G.J.M.G. van der Heijden

Ultrasound therapy for musculoskeletal disorders : a systematic review

BACKGROUNDnUltrasound therapy is used frequently to reduce pain and related disability, mainly by physiotherapists. The objective of this review was to evaluate the effectiveness of ultrasound therapy in the treatment of musculoskeletal disorders.nnnMETHODSnPublished reports of randomized clinical trials investigating the effects of ultrasound therapy on pain, disability or range of motion were identified by a systematic search of MEDLINE, EMBASE and the Cochrane databases, supplemented with citation tracking. The quality of methods of all selected publications was assessed systematically by two independent and blinded reviewers, using ten validity criteria. Data from the original publications were used to calculate the differences between groups for success rate, pain, disability and range of motion. Statistical pooling was performed if studies were homogeneous with respect to study populations, interventions, outcome measures and timing of follow-up.nnnRESULTSn38 Studies were included in the review, evaluating the effects of ultrasound therapy for lateral epicondylitis (n = 6), shoulder pain (n = 7), degenerative rheumatic disorders (n = 10), ankle distorsions (n = 4), temporomandibular pain or myofacial pain (n = 4) and a variety of other disorders (n = 7). In 11 out of 13 placebo-controlled trials with validity scores of at least five out of ten points, no evidence of clinically important or statistically significant results was found. Statistical pooling was only feasible for placebo-controlled trials on lateral epicondylitis, and produced a pooled estimate for the difference in success rate of 15% (95% confidence interval -8%-38%).nnnCONCLUSIONSnAs yet, there seems to be little evidence to support the use of ultrasound therapy in the treatment of musculoskeletal disorders. The large majority of 13 randomized placebo-controlled trials with adequate methods did not support the existence of clinically important or statistically significant differences in favour of ultrasound therapy. Nevertheless, our findings for lateral epicondylitis may warrant further investigation.

Spinal manipulation for low-back pain: an updated systematic review of randomized clinical trials

Study Design Systematic review of randomized clinical trials. Objectives To assess the efficacy of spinal manipulation for patients with low back pain. Summary of Background Data The management of low back pain remains controversial. Spinal manipulation is a widely used treatment option for low back pain. Recently issued clinical guidelines suggest that spinal manipulation may be effective for patients with acute low back pain. Methods A computer‐aided search for published papers was conducted, and the methods of the studies identified were assessed. Scores were assigned for quality of methods (based on four main categories: study population, interventions, measurement of effect, and data presentation and analysis), the conclusion of authors regarding spinal manipulation, and the results based on the main outcome measure. Results Thirty‐six randomized clinical trials comparing spinal manipulation with other treatments were identified. The highest score of a trial was 60 points (maximum score was set at 100 points), indicating that most were of poor quality. Nineteen studies (53%) showed favorable results for manipulation. In addition, five studies (14%) reported positive results in one or more subgroups only. Among the five studies with 50‐60 points, three were positive, and two were positive only for a subgroup of the study population. Eleven trials compared manipulation with some placebo therapy, with inconsistent results. There appeared to be no clear relation between the methodologic score and the overall outcome of the studies. Twelve trials included patients with acute low back pain only. Of these, five reported positive results, four reported negative results, and three reported positive results in a subgroup of the study population only. There were eight trials comparing manipulation with other conservative treatment modalities, focusing on patients with subacute or chronic low back pain. Of these, five reported positive results, two reported negative results, and in one study no conclusion was presented. There were only 16 studies that included an effect measurement of at least 3 months. In only six of these do the authors report positive effects of manipulation. Conclusions The efficacy of spinal manipulation for patients with acute or chronic low back pain has not been demonstrated with sound randomized clinical trials. There certainly are indications that manipulation might be effective in some subgroups of patients with low back pain. These impressions justify additional research efforts on this topic. Methodologic quality remains a critical aspect that should be dealt with in future studies.

Spinal manipulation and mobilisation for back and neck pain: a blinded review.

