AzTrials
AzTrials

Musculoskeletal DisordersMUSKANCT02702466

Active Prevention of Upper Limb Musculoskeletal Disorders in Thermal Environment (MUSKA).

A study testing SPA Therapy in people with Musculoskeletal Disorders, run by Association Francaise pour la Recherche Thermale at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main objective of this work is to demonstrate superiority to three months of a standardized short course of SPA Therapy of 6 days associated with personalized health education program compared to conventional therapy in the management of MSDs on the functional capabilities of the employees in their daily lives… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Musculoskeletal Disorders
What is being tested?
SPA Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
5 sitesFrance
Study dates
Sep 2015to May 2018
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • TMS latent or symptomatic of the upper limbs according to the European Consensus SALTSA / Q score with INRS Nordic > 2
  • With or without a history of work stoppage and occupation at the time of inclusion
  • Age: > 18 years < 65 years
  • Patient affiliated to a social security scheme ( beneficiary entitled )
  • Patient has given its consent in writing to participate in the study

Who cannot join

  • Contraindication to the spa therapy
  • Spa achieved in the last 12 months
  • Trouble behavior or understanding making it impossible to assess

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites

  • Etablissement thermal

    Aix-les-Bains, Auvergne-Rhône-Alpes, 73100

  • Etablissement thermal

    Balaruc-les-Bains, Occitanie, 34540

  • Etablissement thermal

    Châtel-Guyon, Auvergne-Rhône-Alpes, 63140

  • Etablissement thermal

    Royat, Auvergne-Rhône-Alpes, 63408

  • Etablissement thermal

    Saint-Amand-les-Eaux, Hauts-de-France, 59230

Other trials in France

About this study

Official title: Evaluation of the Effectiveness of Personalized Short and Intensive Educational SPA Therapy Prevention of Upper Limb Musculoskeletal Disorders (MSDs).

The main objective of this work is to demonstrate superiority to three months of a standardized short course of SPA Therapy of 6 days associated with personalized health education program compared to conventional therapy in the management of MSDs on the functional capabilities of the employees in their daily lives (personal or professional)

Read the detailed description

Musculoskeletal disorders are the leading occupational disease in industrialized countries. The symptoms are varied, their multiple risk factors, work organization may be involved. Musculoskeletal disorders affect the muscles, tendons and nerves of the mainly upper limbs (neck, shoulder, elbow, wrist and hand). Pain or functional impairment are common to all these disorders.The proposed study is part of an active preventive approach in addressing current employees with latent or symptomatic upper extremity MSD linked to a hyper solicitation. This study provide them 6 days SPA therapy (before or after work) combined with a health education program to help improve their lives over time.

Being tested
SPA Therapy
Keywords
Upper limb musculoskeletal disorders, Spa treatment, Randomized controlled trials, Education, Self- management, Self-care, Exercise, Non pharmacological treatment
Medical subject headings
Musculoskeletal Diseases, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPA TherapyOther

    Also called Non pharmacological intervention

    Immersion bath and shower ( 1 treatment ) Underwater shower with localized massage on the painful area ( 1 treatment ) or equivalent underwater massage Illutations ( 1 treatment ) or equivalent ( poultice ) Mobilization Pool ( 1 care) Education to exercise

Study groups in NCT02702466
Study groupRoleWhat they receive
Immediate SPA TherapyExperimental6 day immediate SPA treatment (soon after randomization) and written information with physical exercises adapted to their pathology and also a program of healthcare at the USB key
Receives: Other: SPA Therapy
Late SPA TherapyActive comparatorWritten information with physical exercises adapted to their pathology and a program of healthcare at the USB key and late 6 day SPA treatment
Receives: Other: SPA Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The score from the scale Quick DASH

    Change from baseline in measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb by Quick DASH measure

    Measured: Month 03

Secondary outcomes (4)

  1. Change of Quick DASH

    Average change from baseline in measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb by Quick DASH measure

    Measured: Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06

  2. Pain intensity

    Pain intensity measured on a Visual Analogical Scale (VAS)

    Measured: Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06

  3. Life quality

    Life quality measured by SF36 (36-item Medical Outcomes Study Short-Form Health Survey - SF-36) Survey - SF-36)

    Measured: Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06

  4. Stopping time of work

    Stopping time of work by self-administered questionnaire.

