Search

EOSQ-24 has been validated in early onset scoliosis (EOS), including congenital scoliosis (CS), and is completed by the caregiver. SRS-22 has been validated in idiopathic scoliosis and is completed by the patient. This study demonstrated a strong correlation between EOSQ-24 and SRS-22 for patients with CS who completed both questionnaires. It may be appropriate for cognitively normal children with EOS due to CS to complete SRS-22.

Background: Femoroacetabular impingement (FAI) can lead to acetabular chondrolabral damage and has been theorized as a causative factor in the development of osteoarthritis. The pathogenesis of FAI is unknown. The purpose of this study was to determine the prevalence of FAI morphology in asymptomatic adolescents., Methods: We identified children 10 to 18 years of age who had undergone a pelvic CT between 2007 and 2012. Exclusion criteria included hip pain, any hip pathology, bone tumor, long-term steroid use, history of chemotherapy or radiation therapy, nonambulatory status, neuromuscular disorder, chromosomal abnormality, and metabolic bone disease. Multiplanar reformatted images were created from axial images to calculate α angles and lateral center-edge angles (LCEA). Cam morphology was defined as an α-angle ≥55 degrees and pincer morphology as a LCEA≥40 degrees., Results: We analyzed 558 patients (1116 hips). There were 276 males and 282 females. The average age was 14.4 years (range, 10.0 to 18.2 y). The mean α-angle was 47.9 degrees (range, 25.7 to 78 degrees) and the mean LCEA was 34.4 degrees (range, 3.9 to 58.6 degrees). Males had a significantly higher mean α-angle (49.7 vs. 46.0 degrees) (P<0.0005) and females had a significantly higher mean LCEA (35.7 vs. 33.0 degrees) (P<0.0005). Ninety-four adolescents (16.8%) had an α-angle ≥55 degrees. Cam morphology was significantly more common in males (23.9% vs. 9.9%) (P<0.001). A total of 181 adolescents (32.4%) had a LCEA≥40 degrees. Pincer morphology was equally common in males and females (29.7% vs. 35.1%) (P=0.17). Thirty-four adolescents (6.1%) had mixed morphologies. Mixed morphologies were found in 21 males (7.6%) and 13 females (4.6%) (P=0.19). The prevalence of pincer morphology increased significantly with increased age in males (P<0.001)., Conclusions: The prevalence of cam-type FAI morphology in asymptomatic adolescents is similar to the reported prevalence in asymptomatic adults. Pincer morphology may be more common than cam morphology in adolescents. Cam morphology is more prevalent in males, whereas pincer and mixed morphologies are equally prevalent in both sexes., Level of Evidence: Level III-diagnostic.

Background: The purpose of this study was to assess the quality of methodology in orthopaedics-related randomized controlled trials (RCTs) published from January 2006 to December 2010 in the top orthopaedic journals based on impact scores from the Thompson ISI citation reports (2010)., Methods: Journals included American Journal of Sports Medicine; Journal of Orthopaedic Research; Journal of Bone and Joint Surgery, American; Spine Journal; and Osteoarthritis and Cartilage. Each RCT was assessed on ten criteria (randomization method, allocation sequence concealment, participant blinding, outcome assessor blinding, outcome measurement, interventionist training, withdrawals, intent to treat analyses, clustering, and baseline characteristics) as having empirical evidence for biasing treatment effect estimates when not performed properly., Results: A total of 232 RCTs met our inclusion criteria. The proportion of RCTs in published journals fell from 6% in 2006 to 4% in 2010. Forty-nine percent of the criteria were fulfilled across these journals, with 42% of the criteria not being amendable to assessment due to inadequate reporting. The results of our regression revealed that a more recent publication year was significantly associated with more fulfilled criteria (β = 0.171; CI = -0.00 to 0.342; p = 0.051)., Conclusion: In summary, very few studies met all ten criteria. Thus, many of these studies likely have biased estimates of treatment effects. In addition, these journals had poor reporting of important methodological aspects.

