six month follow-up questionnaires. Of the 39 allocated the intervention, 23 (59%) attended at least four sessions. At six months, there were no significant differences between the groups (adjusted mean differences in Fatigue Assessment Scale −0.619 (95% CI −4.9631, 3.694; p = 0.768), the Generalised Anxiety Disorder 7 −0.178 (95% CI −3.823, 3.467, p = 0.92), and the Patient Health Questionnaire −0.247 (95% CI −2.935, 2.442, p = 0.851). There were no between-group differences in quality of life, social participation or return to work. Conclusion: Patients can be recruited to a trial of this design. These data will inform the design of further trials in post-stroke fatigue. [ABSTRACT FROM AUTHOR]

The current study aimed to explore the impact of a school-based mindfulness intervention on bullying behaviors among teenagers. A cluster randomized controlled trial was conducted, in which the experimental group (n = 92) received mindfulness intervention, and the control group (n = 97) did not. The measured outcomes included: bullying behavior, self-control, and trait mindfulness. The results were as follows: (1) the post-test scores of trait mindfulness and self-control in the experimental group significantly increased (p < 0.01) while the scores of bullying behavior significantly decreased (p < 0.01); (2) trait mindfulness was positively associated with self-control (r = 0.13 to 0.63, p < 0.05), whereas trait mindfulness and self-control were both negatively associated with bullying behavior (r = −0.38 to −0.13, p < 0.05); and (3) the mediating effect of self-control accounted for 50% of the overall effect of trait mindfulness on bullying behavior. These findings demonstrated that the school-based mindfulness intervention distinctly improves trait mindfulness and self-control and reduces bullying behavior among teenagers. Moreover, self-control plays a mediating role between trait mindfulness and bullying behavior. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study is to evaluate the efficacy and safety of electroacupuncture (EA) treatment for post-stroke depression (PSD). Methods: This study was a single-center, single-blinded, parallel-arm randomized controlled trial. In total, 65 patients with PSD were randomly allocated into EA and sham EA groups. Treatment was administered at GV20, Sishencong, SP6, LR3 and BL18 in both groups. The EA group received EA treatment, while the sham EA group received sham EA treatment using the Park device. Treatment was given three times a week for 4 weeks. The primary outcome was the Hamilton Rating Scale for Depression (HRSD). Secondary outcomes included the Zung Self-Rating Depression Scale (SDS), National Institutes of Health Stroke Scale (NIHSS), Barthel Daily Living Index (BI) and depression scale of traditional Chinese medicine (TCM). Primary and secondary outcomes were assessed at baseline, week 2 after treatment, week 4 after treatment and week 8 of follow-up. Safety assessment was conducted at each visit for 4 weeks of treatment. Results: Significant differences in HRSD, SDS, NIHSS, BI and TCM scale scores were found in the EA group before and after acupuncture treatment (all p < 0.001). Compared with the sham EA group, HRSD scores improved significantly in the EA group at the end of week 2 (F = 31.33, p < 0.001), week 4 (F = 35.58, p < 0.001) and week 8 after treatment onset (F = 25.03, p < 0.001). Similarly, significant improvements were observed in SDS, NIHSS and BI scores. Two participants in the EA group suffered a local hematoma, while no adverse events were reported in the sham EA group. Conclusion: EA appears to be an efficacious and safe treatment for PSD. According to our results, EA may alleviate depressive symptoms, and improve neurological function and capabilities with respect to activities of daily living (ADLs). Trial registration number: ChiCTR-IOR-17012610 (Chinese Clinical Trial Registry). [ABSTRACT FROM AUTHOR]

Objective: To study the long-term effectiveness of case-management rehabilitation intervention on vocational reintegration of patients after myocardial infarction (MI). Design: Blinded simple randomization was used to construct an intervention and control groups that were followed up for two years. Subjects and setting: 151 patients, aged 50.3 ± 5.9 years, who experienced uncomplicated MI and were enrolled in a cardiac rehabilitation program were recruited. Interventions: included an early referral to an occupational physician, tailoring an occupational rehabilitation program, based on individual patient needs, coordination with relevant parties, psychosocial intervention, intensive follow-up sessions during a two-year follow-up. Main measures: Return to work within six months of hospitalization and maintenance of employment at one and two years of follow-up. Results: Return-to-work (RTW) rate in the intervention group was 89% and nearly all maintained employment at one year of follow-up (92%) and two years of follow-up (87%). Moreover, almost all of them returned to and maintained their previous jobs. The corresponding figures were: 98%, 94% and 98%, respectively. The figures for the RTW and employment maintenance for the control group were: 74%, 75%, and 72%, respectively. Only about 75%, in this group kept their previous job. The case-management intervention was associated with increased odds of maintaining employment at follow-up of one year (OR = 5.89, 95% CI 1.42–24.30) and two years (OR = 3.12, 95% CI 1.01–10.03). Conclusions: The extended case-management rehabilitation intervention had a substantial positive impact on both the RTW of MI patients and their maintenance of employment at one and two years of follow-up. Trial Registration: This trial is registered at US National Institutes of Health #NCT04934735. [ABSTRACT FROM AUTHOR]

Objective: To determine the clinical effectiveness of adding virtual reality via the Nintendo Wii console and its Wii Balance Board to physiotherapy treatment in patients with total hip arthroplasty. Design: Randomized controlled trial. Setting: Clinical Hospital San Borja Arriaran, Santiago, Chile. Participants: A total of 73 patients over 50 years of age with total hip arthroplasty were randomly allocated to two groups. Interventions: The control group (n = 37) received 6 weeks of physiotherapy treatment; the intervention group (n = 36) received the same treatment plus virtual reality exercises with the Nintendo Wii console. Outcome measures: The two groups were assessed at baseline and after the 6 weeks of treatment. The primary outcome assessed was the function with the WOMAC questionnaire. The secondary outcomes were the Berg Balance Scale, distance covered with the six-minute walk test, and difference in weight load on the lower extremities. Results: A total of 73 patients, 37 patients in the control group (20 women; mean age of 70.9 ± 9.16 years) and 36 patients in the intervention group (18 women; mean age of 70.39 ± 9.02 years) were analyzed. At the end of the treatment, the difference between groups for the total WOMAC score was −10.4 points (p = 0.00), 4.7 points (p = 0.00) for the Berg Balance Scale, and 45.2 mt (p = 0.00) for the six-minute walk test All differences were in favor of the intervention group. Conclusions: In the short term, the addition of virtual reality via the Nintendo Wii and its Wii Balance Board platform showed statistically significant differences in the function of patients with total hip replacement, but these differences were not minimally clinically important. Trial registration : This research was registered in the Clinical Trials Registry of Australia and New Zealand, with reference ACTRN12618001252202. [ABSTRACT FROM AUTHOR]

Objective: To compare the effectiveness of two different exercise-based programs through telerehabilitation in patients with coronavirus disease 2019. Design: Randomized, controlled, parallel, double-blinded, three-arm clinical trial. Setting: Patients' homes through telerehabilitation devices. Subjects: Subjects with coronavirus disease 2019 in the acute phase. Interventions: Subjects were divided into three groups: breathing exercises group, strength exercises group or no treatment/control group. Main measures: We analysed visual analogue scale for fatigue, 6-minute walking test, 30-seconds sit-to-stand test, multidimensional dyspnoea-12 questionnaire and Borg scale at baseline and 14 days later. Results: From 93 subjects recruited, 88 were enrolled, and 77 patients (mean [SD] age 39.40 [11.71]) completed the 14-days intervention and were included in the analysis: 26 in strength exercises group, 29 in breathing exercises group and 22 in control group. The intergroup analysis shows significant differences between the study groups and control group in all variables (p < 0.05); Borg scale, multidimensional dyspnoea-12 questionnaire (pre–post intervention score: strength exercises group: 7.85 [6.82] – 4.54[4.82], breathing exercises group: 11.04 [6.49] – 5.32 [3.63], control group: 10.27 [6.49] – 10.59[6.58]), visual analogue scale for fatigue, 6-minute walking test and 30-seconds sit-to-stand test (pre–post intervention score: strength exercises group: 12.19 [4.42] – 13.58 [5.37], breathing exercises group: 11.18 [3.42] – 12.79 [4.00], control group: 10.45 [2.15] – 9.86[1.88]). The greatest effect sizes were found in the variables Borg Scale (R 2 = 0.548) and multidimensional dyspnoea-12 questionnaire (R 2 = 0.475). Conclusions: Strength exercises group and breathing exercises group obtained significant improvements in fatigue, dyspnoea, perceived effort, and physical state, compared to control group, although the greatest benefits were found for dyspnoea and aerobic capacity in breathing exercises group. [ABSTRACT FROM AUTHOR]

