Self EfficacyROTATHERMNCT01692249
Efficacy and Safety of Spa Treatment in Chronic Shoulder Pain Due to Rotator Cuff Tendinopathy
A study testing immediate spa therapy in people with Self Efficacy, run by Association Francaise pour la Recherche Thermale at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Self Efficacy
- What is being tested?
- immediate spa therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Self Efficacy
- Being tested
- immediate spa therapy
- Keywords
- chronic shoulder pain, rotator cuff tendinopathy, sap therapy, balneotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate spa therapyOther
Also called spa treatment, balneotherapy, physical 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.
| Study group | Role | What they receive |
|---|---|---|
| immediate spa therapy | Experimental | 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. Receives: Other: immediate spa therapy |
| control group | No intervention | in group (B), spa therapy was delayed for 6 months (control group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: self-reported patient outcomes
Secondary outcomes (3)
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
Measured: self-reported patient outcomes
adverse and severe adverse events
all SAE and AE were recorded during the spa therapy and the 6-month follow-up
Measured: recording of SAE and AE
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
Measured: All treatments were self-recorded by patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startMar 2009
- Primary completionApr 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Self EfficacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Francaise pour la Recherche Thermale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gérard Gay, MD,PhD, Study director, Association Francaise pour la Recherche Thermale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692249
- Sponsor's protocol ID
- AFRETH 2
- Acronym
- ROTATHERM
- Status last verified
- Sep 2012
- First submitted
- 18 Sep 2012
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Forestier R, Desfour H, Tessier JM, Francon 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. Epub 2009 Sep 3.
PubMed 19734131
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spa Therapy in the Treatment of Chronic Shoulder Pain Due to Rotator Cuff Tendinopathy: ROTATHERM, a Large Randomized Multicentre Trial
- ClinicalTrials.gov ID
- NCT01692249
- Acronym / sponsor ID
- ROTATHERM / AFRETH 2
- Conditions
- Self Efficacy
- Keywords
- chronic shoulder pain, rotator cuff tendinopathy, sap therapy, balneotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Association Francaise pour la Recherche ThermaleUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate spa therapy | Experimental | Other: immediate spa therapygroup (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. |
| control group | No intervention | –in group (B), spa therapy was delayed for 6 months (control group). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immediate spa therapyAlso: spa treatment, balneotherapy, physical 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 |
Primary outcome
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
3 secondary outcomes
changes in the Short-form 36 questionnaire (SF-36) between baseline and 6 months
Time frame: self-reported patient outcomes
adverse and severe adverse events
Time frame: recording of SAE and AE
changes in treatment consumption between baseline and 6 months
Time frame: All treatments were self-recorded by patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2012.
- Results publication: PubMed 19734131Forestier R, Desfour H, Tessier JM, Francon 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. Epub 2009 Sep 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gérard Gay, MD,PhD study director
Association Francaise pour la Recherche Thermale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immediate spa therapy in people with Self Efficacy, run by Association Francaise pour la Recherche Thermale at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in the Disability of arm, shoulder and hand score (DASH) between baseline and 6 months (time frame: self-reported patient outcomes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01692249, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2012.