Background: Studies have demonstrated a higher risk of complications when children with fractures in the proximal third of the femur and length-unstable fractures are treated with titanium elastic nails. Alternative treatment methods include open plating and submuscular plating. We are not aware of any published studies that directly compare titanium elastic nail and plate fixation of pediatric subtrochanteric femur fractures. The purpose of the present study was to retrospectively compare the outcomes and complications of titanium elastic nail and plate fixation of subtrochanteric femur fractures in children and young adolescents., Methods: A total of 54 children aged 5 to 12 years with subtrochanteric femur fractures treated with titanium elastic nails or plating at 2 institutions between 2003 and 2010 were identified. We retrospectively compared 25 children treated with titanium elastic nails to 29 children treated with either open plating or submuscular plating. Similar to previous studies, a fracture that was located within 10% of the total femur length below the lesser trochanter was classified as subtrochanteric. Outcomes were classified as excellent, satisfactory, or poor. A major complication was defined as any complication that led to unplanned surgery. Minor complications were defined as complications that resolved with nonoperative treatment or did not require any treatment., Results: Outcome scores were significantly better in the plating group (P=0.03), but both groups demonstrated high rates of excellent and satisfactory results. The overall complication rate was significantly higher in the titanium elastic nails group (48%; 12 of 25) when compared with the plating group (14%; 4 of 29) (P=0.008). Patients in the titanium elastic nails group were advanced to full weightbearing significantly earlier (6.6 vs. 9.9 wk) (P=0.005). The major complication rate, length of hospitalization, and time to radiographic union were similar for the 2 groups., Conclusions: Our results indicate that plate fixation of pediatric subtrochanteric femur fractures is associated with better outcome scores and a lower overall complication rate when compared with titanium elastic nails., Level of Evidence: Therapeutic Level III.

Background. Back pain is a common problem and a major cause of disability and health care utilization. Purpose. To evaluate the efficacy, harms, and costs of the most common CAM treatments (acupuncture, massage, spinal manipulation, and mobilization) for neck/low-back pain. Data Sources. Records without language restriction from various databases up to February 2010. Data Extraction. The efficacy outcomes of interest were pain intensity and disability. Data Synthesis. Reports of 147 randomized trials and 5 nonrandomized studies were included. CAM treatments were more effective in reducing pain and disability compared to no treatment, physical therapy (exercise and/or electrotherapy) or usual care immediately or at short-term follow-up. Trials that applied sham-acupuncture tended towards statistically nonsignificant results. In several studies, acupuncture caused bleeding on the site of application, and manipulation and massage caused pain episodes of mild and transient nature. Conclusions. CAM treatments were significantly more efficacious than no treatment, placebo, physical therapy, or usual care in reducing pain immediately or at short-term after treatment. CAM therapies did not significantly reduce disability compared to sham. None of the CAM treatments was shown systematically as superior to one another. More efforts are needed to improve the conduct and reporting of studies of CAM treatments.