OBJECTIVE--To assess the efficacy of spinal manipulation for patients with back or neck pain. DESIGN--Computer aided search for published papers and blinded assessment of the methods of the studies. SUBJECTS--35 randomised clinical trials comparing spinal manipulation with other treatments. MAIN OUTCOME MEASURES--Score for quality of methods (based on four main categories: study population, interventions, measurement of effect, and data presentation and analysis) and main conclusion of author(s) with regard to spinal manipulation. RESULTS--No trial scored 60 or more points (maximum score 100) suggesting that most were of poor quality. Eighteen studies (51%) showed favourable results for manipulation. In addition, five studies (14%) reported positive results in one or more subgroups. Of the four studies with 50-60 points, one reported that manipulation was better, two reported that manipulation was better in only a subgroup, and one reported that manipulation was no better or worse than reference treatment. Eight trials attempted to compare manipulation with some placebo, with inconsistent results. CONCLUSIONS--Although some results are promising, the efficacy of manipulation has not been convincingly shown. Further trials are needed, but much more attention should be paid to the methods of study.

Physiotherapy for patients with soft tissue shoulder disorders: a systematic review of randomised clinical trials.

Abstract Objective: To assess the effectiveness of physiotherapy for patients with soft tissue shoulder disorders. Design: A systematic computerised literature search of Medline and Embase, supplemented with citation tracking, for relevant trials with random allocation published before 1996. Subjects: Patients treated with physiotherapy for disorders of soft tissue of the shoulder. Main outcome measures: Success rates, mobility, pain, functional status. Results: Six of the 20 assessed trials satisfied at least five of eight validity criteria. Assessment of methods was often hampered by insufficient information on various validity criteria, and trials were often flawed by lack of blinding, high proportions of withdrawals from treatment, and high proportions of missing values. Trial sizes were small: only six trials included intervention groups of more than 25 patients. Ultrasound therapy, evaluated in six trials, was not shown to be effective. Four other trials favoured physiotherapy (laser therapy or manipulation), but the validity of their methods was unsatisfactory. Conclusions: There is evidence that ultrasound therapy is ineffective in the treatment of soft tissue shoulder disorders. Due to small trial sizes and unsatisfactory methods, evidence for the effectiveness of other methods of physiotherapy is inconclusive. For all methods of treatment, trials were too heterogeneous with respect to included patients, index and reference treatments, and follow up to merit valid statistical pooling. Future studies should show whether physiotherapy is superior to treatment with drugs, steroid injections, or a wait and see policy. Key messages Because of the small sample sizes and unsatisfactory methods of most trials, only a few randomised clinical trials of methods of physiotherapy in patients with soft tissue shoulder disorders allow firm conclusions on effectiveness of treatment When compared with placebo or another treatment, ultrasound therapy seems ineffective in patients with shoulder disorders Evidence is insufficient to support the effectiveness of low level laser therapy, heat treatment, cold therapy, electrotherapy, exercise, and mobilisation in such patients Future trials should focus on the effectiveness of exercise and mobilisation in comparison to analgesics, non-steroidal drugs, steroid injections, and advice and a wait and see policy Special attention should also be given to the principles of adequate design and conduct of trials and the standards of reporting

Methodological Quality of Randomized Clinical-Trials on Treatment Efficacy in Low-Back-Pain

Study Design This was a review of criteria-based meta-analyses. Objectives To assess the methodological quality of published randomized clinical trials on the efficacy of commonly used interventions in low back pain. Summary of Background Data During the last several decades, the number of published randomized clinical trials regarding low back pain has continued to grow. For some interventions, considerable numbers of trials are available. Trials have been shown to vary substantially regarding their quality. Methods A computer-aided search was conducted of published randomized clinical trials into the efficacy of spinal manipulation and mobilization, exercise therapy, back schools, bed rest, orthoses, and traction therapy. There was additional screening of journals not covered by Mediline and Embase. The methodological quality of the studies was assessed using a set of predefined criteria. Results Sixty-nine different randomized clinical trials were identified. Methodological secores varied between 16 and 82 points (maximum was 100 points). Methodological quality tended to be associated with the outcomes of the studies. Methodological shortcomings were frequently found-e. g., small sample sizes, no description of the randomization procedure, no description of drop-outs, no placebo-control group, and lack of blinded outcome assessments. Conclusions Although a considerable number of randomized clinical trials have been carried out to evaluate the effecacy of interventions in low back pain, their methodological quality appears to be disappointingly low. Future trials are clearly needed, but much more attention should be paid to the methods of such studies.

