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B Shea

Publications and source records attributed to B Shea.

At least 19 recordsLinked to original sources

Low level laser therapy (Classes I, II and III) for treating rheumatoid arthritis.

BACKGROUND: Rheumatoid arthritis (RA) affects a large proportion of the population. Low Level Laser Therapy (LLLT) was introduced as an alternative non-invasive treatment for RA about ten years ago. LLLT is a light source that generates extremely pure light, of a single wavelength. The effect is not thermal, but rather related to photochemical reactions in the cells. The effectiveness of LLLT for rheumatoid arthritis is still controversial. This review is an update of the original review published in October 1998. OBJECTIVES: To assess the effectiveness of LLLT in the treatment of RA. SEARCH STRATEGY: We initially searched MEDLINE, EMBASE (from 1998), the registries of the Cochrane Musculoskeletal Group and the field of Rehabilitation and Related Therapies as well as the Cochrane Central Register of Controlled Trials (CENTRAL) up to June 2001. This search has now been updated to include articles published up to June 2005. SELECTION CRITERIA: Following an a priori protocol, only randomized controlled trials of LLLT for the treatment of patients with a clinical diagnosis of RA were eligible. Abstracts were excluded unless further data could be obtained from the authors. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials for inclusion, then extracted data and assessed quality using predetermined forms. Heterogeneity was tested using chi-squared. A fixed effects model was used throughout for continuous variables, except where heterogeneity existed, in which case, a random effects model was used. Results were analyzed as weighted mean differences (WMD) with 95% confidence intervals (CI), where the difference between the treated and control groups was weighted by the inverse of the variance. Dichotomous outcomes were analyzed with relative risks. MAIN RESULTS: A total of 222 patients were included in the five placebo-controlled trials, with 130 randomized to laser therapy. Relative to a separate control group, LLLT reduced pain by 1.10 points (95% CI: 1.82, 0.39) on visual analogue scale relative to placebo, reduced morning stiffness duration by 27.5 minutes (95%CI: 2.9 to 52 minutes) and increased tip to palm flexibility by 1.3 cm (95% CI: 0.8 to 1.7). Other outcomes such as functional assessment, range of motion and local swelling did not differ between groups. There were no significant differences between subgroups based on LLLT dosage, wavelength, site of application or treatment length. For RA, relative to a control group using the opposite hand, there was no difference observed between the control and treatment hand for morning stiffness duration, and also no significant improvement in pain relief RR 13.00 (95% CI: 0.79 to 214.06). However, only one study was included as using the contralateral limb as control. . AUTHORS' CONCLUSIONS: LLLT could be considered for short-term treatment for relief of pain and morning stiffness for RA patients, particularly since it has few side-effects. Clinicians and researchers should consistently report the characteristics of the LLLT device and the application techniques used. New trials on LLLT should make use of standardized, validated outcomes. Despite some positive findings, this meta-analysis lacked data on how LLLT effectiveness is affected by four important factors: wavelength, treatment duration of LLLT, dosage and site of application over nerves instead of joints. There is clearly a need to investigate the effects of these factors on LLLT effectiveness for RA in randomized controlled clinical trials.

Arthritis, Rheumatoid↗

Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain.

BACKGROUND: Chronic low-back pain (LBP) affects a significant proportion of the population. Transcutaneous electrical nerve stimulation (TENS) was introduced more than 30 years ago as an adjunct to the pharmacological management of pain. However, despite its widespread use, the usefulness of TENS in chronic LBP is still controversial. OBJECTIVES: The aim of this systematic review was to determine the effectiveness of TENS in the management of chronic LBP. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (Issue 2, 2005), MEDLINE, EMBASE and PEDro up to April 1, 2005. SELECTION CRITERIA: Only randomized controlled clinical trials (RCTs) evaluating the effect of TENS on chronic LBP were included. Abstracts were excluded unless further data could be obtained from the authors. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials and extracted data using predetermined forms. Heterogeneity was tested with Cochrane's Q test. A fixed effect model was used throughout for calculating continuous variables, except where heterogeneity existed, in which case, a random effects model was used. Results are presented as weighted mean differences (WMD) with 95% confidence intervals (95% CI), where the difference between the treated and control groups was weighted by the inverse of the variance. Standardized mean differences (SMD) were calculated by dividing the difference between the treated and control by the baseline variance. SMD were used when different scales were used to measure the same concept. Dichotomous outcomes were analyzed with odds ratios. MAIN RESULTS: The only two RCTs (175 patients) meeting eligibility criteria differed in study design, methodological quality, inclusion and exclusion criteria, type and method of TENS application, treatment schedule, co-interventions and final outcomes. In one RCT, TENS produced significantly greater pain relief than the placebo control. However, in the other RCT, no statistically significant differences between treatment and control groups were shown for multiple outcome measures. Pre-planned subgroup analyses, intended to examine the impact of different stimulation parameters, sites of TENS application, treatment durations and baseline patient characteristics were not possible due to the small number of included trials. AUTHORS' CONCLUSIONS: There is inconsistent evidence to support the use of TENS as a single treatment in the management of chronic LBP. Larger, multi-center, randomized controlled trials are needed to better assess the true effectiveness of TENS. Special attention should be given to the risks and benefits of long-term use, which more appropriately addresses the realities of managing chronic low-back pain.

