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

Self Efficacy Clinical Trial

— ROTATHERM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01692249
• Other study ID #: AFRETH 2
• Status: Completed
• Phase: N/A
• First received: September 18, 2012
• Last updated: September 24, 2012
• Start date: March 2009
• Est. completion date: May 2011

Study information

• Verified date: September 2012
• Source: Association Francaise pour la Recherche Thermale
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French agency for healthcare product safety (AFSSAPS)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: May 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Self Efficacy
• Shoulder Pain
• Tendinopathy

Intervention

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.

Locations

Country	Name	City	State
France	Nancy University Hospital	Vandoeuvre-les-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Association Francaise pour la Recherche Thermale

Country where clinical trial is conducted

France, 

References & Publications (1)

Forestier R, Desfour H, Tessier JM, Françon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in the Disability of arm, shoulder and hand score (DASH) between baseline and 6 months	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	self-reported patient outcomes	No
Secondary	changes in the Short-form 36 questionnaire (SF-36) between baseline and 6 months	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	self-reported patient outcomes	No
Secondary	adverse and severe adverse events	all SAE and AE were recorded during the spa therapy and the 6-month follow-up	recording of SAE and AE	Yes
Secondary	changes in treatment consumption between baseline and 6 months	analgesics, analgesics plus NSAIDs, rehabilitation and topical medications were recorded during the 6-month follow-up	All treatments were self-recorded by patients.	No