Background: Back and neck pain are important health problems with serious societal and economic implications. Conventional treatments have been shown to have limited benefit in improving patient outcomes. Complementary and Alternative Medicine (CAM) therapies offer additional options in the management of low back and neck pain. Many trials evaluating CAM therapies have poor quality and inconsistent results., Objectives: To systematically review the efficacy, effectiveness, cost-effectiveness, and harms of acupuncture, spinal manipulation, mobilization, and massage techniques in management of back, neck, and/or thoracic pain., Data Sources: MEDLINE, Cochrane Central, Cochrane Database of Systematic Reviews, CINAHL, and EMBASE were searched up to 2010; unpublished literature and reference lists of relevant articles were also searched. study selection: All records were screened by two independent reviewers. Primary reports of comparative efficacy, effectiveness, harms, and/or economic evaluations from randomized controlled trials (RCTs) of the CAM therapies in adults (age ≥ 18 years) with back, neck, or thoracic pain were eligible. Non-randomized controlled trials and observational studies (case-control, cohort, cross-sectional) comparing harms were also included. Reviews, case reports, editorials, commentaries or letters were excluded., Data Extraction: Two independent reviewers using a predefined form extracted data on study, participants, treatments, and outcome characteristics., Results: 265 RCTs and 5 non-RCTs were included. Acupuncture for chronic nonspecific low back pain was associated with significantly lower pain intensity than placebo but only immediately post-treatment (VAS: -0.59, 95 percent CI: -0.93, -0.25). However, acupuncture was not different from placebo in post-treatment disability, pain medication intake, or global improvement in chronic nonspecific low back pain. Acupuncture did not differ from sham-acupuncture in reducing chronic non-specific neck pain immediately after treatment (VAS: 0.24, 95 percent CI: -1.20, 0.73). Acupuncture was superior to no treatment in improving pain intensity (VAS: -1.19, 95 percent CI: 95 percent CI: -2.17, -0.21), disability (PDI), functioning (HFAQ), well-being (SF-36), and range of mobility (extension, flexion), immediately after the treatment. In general, trials that applied sham-acupuncture tended to produce negative results (i.e., statistically non-significant) compared to trials that applied other types of placebo (e.g., TENS, medication, laser). Results regarding comparisons with other active treatments (pain medication, mobilization, laser therapy) were less consistent Acupuncture was more cost-effective compared to usual care or no treatment for patients with chronic back pain. For both low back and neck pain, manipulation was significantly better than placebo or no treatment in reducing pain immediately or short-term after the end of treatment. Manipulation was also better than acupuncture in improving pain and function in chronic nonspecific low back pain. Results from studies comparing manipulation to massage, medication, or physiotherapy were inconsistent, either in favor of manipulation or indicating no significant difference between the two treatments. Findings of studies regarding costs of manipulation relative to other therapies were inconsistent. Mobilization was superior to no treatment but not different from placebo in reducing low back pain or spinal flexibility after the treatment. Mobilization was better than physiotherapy in reducing low back pain (VAS: -0.50, 95 percent CI: -0.70, -0.30) and disability (Oswestry: -4.93, 95 percent CI: -5.91, -3.96). In subjects with acute or subacute neck pain, mobilization compared to placebo significantly reduced neck pain. Mobilization and placebo did not differ in subjects with chronic neck pain. Massage was superior to placebo or no treatment in reducing pain and disability only amongst subjects with acute/sub-acute low back pain. Massage was also significantly better than physical therapy in improving back pain (VAS: -2.11, 95 percent CI: -3.15, -1.07) or disability. For subjects with neck pain, massage was better than no treatment, placebo, or exercise in improving pain or disability, but not neck flexibility. Some evidence indicated higher costs for massage use compared to general practitioner care for low back pain. Reporting of harms in RCTs was poor and inconsistent. Subjects receiving CAM therapies reported soreness or bleeding on the site of application after acupuncture and worsening of pain after manipulation or massage. In two case-control studies cervical manipulation was shown to be significantly associated with vertebral artery dissection or vertebrobasilar vascular accident., Conclusions: Evidence was of poor to moderate grade and most of it pertained to chronic nonspecific pain, making it difficult to draw more definitive conclusions regarding benefits and harms of CAM therapies in subjects with acute/subacute, mixed, or unknown duration of pain. The benefit of CAM treatments was mostly evident immediately or shortly after the end of the treatment and then faded with time. Very few studies reported long-term outcomes. There was insufficient data to explore subgroup effects. The trial results were inconsistent due probably to methodological and clinical diversity, thereby limiting the extent of quantitative synthesis and complicating interpretation of trial results. Strong efforts are warranted to improve the conduct methodology and reporting quality of primary studies of CAM therapies. Future well powered head to head comparisons of CAM treatments and trials comparing CAM to widely used active treatments that report on all clinically relevant outcomes are needed to draw better conclusions.