Adverse events of low- to medium-dose oral glucocorticoids in inflammatory diseases: a meta-analysis

Objectives: To systematically analyse the literature on reported adverse events of low- to medium-dose glucocorticoids during ⩾1 month for inflammatory diseases. Methods: Data were systematically retrieved and selected from PUBMED, EMBASE and CINAHL databases (6097 hits). Results: A total of 28 studies (2382 patients) met the inclusion criteria. The risk of adverse events over all studies was 150 per 100 patient-years (95% confidence interval (CI) 132 to 169). Psychological and behavioural adverse events (eg, minor mood disturbances) were most frequently reported, followed by gastrointestinal events (eg, dyspepsia, dysphagia). In 14 studies comprising 796 patients with rheumatoid arthritis the risk of adverse events was 43/100 patient-years (95% CI 30 to 55), in 4 studies of 167 patients with polymyalgia rheumatica the risk of adverse events was 80/100 patient-years (95% CI 15 to146), and in 10 studies of 1419 patients with inflammatory bowel disease the risk of adverse events was 555/100 patient-years (95% CI 391 to 718). High rates of adverse events were reported in high-quality studies with short follow-up, notably in studies of patients with inflammatory bowel disease. Conclusions: The risk of adverse events depends on study design and disease. Studies on inflammatory bowel disease were often of short duration with frequent documentation of adverse events which resulted in higher adverse event rates whereas, in studies of rheumatoid arthritis, the longer follow-up may have resulted in lower adverse event rates. In most studies aimed at efficacy of glucocorticoids or other drugs, adverse events were not systematically assessed. Clear guidelines on assessment of adverse events are lacking.

The responsiveness of the Shoulder Disability Questionnaire

Objective—To evaluate the responsiveness of the Shoulder Disability Questionnaire (SDQ). Methods—The study was conducted within the framework of an observational study on shoulder disorders in primary care. After first presentation of their complaints to the general practitioner and after one and six months, participants completed the SDQ, a single question on functional status (FSQ), and an ordinal 11 point scale for the severity of pain (PSS). Responsiveness of the SDQ was evaluated compared with that of the FSQ and PSS, by calculating responsiveness ratios and by plotting receiver operating characteristic (ROC) curves. Recovery according to the patient was used as an external criterion for clinically relevant improvement (complete recovery or much improved on a six point Likert scale was denoted as clinically relevant improvement). Results—A total of 349 consecutive patients with shoulder disorders were enrolled in the observational study. Response rates ranged between 96% and 89%. Responsiveness ratios were slightly higher for the PSS compared with the SDQ (2.53 versus 2.22 at one month, 2.24 versus 1.89 at six months). The area under the ROC curve was 0.84 for both the SDQ and the PSS, and 0.72 for the FSQ. Conclusion—The results of this study confirm the responsiveness of the SDQ, making it a useful instrument to assess functional disability in longitudinal studies.

