Is radial Extracorporeal Shock Wave Therapy (rEWST) combined with supervised exercises (SE) more effective than sham rESWT and SE in patients with subacromial shoulder pain? Study protocol for a double-blind randomised, sham-controlled trial

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

Effectiveness of Radial Extracorporeal Shock Wave Therapy (rESWT) When Combined With Supervised Exercises in Patients With Subacromial Shoulder Pain: A Double-Masked, Randomized, Sham-Controlled Trial

“…The protocol is previously published. 19 Patients between 25 and 70 years with symptoms of subacromial pain syndrome with and without calcification in the rotator cuff lasting at least 3 months were assessed for eligibility. The inclusion criteria were pain on at least 1 of 2 isometric tests (abduction in 45°, or external rotation, with arm at the side), positive Hawkins-Kennedy impingement sign, and normal passive glenohumeral range of motion.…”

The effectiveness of extracorporeal shockwave treatment in subacromial impingement syndrome and its relation with acromion morphology

“…Kvalvaag et al did not recommend shock wave treatment with subacromial pain syndrome. 25 Otherwise, Santamato et al publicized that combined administration of ESWT and isokinetic exercise resulted in greater functional recovery in the short to medium term compared with ESWT alone. 26 Ozturk et al concluded that ESWT treatment similarly effected physical therapy and sham ESWT treatment on shoulder pain and functional shoulder scores in patients with SIS.…”

Does Additional Extracorporeal Shock Wave Therapy Improve the Effect of Isolated Percutaneous Radiofrequency Coblation in Patients with insertional Achilles Tendinopathy? Study Protocol for a Randomized Controlled Clinical Trial

“…The study of Wei M et al 33 indicates an expected standard deviation (SD) of 6.9 points. We have referred to the sample size calculation method of Kvalvaag, E et al 34 To detect a difference in results between the radical ESWT and the sham-ESWT participants at a level of 5% signi cance and the most likely scenario for 80% power, 15 patients per group will be needed. Assuming a margin of 20% loss of primary outcome data, we propose to recruit a minimum of 38 patients in total.…”

“…The VISA-A score is a validated questionnaire for Achilles tendinopathy and contains 8 questions assessing physical activity and pain (0, no activity/maximum pain; 100, maximum activity/no pain). 34 And it is adapted to the local language (Attachment 1). The Chinese version has been used in clinical trials 37 38 , proving its validity.…”