Objectives: This systematic review was undertaken to evaluate which complementary and alternative medicine (CAM) therapies are being used for persons with back pain in the United States., Data Sources: MEDLINE, CINHAHL, EMBASE, and Cochrane Central, and a variety of CAM specific databases were searched from 1990 to November 2007. A grey literature search was also undertaken, particularly for clinical practice guidelines (CPG) related to CAM., Review Methods: Standard systematic review methodology was employed. Eligibility criteria included English studies of adults with back pain, and a predefined list of CAM therapies., Results: A total of 103 publications were evaluated; of these 29 did not present CAM therapy use stratified for back pain. There were a total of 65 utilization studies, 43 of which were American. Four publications evaluated the concurrent use of four or more CAM therapies and these suggest that chiropractic/manipulation is the most frequently used modality followed by massage and acupuncture. A limited number of publications evaluated utilization rates within multiple regions of the back and show that CAM was used least for treating the thoracic spine and most for the low back. However, rates of the use of massage were similar for neck and lower back regions. Concurrent use of different CAM or conventional therapies was not well reported. From 11 eligible CPG, only one (for electro-acupuncture) provided recommendations for frequency of use for low back pain of all acuity levels. Eighteen cost publications were reviewed and all but one publication (cost-effectiveness) were cost identification studies. There is limited information on the impact of insurance coverage on costs and utilization specific to back pain., Conclusions: There are a few studies evaluating the relative utilization of various CAM therapies for back pain. For those studies evaluating utilization of individual CAM therapies, the specific characteristics of the therapy, the providers, and the clinical presentation of the back pain patients were not adequately detailed; nor was the overlap with other CAM or conventional treatments.

Background: Given that herbal medicinal products are widely used, vary greatly in content and quality, and are actively tested in randomized controlled trials (RCTs), such RCTs must clearly report the specifics of the intervention., Objective: Our objective was to develop recommendations for reporting RCTs of herbal medicine interventions., Methods: We identified and invited potential participants with expertise in clinical trial methodology, clinical trial reporting, pharmacognosy, herbal medicinal products, medical statistics, and/or herbal product manufacturing to participate in phone calls and a consensus meeting. Three phases were conducted: (1) Premeeting item generation via telephone calls, (2) Consensus meeting, and (3) Postmeeting feedback. Sixteen experts participated in premeeting phone calls for item generation, and 14 participants attended a consensus meeting in Toronto, Ontario, Canada, in June of 2004. During the consensus meeting, a modified Delphi technique was used to aid discussion and debate of information required for reporting RCTs of herbal medicines., Results: After extensive discussion, the group decided that context-specific elaborations of nine Consolidated Standards of Reporting Trials (CONSORT) items to RCTs of herbal medicines were necessary: Item 1 (Title and Abstract), 2 (Background), 3 (Participants), 4 (Interventions), 6 (Outcomes), 15 (Baseline data), 20 (Interpretation), 21 (Generalizability), and 22 (Overall evidence)., Discussion: The elaboration of item 4 of the CONSORT statement outlines specific information required for complete reporting of the herbal medicine intervention. The reporting suggestions presented will support clinical trialists, editors, and reviewers in reporting and reviewing RCTs of herbal medicines and readers in interpreting the results.

If randomized controlled trials (RCTs) are to fulfill their potential to allow health care providers to make informed inferences about the validity of the trials upon which they base their clinical practice, then the reporting of key methodological factors must improve. The revised Consolidated Standards for Reporting Trials (CONSORT) were developed to improve the suboptimal reporting of RCTs. We aimed to determine the extent to which RCTs report key methodological factors included in the revised CONSORT recommendations following publication of these recommendations. We conducted an observational study of RCTs published between July 2002 and June 2003 in 5 leading general medicine journals. We determined the proportion and 95% confidence intervals of RCTs that reported sequence generation, allocation concealment, randomization implementation, blinding status of participants, health care providers, outcome assessors, and data analysts, sample size justification, method of analysis (e.g. intention-to-treat), and a participant flow diagram. We included a total of 253 RCTs. RCTs reported: sequence generation 80% (95% CI 75-80%), allocation concealment 48% (95% CI 42-54%), randomization implementation 55% (95% CI 49-61%), blinding status of participants 40% (34-46%), health care providers 17% (95% CI 13-22%), outcome assessors 47% (95% CI 41-53%), data analysts 15% (10-19%), sample size justification 83% (95% CI 78-87%), method of analysis 87% (95% CI 83-91%)), and participant flow diagrams 86% (95% CI 82-90%). Although reporting of some CONSORT recommendations is high, reporting of several essential recommendations remains suboptimal. Authors need to comply with and journals need to enforce reporting of the revised CONSORT recommendations.