Background: Chronic Achilles and patellar tendinopathy are a significant burden in physically active populations. High-volume image-guided injection (HVIGI) proposes to strip away associated neovascularity, disrupt painful nerve ingrowth, and facilitate rehabilitation. Purpose: To investigate the efficacy of HVIGI with and without steroid relative to placebo. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 62 participants were recruited between May 25, 2016, and March 5, 2020. Participants were men aged 18 to 55 years with Achilles or patellar tendinopathy of at least 6-month chronicity that had not improved with nonoperative management (including physical therapy and shockwave therapy), with ultrasound evidence of neovascularization, tendon thickening, and echogenic changes. They were assigned to the following groups: control (3 mL of subcutaneous 0.5% bupivacaine), HVIGI (10 mL of 0.5% bupivacaine and 30 mL of normal saline, ultrasound-guided between tendon and underlying fat pad), or HVIGI with steroid (HVIGIwSteroid; 0.25 mL of 100 mg/mL hydrocortisone). Clinicians and assessors were blinded. All participants were supervised through a pain-guided progressive loading program for 6 months postinjection. The main outcome measures were the Victoria Institute of Sport Assessments (VISA) for Achilles and patellar tendinopathy and the visual analog scale (VAS) for pain at 6 months postinjection. Results: The VISA score improved by a mean of 22.8 points (95% CI, 10.4-35.3 points; effect size [ES], 1.51) in the control group (n = 21), 18.6 points (95% CI, 9.1-28.0 points; ES, 1.31) in the HVIGI group (n = 21), and 18.5 points (95% CI, 3.4-33.6 points; ES, 0.88) in the HVIGIwSteroid group (n = 20). VAS pain improved by a mean of 15 points (interquartile range [IQR], -38.75, 8 points; ES, 0.39) in controls, 13 points (IQR,-34.0, 3.75 points; ES, 0.47) in the HVIGI group, and 27 points (IQR,-38.0, -1.0 points; ES, 0.54) in the HVIGIwSteroid group. The main effects were significant for time (P < .001) but not group (P ≥ .48), with no group x time interaction (P = .71). One participant was lost to follow-up from each group, multiple imputation was used for missing data points. No adverse events occurred. Conclusion: Study findings did not demonstrate superiority of HVIGI over control injection. [ABSTRACT FROM AUTHOR]

Background: Although previous studies have reported good short-term results for superficial medial collateral ligament (sMCL) reconstruction, whether an augmented MCL repair is clinically equivalent remains unclear. Purpose/Hypothesis: The purpose of this study was to compare clinical outcomes between randomized groups that underwent sMCL augmentation repair and sMCL autograft reconstruction. The hypothesis was that there would be no significant differences in objective or subjective outcomes between groups. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients were prospectively enrolled between 2013 and 2019 from 3 centers. Grade III sMCL injuries were confirmed via stress radiography. Patients were randomized to anatomic sMCL reconstruction versus augmented repair with surgical treatment, determined after examination under anesthesia confirmed sMCL incompetence. Postoperative visits occurred at 6 weeks and 6 months for repeat evaluation, with repeat stress radiography at final follow-up. Patient-reported outcome measures were obtained pre- and postoperatively at 6 months, 1 year, and final follow-up. The primary outcome measure was side-to-side difference on valgus stress radiographs at a minimum follow-up of 1 year. The two 1-sided t test procedure was used to test clinical equivalence for side-to-side difference in valgus gapping, and the Mann-Whitney U test was used to compare postoperative patient-reported outcome measures between groups. Results: A total of 54 patients were prospectively enrolled into this study. Of these, 50 patients had 6-month stress radiograph data, while 40 had 1-year postoperative valgus stress radiograph data. The mean (SD) patient age was 38.0 years (14.2), and body mass index was 25.0 (3.6). Preoperative valgus stress radiographs demonstrated 3.74 mm (1.1 mm) of increased side-to-side gapping overall, while it was 4.10 mm (1.46 mm) in the MCL augmentation group and 3.42 mm (0.55 mm) in the MCL reconstruction group. Postoperative valgus stress radiographs at an average of 6 months were obtained in 50 patients after surgery, which showed 0.21 mm (0.81 mm) for the MCL augmentation group and 0.19 mm (0.67 mm) for the MCL reconstruction group (P =.940). At final follow-up (minimum 1 year), median (interquartile range) Lysholm scores were significantly higher in the reconstruction group (90 [83-99]) as compared with the repair group (80 [67-92]) (P =.031). Final International Knee Documentation Committee (IKDC) scores were also significantly higher for the reconstruction group (85 [68-89]) versus the repair group (72 [60-78] (P =.039). Postoperative Tegner scores were not significantly different between the repair group (5 [3.5-6]) and the reconstruction group (5.5 [4-7]) (P =.123). Patient satisfaction was also not significantly different between repair (7.5 [5.75-9.25]) and reconstruction groups (9.0 [7-10]) (P =.184). Conclusion: This study found no difference in objective outcomes between an sMCL augmentation repair and a complete sMCL reconstruction at 1 year postoperatively, indicating equivalence between these procedures. Patient-reported clinical outcomes favored the reconstruction over a repair. In addition, this study demonstrated that anatomic-based treatment of MCL tears with an early knee motion program had a very low risk of graft attenuation and a low risk of arthrofibrosis. [ABSTRACT FROM AUTHOR]

Objective: To examine the effects of the provision of a cane, delivered to ambulatory people with chronic stroke, for improving walking and social participation. Design: Two-arm, randomized trial. Setting: Community-based. Participants: Ambulatory individuals with chronic stroke. Interventions: The experimental intervention was the provision of a single-point cane during one month. The control group received a placebo intervention. Outcome measures: Walking speed, step length, cadence, walking capacity, and walking confidence were measured without the cane to examine its rehabilitative effect. Walking speed was also measured with the cane for inclusiveness, and social participation was measured for examining carry over effects. Outcomes were measured at baseline, and after one and two months. Results: Fifty individuals were included. In the experimental group, mean age was 69 years (SD 14), and walking speed was 0.58 m/s (SD 0.17). In the control group, mean age was 68 years (SD 13), and walking speed was 0.63 m/s (SD 0.15). When walking without the cane, after one and after two months, there were no between-group differences in any measures. When walking with the cane, after one month, the experimental group walked 0.14 m/s (95% CI 0.05–0.23) faster than the control group and after two months, they were still walking 0.18 m/s (95% CI 0.06–0.30) faster. Conclusion: Use of a cane improved walking speed, only when participants walked with the cane. Use of cane for one month did not improve walking outcomes, when walking without the cane. People with stroke would need to continue to use the cane to maintain any benefits in walking speed. [ABSTRACT FROM AUTHOR]

Background: Chronic exertional compartment syndrome (CECS) of the anterior leg compartment (ant-CECS) is frequently treated with a minimally invasive fasciotomy. Several operative techniques and operative devices exist, but none have been compared in a systematic and randomized manner. Purpose: To compare efficacy, safety, and postoperative pain of a novel operative device (FascioMax fasciotome) with a widely accepted device created by Due and Nordstrand (Due fasciotome) during a minimally invasive fasciotomy for ant-CECS. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: Patients with bilateral isolated ant-CECS between October 2013 and April 2018 underwent a minimally invasive fasciotomy using the FascioMax fasciotome in 1 leg and the Due fasciotome in the contralateral leg in a single operative session. Symptom reduction at 3 to 6 months and >1 year, postoperative pain within the first 2 weeks, peri- and postoperative complications, and ability to regain sports were assessed using diaries, physical examination, and timed questionnaires. Results: Included in the study were 50 patients (66% female; median age, 22 years [range, 18-65 years]). No differences between the devices were found in terms of perioperative complications (both had none), minor postoperative complications including hematoma and superficial wound infection (overall complication rate: FascioMax, 8% vs Due, 6%), or reduction of CECS-associated symptoms at rest and during exercise. At long-term follow-up (>1 year), 82% of the patients were able to regain their desired type of sport, and 67% (33/49) were able to exercise at a level that was comparable with or higher than before their CECS-associated symptoms started. Conclusion: Both the FascioMax and the Due performed similarly in terms of efficacy, safety, and levels of pain within the first 2 weeks postoperatively. Registration: NL4274; Netherlands Trial Register. [ABSTRACT FROM AUTHOR]

Background: A strong recommendation against subacromial decompression surgery was issued in 2019. This leaves nonoperative care as the only treatment option, but recent studies suggest that the dose of strengthening exercise is not sufficient in current nonoperative care. At this point, it is unknown if adding more strengthening to current nonoperative care is of clinical value. Purpose: To assess the effectiveness of adding a large dose of shoulder strengthening to current nonoperative care for subacromial impingement compared with usual care alone. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: In this double-blinded, pragmatic randomized controlled trial, we randomly allocated 200 consecutive patients referred to orthopaedic shoulder specialist care for long-standing shoulder pain (>3 months), aged 18 to 65 years and diagnosed with subacromial impingement using validated criteria, to the intervention group (IG) or control group (CG). Outcome assessors were blinded, and participants were blinded to the study hypothesis as well as to the treatment method in the other group. The CG received usual nonoperative care; the IG underwent the same plus an add-on intervention designed to at least double the total dose of shoulder strengthening. The primary outcome was the Shoulder Pain and Disability Index (SPADI; 0-100) at 4-month follow-up, with 10 points defined as the minimal clinically important difference. Secondary outcomes included shoulder strength, range of motion, health-related quality of life, and the Patient Acceptable Symptom State (PASS). Results: Intention-to-treat and per-protocol analyses showed no significant or clinically relevant between-group differences for any outcome. From baseline to 4-month follow-up, SPADI scores improved in both groups (intention-to-treat analysis; IG, –22.1 points; CG, –22.7 points; between-group mean difference, 0.6 points [95% CI, –5.5 to 6.6]). At 4 months after randomization, only 54% of the IG and 48% of the CG (P =.4127) reached the PASS. No serious adverse events were reported. Conclusion: Adding a large dose of shoulder strengthening to current nonoperative care for patients with subacromial impingement did not result in superior shoulder-specific patient-reported outcomes. Moreover, approximately half of all randomized patients did not achieve the PASS after 4 months of nonoperative care, leaving many of these patients with unacceptable symptoms. This study showed that adding more exercise is not a viable solution to this problem. Registration: NCT02747251 (ClinicalTrials.gov identifier) [ABSTRACT FROM AUTHOR]