Chronic Disease↗

Glucosamine therapy for treating osteoarthritis.

BACKGROUND: Osteoarthritis (OA) is the most common form of arthritis, and it is often associated with significant disability and an impaired quality of life. OBJECTIVES: To review all randomized controlled trials (RCTs) evaluating the effectiveness and toxicity of glucosamine in OA. SEARCH STRATEGY: We searched MEDLINE, PREMEDLINE, EMBASE, AMED, ACP Journal Club, DARE, CDSR, and the CCTR. We also wrote letters to content experts, and hand searched reference lists of identified RCTs and pertinent review articles. All searches were updated in January 2005. SELECTION CRITERIA: Relevant studies met the following criteria: 1) RCTs evaluating the effectiveness and safety of glucosamine in OA, 2) Both placebo controlled and comparative studies were eligible, 3) Both single blinded and double blinded studies were eligible. DATA COLLECTION AND ANALYSIS: Data abstraction was performed independently by two investigators and the results were compared for degree of agreement. Gotzsche's method and a validated tool (Jadad 1996) were used to score the quality of the RCTs. Continuous outcome measures were pooled using standardized mean differences (SMD) as the measure of effect size. Dichotomous outcome measures were pooled using relative risk ratios (RR). MAIN RESULTS: Analysis restricted to eight studies with adequate allocation concealment failed to show benefit of glucosamine for pain and WOMAC function. Collectively, the 20 analyzed RCTs found glucosamine favoured placebo with a 28% (change from baseline) improvement in pain (SMD -0.61, 95% CI -0.95, -0.28) and a 21% (change from baseline) improvement in function using the Lequesne index (SMD -0.51 95% CI -0.96, -0.05). However, the results are not uniformly positive, and the reasons for this remain unexplained. WOMAC pain, function and stiffness outcomes did not reach statistical significance. In the 10 RCTs in which the Rotta preparation of glucosamine was compared to placebo, glucosamine was found to be superior for pain (SMD -1.31, 95% CI -1.99, -0.64) and function using the Lequesne index (SMD -0.51, 95% CI -0.96, -0.05). Pooled results for pain (SMD -0.15, 95% CI -0.35, 0.05) and function using the WOMAC index (SMD 0.03, 95% CI -0.18, 0.25) in those RCTs in which a non-Rotta preparation of glucosamine was compared to placebo did not reach statistical significance. In the four RCTs in which the Rotta preparation of glucosamine was compared to an NSAID, glucosamine was superior in two, and equivalent in two. Two RCTs using the Rotta preparation showed that glucosamine was able to slow radiological progression of OA of the knee over a three year period (SMD 0.24, 95% CI 0.04, 0.43). Glucosamine was as safe as placebo in terms of the number of subjects reporting adverse reactions (RR=0.97, 95% CI, 0.88, 1.08). AUTHORS' CONCLUSIONS: This update includes 20 studies with 2570 patients. Pooled results from studies using a non-Rotta preparation or adequate allocation concealment failed to show benefit in pain and WOMAC function while those studies evaluating the Rotta preparation show that glucosamine was superior to placebo in the treatment of pain and functional impairment resulting from symptomatic OA. WOMAC outcomes of pain, stiffness and function did not show a superiority of glucosamine over placebo for both Rotta and non-Rotta preparations of glucosamine. Glucosamine was as safe as placebo.

Adult↗

Low level laser therapy (Classes I, II and III) for treating osteoarthritis.

