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Background: Injection with anaesthetics and/or steroids is one of the treatment modalities used in patients with chronic low back pain which needs evaluation with respect to the effectiveness on short and long term pain relief., Objectives: To evaluate the effectiveness of injection therapy in patients with low back pain lasting longer than one month. We distinguished between three injection sites: facet joint, epidural or local injections., Search Strategy: We searched the Medline and Embase databases up to 1996 and other search methods as advocated by the Back Review Group search strategy. Abstracts and unpublished studies were not included., Selection Criteria: Randomized controlled trials of injection therapy for pain relief (although additional treatments were allowed) in patients with benign low back pain lasting longer than one month and not originating from cancer., Data Collection and Analysis: Two reviewers independently assessed the trials for methodological quality. Subgroup analyses were made between trials with different control groups (placebo and active injections), with different injection site (facet joint, epidural and local injection), and timing of outcome measurement (short and long term). Within the resulting 12 subcategories of studies (2*3*2), the overall relative risks and corresponding 95% confidence intervals were estimated, using a random effects model (DerSimonian and Laird). In the case of trials in which control groups were active injections, we refrained from pooling the results., Main Results: Twenty-one randomized trials were included in this review. All studies involved patients with low back pain lasting longer than one month. Only 11 studies compared injection therapy with placebo injections (explanatory trials). The methodologic quality of many studies was low: only 8 studies had a methodologic score of 50 or more points. There were only three well designed explanatory clinical trials: one on injections into the facet joints with a short-term RR of 0.89 (95% CI: 0.65-1.21) and a long-term RR of 0.90 (95% CI: 0.69-1.17); one on epidural injections with a short-term RR of 0.94 (95% CI: 0.76-1.15) and a long-term RR of 1.00 (95% CI: 0.71-1.41); and one on local injections with a long-term RR of 0.79 (95% CI: 0.65-0.96). Within the 6 subcategories of explanatory studies the pooled RRs with 95% confidence intervals were: facet joint, short-term: RR=0.89 (0.65-1.21); facet joint, long-term: RR=0.90 (0.69-1.17); epidural, short-term: RR=0.93 (0. 79-1.09); epidural, long-term: RR=0.92 (0.76-1.11); local, short-term: RR=0.80 (0.40-1.59); local, long-term: RR=0.79 (0.65-0. 96)., Reviewer's Conclusions: Convincing evidence is lacking on the effects of injection therapies for low back pain. There is a need for more, well designed explanatory trials in this field.

To evaluate the effect of physiotherapy after partial arthroscopic meniscectomy, we performed a prospective, randomised and partially blinded study. This pilot study was performed from October 1996 to June 1997. The control group received the standard treatment, consisting of verbal and written advice and exercises. The physiotherapy group performed exercises according to a dynamic protocol under the supervision of a physiotherapist. During a 3-week period, nine treatment sessions were given of 30 min each. Twenty patients, who had undergone arthroscopic meniscectomy without any other pathology of the knee, were randomised into two groups of ten patients each. The effects of therapy were evaluated by a blinded observer. We measured the distance and height of one-leg jumps (hops), the VAS pain scale, the Tegner and Lysholm scores and the SARS/FORS score. Recovery and satisfaction with the treatment were also evaluated. The effect measurements were performed at 7 (T1), 14 (T2), 21 (T3) and 28 days (T4) following surgery. Statistical analysis was performed with the Student's t-test. The physiotherapy group showed significantly better results than the control group regarding the SARS score, the hop test and the distance jumps. Moreover, the measurements showed clear progression in favour of the physiotherapy group. In conclusion, exercising under the supervision of a physiotherapist led to high patient satisfaction and good functional rehabilitation after partial arthroscopic meniscectomy.

Most systematic reviews rely substantially on the assessment of the methodological quality of the individual trials. The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of randomized clinical trials (RCTs). The invited participants were experts in the field of quality assessment of RCTs. The initial item pool contained all items from existing criteria lists. Subsequently, we reduced the number of items by using the Delphi consensus technique. Each Delphi round comprised a questionnaire, an analysis, and a feedback report. The feedback report included staff team decisions made on the basis of the analysis and their justification. A total of 33 international experts agreed to participate, of whom 21 completed all questionnaires. The initial item pool of 206 items was reduced to 9 items in three Delphi rounds. The final criteria list (the Delphi list) was satisfactory to all participants. It is a starting point on the way to a minimum reference standard for RCTs on many different research topics. This list is not intended to replace, but rather to be used alongside, existing criteria lists.