Background: Early integration of palliative care into oncology treatment is widely recommended. Palliative rehabilitation has been suggested as a paradigm which integrates enablement, self-management, and self-care into the holistic model of palliative care. Aim: We hypothesized that early integration of palliative rehabilitation could improve quality of life. Design: The Pal-Rehab study (ClinicalTrials.gov NCT02332317) was a randomized controlled trial. The 12-week intervention offered by a specialized palliative care team was two mandatory consultations and the opportunity of participating in an interdisciplinary group program. Supplementary individual consultations were offered, if needed. Setting/participants: At Vejle University Hospital, Denmark, adults diagnosed with advanced cancer within the last 8 weeks were randomized 1:1 to standard oncology care or standard care plus intervention. Assessments at baseline and after six and 12 weeks were based on the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30). At baseline participants were asked to choose a "primary problem" from a list of QLQ-C30 domains. The primary endpoint was the change in that "primary problem" measured as area under the curve across 12 weeks (T -scores, European mean value = 50, SD = 10). Results: In all, 288 were randomized of whom 279 were included in the modified intention-to-treat analysis (146 in the standard care group and 133 in the intervention group). The between-group difference for the primary outcome was 3.0 (95% CI [0.0–6.0]; p = 0.047) favoring the intervention. Conclusion: Early integration of palliative rehabilitation into standard oncology treatment improved quality of life for newly diagnosed advanced cancer patients. Trial registration: Clinicaltrials.gov Identifier: NCT02332317, registered on December 30, 2014. [ABSTRACT FROM AUTHOR]

Background: Few randomized controlled trials with a midterm follow-up have compared matrix-assisted autologous chondrocyte transplantation (MACT) with microfracture (MFx) for knee cartilage lesions. Purpose: To compare the structural, clinical, and safety outcomes at midterm follow-up of MACT versus MFx for treating symptomatic knee cartilage lesions. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 48 patients aged between 18 and 50 years, with 1- to 4-cm2 International Cartilage Repair Society (ICRS) grade III to IV knee chondral lesions, were randomized in a 1:1 ratio to the MACT and MFx treatment groups. A sequential prospective evaluation was performed using magnetic resonance imaging (MRI) T2 mapping, the MOCART (magnetic resonance observation of cartilage repair tissue) score, second-look arthroscopic surgery, patient-reported outcome measures, the responder rate (based on achieving the minimal clinically important difference for the Knee injury and Osteoarthritis Outcome Score [KOOS] pain and KOOS Sport/Recreation), adverse events, and treatment failure (defined as a reoperation because of symptoms caused by the primary defect and the detachment or absence of >50% of the repaired tissue during revision surgery). Results: Overall, 35 patients (18 MACT and 17 MFx) with a mean chondral lesion size of 1.8 ± 0.8 cm2 (range, 1-4 cm2) were followed up to a mean of 6 years postoperatively (range, 4-9 years). MACT demonstrated significantly better structural outcomes than MFx at 1 to 6 years postoperatively. At final follow-up, the MRI T2 mapping values of the repaired tissue were 37.7 ± 8.5 ms for MACT versus 46.4 ± 8.5 ms for MFx (P =.003), while the MOCART scores were 59.4 ± 17.3 and 42.4 ± 16.3, respectively (P =.006). More than 50% defect filling was seen in 95% of patients at 2 years and 82% at 6 years in the MACT group and in 67% at 2 years and 53% at 6 years in the MFx group. The second-look ICRS scores at 1 year were 10.7 ± 1.3 for MACT and 9.0 ± 1.8 for MFx (P =.001). Both groups showed significant clinical improvements at 6 years postoperatively compared with their preoperative status. Significant differences favoring the MACT group were observed at 2 years on the KOOS Activities of Daily Living (P =.043), at 4 years on all KOOS subscales (except Symptoms; P <.05) and the Tegner scale (P =.008), and at 6 years on the Tegner scale (P =.010). The responder rates at 6 years were 53% and 77% for MFx and MACT, respectively. There were no reported treatment failures after MACT; the failure rate was 8.3% in the MFx group. Neither group had serious adverse events related to treatment. Conclusion: Patients who underwent MACT had better structural outcomes than those who underwent MFx at 1 to 6 years postoperatively. Both groups of patients showed significant clinical improvements at final follow-up compared with their preoperative status. MACT showed superiority at 4 years for the majority of the KOOS subscales and for the Tegner scale at 4 to 6 years. The MACT group also had a higher responder rate and lower failure rate at final follow-up. Registration: NCT01947374 (ClinicalTrials.gov identifier). [ABSTRACT FROM AUTHOR]

Background: Evidence for the effect of minimal acupuncture in infants with colic is limited. Aim: To compare the effect of standardized minimal acupuncture, individualized acupuncture (where traditional acupuncture points were chosen according to the infant's symptoms) and no acupuncture on objective measures of stooling, feeding and sleeping in infants with colic (based on diaries) and perceived changes in these parameters (based on parental questionnaires). Methods: This was a secondary analysis of a multicentre randomized controlled three-armed trial conducted in four counties in Sweden between January 2013 and May 2015 (ACU-COL). The effect on crying has already been published and showed a decrease in crying time for the acupuncture groups. Infants, 2–8 weeks old, who cried and fussed for more than 3 h/day for more than 3 days/week, and thereby fulfilled the criteria for infantile colic, received four extra visits to their ordinary child health centre. The infants (n = 147) were randomly allocated via a computer-generated list to standardized minimal acupuncture at LI4 for 5 s (group A, n = 48), semi-standardized individual acupuncture with a maximum of five insertions for up to 30 s (group B, n = 49), or no acupuncture (group C, n = 48). The parents and the ordinary staff were blinded. Data were collected using: (1) diaries at baseline, during the two intervention weeks and 1-week follow-up; and (2) questionnaires with quantitative and qualitative components used at the second and fourth visits and during a follow-up telephone call. Outcomes were the changes in frequency of stooling and in hours of sleep per day. Results: There were no differences between groups for stooling, feeding, or sleeping at any time point according to data from the diaries. At the follow-up phone call, more parents in groups A and B (compared to group C) perceived that feeding and sleep had changed and that the symptoms of colic had improved. [ABSTRACT FROM AUTHOR]

Background: Needle aspiration of calcific deposits (NACD) is a frequently used treatment for rotator cuff calcific tendinitis (RCCT). However, a substantial number of patients experience recurrent or persisting shoulder symptoms after NACD. Purpose: To compare the effects of adjuvant application of platelet-rich plasma (PRP) after NACD (NACP+PRP) with those of conventional NACD with corticosteroids (NACD+corticosteroids) on pain, shoulder function, and quality of life (QoL). Study Design: Randomized controlled trial; Level of evidence, 1. Methods: In a single-center, double-blinded, randomized controlled trial, 80 adults with symptomatic RCCT were randomly allocated to receive NACD+corticosteroids or NACD+PRP. Pain, shoulder function, and QoL were assessed at baseline; 6 weeks; and 3, 6, 12, and 24 months after treatment using a numeric rating scale for pain (NRS); the Constant-Murley score (CMS); the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH); the Oxford Shoulder Score (OSS); and the EuroQol 5-dimension scale (EQ-5D). Additionally, resorption of calcific deposits and the integrity of rotator cuff tendons were assessed by using standard radiographs and ultrasound examination, respectively. The results were analyzed using noninferiority analysis for NRS scores and a mixed model for repeated measures. Results: Eighty patients were included (48 female; mean age, 49 ± 6 years; 41 patients in the NACD+PRP group). Both groups showed improvement of clinical scores at the 2-year follow-up (P <.001 for all clinical scores). NACD+PRP was found to be noninferior to NACD+corticosteroids with regard to the mean decrease of NRS scores (4.34 vs 3.56; P =.003). Mixed-model analysis showed a significant difference in favor of NACD+PRP (CMS, P <.001; DASH, P =.002; OSS, P =.010; EQ-5D, P <.001). However, clinically relevant differences in favor of NACD+PRP were only seen at the 6-month follow-up for NRS and CMS scores, whereas at the 6-week follow-up a clinically relevant difference in favor of NACD+corticosteroids was found for all clinical scores except for the NRS. Full resorption of calcific deposits was present in 84% of the NACD+PRP group compared with 66% in the NACD+corticosteroids group (P =.081). In the NACD+PRP group, 10 (24%) patients required a second NACD procedure compared with 19 (49%) patients in the NACD+corticosteroids group (P =.036). Six complications, of which 5 were frozen shoulders, occurred in the NACD+PRP group compared with 1 complication in the NACD+corticosteroids group (P =.11). Conclusion: NACD+PRP resulted in worse clinical scores at the 6-week follow-up but better clinical scores at the 6-month follow-up compared with NACD+corticosteroids. At the 1- and 2-year follow-ups, the results were comparable between groups. Furthermore, PRP seemed to reduce the need for additional treatments but was associated with more complications. In conclusion, NACD+corticosteroids had a favorable early effect on pain and function combined with low comorbidity. Thus, it remains the treatment of choice for patients with RCCT. Registration: NCT02173743 (ClinicalTrials.gov identifier). [ABSTRACT FROM AUTHOR]