BACKGROUND: Osteoarthritis (OA) affects a large proportion of the population. Low Level Laser Therapy (LLLT) is a light source that generates extremely pure light, of a single wavelength. The effect is not thermal, but rather related to photochemical reactions in the cells. LLLT was introduced as an alternative non-invasive treatment for OA about 20 years ago, but its effectiveness is still controversial. OBJECTIVES: To assess the effectiveness of LLLT in the treatment of OA. SEARCH STRATEGY: We searched MEDLINE, EMBASE, the Cochrane Musculoskeletal registry, the registry of the Rehabilitation and Related Therapies field and the Cochrane Controlled Trials Register up to January 30, 2004. SELECTION CRITERIA: Following an a priori protocol, only controlled clinical trials of LLLT for the treatment of patients with a clinical diagnosis of OA were eligible. Abstracts were excluded unless further data could be obtained from the authors. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials and abstracted data using predetermined forms. Heterogeneity was tested with Cochran's Q test. A fixed effects model was used throughout for continuous variables, except where heterogeneity existed, in which case, a random effects model was used. Results were analyzed as weighted mean differences (WMD) with 95% confidence intervals (CI), where the difference between the treated and control groups was weighted by the inverse of the variance. Standardized mean differences (SMD) were calculated by dividing the difference between treated and control by the baseline variance. SMD were used when different scales were used to measure the same concept (e.g. pain). Dichotomous outcomes were analyzed with odds ratios. MAIN RESULTS: Seven trials were included, with 184 patients randomized to laser, 161 patients to placebo laser. Treatment duration ranged from 4 to 12 weeks. Pain was assessed by four trials. The pooled estimate (random effects) of three trials showed no effect on pain measured using a scale (SMD: -0.2, 95% CI: -1.0, +0.6), but there was statistically significant heterogeneity (p>0,05). Three of the trials showed no effect and two demonstrated very beneficial effects with laser. In another trial, with no scale-based pain outcome, significantly more patients reported pain relief (yes/no) with laser with an odds ratio of 0.05, (95% CI: 0.0 to 1.56). Only one study found significant results for increased knee range of motion (WMD: -10.62 degrees, 95% CI: -14.07,-7.17). Other outcomes of joint tenderness and strength were not significant. Lower dosage of LLLT was found as effective than higher dosage for reducing pain and improving knee range of motion. REVIEWERS' CONCLUSIONS: For OA, the results are conflicting in different studies and may depend on the method of application and other features of the LLLT application. Clinicians and researchers should consistently report the characteristics of the LLLT device and the application techniques used. New trials on LLLT should make use of standardized, validated outcomes. Despite some positive findings, this meta-analysis lacked data on how LLLT effectiveness is affected by four important factors: wavelength, treatment duration of LLLT, dosage and site of application over nerves instead of joints. There is clearly a need to investigate the effects of these factors on LLLT effectiveness for OA in randomized controlled clinical trials.

Hand↗

Calcium supplementation on bone loss in postmenopausal women.

BACKGROUND: Although calcium is one the simplest and least expensive strategies for preventing osteoporotic fractures calcium supplementation is nevertheless not without controversy (Kanis 1989; Nordin 1990). The Food and Drug Administration in the US has permitted a bone health claim for calcium-rich foods, and the NIH in its Consensus Development Process approved a statement that high calcium intake reduces the risk of osteoporosis. OBJECTIVES: To assess the effects of calcium on bone density and fractures in postmenopausal women. SEARCH STRATEGY: We searched Cochrane Controlled Register, MEDLINE and EMBASE up to 2001, and examined citations of relevant articles and proceedings of international meetings. SELECTION CRITERIA: Trials that randomized postmenopausal women to calcium supplementation or usual calcium intake in the diet and reported bone mineral density of the total body, vertebral spine, hip, or forearm or recorded the number of fractures, and followed patients for at least one year were considered for inclusion. DATA COLLECTION AND ANALYSIS: Three independent reviewers assessed the methodologic quality and extracted data for each trial. For each bone density site (lumbar spine, total body, combined hip and combined forearm), we calculated the weighted mean difference in bone density between treatment and control groups using the percentage change from baseline. We constructed regression models in which the independent variables were year and dose, and the dependent variable was the effect size. This regression was used to determine the years across which pooling was appropriate. Heterogeneity was assessed. For each fracture analysis we calculated a risk ratio. MAIN RESULTS: Fifteen trials, representing 1806 participants, were included. Calcium was more effective than placebo in reducing rates of bone loss after two or more years of treatment. The pooled difference in percentage change from baseline was 2.05% (95% CI 0.24 to 3.86) for total body bone density, 1.66% (95% CI 0.92 to 2.39) for the lumbar spine at 2 years, 1.60% (95% CI 0.78 to 2.41) for the hip, and 1.91% (95% CI 0.33 to 3.50) for the distal radius. The relative risk of fractures of the vertebrae was 0.79 (95% CI 0.54 to 1.09); the relative risk for non-vertebral fractures was 0.86 (95% CI 0.43 to 1.72). REVIEWER'S CONCLUSIONS: Calcium supplementation alone has a small positive effect on bone density. The data show a trend toward reduction in vertebral fractures, but it is unclear if calcium reduces the incidence of non vertebral fractures.

Bone Density↗

Leflunomide for treating rheumatoid arthritis.

