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Abstract Background Shoulder impingement syndrome is a common musculoskeletal complaint leading to significant reduction of health and disability. Physiotherapy is often the first choice of treatment although its effectiveness is still under debate. Systematic reviews in this field highlight the need for more high quality trials to investigate the effectiveness of physiotherapy interventions in patients with subacromial impingement syndrome. Methods/Design This randomized controlled trial will investigate the effectiveness of individualized physiotherapy in patients presenting with clinical signs and symptoms of subacromial impingement, involving 90 participants aged 18-75. Participants are recruited from outpatient physiotherapy clinics, general practitioners, and orthopaedic surgeons in Germany. Eligible participants will be randomly allocated to either individualized physiotherapy or to a standard exercise protocol using central randomization. The control group will perform the standard exercise protocol aiming to restore muscular deficits in strength, mobility, and coordination of the rotator cuff and the shoulder girdle muscles to unload the subacromial space during active movements. Participants of the intervention group will perform the standard exercise protocol as a home program, and will additionally be treated with individualized physiotherapy based on clinical examination results, and guided by a decision tree. After the intervention phase both groups will continue their home program for another 7 weeks. Outcome will be measured at 5 weeks and at 3 and 12 months after inclusion using the shoulder pain and disability index and patients' global impression of change, the generic patient-specific scale, the average weekly pain score, and patient satisfaction with treatment. Additionally, the fear avoidance beliefs questionnaire, the pain catastrophizing scale, and patients' expectancies of treatment effect are assessed. Participants' adherence to the protocol, use of additional treatments for the shoulder, direct and indirect costs, and sick leave due to shoulder complaints will be recorded in a shoulder log-book. Discussion To our knowledge this is the first trial comparing individualized physiotherapy based on a defined decision making process to a standardized exercise protocol. Using high-quality methodologies, this trial will add evidence to the limited body of knowledge about the effect of physiotherapy in patients with SIS. Trial registration Current Controlled Trials ISRCTN86900354

Objective: To critically summarize the effectiveness of physio-therapy in patients presenting clinical signs of shoulder impingement syndrome., Design: Systematic review., Methods: Randomized controlled trials were searched electronically and manually from 1966 to December 2007. Study quality was independently assessed by 2 reviewers using the Physiotherapy Evidence Database (PEDro) scale. If possible, relative risks and weighted mean differences were calculated for individual studies, and relative risks or standardized mean differences for pooled data, otherwise results were summarized in a best evidence synthesis., Results: Sixteen studies were included, with a mean quality score of 6.8 points out of 10. Many different diagnostic criteria for shoulder impingement syndrome were applied. Physio-therapist-led exercises and surgery were equally effective treatments for shoulder impingement syndrome in the long term. Also, home-based exercises were as effective as combined physiotherapy interventions. Adding manual therapy to exercise programmes may have an additional benefit on pain at 3 weeks follow-up. Moderate evidence exists that passive treatments are not effective and cannot be justified., Conclusion: This review shows an equal effectiveness of physiotherapist-led exercises compared with surgery in the long term and of home-based exercises compared with combined physiotherapy interventions in patients with shoulder impingement syndrome in the short and long term; passive treatments cannot be recommended for shoulder impingement syndrome. However, in general, the samples were small, and different diagnostic criteria were applied, which makes a firm conclusion difficult. More high-quality trials with longer follow-ups are recommended.