Background: Traumatic full-thickness rotator cuff tears are typically managed surgically, followed by rehabilitation, but the load progression to reach an optimal clinical outcome during postoperative rehabilitation is unknown. Purpose: To evaluate whether there was a superior effect of 12 weeks of progressive active exercise therapy on shoulder function, pain, and quality of life compared with usual care. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients with surgically repaired traumatic full-thickness rotator cuff tears were recruited from 2 orthopaedic departments and randomized to progressive active exercise therapy (PR) or limited passive exercise therapy (UC [usual care]). The primary outcome was the change in the Western Ontario Rotator Cuff Index (WORC) score between groups from before surgery to 12 weeks after surgery. Secondary outcomes included changes in the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire score, pain, range of motion, and strength. Adverse events were registered during the intervention period. Results: A total of 82 patients were randomized to the PR (n = 41) or UC (n = 41) group. All 82 patients (100%) participated in the 12-week assessment and 79 in the 1-year follow-up. At 12 weeks, there was no significant difference between the groups in the change in the WORC score from baseline adjusted for age, sex, and center (physical symptoms: P =.834; sports and recreation: P =.723; work: P =.541; lifestyle: P =.508; emotions: P =.568). Additionally, there was no between-group difference for the secondary outcomes including the WORC score at 1 year and the DASH score, pain, range of motion, and strength at 12 weeks and 1 year. Both groups showed significant improvements over time in all outcomes. In total, there were 13 retears (16%) at 1-year follow-up: 6 in the PR group and 7 in the UC group. Conclusion: PR did not result in superior patient-reported and objective outcomes compared with UC at either short- or long-term follow-up (12 weeks and 1 year). Registration: NCT02969135 (ClinicalTrials.gov identifier) [ABSTRACT FROM AUTHOR]

Background: Femoroacetabular impingement (FAI) is a condition known to cause hip pain in young adults. Purpose: To evaluate the efficacy of the surgical correction of FAI via arthroscopic osteochondroplasty with or without labral repair compared with arthroscopic lavage of the hip joint with or without labral repair. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 220 male and female participants aged 18 to 50 years with nonarthritic FAI suitable for surgical treatment were recruited for the trial at 10 clinical centers in Canada, Finland, and Denmark between October 2012 and November 2017, of whom 214 were included in the final analysis. In the osteochondroplasty group, cam- and/or pincer-type lesions were resected using fluoroscopic guidance. In the lavage group, the joint was washed out with 3 L of normal saline. Surgeons were instructed to repair the labrum in both groups if it was mechanically unstable once probed, showing visible displacement or chondrolabral separation. The primary outcome was patient-reported pain (using the 100-point visual analog scale [VAS]) at 12 months. Secondary outcomes included hip function (Hip Outcome Score [HOS] and International Hip Outcome Tool), physical and mental health (12-Item Short Form Health Survey), and health utility (EuroQol–5 Dimensions) at 12 months as well as any reoperations and other hip-related adverse events at 24 months. Results: At 12 months, there was no difference in pain (VAS) between the groups (mean difference [MD], 0.11 [95% CI, –7.22 to 7.45]; P =.98). Also, 88.3% (189/214) of participants had a labral tear, of which 60.3% were repaired. For the secondary outcomes, there were no significant differences between treatment groups, with the exception of the HOS activities of daily living domain in which lavage showed significant improvement compared with osteochondroplasty (MD, –5.03 [95% CI, −10.40 to −0.03]; P =.049). By 24 months, there were significantly fewer reoperations reported in the osteochondroplasty group (8/105) than the lavage group (19/104) (odds ratio, 0.37 [95% CI, 0.15-0.89]; P =.026). The primary reasons for a reoperation included hip pain (15/27; 55.6%) and a reinjury of the labrum (11/27; 40.7%). Conclusion: Both the osteochondroplasty and the lavage groups with or without labral repair for FAI had significantly improved pain or function significantly at 1 year. By 2 years, the reoperation rate was significantly lower in the osteochondroplasty group. Registration: NCT01623843 (ClinicalTrials.gov identifier) [ABSTRACT FROM AUTHOR]

Previous research has demonstrated that college students who view TakeCARE, a video bystander program designed to encourage students to take action to prevent sexual and relationship violence (i.e., bystander behavior), display more bystander behavior relative to students who view a control video. The current study aimed to replicate and extend these findings by testing two different methods of administering TakeCARE and examining moderators of TakeCARE's effects on bystander behavior. Students at four universities (n = 557) were randomly assigned to one of three conditions: (a) view TakeCARE in a monitored computer lab, (b) view TakeCARE at their own convenience after receiving an email link to the video, or (c) view a video about study skills (control group). Participants completed measures of bystander behavior at baseline and at a 1-month follow-up. Participants in both TakeCARE conditions reported more bystander behavior at follow-up assessments, compared with participants in the control condition. The beneficial effect of TakeCARE did not differ significantly across administration methods. However, the effects of TakeCARE on bystander behavior were moderated by students' perceptions of campus responsiveness to sexual violence, with more potent effects when students perceived their institution as responsive to reports of sexual violence. [ABSTRACT FROM AUTHOR]

Objectives: Tinnitus is a common and distressing otologic symptom, with various probable pathophysiologic mechanisms, such as an imbalance between excitatory and inhibitory mechanisms. Acamprosate, generally used to treat alcoholism, is a glutaminergic antagonist and GABA agonist suggested for treating tinnitus. Thus, we aimed to evaluate the efficacy and safety of acamprosate in the treatment of tinnitus. Methods: The current randomized-controlled trial study included 20 subjects with chronic tinnitus. After performing psycho-acoustic, psychometric and electrophysiological evaluations, all studied tinnitus subjects were randomly divided into two groups of acamprosate and placebo. The first group received oral acamprosate (two tablets of 333 mg/d, three times a day), whereas the second group was given placebo treatment (two tablets, three times a day). After the first 30 days, all evaluations were repeated for the studied groups just in the same manner before the study. Subsequently, the final results of each evaluation were compared together with the baseline values. Results: Nine studied subjects randomly received acamprosate, whereas eleven others received a placebo. There was no significant improvement in the psycho-acoustic tests, except a decrease was observed in the pitch match of tinnitus (P =.039). For those subjects who were receiving acamprosate, a significant reduction was observed in tinnitus handicap inventory (P =.006), tinnitus questionnaire scores (P =.007), and the visual analog scores (P =.007) compared to the placebo group. There was a significant reduction in Action Potential latency (P =.048) as well as an increase in the amplitude of distortion product otoacoustic emissions at 4 kHz (P =.048). Conclusions: The study results indicated a subjective relief of tinnitus as well as some degree of the electrophysiological improvement at the level of the cochlear and the distal portion of the auditory nerve among the subjects who received the acamprosate. Clinical trial registration code: IRCT2013121115751N1 [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of a dialogue-based intervention targeting psychosocial well-being at 12 months post-stroke. Design: Multicenter, prospective, randomized, assessor-blinded, controlled trial with two parallel groups. Setting: Community. Subjects: Three-hundred and twenty-two adults (⩾18 years) with stroke within the last four weeks were randomly allocated into intervention group (n = 166) or control group (n = 156). Interventions: The intervention group received a dialogue-based intervention to promote psychosocial well-being, comprising eight individual 1–1½ hour sessions delivered during the first six months post-stroke. Main measures: The primary outcome measure was the General Health Questionnaire-28 (GHQ-28). Secondary outcome measures included the Stroke and Aphasia Quality of Life Scale-39g, the Sense of Coherence scale, and the Yale Brown single-item questionnaire. Results: The mean (SD) age of the participants was 66.8 (12.1) years in the intervention group and 65.7 (13.3) years in the control group. At 12 months post-stroke, the mean (SE) GHQ-28 score was 20.6 (0.84) in the intervention group and 19.9 (0.85) in the control group. There were no between-group differences in psychosocial well-being at 12 months post-stroke (mean difference: −0.74, 95% confidence interval (CI): −3.08, 1.60). The secondary outcomes showed no statistically significant between-group difference in health-related quality of life, sense of coherence, or depression at 12 months. Conclusion: The results of this trial did not demonstrate lower levels of emotional distress and anxiety or higher levels of health-related quality of life in the intervention group (dialogue-based intervention) as compared to the control group (usual care) at 12 months post-stroke. [ABSTRACT FROM AUTHOR]