BACKGROUND: Rheumatoid arthritis (RA) is a chronic inflammatory joint disease. Leflunomide, as an inhibitor of pyrimidine synthesis, has a different mechanism of action than other existing disease modifying anti-rheumatic drugs (DMARD). OBJECTIVES: To determine the efficacy and toxicity of leflunomide compared to placebo or other DMARDs in the treatment of RA. SEARCH STRATEGY: We conducted a search in MEDLINE, EMBASE, Current Contents and the Cochrane Controlled Trial Register for trials up to December 2001. We also hand-searched reference lists and consulted content experts. SELECTION CRITERIA: Two independent reviewers selected the trials that met predetermined inclusion criteria. DATA COLLECTION AND ANALYSIS: Two independent reviewers extracted data and assessed methodologic quality using standardized forms. MAIN RESULTS: Six trials were included in this review. Using the ACR20 improvement criteria, there was an absolute difference in improvement of 28% (95% confidence interval: 21 - 35%) favouring leflunomide (232 out of 413 leflunomide treated patients compared to 89 out of 311 placebo patients met the criteria). There was no difference in ACR20 response rate between the patients treated with leflunomide and SSZ or MTX at 6 and 12 months. Other clinical outcomes were improved significantly in the leflunomide group compared to placebo but not different from SSZ or MTX. Withdrawals due to adverse events with leflunomide were 10% greater than placebo (70 out of 416 compared to 18 out of 311 respectively). Important adverse events included gastrointestinal symptoms, elevated liver function tests, alopecia, and infections. Overall adverse events and withdrawals in the leflunomide group were not significantly different from SSZ or MTX. REVIEWER'S CONCLUSIONS: Leflunomide appears to improve all clinical outcomes and delay radiologic progression at both 6 and 12 months of treatment compared to placebo. Its efficacy and adverse events at 2 years of treatment are comparable to SSZ and MTX. Long-term efficacy and toxicity remains to be established.

Anti-Inflammatory Agents, Non-Steroidal↗

Risedronate for the prevention and treatment of postmenopausal osteoporosis.

BACKGROUND: Postmenopausal osteoporosis results in an increased susceptibility to low-trauma fractures due to reduced bone volume and microarchitectural deterioration. Risedronate, a third generation bisphosphonate, has been shown in multiple clinical trials to reduce fracture risk and improve bone mineral density in postmenopausal women with osteoporosis. First and second generation bisphosphonates are known to have gastrointestinal side-effects and risedronate may be better tolerated. OBJECTIVES: To systematically review the efficacy of risedronate on bone density, and fracture reduction in postmenopausal women. SEARCH STRATEGY: The Cochrane Controlled Trials Registry Medline, and Current Contents were searched from 1990 - 2001. The electronic search was supplemented by handsearching four osteoporosis journals and their conference proceedings, as well as contacting content experts and industry sources for unpublished data. SELECTION CRITERIA: We included eight trials that randomised women to risedronate or an alternative (placebo or calcium and /or vitamin D) and measured bone mineral density for at least one year. DATA COLLECTION AND ANALYSIS: For each trial three independent reviewers assessed the methodological quality and abstracted data. Data was extracted for outcomes of fracture, bone mineral density and adverse events. The more conservative random effects model was used to pool data. The quality of trials was assessed according to the Jadad five-point scale. MAIN RESULTS: Both vertebral and non-vertebral fractures were statistically and clinically reduced with risedronate. Eleven out of one hundred women who received risedronate had a vertebral fracture compared to 17 out of one hundred of those who received an alternative treatment (pooled relative risk for vertebral fractures of 0.64 (95% CI 0.52 - 0.77). Three percent of participants who received risedronate had a non-vertebral fracture compared to 4.6% of those who received an alternative treatment (pooled relative risk for nonvertebral fractures of 0.73 (95% CI 0.61 - 0.87). The weighted mean difference for the percent change from baseline for bone mineral density with 5 mg daily for lumbar spine, femoral neck and trochanter was 4.54% (95%CI 4.12 - 4.97), p<0.01; 2.75% (95% CI 2.32 - 3.17), p<0.01; and 4.38% (95% CI 3.51 - 5.25), p<0.01 respectively. REVIEWER'S CONCLUSIONS: There is good evidence for the efficacy of risedronate in the reduction of both vertebral and non-vertebral fractures. In addition, there is evidence from randomized trials that risedronate is able to achieve this without increasing risk for overall withdrawals due to adverse effects.

Bone Density↗

Calcium supplementation on bone loss in postmenopausal women.

BACKGROUND: Although calcium is one the simplest and least expensive strategies for preventing osteoporotic fractures calcium supplementation is nevertheless not without controversy (Kanis 1989; Nordin 1990). The Food and Drug Administration in the US has permitted a bone health claim for calcium-rich foods, and the NIH in its Consensus Development Process approved a statement that high calcium intake reduces the risk of osteoporosis. OBJECTIVES: To assess the effects of calcium on bone density and fractures in postmenopausal women. SEARCH STRATEGY: We searched Cochrane Controlled Register, MEDLINE and EMBASE up to 2001, and examined citations of relevant articles and proceedings of international meetings. SELECTION CRITERIA: Trials that randomized postmenopausal women to calcium supplementation or usual calcium intake in the diet and reported bone mineral density of the total body, vertebral spine, hip, or forearm or recorded the number of fractures, and followed patients for at least one year were considered for inclusion. DATA COLLECTION AND ANALYSIS: Three independent reviewers assessed the methodologic quality and extracted data for each trial. For each bone density site (lumbar spine, total body, combined hip and combined forearm), we calculated the weighted mean difference in bone density between treatment and control groups using the percentage change from baseline. We constructed regression models in which the independent variables were year and dose, and the dependent variable was the effect size. This regression was used to determine the years across which pooling was appropriate. Heterogeneity was assessed. For each fracture analysis we calculated a risk ratio. MAIN RESULTS: Fifteen trials, representing 1806 participants, were included. Calcium was more effective than placebo in reducing rates of bone loss after two or more years of treatment. The pooled difference in percentage change from baseline was 2.05% (95% CI 0.24 to 3.86) for total body bone density, 1.66% (95% CI 0.92 to 2.39) for the lumbar spine at 2 years, 1.60% (95% CI 0.78 to 2.41) for the hip, and 1.91% (95% CI 0.33 to 3.50) for the distal radius. The relative risk of fractures of the vertebrae was 0.79 (95% CI 0.54 to 1.09); the relative risk for non-vertebral fractures was 0.86 (95% CI 0.43 to 1.72). REVIEWER'S CONCLUSIONS: Calcium supplementation alone has a small positive effect on bone density. The data show a trend toward reduction in vertebral fractures, but it is unclear if calcium reduces the incidence of non vertebral fractures.