Objective: To test the efficacy of low-level laser therapy on lateral ankle sprains as an addition to a standardized treatment regimen, a trial was conducted in which high-dose laser (5J/cm2), low-dose laser (0.5J/cm2), and placebo laser therapy (0J/cm2) at skin level were compared., Design: Randomized, double-blind, controlled clinical trial with a follow-up of 1 year. Patients, therapists, assessors, and analysts were blinded to the assigned treatment., Setting: An ambulatory care setting., Patients: After informed consent and verification of exclusion criteria, 217 patients with acute lateral ankle sprains were randomized to three groups from September 1, 1993, through December 31, 1995., Interventions: Twelve treatments of 904nm laser therapy in 4 weeks as an adjunct to a standardized treatment regimen of 4 weeks of brace therapy combined with standardized home exercises and advice. The laser therapy device used was a 904nm Ga-As laser, with 25-watt peak power and 5,000 or 500Hz frequency, a pulse duration of 200nsec, and an irradiated area of 1cm2., Primary Outcome Measures: Pain and function as reported by the patient., Results: Intention-to-treat analysis of the short-term results showed no statistically significant difference on the primary outcome measure, pain (p = .41), although the placebo group showed slightly less pain. Function was significantly better in the placebo group at 10 days (p = .01) and 14 days (p = .03) after randomization. The placebo group also performed significantly better on days of sick leave (p = .02) and at some points for hindrance in activities in daily life and pressure pain, as well as subjective recovery (p = .05). Intention-to-treat analysis showed that total days of absenteeism from work and sports were remarkably lower in the placebo group than in the laser groups, ranging from 3.7 to 5.3 and 6 to 8 days, respectively. The total number of relapses at 1 year in the low-dose laser group (n = 22) was significantly higher (p = .04) than in the other two groups (high laser, n = 13; placebo, n = 13). Subgroup analysis to correct for possible confounders did not alter these findings., Conclusions: Neither high- nor low-dose laser therapy is effective in the treatment of lateral ankle sprains.

Objective: To assess the efficacy of physical therapies for first-line use in the treatment and prevention of stress urinary incontinence (SUI) in women, using a systematic review of randomized clinical trials (RCTs)., Materials and Methods: A computer-aided and manual search for published RCTs investigating treatment and prevention of SUI using physical therapies, e.g. pelvic floor muscle (PFM) exercises, with or without other treatment modalities, were carried out. The methodological quality of the included trials was assessed using criteria based on generally accepted principles of interventional research., Results: Twenty-four RCTs (22 treatment and two prevention) were identified; the methodological quality of the studies included was moderate and 11 RCTs were of sufficient quality to be included in further analysis. Based on levels-of-evidence criteria, there is strong evidence to suggest that PFM exercises are effective in reducing the symptoms of SUI. There is limited evidence for the efficacy of high-intensity vs a low-intensity regimen of PFM exercises. Despite significant effects of biofeedback after testing as an adjunct to PFM exercises, there is no evidence that PFM exercises with biofeedback are more effective than PFM exercises alone. There is little consistency (of stimulation types and parameters) in the studies of electrical stimulation, but when the results are combined there is strong evidence to suggest that electrostimulation is superior to sham electrostimulation, and limited evidence that there is no difference between electrostimulation and other physical therapies. In the prevention of SUI the efficacy of PFM exercises, with or without other adjuncts, is uncertain.

This study investigates aspects of the reliability of the Maastricht criteria list for quality assessment in systematic reviews, and whether blinded reviewing is necessary to prevent review bias. We used the data set of 12 articles from a systematic review concerning the efficacy of balneotherapy in patients with arthritis. Twenty reviewers participated of which two reviewers, who have been involved in developing the Maastricht criteria list, acted as reference standard. Half of all assessments were performed blindly. A high level of agreement was found between the reviewers and a high level of correlation with the reference standard. The quality scores between the blinded and unblinded assessment did not differ much. Based on the results we conclude that the Maastricht criteria list is a reliable instrument in quality assessment of clinical trials. Within the limits of this study we found no evidence that blinding is necessary to prevent review bias.

Objective: To review English, French, German, and Dutch language studies of the effectiveness of balneotherapy. Balneotherapy (hydrotherapy or spa therapy) is one of the oldest forms of therapy for patients with arthritis. One of the aims of balneotherapy is to relieve pain., Methods: We performed a systematic review that included randomized and nonrandomized studies. Quality scores of the studies were determined using a criteria list., Results: Most studies report positive findings, but all studies showed methodological flaws. A quality of life measurement was never reported as an outcome measure. None of the randomized clinical trials included intention-to-treat analysis or comparison of effects between groups., Conclusion: Because of the methodological flaws a conclusion about the efficacy of balneotherapy cannot be provided from studies we reviewed. We conclude that most flaws found could be avoidable in future research.

Objective: To determine the ability of two diagnostic tests that examine sensory disturbance in whiplash patients to discriminate between 'extreme' groups., Background: The neuromuscular theories have been accepted as explanations of the symptoms after a whiplash injury. Dutch manual therapists often use the diagnostic tests under study to diagnose and treat sensory disturbances after such an injury. The validity of a test needs to be assessed before its efficacy as a treatment in whiplash patients can be tested. The aim of this study was to validate two diagnostic tests and to initiate further research on the efficacy of a treatment of a sensory disturbance in whiplash patients., Method: Twelve subjects with chronic symptoms (> 3 months) after a whiplash injury (patient group) and 18 subjects without any head or neck problems (control group) were studied. The tests under study were the extension test and the coordination test. All researchers were blind to the characteristics of the subjects., Results: The extension test and the coordination test were able to discriminate adequately between subjects with symptoms after a whiplash injury (patients) and subjects without any head or neck complaints (control subjects). Patients clearly show a smaller degree of extension compared with the control subjects and an increase of extension movement with external fixation. The sensitivity as well as the specificity of the coordination test were good (both > .80)., Conclusion: These diagnostic tests seemed to be valid instruments for discriminating between whiplash patients with symptoms and healthy people.

