- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01692249
Efficacy and Safety of Spa Treatment in Chronic Shoulder Pain Due to Rotator Cuff Tendinopathy (ROTATHERM)
September 24, 2012 updated by: Association Francaise pour la Recherche Thermale
Spa Therapy in the Treatment of Chronic Shoulder Pain Due to Rotator Cuff Tendinopathy: ROTATHERM, a Large Randomized Multicentre Trial
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
186
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Vandoeuvre-les-Nancy, France, 54511
- Nancy University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- chronic shoulder pain (symptom duration of more than 6 months) due to primary or secondary tendinopathy of the rotator cuff.
In cases of rotator cuff tendinopathy related to traumatic events, the trauma was required to have happened at least 6 months previously. Corticosteroid treatment for concomitant disease could be continued at a stable dose. Shoulder x-rays within the previous 18 months were required in all cases.
Exclusion Criteria:
- shoulder pain related to neurological or vascular disorders or neoplasms; referred pain from internal organs; systemic rheumatic conditions; inability to complete questionnaires because of cognitive impairment, or language difficulty; contraindication (immune deficiency, evolving cardiovascular conditions, cancer, infection, non-equilibrated diabetes mellitus) or intolerance to any aspect of spa treatment; spa treatment within the previous 6 months; steroid injection within the previous 3 months; physiotherapy in the previous month; changes in non-steroidal anti-inflammatory drug (NSAID) administration within the previous 5 days or in other analgesic drug use within the previous 12 hours.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: immediate spa therapy
group (A) received immediate spa treatment, 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.
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, 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.
Other Names:
|
No Intervention: control group
in group (B), spa therapy was delayed for 6 months (control group).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in the Disability of arm, shoulder and hand score (DASH) between baseline and 6 months
Time Frame: self-reported patient outcomes
|
The domains explored by the Quick DASH are: (1) physical arm, shoulder or hand activity problems (6 items); (2) severity of pain and tingling (2 items); (3) social activities, work, and sleep (3 items).
Each item has five response options, ranging from 1, ''no difficulty or no symptom,'' to 5, ''unable to perform activity or very severe symptom.''
If at least 10 of the 11 items are completed, a score ranging from 0 (no disability) to 100 (most severe disability) can be calculated [(sum of n responses/n) - 1] x 25.the effect size and the percentage of patients reaching Minimal Clinical Important Improvement was determined
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self-reported patient outcomes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in the Short-form 36 questionnaire (SF-36) between baseline and 6 months
Time Frame: self-reported patient outcomes
|
The SF-36 is the most widely used generic instrument for assessing physical, mental, and psychosocial health based on eight scales and two component summary scales (Physical and Mental Component Summary) containing a total of 36 items
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self-reported patient outcomes
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adverse and severe adverse events
Time Frame: recording of SAE and AE
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all SAE and AE were recorded during the spa therapy and the 6-month follow-up
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recording of SAE and AE
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changes in treatment consumption between baseline and 6 months
Time Frame: All treatments were self-recorded by patients.
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analgesics, analgesics plus NSAIDs, rehabilitation and topical medications were recorded during the 6-month follow-up
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All treatments were self-recorded by patients.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Gérard Gay, MD,PhD, Association Francaise pour la Recherche Thermale
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
September 18, 2012
First Submitted That Met QC Criteria
September 24, 2012
First Posted (Estimate)
September 25, 2012
Study Record Updates
Last Update Posted (Estimate)
September 25, 2012
Last Update Submitted That Met QC Criteria
September 24, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AFRETH 2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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