Bone Density↗

Exercise for preventing and treating osteoporosis in postmenopausal women.

BACKGROUND: Osteoporosis is a condition resulting in an increased risk of skeletal fractures due to a reduction in the density of bone tissue. Prevention of osteoporotic-related fractures is dependent on the ability to detect individuals with low bone mass, including those women who are asymptomatic. Treatment of osteoporosis involves the use of either anti-resorptive (e.g. estrogen and bisphosphonate) or bone formation agents (e.g. fluoride and PTH). The value of exercise as an intervention for the prevention of postmenopausal bone loss is a controversial subject. OBJECTIVES: To examine the effectiveness of exercise therapy at preventing bone loss and fractures in postmenopausal women. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Group's specialised register, MEDLINE, EMBASE, Current Contents and the Cochrane Controlled Trials Registry up to January 2000 according to the methods suggested by Dickersin et al and Haynes et al and the Cochrane Handbook. We hand searched reference lists and consulted content experts. SELECTION CRITERIA: This review was proceeded by a peer reviewed protocol published in the Cochrane Library. Two reviewers independently selected all randomized controlled trials (RCTs) which met our predetermined inclusion criteria. DATA COLLECTION AND ANALYSIS: The same two reviewers abstracted the data using predetermined forms and assessed trial quality using a validated assessment tool. For dichotomous outcomes (fractures), relative risks were calculated using fixed effects models. For continuous data, weighted mean differences (WMD) of the percentage change from baseline were calculated. Where heterogeneity existed (determined by a chi square test), a random effects model was used. MAIN RESULTS: Eighteen randomized controlled trials (RCTs) met the inclusion criteria. The trials had a mean methodological quality score of 2.53. Aerobics, weight bearing and resistance exercises were all effective on the BMD of the spine. The WMD for the combined aerobics and weight bearing program on the spine was 1.79 [95%CI (0.58, 3.01)]. The analyzed results showed walking to be effective on both BMD of the spine 1.31[95%CI (-0.03, 2.65) and the hip 0.92[95%CI (0.21, 1.64). Aerobic exercise was effective in increasing BMD of the wrist 1.22[95%CI (0.71, 1.74)]. REVIEWER'S CONCLUSIONS: Aerobics, weight bearing and resistance exercises are all effective in increasing the BMD of the spine in postmenopausal women. Walking is also effective on the hip. The quality of the reporting of the trials in the meta-analysis was low, in particular, in the areas of allocation concealement and blinding.

Exercise↗

Deep transverse friction massage for treating tendinitis.

BACKGROUND: Deep transverse friction massage (DTFM) is one of several physiotherapy interventions suggested for the management of pain due to iliotibial band friction syndrome (ITBFS). OBJECTIVES: To assess the effectiveness of DTFM for treating ITBFS observed in runners. SEARCH STRATEGY: We searched the Medline, Embase, Healthstar, Sports Discus, CINAHL, the Cochrane Controlled Trials Register, PEDro, the specialized registry of the Cochrane musculoskeletal group and the Cochrane field of Physical and Related Therapies up to the end of December 2000, using the sensitive search strategy developed by the Cochrane Collaboration. The search was complemented with bibliography searching of the reference list of the trials retrieved from the electronic search. Key experts in the area were contacted for further published and unpublished articles. SELECTION CRITERIA: All randomized controlled trials (RCTs) and controlled clinical trials (CCTs) comparing therapeutic ultrasound against placebo or another active intervention in patients with patellofemoral pain syndrome were selected. DATA COLLECTION AND ANALYSIS: Two reviewers determined the studies to be included based on inclusion and exclusion criteria (LB, VR). Data were independently abstracted by two reviewers (VR, LB), and checked by a third reviewer (BS) using a pre-developed form of the Cochrane Musculoskeletal Group. The same two reviewers, using a validated scale, assessed the methodological quality of the RCTs and CCTs independently. Iliotibial band friction syndrome outcome measures were extracted from the publications. The pooled analysis was performed using weighted mean differences (WMDs) for pain relief as described as 1) daily pain; 2) pain while running and 3) percentage of maximum pain when running. A chi-square test was used to assess heterogeneity among trials. Fixed effects models were used throughout and random effects for outcomes showing heterogeneity. MAIN RESULTS: One RCT, including 17 patients with ITBFS was included. The experimental group (DTFM combined to rest, stretching exercises, cryotherapy and therapeutic ultrasound) (n=9) was compared to the control group (rest, stretching exercises, cryotherapy and therapeutic ultrasound only) (n=8). This trial showed no statistical difference in the three types of pain relief measured after four consecutive sessions of DTFM combined with other physiotherapy modalities for runners. Despite lack of statistical significance, there was a clinically important relative percentage difference in pain while running of 22%. REVIEWER'S CONCLUSIONS: DTFM combined with other physiotherapy modalities did not show consistent benefit over control of pain for runners experiencing ITBFS. These conclusions are limited by the low methodological quality of the one small sample size trial (n=17) included. No conclusions can be drawn about the use or non use of DTFM for the treatment of ITBFS. Future trials, utilizing appropriate methods and adequate sample sizes are needed before conclusions can be drawn regarding the effect of massage on iliotibial band friction syndrome.

