Abstract
BackgroundSubacromial shoulder pain is a common complaint. Radial Extracorporeal Shock Wave Therapy (rESWT) has being increasingly used to treat calcific and non-calcific tendinosis, although there is no evidence of the effectiveness of rESWT in non-calcific tendinosis of the rotator cuff. A randomised single blind study showed that the short-term effect of supervised exercises (SE) was significantly better than rESWT on subacromial shoulder pain, but both groups improved. In a clinical trial on achilles tendinopathy rESWT improved the effectiveness of treatment with eccentric loading. The objective of this present study is to evaluate if rESWT in addition to SE is more effective in improving shoulder pain and function compared with sham rESWT and SE in patients with subacromial shoulder pain.Methods/DesignThis is a double blind, randomised sham-controlled trial which is performed at the shoulder clinic at the Department of Physical Medicine and Rehabilitation in Oslo University Hospital, Norway. One-hundred-forty-four patients with subacromial shoulder pain lasting at least 3 months, age from 25 to 70 years old are included in the trial. Patients are randomly allocated in 1:1 ratio to receive either rESWT or sham rESWT once a week in addition to SE once a week for the initial 4 weeks. Subsequently SE are provided twice a week for 8 weeks. The primary outcome measure is a change in the Shoulder Pain and Disability Index (SPADI) at 24 weeks follow-up. Secondary outcomes include return to work, pain at rest and on activity, function, and health related quality of life. The patients, the physiotherapist providing the exercise regimen and the outcome assessor are blinded to group assignment. The physiotherapist providing the rESWT is not blinded.DiscussionBecause of the extensive use of rESWT in the treatment of subacromial shoulder pain the results of this trial will be of importance and have impact on clinical practice.Trial registrationClinicalTrials.gov NCT01441830
Highlights
Subacromial shoulder pain is a common complaint
Because of the extensive use of Radial Extracorporeal Shock Wave Therapy (rESWT) in the treatment of subacromial shoulder pain the results of this trial will be of importance and have impact on clinical practice
One early trial in patients with subacromial shoulder pain reported that sham Extracorporeal Shock Wave Therapy (ESWT) was superior to ESWT [36]
Summary
Shoulder pain is a common complaint, and in Norway about half of the population reports to have at least one episode of shoulder pain annually [1]. In contrast to regular focused shock wave therapy (ESWT), rESWT creates a diverging pressure field, which reaches a maximal pressure already at the source, and has a more superficial, but broader, effect than ESWT [12] This treatment is increasingly used for calcific and non-calcific tendinopathy, probably because it is easier to apply and more affordable than ESWT. With respect to routine radiological examination (MRI and ultrasound), a recent study found that structural changes in the rotator cuff and subacromial bursa did not predict short-term outcome after corticosteroid injection therapy [16]. In a recent randomised single blind study the short-term effect of supervised exercises was significantly better than the effect of rESWT on subacromial shoulder pain, but both groups improved [17]. Previous studies have reported that the prognosis of subacromial shoulder pain is affected by education, work status, polymedication and high baseline pain and disability [16, 19, 20]
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