    Measured: Month 06

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2016 (estimated)
  2. Study startSep 2015
  3. Primary completionFeb 2018
  4. Study completionMay 2018

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02702466
Sponsor's protocol ID
MUSKA
Acronym
MUSKA
Status last verified
Jun 2018
First submitted
3 Mar 2016
Last updated
27 Jun 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • McBeth J, Jones K. Epidemiology of chronic musculoskeletal pain. Best Pract Res Clin Rheumatol. 2007 Jun;21(3):403-25. doi: 10.1016/j.berh.2007.03.003.

    PubMed 17602991

  • Kamaleri Y, Natvig B, Ihlebaek CM, Bruusgaard D. Localized or widespread musculoskeletal pain: does it matter? Pain. 2008 Aug 15;138(1):41-46. doi: 10.1016/j.pain.2007.11.002. Epub 2008 Feb 20.

    PubMed 18077092

  • Solidaki E, Chatzi L, Bitsios P, Markatzi I, Plana E, Castro F, Palmer K, Coggon D, Kogevinas M. Work-related and psychological determinants of multisite musculoskeletal pain. Scand J Work Environ Health. 2010 Jan;36(1):54-61. doi: 10.5271/sjweh.2884. Epub 2009 Dec 11.

    PubMed 20011982

  • Fan ZJ, Smith CK, Silverstein BA. Assessing validity of the QuickDASH and SF-12 as surveillance tools among workers with neck or upper extremity musculoskeletal disorders. J Hand Ther. 2008 Oct-Dec;21(4):354-65. doi: 10.1197/j.jht.2008.02.001.

    PubMed 19006762

  • Polson K, Reid D, McNair PJ, Larmer P. Responsiveness, minimal importance difference and minimal detectable change scores of the shortened disability arm shoulder hand (QuickDASH) questionnaire. Man Ther. 2010 Aug;15(4):404-7. doi: 10.1016/j.math.2010.03.008.

    PubMed 20434942

  • Fayad F, Lefevre-Colau MM, Gautheron V, Mace Y, Fermanian J, Mayoux-Benhamou A, Roren A, Rannou F, Roby-Brami A, Revel M, Poiraudeau S. Reliability, validity and responsiveness of the French version of the questionnaire Quick Disability of the Arm, Shoulder and Hand in shoulder disorders. Man Ther. 2009 Apr;14(2):206-12. doi: 10.1016/j.math.2008.01.013. Epub 2008 Apr 23.

    PubMed 18436467

  • Fayad F, Lefevre-Colau MM, Mace Y, Fermanian J, Mayoux-Benhamou A, Roren A, Rannou F, Roby-Brami A, Gautheron V, Revel M, Poiraudeau S. Validation of the French version of the Disability of the Arm, Shoulder and Hand questionnaire (F-DASH). Joint Bone Spine. 2008 Mar;75(2):195-200. doi: 10.1016/j.jbspin.2007.04.023. Epub 2007 Aug 30.

    PubMed 17983829

  • Meroni R, Scelsi M, Boria P, Sansone V. Shoulder disorders in female working-age population: a cross sectional study. BMC Musculoskelet Disord. 2014 Apr 4;15:118. doi: 10.1186/1471-2474-15-118.

    PubMed 24708552

  • Parot-Schinkel E, Descatha A, Ha C, Petit A, Leclerc A, Roquelaure Y. Prevalence of multisite musculoskeletal symptoms: a French cross-sectional working population-based study. BMC Musculoskelet Disord. 2012 Jul 20;13:122. doi: 10.1186/1471-2474-13-122.

    PubMed 22818516

  • Lanhers C, Grolier M, Dutheil F, Gay C, Goldstein A, Mourgues C, Levyckyj C, Pereira B, Coudeyre E. Comparison of self-management and spa therapy for upper-extremity musculoskeletal disorders: A randomized controlled trial. Ann Phys Rehabil Med. 2024 Apr;67(3):101813. doi: 10.1016/j.rehab.2023.101813. Epub 2024 Mar 12.

    PubMed 38479114

  • Lanhers C, Pereira B, Gay C, Herisson C, Levyckyj C, Dupeyron A, Coudeyre E. Evaluation of the efficacy of a short-course, personalized self-management and intensive spa therapy intervention as active prevention of musculoskeletal disorders of the upper extremities (Muska): a research protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2016 Dec 9;17(1):497. doi: 10.1186/s12891-016-1353-8.

    PubMed 27938361

Questions about this trial

What is this clinical trial studying?

A study testing SPA Therapy in people with Musculoskeletal Disorders, run by Association Francaise pour la Recherche Thermale at 5 sites 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 5 inclusion and 3 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 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

The score from the scale Quick DASH (time frame: Month 03). 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 NCT02702466, which also lists 11 linked publications.

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 27 Jun 2018.

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