NCT01692249

Efficacy and Safety of Spa Treatment in Chronic Shoulder Pain Due to Rotator Cuff Tendinopathy

Spa Therapy in the Treatment of Chronic Shoulder Pain Due to Rotator Cuff Tendinopathy: ROTATHERM, a Large Randomized Multicentre Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Association Francaise pour la Recherche Thermale · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To determine whether spa therapy has a beneficial effect on pain and disability in the management of shoulder pain due to chronic rotator cuff lesions, this multicentre randomized prospective clinical trial includes patients with shoulder pain due to chronic degenerative rotator cuff tendinopathy who attend French spa resorts as outpatients. Subjects are randomized into two groups: immediate spa therapy (18 days of standardized treatment) and control (spa therapy delayed for 6 months). All patients continue usual treatments during the 6-month follow-up period. The main endpoint is the mean change in the DASH score at 6 months. Secondary endpoints are the mean change in SF-36 components, treatments used, and tolerance. The effect size of spa therapy is calculated and the proportion of patients reaching minimal clinically important improvement (MCII) is compared between groups.

Conditions

• Self Efficacy

Interventions

Type	Name	Description
OTHER	immediate spa therapy	, with 18 days of therapy over 3 weeks; The standardized shoulder therapy program was designed by experienced spa therapy physicians. Spa mineral water and treatments are approved and controlled by the French authorities. Spa treatment included: bubble buses at 36°C for 15 minutes, applications of mineral matured mud at 45°C to the shoulder for 20 minutes, mineral hydrojet sessions at 39°C for 7 minutes and general mobilization in a collective mineral water pool at 35°C for 20 minutes supervised by a registered physiotherapist.

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-04-01
• Completion: 2011-05-01
• First posted: 2012-09-25
• Last updated: 2012-09-25

Locations

1 site across 1 country: France