One year results of a randomized controlled trial on radial Extracorporeal Shock Wave Treatment, with predictors of pain, disability and return to work in patients with subacromial pain syndrome.

BACKGROUND: Radial Extracorporeal Shock Wave Therapy (rESWT) is increasingly used to treat patients with subacromial pain syndrome despite conflicting evidence of its effectiveness. Better knowledge regarding prognostic factors may contribute to the improvement in treatment and prognosis for the patients. AIM: The first aim of this study was to evaluate the effect of rESWT in addition to supervised exercises in patients with subacromial pain syndrome after one year. The second aim was to identify predictors of pain and disability and work status after one year in this patient group. DESIGN: A randomized, double-blind, sham-controlled trial. SETTING: An outpatient shoulder clinic of a University hospital. METHODS: Patients aged 25 to 70 years, with subacromial pain syndrome lasting at least three months were included and randomly assigned to receive either rESWT and supervised exercises or sham rESWT and supervised exercises. The Shoulder Pain and Disability Index (SPADI) and work status were assessed after one year. RESULTS: We screened 265 patients and enrolled 143; 74 were allocated to receive sham rESWT and exercises, and 69 were allocated to receive rESWT and exercises. After one year, no differences were found for the SPADI Score (mean difference -1.6, 95% confidence interval (CI) -10.2 to 7.0, P=0.71). Subgroup analysis of patients with calcification in the rotator cuff demonstrated no significant additional effect of rESWT to supervised exercises (mean difference -6.3, 95% CI -22.4 to 9.8, P=0.44). Marital status (single), frequent use of pain medication, not working at baseline, negative outcome expectations, low self-reported general health status and few supervised exercise sessions predicted a poor outcome on SPADI after one year. CONCLUSIONS: Radial ESWT was not superior to sham rESWT in addition to supervised exercises in the long term for patients with subacromial pain syndrome. The identified predictors for pain, disability and work should be assessed in future studies and addressed by clinicians in order to improve the effectiveness of supervised exercises. CLINICAL REHABILITATION IMPACT: Radial ESWT should not be recommended for patients with subacromial pain syndrome. Clinicians should assess patient`s outcome expectations, and if possible reduce the use of pain medication and sick leave in this patient group.

Shoulder MRI features with clinical correlations in subacromial pain syndrome: a cross-sectional and prognostic study.

BACKGROUND: Previous studies on shoulder patients have suggested that the prevalence of rotator cuff or bursa abnormalities are weakly related to symptoms and that similar findings are often found in asymptomatic persons. In addition, it is largely unknown whether structural changes identified by magnetic resonance imaging (MRI) affect outcome after treatment for shoulder pain. The purpose of this study was therefore to evaluate the presence of structural changes on MRI in patients with subacromial pain syndrome and to determine to what extent these changes are associated with symptoms and predict outcome after treatment (evaluated by the Shoulder Pain and Disability Index (SPADI)). METHODS: A prospective, observational assessment of a subset of shoulder patients who were included in a randomized study was performed. All participants had an MRI of the shoulder. An MRI total score for findings at the AC joint, subacromial bursa and rotator cuff was calculated. Multiple linear regression analysis was applied to examine the relationship between the MRI total score and the outcome measure at baseline and to examine to what extent the MRI total score was associated with the change in the SPADI score from baseline to the one year follow-up. RESULTS: There was a weak, inverse association between the SPADI score at baseline and the MRI total score (ß = -3.1, with 95% CI -5.9 to -0.34; p = 0.03), i.e. the SPADI score was higher for patients with a lower MRI total score. There was an association between the change in the SPADI score from baseline to the one year follow-up and the MRI total score (ß = 8.1, 95% CI -12.3 to -3.8; p < 0.001), with a poorer outcome for patients with a higher MRI total score. Both tendinosis (p = 0.01) and bursitis (p = 0.04) were associated with a poorer outcome after one year. CONCLUSIONS: In this study, MRI findings were significantly associated with the change in the SPADI score from baseline and to one year follow-up, with a poorer outcome after treatment for the patients with higher MRI total score, tendinosis and bursitis on MRI. TRIAL REGISTRATION: Clinicaltrials.gov no NCT01441830 . September 28, 2011.

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.

BACKGROUND: Subacromial shoulder pain is a common complaint, and radial extracorporeal shock wave therapy (rESWT) is increasingly used to treat this condition. Although many therapists use rESWT in combination with supervised exercises, no studies have evaluated the additional effect of rESWT with supervised exercises for subacromial shoulder pain. PURPOSE: To assess whether rESWT is more effective than sham rESWT when combined with supervised exercises for improving pain and function in patients with subacromial shoulder pain. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: Patients between 25 and 70 years of age with subacromial shoulder pain with and without calcification in the rotator cuff lasting at least 3 months were assessed for eligibility; 143 patients were recruited. Participants were allocated (1:1) by computer-generated randomization in blocks of 20 to receive either rESWT or sham rESWT in addition to supervised exercises. The rESWT and sham rESWT were performed once a week with additional supervised exercises once a week for the first 4 weeks. The following 8 weeks, the patients received supervised exercises twice a week. The primary outcome was change in the Shoulder Pain and Disability Index (SPADI) after 24 weeks. Patients and outcome assessors were masked to group assignment. RESULTS: At 24 weeks, participants in both the sham group and the rESWT group had improved ( P < .001) in SPADI score compared with baseline (-23.9 points [SD, 23.8 points] and -23.3 points [SD, 25.0 points], respectively), but there were no differences between the groups (mean difference 0.7; 95% CI, -6.9 to 8.3; P = .76). Prespecified subgroup analysis of patients with calcification in rotator cuff showed that the rESWT group had a greater improvement in SPADI score after 24 weeks (mean difference -12.8; 95% CI, -24.8 to -0.8; P = .018). CONCLUSION: Radial ESWT offered no additional benefit to supervised exercises in the treatment of subacromial shoulder pain after 24 weeks, except in the subgroup of patients with calcification in the rotator cuff. Registration: NCT01441830 ( ClinicalTrials.gov identifier).

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.

BACKGROUND: Subacromial 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/DESIGN: This 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. DISCUSSION: Because 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 REGISTRATION: ClinicalTrials.gov NCT01441830.