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 of age; 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%.
Conclusion:
In patients with shoulder impingement syndrome, arthroscopic decompression with acromioplasty plus structured exercise did not provide any clinical benefit over structured exercise alone and was more expensive.
Almost thirty years ago Neer described impingement as the pathoetiology of rotator cuff damage with a spectrum of disease from tendinitis to frank tendon tear, the suggested treatment for which was acromioplasty with tendon repair as needed1,2. However, as our understanding of intrinsic tendon disease has grown, causes other than impingement have been proposed3 and randomized trials have failed to support the need for routine acromioplasty at the time of rotator cuff repair4,5. Tendinitis is even more complex because the diagnosis of impingement is made on the basis of clinical examination and may be confused with other conditions. Furthermore, much has been made of the overuse of the impingement concept in young athletes who have arm pain when they engage in overhead motion6.
The decision to perform arthroscopic acromioplasty in patients whose conditions are refractory to rest, anti-inflammatory medications, subacromial cortisone injections, and physical therapy has been based more on opinion and retrospective reviews than on high-level evidence. While previous studies comparing acromioplasty with physiotherapy have included patients who had not yet completed a trial of physiotherapy7, this study by Ketola and colleagues examines patients most likely to be considered as candidates for surgical treatment.
While all patients had relief with a subacromial anesthetic injection, fourteen of the seventy patients undergoing arthroscopy were found to have labral lesions that were deemed to require repair and, in five patients, these labral lesions were believed to be the main cause of the symptoms. Although full-thickness cuff tears were excluded, it is unclear whether partial tears or lesions of the biceps tendon might have been responsible for pain. Finally, bursal-view findings on the undersurface of the acromion consistent with impingement, routinely used today as confirmatory of the diagnosis before proceeding with acromioplasty8, were not systematically described.
While there may have been faster recovery in the combined treatment group, this was not measurable past two years.
In conclusion, this study provides evidence that combined acromioplasty and physical therapy treatment is not effective or cost-effective compared with physical therapy alone.
References
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