Clinical Trials as Topic↗

Therapeutic ultrasound for the treatment of rheumatoid arthritis.

BACKGROUND: Ultrasound is often used, by rehabilitation specialists, as an adjunct therapy for the symptomatic treatment of rheumatoid arthritis (RA). Its mechanical energy has antiinflammatory as well as analgesic properties. OBJECTIVES: To evaluate the effects of ultrasound on objective and subjective measures of disease activity in patients with RA. SEARCH STRATEGY: A comprehensive search was conducted up to September 2001 with MEDLINE, EMBASE, PEDro, Current Contents, Sports Discus and CINAHL. The Cochrane Field of Rehabilitation and Related Therapies and the Cochrane Musculoskeletal Review Group specialized registers were also searched. Handsearching was conducted on all retrieved papers and content experts were contacted to identify additional studies. SELECTION CRITERIA: Comparative controlled studies, such as randomized controlled trials and clinical controlled trials in patients with RA were eligible. No language restrictions were applied. Abstracts were accepted. DATA COLLECTION AND ANALYSIS: Two independent reviewers identified potential articles from the literature search. These reviewers extracted data using pre-defined extraction forms. Consensus was reached on all the extracted data. Quality was assessed by two reviewers using a 5 point validated assessment tool that measures the quality of randomization, double-blinding and description of withdrawals. MAIN RESULTS: Two studies (n=80 participants) met the inclusion criteria. Ultrasound to the palmar and dorsal aspect of the hand significantly increases grip strength when compared to a control (weighted mean difference (WMD) 28.07, 95CI: 13.37 to 42.77). Ultrasound to the palmar and dorsal aspects of the hand also appears to have beneficial effects to the following outcome measures: wrist dorsal flexion (WMD 1.90, 95%CI: 0.64 to 3.16), duration of morning stiffness (WMD 28.54, 95%CI: 0.18 to 56.90), number of swollen joints (WMD 1.02, 95%CI: 0.45 to 1.59) and the number of painful joints (WMD 1.20, 95%CI: 0.45 to 1.95). There is no significant difference between a)exercises and wax, b)exercises with ultrasound, c)exercises with ultrasound and faradic hand baths for the following outcome measures: pain score, grip strength, circumference of proximal interphalangeal (PIP) joints, articular index, range of motion or level of activity. REVIEWER'S CONCLUSIONS: The reviewers concluded that ultrasound in combination with the following treatment modalities; exercises, faradic current and wax baths, is not supported and cannot be recommended. Ultrasound alone can however, be used on the hand to increase grip strength, and to a lesser extent, based on the borderline results, increase wrist dorsal flexion, decrease morning stiffness, reduce the number of swollen joints and reduce the number of painful joints. It is important to note that these conclusions are limited by the methodological considerations such as poor quality of the trials, the low number of clinical trials, and the small sample size of the included studies.

Arthritis, Rheumatoid↗

Celecoxib for rheumatoid arthritis.

