<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01692249</url>
  </required_header>
  <id_info>
    <org_study_id>AFRETH 2</org_study_id>
    <nct_id>NCT01692249</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Spa Treatment in Chronic Shoulder Pain Due to Rotator Cuff Tendinopathy</brief_title>
  <acronym>ROTATHERM</acronym>
  <official_title>Spa Therapy in the Treatment of Chronic Shoulder Pain Due to Rotator Cuff Tendinopathy: ROTATHERM, a Large Randomized Multicentre Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association Francaise pour la Recherche Thermale</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Association Francaise pour la Recherche Thermale</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine whether spa therapy has a beneficial effect on pain and disability in the&#xD;
      management of shoulder pain due to chronic rotator cuff lesions, this multicentre randomized&#xD;
      prospective clinical trial includes patients with shoulder pain due to chronic degenerative&#xD;
      rotator cuff tendinopathy who attend French spa resorts as outpatients. Subjects are&#xD;
      randomized into two groups: immediate spa therapy (18 days of standardized treatment) and&#xD;
      control (spa therapy delayed for 6 months). All patients continue usual treatments during the&#xD;
      6-month follow-up period. The main endpoint is the mean change in the DASH score at 6 months.&#xD;
      Secondary endpoints are the mean change in SF-36 components, treatments used, and tolerance.&#xD;
      The effect size of spa therapy is calculated and the proportion of patients reaching minimal&#xD;
      clinically important improvement (MCII) is compared between groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2009</start_date>
  <completion_date type="Actual">May 2011</completion_date>
  <primary_completion_date type="Actual">April 2010</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in the Disability of arm, shoulder and hand score (DASH) between baseline and 6 months</measure>
    <time_frame>self-reported patient outcomes</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in the Short-form 36 questionnaire (SF-36) between baseline and 6 months</measure>
    <time_frame>self-reported patient outcomes</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse and severe adverse events</measure>
    <time_frame>recording of SAE and AE</time_frame>
    <description>all SAE and AE were recorded during the spa therapy and the 6-month follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in treatment consumption between baseline and 6 months</measure>
    <time_frame>All treatments were self-recorded by patients.</time_frame>
    <description>analgesics, analgesics plus NSAIDs, rehabilitation and topical medications were recorded during the 6-month follow-up</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">186</enrollment>
  <condition>Self Efficacy</condition>
  <arm_group>
    <arm_group_label>immediate spa therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>in group (B), spa therapy was delayed for 6 months (control group).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>immediate spa therapy</intervention_name>
    <description>, 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.</description>
    <arm_group_label>immediate spa therapy</arm_group_label>
    <other_name>spa treatment</other_name>
    <other_name>balneotherapy</other_name>
    <other_name>physical treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic shoulder pain (symptom duration of more than 6 months) due to primary or&#xD;
             secondary tendinopathy of the rotator cuff.&#xD;
&#xD;
        In cases of rotator cuff tendinopathy related to traumatic events, the trauma was required&#xD;
        to have happened at least 6 months previously. Corticosteroid treatment for concomitant&#xD;
        disease could be continued at a stable dose. Shoulder x-rays within the previous 18 months&#xD;
        were required in all cases.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  shoulder pain related to neurological or vascular disorders or neoplasms; referred&#xD;
             pain from internal organs; systemic rheumatic conditions; inability to complete&#xD;
             questionnaires because of cognitive impairment, or language difficulty;&#xD;
             contraindication (immune deficiency, evolving cardiovascular conditions, cancer,&#xD;
             infection, non-equilibrated diabetes mellitus) or intolerance to any aspect of spa&#xD;
             treatment; spa treatment within the previous 6 months; steroid injection within the&#xD;
             previous 3 months; physiotherapy in the previous month; changes in non-steroidal&#xD;
             anti-inflammatory drug (NSAID) administration within the previous 5 days or in other&#xD;
             analgesic drug use within the previous 12 hours.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gérard Gay, MD,PhD</last_name>
    <role>Study Director</role>
    <affiliation>Association Francaise pour la Recherche Thermale</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nancy University Hospital</name>
      <address>
        <city>Vandoeuvre-les-Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>19734131</PMID>
  </results_reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>September 24, 2012</last_update_submitted>
  <last_update_submitted_qc>September 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>chronic shoulder pain</keyword>
  <keyword>rotator cuff tendinopathy</keyword>
  <keyword>sap therapy</keyword>
  <keyword>balneotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
    <mesh_term>Tendinopathy</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01692249
org study id: AFRETH 2
nct id: NCT01692249
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: changes in the Disability of arm, shoulder and hand score (DASH) between baseline and 6 months
time frame: self-reported patient outcomes
description: 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
measure: changes in the Short-form 36 questionnaire (SF-36) between baseline and 6 months
time frame: self-reported patient outcomes
description: 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
measure: adverse and severe adverse events
time frame: recording of SAE and AE
description: all SAE and AE were recorded during the spa therapy and the 6-month follow-up
measure: changes in treatment consumption between baseline and 6 months
time frame: All treatments were self-recorded by patients.
description: analgesics, analgesics plus NSAIDs, rehabilitation and topical medications were recorded during the 6-month follow-up
arm group label: immediate spa therapy
arm group type: Experimental
description: 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.
arm group label: control group
arm group type: No Intervention
description: in group (B), spa therapy was delayed for 6 months (control group).
intervention type: Other
intervention name: immediate spa therapy
description: , 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.
arm group label: immediate spa therapy
other name: spa treatment
other name: balneotherapy
other name: physical treatment
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Gérard Gay, MD,PhD
role: Study Director
affiliation: Association Francaise pour la Recherche Thermale
facility: 
country: France
citation: 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.
PMID: 19734131
responsible party type: Sponsor
mesh term: Shoulder Pain
mesh term: Tendinopathy