Objective: This research study aims to evaluate the effectiveness of a multicomponent intervention that combines a cognitive stimulation group and tai chi to reduce cognitive decline among community-dwelling Chinese older adults with probable dementia. Methods: A multi-center, randomized controlled trial design was adopted in this study. In addition to treat as usual, the treatment group (n = 41) participated in a structured cognitive stimulation group followed by tai chi twice a week, with a total of 14 sessions held during the study period. The control group (n = 39) received treat as usual. Mattis Dementia Rating Scale and Mini-Mental State Examination were used for assessing the cognitive abilities of participants in the pre- and post-treatment periods. Results: A 2 × 2 repeated measures analysis of covariance demonstrated that the treatment group was more effective than the control group on improving Dementia Rating Scale score (F = 7.45, p <.01) with a moderate effect size (partial eta square =.09) and Mini-Mental State Examination score (F = 9.96, p <.01) with a moderate to large effect size (partial eta square =.12) after controlling for age, gender, educational level, marital status, and number of physical illnesses. Conclusion: The present study demonstrates the effectiveness of the multicomponent intervention on improving cognitive ability among community-dwelling older adults with probable dementia, suggesting that the multicomponent intervention can facilitate early identification, assessment, and treatment for community-dwelling older adults with probable dementia. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of acceptance and commitment therapy (ACT) on depressive symptoms in physically disabled persons. Design: Randomized controlled trial. Setting: State welfare organization in Kamyaran, Kurdistan, Iran. Participants: Fifty-two physically disabled participants with a primary diagnosis of depression were randomly assigned to either ACT or control groups. Interventions: Participants in the ACT group (n = 23) received eight weekly 90-minute group sessions based on standard ACT protocol for depression. Participants in the control group (n = 29) received psychoeducation regarding depression. Main measures: Measures were recorded at baseline, eight weeks (end of treatment), and 16 weeks (follow-up). The outcomes were the change in the depressive symptoms, measured by Beck Depression Inventory-II (BDI-II), psychological flexibility, emotion regulation, and psychological well-being measured by Acceptance and Action Questionnaire-II (AAQ-II), Emotion Regulation Questionnaire (ERQ), and Scales of Psychological Well-Being (SPWB), respectively. Results: After eight weeks, significant changes in depressive symptoms was observed in the experimental group (ACT –10.39 ± 0.79 vs control 0.66 ± 0.68, P < 0.001). Compared to the control group, the experimental group also showed significant improvement in psychological flexibility (ACT 8.13 ± 0.52 vs control –0.03 ± 0.51, P < 0.001), adaptive emotion regulation strategies (ACT 10.74 ± 0.62 vs control 0.03 ± 1.03, P < 0.001), and psychological well-being (ACT 66.95 ± 4.01 vs control –1.90 ± 1.04, P < 0.001). Conclusion: Compared with control group, ACT significantly reduced the participants' depression, and changed psychological flexibility, emotion regulation, and psychological well-being in persons with physical disability. [ABSTRACT FROM AUTHOR]

Objective: To estimate, among people with multiple sclerosis, the extent to which a personally tailored exercise programme (MSTEP©) resulted in greater improvements in exercise capacity and related outcomes over 12 months in comparison with general exercise guidelines. Design: Two-group randomized trial. Subjects: Ambulatory and sedentary. Interventions: MSTEP©, a personally adapted exercise regimen done on most days including two days of high intensity exercise; guidelines recommending 30 minutes of moderate intensity aerobic and strength training two times per week. Main measures: Primary outcome was peak oxygen consumption (VO2peak) at 12 months; secondary outcomes were composite measures of physical function, fatigue, and health-related quality of life. Results: In total, 137 people were randomized, 66 were lost over 12 months leaving 71 with outcome data, 34 in MSTEP© group, and 37 in the Guideline group. Exercise enjoyment and confidence and exercise-induced fatigue predicted retention. There were no differences between groups on the proportion making a 10% increase in VO2peak (27.1% MSTEP© vs 29.6% Guidelines; OR: 0.83; 95% CI: 0.23–3.08) by the 12 month assessment. The effect on fatigue was larger in the MSTEP© group than the Guideline groups (OR: 1.59; 95% CI: 0.93–2.74), the effect on physical function was more modest (OR: 1.35; 95% CI: 0.80–2.25), and null for health-related quality of life outcomes. Conclusions: The disappointing exercise retention suggests that people with multiple sclerosis may not consider exercise important to their brain health. Either type of exercise resulted in stable exercise capacity over 1 year in those sticking with the programme. [ABSTRACT FROM AUTHOR]

Objective: To analyze the effectiveness of an electrotherapy intervention with galvanic current on symptoms associated with Raynaud's phenomenon. Design: Single-blind randomized controlled trial, parallel design (1:1 ratio) and intention-to-treat analysis. Setting: Virgen de las Nieves Hospital, Granada, Spain. Subjects: Thirty-four participants with Raynaud's phenomenon, with a mean (SD) age of 43.43 (17.62) years. Interventions: The patients were randomly assigned to a control group with conservative treatment (anti-inflammatory, vasodilatory and analgesic drugs) or an intervention group that received conservative treatment and vasodilatory electrical stimulation during seven weeks, three times/week for a total of 20 sessions. Main measures: The primary outcome was the number of attacks. Secondary outcomes were pain, peripheral blow flow, oxygen saturation, upper limb disability, central sensitization, pain catastrophizing and temperature recovery. All outcomes were assessed at baseline, posttreatment and at two months of follow-up. Results: The galvanic current electrotherapy group showed significantly greater improvements in the number of attacks (mean difference = 26.3, 95% confidence interval (CI) = 14.4 to 38.3), pre-cold stress pain (95% CI = 0.6 to 2.4), radial artery blood flow (95% CI = −7.8 ⩾ x ⩽ 1.3), ulnar artery blood flow (95% CI = −8.63 to 0.60), oxygen saturation (95% CI = −1.7 ⩾ x ⩽ −0.29), upper limb disability (95% CI = 1.1 to 22.3), central sensitization (95% CI = 6.7 to 18.2) and temperature recovery (95% CI = −5.7 ⩾ x ⩽ −0.32) than the conservative treatment group. Conclusion: This study suggests that a complementary treatment with galvanic current in combination to conservative approach is superior to conservative applied as isolate, in reducing the clinical manifestations and disability in Raynaud's phenomenon. [ABSTRACT FROM AUTHOR]

Objectives: To compare the effects of continuous and pulsed therapeutic ultrasound combined with strengthening exercises. Design: This is a double-blind randomized controlled trial. Setting: Pontifical Catholic University. Subjects: One hundred participants with Grade 2–4 knee osteoarthritis and both genders were involved. Intervention: Participants were randomized into five groups: Group I (n = 20; in the first month, continuous ultrasound was applied), Group II (n = 20; in the first month, pulsed ultrasound was applied), Group III (n = 20; in the first and second months, continuous ultrasound was applied), Group IV (n = 20; in the first and second months, pulsed ultrasound was applied) and Group V (n = 20; patients received only exercise sessions for eight weeks). All patients in the groups that received ultrasound application performed exercises in the second month of treatment. The sessions occurred three times a week. Main measures: Pain was assessed using the visual analogical scale, functionality was assessed using the Lequesne questionnaire, range of motion was assessed using a universal goniometer, muscular strength was assessed using a dynamometer, mobility was assessed using the Timed Up and Go test and 8-meter walk test and the activity level was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. Results: Statistically significant differences (P < 0.05) were presented by Group III in the variables pain during activities of daily living (ADLs) 5.89 (2.18), mobility assessed by 8-meter test 2.68 (2.56), in pain 10.65 (4.40), function 25.50 (10.87) and total 38.65 (15.29) of WOMAC and functionality 9.10 (5.15). Conclusion: Prolonged applications of continuous ultrasound combined with exercises are effective in providing pain, mobility, functionality and activity in subjects with knee osteoarthritis. [ABSTRACT FROM AUTHOR]

The use of a placebo is the gold standard for establishing the efficacy of new treatments in randomized controlled trials (RCTs). Placebo treatments are inert; this allows specific effects of the experimental treatment to be separated from nonspecific physiological, psychological, and social effects. The aim of this study was to scrutinize the workings of an audiobook (AB) placebo treatment, which was used in a placebo-controlled, investigator-blinded, RCT of the effect of guided imagery (GI) to improve pain and function in persons undergoing total knee replacement. A secondary analysis of quantitative and narrative data collected during the RCT was performed. The AB treatment provided attention control. Participants in the AB group identified benefits—pleasant get-away, new knowledge, quiet time-out, and inspiration; however, there was also evidence of resentful demoralization, especially in the postoperative period. The use of ABs as a placebo treatment in GI RCTs should be executed with caution. [ABSTRACT FROM AUTHOR]