Background and Purpose: The purposes of this study were to determine whether a Dutch translation of the Quebec Back Pain Disability Scale (QBPDS) retains the high levels of reliability and validity of the original English version and to determine whether it is therefore more practical to translate this scale, and possibly other scales, than to generate language- and culture-specific instruments., Subjects: Subjects were 120 individuals with chronic low back pain., Methods: The QBPDS was filled out at the beginning of the study, after 1 week, and after 4 months. Reliability was determined by calculating Pearson correlation coefficients and intraclass correlation coefficients in addition to Cronbach's alpha and item-total correlation at the beginning of the study and after 4 months. Validity was examined by correlating the QBPDS scores to external criteria scores at a single point in time (cross-sectional) and over a period of time (longitudinal)., Results: Pearson and intraclass correlation coefficients for test-retest reliability were .90. Cronbach's alpha was .95. The cross-sectional construct validity coefficients were .80 (RDQ) and .70 (pain severity). The longitudinal construct validity coefficients were .60 (RDQ), .53 (pain severity), and .35 (course of the complaint)., Conclusion and Discussion: Our results support previous findings of the English and French versions of the QBPDS. Whether this instrument can be used as an evaluative instrument remains unknown.

Unlabelled: We performed a randomized clinical trial on the efficacy of physical therapy on genuine stress incontinence., Study Objective: "Is a physical therapeutical training program (pelvic floor muscle training) combined with biofeedback, more effective than the same program without biofeedback in patients with mild or moderate stress incontinence?" Forty-four patients were referred by a general practitioner or a urologist. After informed consent, 40 patients were randomized in an exercises and biofeedback group (BF), or treated with exercises exclusively (pelvic floor muscle training = PFMT). After a diagnostic phase of 1 week every patient received twelve treatment sessions, three times weekly. The primary measure of effect, the quantity of involuntary urine loss, was measured with the 48 hours PAD test (Inco-test Mölnlycke). Before every treatment session the Symptoms questionnaire was filed out by the patient and the Patient dairy was controlled. The data of the trial were analysed according to the principal of intention to treat. During the trial there was 100% compliance. There were no drop-outs. Both treatment modalities appeared to be effective. After twelve treatment sessions there was a mean improvement of +/- 55% (P = 0.00) in both treatment groups, measured by the primary measure of effect. In the group with BF this improvement was already realized after six treatment sessions (P = 0.01). Yet, the difference between BF and PFMT faded to reach significance at six treatment sessions (P = 0.08). Although differences in treatment effects between both groups were not significant, our findings suggest that adding biofeedback to pelvic floor muscle exercises might be more effective than pelvic floor muscle exercises alone after six treatments.

In order to summarize the available clinical evidence for the efficacy of physiotherapy, 400 randomized clinical trials were identified from the literature. Studies were found by using bibliographic databases, citation tracking, and correspondence with researchers in the field. Focusing on disorders of the musculoskeletal system, a number of criterion based meta-analyses were performed on 180 trials in order to summarize the available evidence. For each randomized clinical trial in each meta-analysis a methodological score was calculated using a set of explicit criteria and weighting factors applied by two or three independent reviewers who were blinded as to the outcomes, the journal and the authors of the publication. In each meta-analysis the randomized clinical trials were ordered hierarchically depending on their score for methodological quality. Meta-analyses were performed for spinal manipulation, exercise therapy, traction, ultrasound, and laser therapy, and for disorders of the back, neck, shoulder and knee. In general, the methodological quality of the studies appeared to be low, and the efficacy of physiotherapy was shown to be convincing for only a few indications and treatments. On the other hand, because of the prevalence of serious methodological flaws, it cannot be concluded that physiotherapy has no effect.

The efficacy of laser therapy for musculoskeletal and skin disorders has been assessed on the basis of the results of 36 randomized clinical trials (RCTs) involving 1,704 patients. For this purpose, a criteria-based meta-analysis that took into account the methodological quality of the individual trials was used. The studies with a positive outcome were generally of a better quality than the studies with a negative outcome. No clear relationship could be demonstrated between the laser dosage applied and the efficacy of laser therapy, or between the dosage and the methodological score. In general, the methodological quality of these studies appeared to be rather low. Consequently, no definite conclusions can be drawn about the efficacy of laser therapy for skin disorders. The efficacy of laser therapy for musculoskeletal disorders seems, on average, to be larger than the efficacy of a placebo treatment. More specifically, for rheumatoid arthritis, posttraumatic joint disorders, and myofascial pain, laser therapy seems to have a substantial specific therapeutic effect. Further RCTs, avoiding the most prevalent methodological errors, are needed in order to enable the benefits of laser therapy to be more precisely and validly evaluated.