No effect of bipolar interferential electrotherapy and pulsed ultrasound for soft tissue shoulder disorders: a randomised controlled trial

OBJECTIVE To assess the efficacy of bipolar interferential electrotherapy (ET) and pulsed ultrasound (US) as adjuvants to exercise therapy for soft tissue shoulder disorders (SD). METHODS Randomised placebo controlled trial with a two by two factorial design plus an additional control group in 17 primary care physiotherapy practices in the south of the Netherlands. Patients with shoulder pain and/or restricted shoulder mobility, because of a soft tissue impairment without underlying specific or generalised condition, were enrolled if they had not recovered after six sessions of exercise therapy in two weeks. They were randomised to receive (1) active ET plus active US; (2) active ET plus dummy US; (3) dummy ET plus active US; (4) dummy ET plus dummy US; or (5) no adjuvants. Additionally, they received a maximum of 12 sessions of exercise therapy in six weeks. Measurements at baseline, 6 weeks and 3, 6, 9, and 12 months later were blinded for treatment. Outcome measures: recovery, functional status, chief complaint, pain, clinical status, and range of motion. RESULTS After written informed consent 180 patients were randomised: both the active treatments were given to 73 patients, both the dummy treatments to 72 patients, and 35 patients received no adjuvants. Prognosis of groups appeared similar at baseline. Blinding was successfully maintained. At six weeks seven patients (20%) without adjuvants reported very large improvement (including complete recovery), 17 (23%) and 16 (22%) with active and dummy ET, and 19 (26%) and 14 (19%) with active and dummy US. These proportions increased to about 40% at three months, but remained virtually stable thereafter. Up to 12 months follow up the 95% CI for differences between groups for all outcomes include zero. CONCLUSION Neither ET nor US prove to be effective as adjuvants to exercise therapy for soft tissue SD.

Adenotonsillectomy for upper respiratory infections: Evidence based?

Background: Despite high rates of (adeno)tonsillectomy for upper respiratory infections in western countries, the medical literature offers the physician little support in deciding which child might benefit from the operation. Methods: A literature search was performed to identify randomised trials and non-randomised controlled studies into the efficacy of tonsillectomy with or without adenoidectomy in children under 18 years. For the outcomes sore throat episodes, sore throat associated school absence, and upper respiratory infections, pooled estimates of the incidence rate ratios and rate differences with 95% confidence intervals were calculated, assuming a Poisson distribution. Results: Six randomised trials and seven non-randomised controlled studies on the efficacy of adenotonsillectomy in children were evaluated. For sore throat episodes data for 2483 person-years were available. The pooled risk difference was −1.2 episodes per person-year (95% CI −1.3 to −1.1). For sore throat associated school absence 1669 person-years were analysed. The pooled risk difference was −2.8 days per person-year (95% CI −3.9 to −1.6). For upper respiratory infections 1596 person-years were available. The pooled risk difference was −0.5 episodes per person-year (95% CI −0.7 to −0.3). Conclusions: All available randomised trials and non-randomised controlled studies into the efficacy of (adeno)tonsillectomy had important limitations. The frequency of sore throat episodes and upper respiratory infections reduces with time whether (adeno)tonsillectomy has been performed or not. (Adeno)tonsillectomy gives an additional, but small, reduction of sore throat episodes, days of sore throat associated school absence, and upper respiratory infections compared to watchful waiting

Systematic review shows lowered risk of nonunion after reamed nailing in patients with closed tibial shaft fractures.

Nonunion after intramedullary nailing (IMN) in patients with tibial shaft fractures occurs up to 16%. There is no agreement whether reaming prior to IMN insertion would reduce the nonunion rate. We aimed to compare the nonunion rate between reamed and unreamed IMN in patients with tibial shaft fractures. A systematic search was conducted in Pubmed, Embase, and the Cochrane Library. The selected publications were: (1) randomised controlled trials; (2) comparing the nonunion rate; (3) in patients with tibial shaft fractures; (4) treated with either reamed or unreamed IMN. Seven studies that satisfied the criteria were identified. They showed that reamed IMN led to reduction of nonunion rate compared to unreamed IMN in closed tibial shaft fractures (risk difference ranging 7.0-20%, number needed to treat ranging 5-14), while the difference between compared treatments for open tibial shaft fractures was not clinically relevant. The evidence showed a consistent trend of reduced nonunion rate in closed tibial shaft fracture treated with reamed compared to unreamed IMN.