Arthroscopic decompression with acromioplasty and structured exercise was no more effective and was more expensive than exercise alone.

Question: In patients with shoulder impingement syndrome, what is the effectiveness and cost-effectiveness of arthroscopic decompression with acromioplasty and structured exercise compared with structured exercise alone? Design: Randomized (allocation concealed), blinded (outcome assessor) controlled trial with 2-year follow-up. Setting: 2 hospitals in Finland. Patients: 140 patients (18 to 60 years ofage; mean age, 47 y; 63% women) who had suspected shoulder impingement syndrome. Inclusion criteria were a positive Neer test; shoulder pain resistant to rest, anti-inflammatory drugs, subacromial glucocorticosteroid injections, and physiotherapy; and symptoms persisting for 3 months. Exclusion criteria were glenohumeral or acromioclavicular osteoarthritis, signs of glenohumeral instability, previous surgery to the affected shoulder, full-thickness tear of the rotator cuff, cervical radicular syndrome, adhesive capsulitis, or neuropathy of the shoulder area. End-point data were available for 134 patients (96%). Intervention: Patients were allocated to combined surgery plus structured exercise (n = 70) or exercise alone (n = 70). The structured exercise program consisted of an individually tailored home-exercise regimen that aimed to restore painless and normal mobility of the shoulder complex and increase the dynamic stability of the glenohumeral joint and scapula. Training involved the use of stretch bands and light weights. Sessions were held 4 times per week with use of 9 different exercises with 30 to 40 repetitions 3 times. As ability and strength improved, the resistance was increased and the repetitions were decreased. During arthroscopic decompression, the arthroscope was introduced through a standard posterior portal and debridement and decompression were done by shaver or vaporizer. Acromioplasty was performed with a burr drill, starting anteriorly and progressing posterolaterally. 7 to 10 days after surgery, sutures and dressings were removed and patients received the same individually tailored exercise program as provided to the exercise-alone group. Main outcome measures: The primary outcome was self-reported pain on a visual analog scale (VAS) of 0 to 10 (0 = no pain, 10 = maximum imaginable pain; 1.5 was the minimal clinically important difference). Secondary outcomes were disability, pain at night, working ability, shoulder questionnaire score, number of painful days in the previous 3 months, and the proportion of pain-free patients (VAS ≤3). Costs were in 2004 prices (€) and included direct healthcare (operation, hospitalization) and non-healthcare (travel, massage, manipulation) resources. Main results: Analysis was by intention to treat. The study had sufficient power to detect at least a 1.5-unit difference in self-reported pain between combined treatment and exercise. A decrease in self-reported pain exceeding the minimal clinically important difference occurred in both the combined treatment and exercise-alone groups. Between-group differences were not significant (Table). The groups were not different for any of the secondary outcomes. The mean total cost was €2961 in the combined treatment group and €1864 in the exercise group (mean incremental cost €1097). The incremental cost-effectiveness ratio was €5431 per minimal clinically important difference unit With a willingness to pay of €8000 for 1 additional minimal clinically important difference unit, the probability that combined treatment would be acceptable was 56%.