Cost-effectiveness of exercise therapy versus general practitioner care for osteoarthritis of the hip: design of a randomised clinical trial.

BACKGROUND: Osteoarthritis (OA) is the most common joint disease, causing pain and functional impairments. According to international guidelines, exercise therapy has a short-term effect in reducing pain/functional impairments in knee OA and is therefore also generally recommended for hip OA. Because of its high prevalence and clinical implications, OA is associated with considerable (healthcare) costs. However, studies evaluating cost-effectiveness of common exercise therapy in hip OA are lacking. Therefore, this randomised controlled trial is designed to investigate the cost-effectiveness of exercise therapy in conjunction with the general practitioner's (GP) care, compared to GP care alone, for patients with hip OA. METHODS/DESIGN: Patients aged ≥ 45 years with OA of the hip, who consulted the GP during the past year for hip complaints and who comply with the American College of Rheumatology criteria, are included. Patients are randomly assigned to either exercise therapy in addition to GP care, or to GP care alone. Exercise therapy consists of (maximally) 12 treatment sessions with a physiotherapist, and home exercises. These are followed by three additional treatment sessions in the 5th, 7th and 9th month after the first treatment session. GP care consists of usual care for hip OA, such as general advice or prescribing pain medication. Primary outcomes are hip pain and hip-related activity limitations (measured with the Hip disability Osteoarthritis Outcome Score [HOOS]), direct costs, and productivity costs (measured with the PROductivity and DISease Questionnaire). These parameters are measured at baseline, at 6 weeks, and at 3, 6, 9 and 12 months follow-up. To detect a 25% clinical difference in the HOOS pain score, with a power of 80% and an alpha 5%, 210 patients are required. Data are analysed according to the intention-to-treat principle. Effectiveness is evaluated using linear regression models with repeated measurements. An incremental cost-effectiveness analysis and an incremental cost-utility analysis will also be performed. DISCUSSION: The results of this trial will provide insight into the cost-effectiveness of adding exercise therapy to GPs' care in the treatment of OA of the hip. This trial is registered in the Dutch trial registry http://www.trialregister.nl: trial number NTR1462.

The addition of electrical stimulation to progressive resistance training does not enhance the wrist strength of people with tetraplegia: a randomized controlled trial.

OBJECTIVE: To determine whether the addition of electrical stimulation to progressive resistance training increases the voluntary strength of the wrist muscles in people with tetraplegia. DESIGN: Assessor-blind within-subject randomised controlled trial. SETTING: Two Australian spinal cord injury units and the community. PARTICIPANTS: Sixty-four wrists of 32 people with tetraplegia and bilateral weakness of the wrist extensor or flexor muscles (grade 2 - 4 Medical Research Council grades). INTERVENTIONS: Participants' wrists were randomly allocated to one of two conditions. Wrist muscles of the experimental arm received electrical stimulation superimposed on progressive resistance training. The wrist muscles of the contralateral arm received sham electrical stimulation superimposed on progressive resistance training. Both arms received 6 sets of 10 contractions three times a week for eight weeks such that the only difference between arms was the application of electrical stimulation. MAIN MEASURES: The primary outcome was maximal voluntary isometric strength. Secondary outcomes were a fatigue resistance ratio representing voluntary and electrically-stimulated endurance. Measurements were taken at the start and end of the eight-week treatment period. RESULTS: The mean treatment effect (95% Confidence Interval) of electrical stimulation for voluntary strength was 0.04 Nm (95% CI, -0.5 to 0.6; p =0.89). The mean treatment effect (95% CI) for fatigue ratio representing voluntary endurance and electrically-stimulated endurance was -0.01 (95% CI, -0.1 to 0.1; p =0.78) and -0.07 (95% CI, -0.3 to 0.1; p =0.47), respectively. CONCLUSIONS: Voluntary strength of the wrist is not enhanced by the addition of electrical stimulation to progressive resistance training programs in people with tetraplegia.

Efficacy of electrical stimulation to increase muscle strength in people with neurological conditions: a systematic review.

BACKGROUND AND PURPOSE: Weakness in partially paralysed muscles is a disabling impairment for people with neurological conditions. Strength training programmes are widely administered to address this impairment. There is a common belief that the effectiveness of strength training programmes can be enhanced by the addition of electrical stimulation. The purpose of this systematic review was to assess the efficacy of electrical stimulation for increasing voluntary strength in people with neurological conditions. METHOD: Eligible randomized trials of electrical stimulation were identified by searches of computerized databases. The search yielded 11,267 abstracts, of which 60 were retrieved. Two assessors independently reviewed full text versions of these articles. RESULTS: Eighteen studies satisfied the inclusion criteria. These studies involved participants with spina bifida (n = 1), cerebral palsy (n = 1), peripheral nerve lesion (n = 1), multiple sclerosis (n = 1), spinal cord injury (n = 3) and stroke (n = 11). The mean (SD) PEDro score for trial quality was 4.9 (1.0) out of 10. Meta-analyses of studies involving similar patients were not done because of insufficient data or lack of homogeneity. The results of all studies were analysed individually. CONCLUSION: Several studies suggest a modest beneficial effect of electrical stimulation in patients with stroke. It is not clear whether patients with other types of neurological disabilities benefit from electrical stimulation in the same way.