Objectives: The main objective of this study is to determine the feasibility of recruiting and retaining patients recently diagnosed with thoracic cancer to a trial of short-term integrated rehabilitation; evaluate uptake of theoretically informed components targeting physical function, symptom self-management and participation; estimate sample size requirements for an efficacy trial. Design: Parallel group randomized controlled feasibility trial. Setting: Three U.K. hospitals. Participants: Patients ⩽eight weeks of thoracic cancer diagnosis, Eastern Cooperative Oncology Group Performance Status 0–3, any cancer stage and treatment plan. Interventions: Participants randomly allocated (1:1) to short-term integrated rehabilitation and standard care or standard care alone over 30 days. Main measures: Primary: participant recruitment and retention, targeting ⩾30% of eligible patients enrolling and ⩾50% of participants reporting outcomes at 30 days. Secondary: intervention fidelity; missing data and performance of outcome measures for self-efficacy, symptoms, physical activity and health-related quality of life. Results: Of 159 eligible patients approached, 54 (34%) were recruited. A total of 44 (82%) and 39 (72%) participants reported outcomes at 30 and 60 days, respectively. Intervention fidelity was high. Rehabilitation was delivered across 3 (1–3) sessions over 32 (22–45) days (median (range)). Changes in clinical outcomes were modest but most apparent at 60 days for health-related quality of life: Functional Assessment of Cancer Therapy Lung Cancer score median (interquartile range) change 9.7 (−12.0 to 16.0) rehabilitation versus 2.3 (−15.0 to 14.5) standard care. Conclusion: A trial to examine efficacy of short-term integrated rehabilitation for people newly diagnosed with thoracic cancer is feasible. A sample of 336 participants could detect a meaningful effect on health-related quality of life as the primary outcome. [ABSTRACT FROM AUTHOR]

Youth is a period in life when the risk of violence victimization is high and association between victimization and ill health is well established. Youth rarely reveal violence victimization to health professionals if not directly asked but favor health professionals asking about victimization. The study's primary aim was to examine health outcomes in young women being routinely asked about violence victimization and offered subsequent support, compared with controls, at 12-month follow-up. Secondary aims were to examine to what extent routine inquiry altered the consultation and re-victimization rates during the study period. A randomized controlled intervention study was conducted at Swedish youth health centers. Participants assigned to the intervention group were asked structured questions about violence. Victimized participants received empowering strategies and were offered further counseling. Participants in the control group completed questionnaires about victimization after the visit. Both groups answered questions about sociodemographics and health, constructed from validated instruments. A questionnaire was administered to all participants 12 months after baseline. Of 1,445 eligible young women, 1,051 (73%) participated, with 54% of the participants completing the 12-month follow-up. Lifetime violence victimization was reported by 53% in the intervention group and 60% in the control group, ns. There were no significant differences in health outcomes, between baseline and 12-month follow-up, within either group or between groups. Re-victimization rates were 16% in the intervention group and 12% in the control group, ns. Of victimized young women in the intervention group, 14% wanted and received further counseling. Routine inquiry about violence victimization and empowering strategies were feasible within ordinary consultations at youth health centers but did not demonstrate improved health outcomes at 12-month follow-up compared with controls. Questions about violence led to a high degree of disclosure, and 14% of victimized young women in the intervention group received further counseling as a result. [ABSTRACT FROM AUTHOR]

Chronic constipation is the disturbances of intestinal motility which is a challenge in primary healthcare around the world. In this study, Court-type Thai traditional massage and Senokot, treatments were assessed and compared in terms of their efficacy in relieving constipation. Forty subjects diagnosed with constipation were recruited and randomized into the massage group and drug group. For 7 days, Thai traditional abdominal massage was provided regularly for the patients in the massage group, while the drug group was subjected to Senokot treatment only. The Bristol stool chart scale and demographics questionnaire were used as instruments. As a result, both court type Thai traditional massage and Senokot are effective in relieving constipation. However, although both treatment options can increase the frequency of defecations and the sensation of complete evacuation, the court type Thai traditional massage seems to be better since it leads to normal defecations rather than watery or entirely liquid defecations with no solid pieces (p < 0.05). This randomized controlled trial suggested that Thai traditional abdominal massage can be used as an optional public health treatment for constipation. [ABSTRACT FROM AUTHOR]

Objective: To verify the effect of adjusting the challenge–skill balance with respect to rehabilitation process. Design: A single-blind, two-arm, parallel-group, randomized controlled trial. Setting: Recovery rehabilitation unit of Harue Hospital, Japan. Subjects: The trial included 72 clients (mean (SD): age, 74.64 (9.51) years; Functional Independence Measure score, 98.26 (15.27)) with cerebral or spinal disease or musculoskeletal disease. Interventions: Clients were randomly divided into two groups: the experimental group, who received occupational therapy with adjustment of the challenge–skill balance, and the control group who received conventional occupational therapy. Time from admission to discharge was considered the implementation period; the final evaluation was conducted at three months after discharge. Main measures: The primary outcome was subjective quality of life (Ikigai-9). Secondary outcomes were the health-related quality of life (EuroQol–5 Dimensions, Five Levels (EQ-5D-5L)), the Flow State Scale for Occupational Tasks, and the Functional Independence Measure. A cost-effectiveness analysis was conducted using total cost and quality-adjusted life-year based on the EQ-5D-5L. Results: Significant differences were observed between the experimental and control groups with respect to the Ikigai-9 score (P = 0.008) and EQ-5D-5L (P = 0.038), and the effect sizes were 0.76 (95% confidence interval [CI]: 0.27–1.24) and 0.62 (95% CI: 0.14–1.10), respectively. No significant between-group differences in other outcomes were observed, for example, the Functional Independence Measure score improved in both experimental and control groups (119.80 (5.50) and 118.84 (6.97), respectively. The incremental cost-effectiveness ratio was US$5518.38. Conclusions: Adjusting the challenge–skill balance may be a useful approach to improve the participant's subjective quality of life in the rehabilitation process. [ABSTRACT FROM AUTHOR]

Objective: To test the effectiveness of an educational intervention including "face to face" training, compared to a standard information program, to reduce microstomia in women with systemic sclerosis. Design: Single-blind, two-arm, randomized controlled study with a 12-month follow-up period. Setting: Hospital wards of a large Italian dermatological reference center. Subjects: Female inpatients with diagnosis of systemic sclerosis. Interventions: For both groups an information brochure and an audio-visual DVD were developed specifically for the study. The control group was assigned to educational materials alone (i.e. brochures and DVD), while the experimental group, in addition to the same educational materials, received specific "face-to-face" interventions, repeated at each follow-up visit. Main measures: Primary outcome was measurement of the opening of the mouth. Secondary outcomes was the self-reported mouth disability. Results: The intention-to-treat analysis included 63 patients. Compared to the baseline measurement, we observed an increase of the mouth opening of 0.31 cm (95% confidence interval: 0.13–0.49), P = 0.003; in the control group, the increase was 0.13 cm (95% confidence interval: 0.01–0.25), P = 0.06. The difference in improvement between the two groups was not statistically significant (P = 0.10); however, it reached statistical significance in the per-protocol analysis (39 patients, P = 0.02). Conclusion: Face-to-face nursing rehabilitation training seems to improve microstomia to a greater extent, when compared to a standard intervention based only on written and audio-visual materials. [ABSTRACT FROM AUTHOR]

Background: Throwing injuries of the shoulder and elbow are common among youth baseball players. Hypothesis: A prevention program will reduce the incidence of throwing injuries of the shoulder and elbow by 50% among youth baseball players. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: The authors block randomized 16 youth baseball teams consisting of 237 players aged 9 to 11 years into an intervention group (8 teams, 117 players) and a control group (8 teams, 120 players). The intervention program consisted of 5 stretching, 2 dynamic mobility, and 2 balance training exercises performed during warm-up. Both groups were followed up for 12 months, during which the incidence of shoulder and elbow injuries was recorded. In addition, ball speed during pitching as a performance-related factor and variables of physical function (passive range of motion of the elbow, shoulder and hip, dynamic balance, and thoracic kyphosis angle) were assessed during the pre- and postintervention periods. Results: The incidence of shoulder and elbow injuries in the intervention group (1.7 per 1000 athlete-exposures) was significantly lower than that in the control group (3.1 per 1000 athlete-exposures) (hazard ratio, 1.940; 95% CI, 1.175-3.205; P =.010). The factors related to pitching performance, as assessed by ball speed, tended to increase in the intervention group as compared with the control group (P =.010). The program also improved shoulder horizontal adduction deficits on the dominant side, hip internal rotation on the nondominant side, and the thoracic kyphosis angle. Conclusion: A prevention program decreases throwing injuries of the shoulder and elbow and enhances the parameter of pitching performance in youth baseball players. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to test and compare the effect of (1) a systematic discharge assessment with targeted advice and (2) a motivational interview followed by a home visit. Design: This was a three-armed randomized controlled study. Setting: This study was conducted in the Medical department in a university hospital. Subjects: Patients ⩾65 years of age with health problems at discharge participated in the study. Interventions: Group A (n = 117): patients were informed of health problems and self-care interventions; Group B (n = 116): a motivational conversation targeting activities of daily living with a home care nurse and a home visit. Main measures: The main measures of this study were readmissions, handgrip strength, chair-to-stand test, health-related quality of life, depression signs, mortality, and call on municipality services. Results: Risk of readmission was reduced for intervention groups by 30% (A; P = 0.26) and 22 % (B; P = 0.46). Mean number of days to first readmission was 49.5 (±51.0) days for the control group (n = 116) and 57.9 (±53.6) and 67.2 (±58.1) days for the intervention groups A (P = 0.43) and B (P = 0.10), respectively. Mean loss of handgrip strength was 10.6 (±16.6) kg for men in the control group and 7 (±19.2) and 1.4 (±17.1) kg for the intervention groups A (P = 0.38) and B (P = 0.01), respectively. Health-related quality of life improved with 0.3 (±23.7) points in the control group and 7.4 (±24.4) and 3.2 (±22.3) points in the intervention groups A (P = 0.04) and B (P = 0.37), respectively. In total, 17 (16.3%) in the control group were provided with assistive devices after three months and 8 (7.3%) and 19 (17.6%) in the intervention groups A (P = 0.04) and B (P = 0.81), respectively. Conclusion: The interventions reduced the risk of readmission and improved handgrip strength, quality of life, and use of assistive devices. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the clinical and cost effectiveness of a group-based memory rehabilitation programme for people with traumatic brain injury. Design: Multicentre, pragmatic, observer-blinded, randomized controlled trial in England. Setting: Community. Participants: People with memory problems following traumatic brain injury, aged 18–69 years, able to travel to group sessions, communicate in English, and give consent. Interventions: A total of 10 weekly group sessions of manualized memory rehabilitation plus usual care (intervention) vs. usual care alone (control). Main measures: The primary outcome was the patient-reported Everyday Memory Questionnaire (EMQ-p) at six months post randomization. Secondary outcomes were assessed at 6 and 12 months post randomization. Results: We randomized 328 participants. There were no clinically important differences in the primary outcome between arms at six-month follow-up (mean EMQ-p score: 38.8 (SD 26.1) in intervention and 44.1 (SD 24.6) in control arms, adjusted difference in means: –2.1, 95% confidence interval (CI): –6.7 to 2.5, p = 0.37) or 12-month follow-up. Objectively assessed memory ability favoured the memory rehabilitation arm at the 6-month, but not at the 12-month outcome. There were no between-arm differences in mood, experience of brain injury, or relative/friend assessment of patient's everyday memory outcomes, but goal attainment scores favoured the memory rehabilitation arm at both outcome time points. Health economic analyses suggested that the intervention was unlikely to be cost effective. No safety concerns were raised. Conclusion: This memory rehabilitation programme did not lead to reduced forgetting in daily life for a heterogeneous sample of people with traumatic brain injury. Further research will need to examine who benefits most from such interventions. [ABSTRACT FROM AUTHOR]

