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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Association Francaise pour la Recherche Thermale
ClinicalTrials.gov Identifier:
NCT01692249
First received: September 18, 2012
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Self Efficacy
Other: immediate spa therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Spa Therapy in the Treatment of Chronic Shoulder Pain Due to Rotator Cuff Tendinopathy: ROTATHERM, a Large Randomized Multicentre Trial

Resource links provided by NLM:


Further study details as provided by Association Francaise pour la Recherche Thermale:

Primary Outcome Measures:
  • changes in the Disability of arm, shoulder and hand score (DASH) between baseline and 6 months [ Time Frame: self-reported patient outcomes ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • changes in the Short-form 36 questionnaire (SF-36) between baseline and 6 months [ Time Frame: self-reported patient outcomes ] [ Designated as safety issue: No ]
    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

  • adverse and severe adverse events [ Time Frame: recording of SAE and AE ] [ Designated as safety issue: Yes ]
    all SAE and AE were recorded during the spa therapy and the 6-month follow-up

  • changes in treatment consumption between baseline and 6 months [ Time Frame: All treatments were self-recorded by patients. ] [ Designated as safety issue: No ]
    analgesics, analgesics plus NSAIDs, rehabilitation and topical medications were recorded during the 6-month follow-up


Enrollment: 186
Study Start Date: March 2009
Study Completion Date: May 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Other Names:
  • spa treatment
  • balneotherapy
  • physical treatment
No Intervention: control group
in group (B), spa therapy was delayed for 6 months (control group).

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01692249

Locations
France
Nancy University Hospital
Vandoeuvre-les-Nancy, France, 54511
Sponsors and Collaborators
Association Francaise pour la Recherche Thermale
Investigators
Study Director: Gérard Gay, MD,PhD Association Francaise pour la Recherche Thermale
  More Information

Publications:
Responsible Party: Association Francaise pour la Recherche Thermale
ClinicalTrials.gov Identifier: NCT01692249     History of Changes
Other Study ID Numbers: AFRETH 2
Study First Received: September 18, 2012
Last Updated: September 24, 2012
Health Authority: France: French agency for healthcare product safety (AFSSAPS)

Keywords provided by Association Francaise pour la Recherche Thermale:
chronic shoulder pain
rotator cuff tendinopathy
sap therapy
balneotherapy

Additional relevant MeSH terms:
Shoulder Pain
Tendinopathy
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Muscular Diseases
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on August 01, 2014