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

NCT01692249 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2012-09-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Association Francaise pour la Recherche Thermale

    lead OTHER

Principal Investigators

  • Gérard Gay, MD,PhD · Association Francaise pour la Recherche Thermale

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-04-30
Completion
2011-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01692249 on ClinicalTrials.gov