Objective: Explore qualitative differences between interventions (DVD and booklet (DVDB) versus face-to-face and booklet (F2FB) versus usual care) in the BREATHE (Breathing Retraining for Asthma Trial of Home Exercises) trial of breathing retraining for asthma. Design: Quantitative process analysis exploring group expectancy, experience and practice before and after intervention delivery for the main trial. Setting: Primary care. Subjects: Adults with asthma (DVD and booklet, n = 261; F2FB, n = 132). Main measures: Baseline – expectancy about breathing retraining; follow-up 3, 6 and 12 months – self-efficacy, treatment experience (enjoyment of treatment, perceptions of physiotherapist, perceptions of barriers), amount of practice (weeks, days/week, times/day), continued practice; all time points – anxiety (Hospital Anxiety and Depression Scale), AQLQ (Asthma Quality of Life Questionnaire). Results: No group differences in baseline expectancy. Statistically significant results (P < 0.05) indicated that at follow-up, F2FB participants perceived greater need for a physiotherapist than DVD and booklet participants (3.43 (0.87) versus 2.15 (1.26)). F2FB participants reported greater enjoyment of core techniques (such as stomach breathing: 7.42 (1.67) versus 6.13 (1.99) (DVD and booklet)). Fewer F2FB participants reported problems due to doubts (24 (22.9%) versus 90 (54.2%)). F2FB participants completed more practice sessions (75.01 (46.38) versus 48.56 (44.71)). Amount of practice was not significantly related to quality of life. In the DVD and booklet arm, greater confidence in breathing retraining ability explained 3.9% of variance in quality of life at 12 months. Conclusion: Adults with asthma receiving breathing retraining face-to-face report greater enjoyment and undertaking more practice than those receiving a DVD and booklet. Greater confidence in ability to do breathing retraining is associated with improved QoL. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of acupuncture in patients with vascular cognitive impairment no dementia (VCIND) in comparison with citicoline, an agent for cognitive disturbances associated with chronic cerebral disorders. Design: A randomized controlled multicenter trial. Setting: In three hospitals in Beijing, China. Subjects: A total of 216 patients with VCIND were recruited. Interventions: Patients with VCIND (mean age of 65.4 years) were randomized to receive acupuncture (two sessions per week) or oral citicoline (100 mg three times daily) over three months. Main measures: The primary outcome was the change from baseline to three months in cognitive symptom, measured by Alzheimer's disease Assessment Scale, cognitive subscale (ADAS-cog). Secondary outcomes included changes from baseline to six months in ADAS-cog, executive function measured by the Clock Drawing Test (CDT), and functional disability measured by the Ability of Daily Living (ADL) scale at three and six months. Results: At three months, the acupuncture group had a greater decrease in mean ADAS-cog score (−2.33 ± 0.31) than the citicoline group (−1.38 ± 0.34) with a mean difference of −0.95 (95% CI, −1.84 to −0.07, P = 0.035). The mean change from baseline to six months in ADAS-cog also significantly favored acupuncture treatments (acupuncture change −2.61 vs citicoline −1.25, difference: −1.36 points; 95% CI, −2.20 to −0.51; P = 0.002). There was no difference between the two groups on CDT and ADL scores at either time point. Conclusion: Compared with citicoline, acupuncture has comparable and even superior efficacy with improved cognitive and daily living performance as a complementary and alternative medicine treatment for VCIND. [ABSTRACT FROM AUTHOR]

This study examined the treatment effects between unilateral hybrid therapy (UHT; unilateral robot-assisted therapy [RT] + modified constraint-induced movement therapy) and bilateral hybrid therapy (BHT; bilateral RT + bilateral arm training) compared with RT. Thirty patients with chronic stroke were randomized to UHT, BHT, or RT groups. Preliminary efficacy was assessed using the Fugl-Meyer Assessment (FMA), the Chedoke Arm and Hand Activity Inventory (CAHAI), and the goal attainment scaling (GAS). Possible adverse effects of abnormal muscle tone, pain, and fatigue were recorded. All groups showed large improvements in motor recovery and individual goals. Significant between-group differences were found on GAS favoring the hybrid groups but not on FMA and CAHAI. No adverse effects were reported. Hybrid therapies are safe and applicable interventions for chronic stroke and favorable for improving individual functional goals. Treatment effects on motor recovery and functional activity might be similar among the three groups. [ABSTRACT FROM AUTHOR]

Objective: This pre-planned secondary analysis of geriatric interdisciplinary home rehabilitation, which was initially found to shorten the postoperative length of stay in hospital for older individuals following hip fracture, investigated whether such rehabilitation reduced the numbers of complications, readmissions, and total days spent in hospital after discharge during a 12-month follow-up period compared with conventional geriatric care and rehabilitation. Design: Randomized controlled trial. Setting: Geriatric department, participants' residential care facilities, and ordinary housing. Subjects: Individuals aged ⩾70 years with acute hip fracture (n = 205) were included. Intervention: Geriatric interdisciplinary home rehabilitation was individually designed and aimed at early discharge with the intention to prevent, detect, and treat complications after discharge. Main measures: Complications, readmissions, and days spent in hospital were registered from patients' digital records and interviews conducted during hospitalization and at 3- and 12-month follow-up visits. Results: No significant difference in outcomes was observed. Between discharge and the 12-month follow-up, among participants in the geriatric interdisciplinary home rehabilitation group (n = 106) and control group (n = 93), 57 (53.8%) and 44 (47.3%) had complications (P = 0.443), 46 (43.4%) and 38 (40.9%) fell (P = 0.828), and 38 (35.8%) and 27 (29.0%) were readmitted to hospital (P = 0.383); the median total days spent in hospital were 11.5 and 11.0 (P = 0.353), respectively. Conclusion: Geriatric interdisciplinary home rehabilitation for older individuals following hip fracture resulted in similar proportions of complications, readmissions, and total days spent in hospital after discharge compared with conventional geriatric care and rehabilitation. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of acupuncture for pain relief and function improvement in patients with knee osteoarthritis and to determine the feasibility of an eight-week acupuncture intervention. Design: Pilot randomized controlled trial. Setting: Three teaching hospitals in China. Subjects: Patients with knee osteoarthritis (Kellgren grade II or III). Interventions: Patients were randomly assigned to an eight-week (three sessions per week) intervention of either traditional Chinese acupuncture or sham acupuncture. Main measures: The primary outcome was response rate—the proportion of patients achieving score ⩾36% decrease in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function at week 8 compared with baseline. Secondary outcomes included pain, function and quality of life. Results: Of 42 patients randomized, 36 (85.7%) completed the study. There was no significant difference in response rate between the traditional Chinese acupuncture and control groups: 61.9% (13 of 21) versus 42.9% (9 of 21) achieved score ⩾36% decrease in WOMAC pain and function at week 8 (P = 0.217). The sum of WOMAC pain and function scores at week 8 was 11.6 (9.1) in the traditional Chinese acupuncture group compared with 16.3 (10.9) in the control group (P = 0.183). There was no significant difference between groups. Three adverse events were recorded and were classified as mild. Conclusion: It showed that three sessions per week acupuncture intervention of knee osteoarthritis was feasible and safe. No difference was observed between groups due to small sample size. Larger (sample size ⩾ 296) randomized controlled trials of this intervention appear justified. [ABSTRACT FROM AUTHOR]