BACKGROUND: Rheumatoid arthritis (RA) is a systemic auto-immune disorder, involving persistent joint inflammation. NSAIDs are used to control the symptoms of RA, but are associated with significant gastro-intestinal toxicity, including a risk of potentially life threatening gastroduodenal perforations, ulcers and bleeds. The NSAIDs known as the selective Cox II inhibitors, of which celecoxib is a member, were developed in order to reduce the GI toxicity, but are more expensive. OBJECTIVES: To establish the efficacy and safety of celecoxib in the management of RA by systematic review of available evidence. SEARCH STRATEGY: We searched the following databases up to August 2002: MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Controlled Trials Register, National Research Register, NHS Economic Evaluation Database, Health Technology Assessment Database. The bibliographies of retrieved papers and content experts were consulted for additional references. SELECTION CRITERIA: All eligible randomised controlled trials (RCTs) were included. No unpublished RCTs were included in this edition of the review. DATA COLLECTION AND ANALYSIS: Data were abstracted independently by two reviewers. Data was analysed using a fixed effects model. A validated checklist was used to score the quality of the RCTs. The planned analysis was to pool, where appropriate continuous outcomes using mean differences and dichotomous outcomes using relative risk ratios. This was not however possible due to the lack of data. MAIN RESULTS: Five RCTs were included (4465 participants); three of the studies also enrolled individuals with OA. The comparators were placebo, naproxen, diclofenac and ibuprofen. The evidence reviewed suggests that celecoxib controls the symptoms of RA to a similar degree to that of the active comparators examined (naproxen, diclofenac and ibuprofen). When compared to placebo, the percentage of patients showing improvement according to ACR 20 criteria at week 4 were 42/82 (51%) in the twice daily celecoxib 200mg group and 43/82 (52%) in the twice daily celecoxib 400mg group; these were significantly different from the placebo group in which 25/85 (29%) improved. The six month data reviewed support a reduced rate of UGI complications with celecoxib but there is also evidence to suggest that these benefits may not be evident in the long-term and that celecoxib offers no additional benefit in patients who are also receiving cardio-prophylactic low dose aspirin. REVIEWER'S CONCLUSIONS: For an individual with RA the potential benefits of celecoxib need to be balanced against the uncertainty that the short-term reduced incidence of upper GI complications are maintained in the long-term and its increased cost in comparison to traditional NSAIDs.

Anti-Inflammatory Agents, Non-Steroidal↗

Meta-analysis of randomised controlled trials of the effectiveness of antiarrhythmic agents at promoting sinus rhythm in patients with atrial fibrillation.

OBJECTIVE: To conduct a meta-analysis of randomised controlled trials to estimate the effectiveness of antiarrhythmic drugs at promoting sinus rhythm in patients with atrial fibrillation. DESIGN: Articles were identified by using a comprehensive search of English language papers indexed in Medline from 1966 to August 2001. For the outcomes of sinus rhythm and death, a random effects model was used to model repeated assessments within a study at different time points. SETTING: Emergency departments and ambulatory clinics. PATIENTS: Patients with atrial fibrillation. INTERVENTIONS: Antiarrhythmic agents grouped according to their Vaughan-Williams class. MAIN OUTCOME MEASURES: Sinus rhythm and mortality. RESULTS: 91 articles met a priori criteria for inclusion in the analysis. Median duration of follow up was one day (range 0.04-1096, mean (SD) 46 (136) days). The median proportion of patients in sinus rhythm at follow up was 55% (range 0-100%) and 32% (range 0-90%) receiving active treatment and placebo, respectively. Median survival was 99% (range 55-100%) and 99% (range 55-100%). Compared with placebo, the following drug classes were associated with increased sinus rhythm at follow up: IA (treatment difference 21.5%, 95% confidence interval (CI) 16.3% to 26.8%); IC (treatment difference 33.1%, 95% CI 23.3% to 42.9%); and III (treatment difference 17.4%, 95% CI 11.5% to 23.3%). Class IC drugs were associated with increased sinus rhythm at follow up compared with class IV drugs (treatment difference 43.2%, 95% CI 11.5% to 75.0%). There was no significant difference in mortality between any drug classes. CONCLUSIONS: Class IA, IC, and III drugs are associated with increased sinus rhythm at follow up compared with placebo. It is unclear whether any antiarrhythmic drug class is associated with increased or decreased mortality.

Anti-Arrhythmia Agents↗

Bone metastasis and rehabilitation.

Patients with cancer that has metastasized to bone will frequently develop functional problems that may respond to rehabilitative treatment. Many rehabilitation professionals, however, are concerned about the possibility of producing pathologic fracture with their treatment. Several methods have been proposed for identifying which malignant lesions in bone are at risk of fracture. In this article, these methods are reviewed and statistical analyses of them are presented. The risk of rehabilitating patients with bony metastases is also reviewed, as are the reported outcomes of these rehabilitation efforts. Standard approaches to the rehabilitation of these patients have evolved, although most of them have not been rigorously validated, and these are discussed. None of the methods for identifying lesions at risk of pathologic fracture are useful in other than long bones, and they are limited even there. The risk of producing pathologic fractures in cancer patients by increasing mobility and function, however, is low. Satisfactory outcomes have been demonstrated in attempting to rehabilitate patients who have had recent surgical repair of pathologic or impending fractures. Rehabilitation of cancer patients with bony metastases can be safely and effectively accomplished using standard approaches to the treatment of these patients.

Bone Neoplasms↗

Persistence of immunoglobulin M or immunoglobulin G antibody responses to Borrelia burgdorferi 10-20 years after active Lyme disease.

