Transmural project for subacromial impingement syndrome: a randomized controlled trial comparing a new transmural treatment strategy (TRANSIT) with usual medical care

INTERVENTION: Intervention group: the treatment is an arthroscopic subacromial decompression performed within six weeks after randomization. Control group: the treatment is ?usual medical care?, which consists of treatment in general practice according to the Guidelines for Shoulder Complaints of the Dutch College of General Practitioners (issued in 1999). Both groups will be followed for one year post‐randomization. CONDITION: Subacromial impingement syndrome ; Musculoskeletal Diseases ; Subacromial impingement syndrome PRIMARY OUTCOME: Shoulder Disability Questionnaire: a 16‐item measure for functional status limitation in patients with shoulder disorders (Van der Heijden et al, 2000).; Study data will be collected at the following moments: at inclusion, at randomization and three, six and twelve months after randomization. SECONDARY OUTCOME: 1. Constant‐Murley score ‐ a shoulder‐specific scoring system in which patient‐reported subjective assessment and objective measurement of shoulder function takes place (Constant et al, 1987); 2. Shoulder Pain Score ‐ a concise questionnaire for the assessment of pain experienced by patients with shoulder complaints (Winters et al, 1996); 3. Shoulder Rating Questionnaire (SRQ��DLV) ‐ a self‐administered patient based instrument which assesses shoulder function in seven domains (Vermeulen et al, 2005); 4. Patient‐perceived recovery ‐ a one‐item score concerning recovery following treatment measured on a seven‐point ordinal scale; 5. (Dutch) Short‐form 36 Health Survey ‐ a Health‐related Quality of Life Assessment system composed of 36 questions and standardized response choices, organized into eight multi‐item scales (Aaronson, 1998).; 6. Cost‐effectiveness ‐ an economic evaluation will be performed using a questionnaire for assessment of direct health care costs as well as direct non‐health related costs. These data will be used for a cost‐effectiveness analysis. INCLUSION CRITERIA: 1. Pain on abduction of the shoulder 2. Shoulder pain as a recurrence of an episode with a maximum duration of 12 months in which a partial or good response is achieved with (a) subacromial corticosteroid injection(s) 3. A maximum duration of three months of shoulder complaints prior to the first subacromial injection, possibly treated with non‐steroidal anti‐inflammatory drug (NSAID) and/or physiotherapy 4. No shoulder complaints for at least two years prior to the current episode of shoulder pain 5. Men and women, aged between 30 and 60 years 6. Being able to give an informed consent Amendment to inclusion criterion number 3 as of 24/07/2006: 3. A maximum duration of six months of shoulder complaints prior to the first subacromial injection, possibly treated with non‐steroidal anti‐inflammatory drug (NSAID) and/or physiotherapy