Background: The recommended initial treatment for multidirectional instability (MDI) of the shoulder is a rehabilitation program, yet there is very low-quality evidence to support this approach. Purpose/Hypothesis: The purpose was to compare the Watson MDI program and Rockwood Instability program among patients with nontraumatic, nonstructural MDI. The hypothesis was that the Watson MDI program would produce clinically and statistically superior outcomes over the Rockwood Instability program. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: Forty-one participants with MDI were randomly allocated to the Watson MDI or Rockwood Instability program. Participants attended 12 weekly physiotherapy sessions for exercise prescription. Outcomes were assessed at baseline and 6, 12, and 24 weeks after randomization. Primary outcomes were the Melbourne Instability Shoulder Score (MISS) and the Western Ontario Shoulder Index (WOSI). Secondary outcomes included the Orebro Musculoskeletal Pain Questionnaire, pain, muscle strength, scapular upward rotation, scapular coordinates, global rating of change, satisfaction scales, limiting angle in abduction range, limiting factor in abduction range, and incidence of dislocation. Primary analysis was by intention to treat based on linear mixed models. Results: Between-group differences showed significant effects favoring the Watson program for the WOSI (effect size [ES], 11.1; 95% CI, 1.9-20.2; P = .018) and for the limiting factor in abduction (ES, 0.1; 95% CI, 0.0-1.6; P = .023) at 12 weeks, and for the WOSI (ES, 12.6; 95% CI, 3.4-21.9; P =. 008), MISS (ES, 15.4; 95% CI, 5.9-24.8; P = .002), and pain (ES, -2.0; CI: -2.3 to -0.7, P = .003) at 24 weeks. Conclusion: For people with MDI, 12 sessions of the Watson MDI program were more effective than the Rockwood program at 12- and 24-week follow-up. Registration: ACTRN12613001240730 (Australian New Zealand Clinical Trials Registry). [ABSTRACT FROM AUTHOR]

Objective: Our aim was to evaluate the effect of aquatic obstacle training on balance parameters in comparison with a traditional aquatic therapy in patients with Parkinson’s disease. Design: A randomized single-blind controlled trial. Setting: Outpatients in the rehabilitation department. Subjects: A total of 46 patients with Parkinson’s disease in Hoehn–Yahr stage 2–3. Interventions: Participants were randomly assigned to (1) aquatic therapy or (2) obstacle aquatic therapy. All participants undertook aquatic therapy for 30 minutes, five times per week for six weeks. Main measures: The Freezing of Gait Questionnaire, Functional Reach Test, Timed Up and Go test and Berg Balance Scale were assessed at baseline, posttreatment and at six-month follow-up. Results: Both groups of patients had improved primary outcomes after the training program. A between-group comparison of the changes revealed that obstacle aquatic therapy was significantly higher for the Freezing of Gait Questionnaire (after treatment: 8.7 ± 3.3 vs 6.2 ± 2.1, P = 0.004; posttest: 7.7 ± 3.1 vs 5.3 ± 2.0, P = 0.003) and Timed Up and Go test (after treatment: 17.1 ± 2.9 vs 13.8 ± 1.9, P < 0.001; posttest: 16.3 ± 2.8 vs 12.9 ± 1.4, P < 0.001). Conclusion: Obstacle aquatic therapy in this protocol seems to be more effective than traditional protocols for gait and balance in patients with Parkinson’s disease, and the effect lasts for six months. [ABSTRACT FROM AUTHOR]

Objective: To report on the control group of a trial primarily designed to investigate exercise for improving mobility in people with Parkinson’s disease (pwP). The control group undertook a handwriting intervention to control for attention and time spent practising a specific activity. Design: Secondary analysis of a two-arm parallel phase II randomized controlled trial with blind assessment. Setting: Community. Participants: PwP able to walk ⩾100 m and with no contraindication to exercise were recruited from the Thames Valley, UK, and randomized (1:1) to exercise or handwriting, via a concealed computer-generated list. Intervention: Handwriting was undertaken at home and exercise in community facilities; both were delivered through workbooks with monthly support visits and involved practice for 1 hour, twice weekly, over a period of six months. Main measures: Handwriting was assessed, at baseline, 3, 6 and 12 months, using a pangram giving writing speed, amplitude (area) and progressive reduction in amplitude (ratio). The Movement Disorder Society (MDS)–Unified Parkinson’s Disease Rating Scale (UPDRS) item 2.7 measured self-reported handwriting deficits. Results: In all, 105 pwP were recruited (analysed: n = 51 handwriting, n = 54 exercise). A total of 40 pwP adhered to the handwriting programme, most completing ⩾1 session/week. Moderate effects were found for amplitude (total area: d = 0.32; 95% confidence interval (CI): −0.11 to 0.7; P = 0.13) in favour of handwriting over a period of12 months; effects for writing speed and ratio parameters were small ≤0.11. Self-reported handwriting difficulties also favoured handwriting (UPDRS 2.7: odds ratio (OR) = 0.55; 95% CI: 0.34 to 0.91; P = 0.02). No adverse effects were reported. Conclusion: PwP generally adhere to self-directed home handwriting which may provide benefit with minimal risk. Encouraging effects were found in writing amplitude and, moreover, perceived ability. [ABSTRACT FROM AUTHOR]

Objective: To study the six-month clinical effects of providing ankle-foot orthoses at different moments (early or delayed) in (sub)acute stroke; this is a follow-up to a published trial. Design: Randomized controlled trial. Setting: Rehabilitation centre. Subjects: Unilateral hemiparetic stroke subjects maximal six weeks post-stroke with indication for ankle-foot orthosis use. Interventions: Subjects were randomly assigned to early (at inclusion; week 1) or delayed provision (eight weeks later; week 9). Outcome measures: Functional tests assessing balance and mobility were performed bi-weekly for 17 weeks and at week 26. Results: In all, 33 subjects were randomized. No differences at week 26 were found between both groups for any of the outcome measures. However, results suggest that early provision leads to better outcomes in the first 11–13 weeks. Berg Balance Scale (P = 0.006), Functional Ambulation Categories (P = 0.033) and 6-minute walk test (P < 0.001) showed significantly different patterns over time. Clinically relevant but statistically non-significant differences of 4–10 weeks in reaching independent walking with higher balance levels were found, favouring early provision. Conclusion: No six-month differences in functional outcomes of providing ankle-foot orthoses at different moments in the early rehabilitation after stroke were found. Results suggest that there is a period of 11–13 weeks in which early provision may be beneficial, possibly resulting in early independent and safe walking. However, our study was underpowered. Further research including larger numbers of subjects is warranted. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the feasibility of conducting a randomized controlled trial comparing group-based outpatient physiotherapy with usual care in patients following total knee replacement. Design: A feasibility study for a randomized controlled trial. Setting: One secondary-care hospital orthopaedic centre, Bristol, UK. Participants: A total of 46 participants undergoing primary total knee replacement. Interventions: The intervention group were offered six group-based exercise sessions after surgery. The usual care group received standard postoperative care. Participants were not blinded to group allocation. Outcome measures: Feasibility was assessed by recruitment, reasons for non-participation, attendance, and completion rates of study questionnaires that included the Lower Extremity Functional Scale and Knee Injury and Osteoarthritis Outcome Score. Results: Recruitment rate was 37%. Five patients withdrew or were no longer eligible to participate. Intervention attendance was high (73%) and 84% of group participants reported they were 'very satisfied' with the exercises. Return of study questionnaires at six months was lower in the usual care (75%) than in the intervention group (100%). Mean (standard deviation) Lower Extremity Functional Scale scores at six months were 45.0 (20.8) in the usual care and 57.8 (15.2) in the intervention groups. Conclusion: Recruitment and retention of participants in this feasibility study was good. Group-based physiotherapy was acceptable to participants. Questionnaire return rates were lower in the usual care group, but might be enhanced by telephone follow-up. The Lower Extremity Functional Scale had high responsiveness and completion rates. Using this outcome measure, 256 participants would be required in a full-scale randomized controlled trial. [ABSTRACT FROM AUTHOR]

Improving early detection and treatment of atrial fibrillation (AF) is critical because untreated AF is a major contributor to stroke and heart failure. We sought to generate knowledge about the feasibility of conducting a randomized controlled trial to test the effect of the Alert for AFib intervention on knowledge, attitudes, and beliefs about treatment-seeking for signs and symptoms of AF. Adults ≥65 years old (96% White) at risk for developing AF were randomized to receive the Alert for AFib intervention (n = 40) or an attention control session (n = 40). Feasibility goals for recruitment, participant retention, adherence, perceived satisfaction and burden, and intervention fidelity were met. From baseline to study completion, knowledge (p = .005) and attitudes (p < .001) about treatment-seeking improved more in the intervention group compared with the control group. Results support testing the effectiveness of the Alert for AFib intervention in a large trial. [ABSTRACT FROM AUTHOR]