The interpretation of serological results for patients who had Lyme disease many years ago is not well defined. We studied the serological status of 79 patients who had had Lyme disease 10-20 years ago and did not currently have signs or symptoms of active Lyme disease. Of the 40 patients who had had early Lyme disease alone, 4 (10%) currently had IgM responses to Borrelia burgdorferi, and 10 (25%) still had IgG reactivity to the spirochete, as determined by a 2-test approach (enzyme-linked immunosorbent assay and Western blot). Of the 39 patients who had had Lyme arthritis, 6 (15%) currently had IgM responses and 24 (62%) still had IgG reactivity to the spirochete. IgM or IgG antibody responses to B. burgdorferi may persist for 10-20 years, but these responses are not indicative of active infection.

Anti-Bacterial Agents↗

Glucosamine therapy for treating osteoarthritis.

BACKGROUND: Osteoarthritis (OA) is the most common form of arthritis, and it is often associated with significant disability and an impaired quality of life. OBJECTIVES: To review all randomized controlled trials (RCTs) evaluating the effectiveness and toxicity of glucosamine in osteoarthritis (OA). SEARCH STRATEGY: We searched MEDLINE, Embase, and Current Contents up to November 1999, and the Cochrane Controlled Trials Register. We also wrote letters to content experts, and hand searched reference lists of identified RCTs and pertinent review articles. SELECTION CRITERIA: Relevant studies met the following criteria: 1) RCTs evaluating the effectiveness and safety of glucosamine in OA, 2) Both placebo based and comparative studies were eligible, 3) Both single blinded and double-blinded studies were eligible. DATA COLLECTION AND ANALYSIS: Data abstraction was performed independently by two investigators and the results were compared for degree of agreement. Gotzsche's method and a validated tool (Jadad 1995) were used to score the quality of the RCTs. Continuous outcome measures were pooled using standardized mean differences. Dichotomous outcome measures were pooled using Peto Odds Ratios. MAIN RESULTS: Collectively, the 16 identified RCTs provided evidence that glucosamine is both effective and safe in OA. In the 13 RCTs in which glucosamine was compared to placebo, glucosamine was found to be superior in all RCTs, except one. In the four RCTs in which glucosamine was compared to an NSAID, glucosamine was superior in two, and equivalent in two. REVIEWER'S CONCLUSIONS: Further research is necessary to confirm the long term effectiveness and toxicity of glucosamine therapy in OA. Most of the trials reviewed only evaluated the Rotta preparation of glucosamine sulfate. It is not known whether different glucosamine preparations prepared by different manufacturers are equally effective in the therapy of OA.

Double-Blind Method↗

Transcutaneous electrical nerve stimulation (TENS) for chronic low back pain.

BACKGROUND: Low back pain (LBP) affects a large proportion of the population. Transcutaneous electrical nerve stimulation (TENS) was introduced more than 30 years ago as an alternative therapy to pharmacological treatments for chronic pain. However, despite its widespread use, the effectiveness of TENS is still controversial. OBJECTIVES: The aim of this systematic review was to determine the efficacy of TENS in the treatment of chronic LBP. SEARCH STRATEGY: We searched MEDLINE, EMBASE, PEDro and the Cochrane Controlled Trials Register up to June 1, 2000. SELECTION CRITERIA: Only randomized controlled clinical trials of TENS for the treatment of patients with a clinical diagnosis of chronic LBP were included. Abstracts were excluded unless further data could be obtained from the authors. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials and extracted data using predetermined forms. Heterogeneity was tested with Cochran's Q test. A fixed effects model was used throughout for continuous variables, except where heterogeneity existed, in which case, a random effects model was used. Results are presented as weighted mean differences (WMD) with 95% confidence intervals (95% CI), where the difference between the treated and control groups was weighted by the inverse of the variance. Standardized mean differences (SMD) were calculated by dividing the difference between the treated and control by the baseline variance. SMD were used when different scales were used to measure the same concept. Dichotomous outcomes were analyzed with odds ratios. MAIN RESULTS: Five trials were included, with 170 subjects randomized to the placebo group receiving sham-TENS and 251 subjects receiving active TENS (153 for conventional mode, 98 for acupuncture-like TENS). The schedule of treatments varied greatly between studies ranging from one treatment/day for two consecutive days, to three treatments/day for four weeks. There were no statistically significant differences between the active TENS group when compared to the placebo TENS group for any outcome measures. Subgroup analysis performed on TENS application and methodological quality did not demonstrate a significant statistical difference. Remaining pre-planned subgroup analysis was not conducted due to the small number of included trials and the variety of outcome measures reported. REVIEWER'S CONCLUSIONS: The results of the meta-analysis present no evidence to support the use of TENS in the treatment of chronic low back pain. Clinicians and researchers should consistently report the characteristics of the TENS device and the application techniques used. New trials on TENS should make use of standardized outcome measures. This meta-analysis lacked data on how TENS effectiveness is affected by four important factors: type of applications, site of application, treatment duration of TENS, optimal frequencies and intensities.

Chronic Disease↗