Background: We aimed to determine if specialist journals implement specific Consolidated Standards for Reporting Trials (CONSORT) recommendations to the same extent as general medical journals., Methods: Analysis of random controlled trials (RCTs) in five general medical journals (n=100) and 10 specialist journals (n=100), all endorsing CONSORT. We evaluated the likelihood of reporting important methodologic criteria. Analyses controlled for the nested effect of journal within each journal type., Results: General medical journals published, on average, more CONSORT items per RCT than specialist journals (7.9 [SD 1.8] vs. 6.5 [SD 2.2] out of 11 possible items, P=.02). When compared with specialist journals, RCTs in general medical journals published a participant flow diagram more frequently (83 vs. 42%, odds ratio [OR] 6.7, 95% confidence interval [CI] 3.4-12.9) and more likely to report the method of randomization (78 vs. 55%, OR 2.9, 95% CI 1.5-5.3) and allocation concealment (48 vs. 26%, OR 2.6, 95% CI 1.4-4.7); they were less likely to publish RCTs reporting adverse events (58 vs. 78%, OR 0.3, 95% CI 0.2-0.7). Both page length and impact factor were weakly associated with number of CONSORT items reported., Conclusion: General medical and specialist journals that endorse CONSORT do not enforce reporting issues consistently, with specialty journals lagging behind general medical journals.

: BACKGROUND: Acupuncture is a commonly used treatment option for the treatment of addictions such as alcohol, nicotine and drug dependence. We systematically reviewed and meta-analyzed the randomized controlled trials of acupuncture for the treatment of cocaine addiction. METHODS: Two reviewers independently searched 10 databases. Unpublished studies were sought using Clinicaltrials.gov, the UK National Research Register and contacting content experts. Eligible studies enrolled patients with the diagnosis of cocaine dependence of any duration or severity randomly allocated to either acupuncture or sham or other control. We excluded studies of acupuncture methods and trials enrolling patients with polysubstance use or dependence. We abstracted data on study methodology and outcomes. We pooled the studies providing biochemical confirmation of cocaine abstinence. RESULTS: Nine studies enrolling 1747 participants met inclusion criteria; 7 provided details for biochemical confirmation of cocaine abstinence. On average, trials lost 50% of enrolled participants (range 0-63%). The pooled odds ratio estimating the effect of acupuncture on cocaine abstinence at the last reported time-point was 0.76 (95% CI, 0.45 to 1.27, P = 0.30, I2 = 30%, Heterogeneity P = 0.19). CONCLUSION: This systematic review and meta-analysis does not support the use of acupuncture for the treatment of cocaine dependence. However, most trials were hampered by large loss to follow up and the strength of the inference is consequently weakened.

Background: Niacin is widely available over the counter (OTC). We sought to determine the safety of 500 mg immediate release niacin, when healthy individuals use them as directed., Methods: 51 female and 17 male healthy volunteers (mean age 27 years SD 4.4) participated in a randomized placebo-controlled blinded trial of a single dose of an OTC, immediate-release niacin 500 mg (n = 33), or a single dose of placebo (n = 35) on an empty stomach. The outcomes measured were self-reported incidence of flushing and other adverse effects., Results: 33 volunteers on niacin (100%) and 1 volunteer on placebo (3%) flushed (relative risk 35, 95% confidence interval (CI) 6.8-194.7). Mean time to flushing on niacin was 18.2 min (95% CI: 12.7-23.6); mean duration of flushing was 75.4 min (95% CI: 62.5-88.2). Other adverse effects occurred commonly in the niacin group: chills (51.5% vs. 0%, P <.0001), generalized pruritus (75% vs. 0%, P = <.001), gastrointestinal upset (30% vs. 3%, P =.005), and cutaneous tingling (30% vs. 0%, P = <.001). Six participants did not tolerate the adverse effects of niacin and 3 required medical attention., Conclusion: Clinicians counseling patients about niacin should alert patients not only about flushing but also about gastrointestinal symptoms, the most severe in this study. They should not trust that patients would receive information about these side effects or their prevention (with aspirin) from the OTC packet insert.