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

June 26, 2018 updated by: Association Francaise pour la Recherche Thermale

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Auvergne-Rhône-Alpes
      • Aix-les- Bains, Auvergne-Rhône-Alpes, France, 73100
        • Etablissement thermal
      • Châtelguyon, Auvergne-Rhône-Alpes, France, 63140
        • Etablissement thermal
      • Royat, Auvergne-Rhône-Alpes, France, 63408
        • Etablissement thermal
    • Languedoc-Roussillon-Midi-Pyrénées
      • Balaruc-les Bains, Languedoc-Roussillon-Midi-Pyrénées, France, 34540
        • Etablissement thermal
    • Nord-Pas-de-Calais
      • Saint-amand-les-eaux, Nord-Pas-de-Calais, France, 59230
        • Etablissement thermal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate SPA Therapy
6 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
Other: SPA Therapy
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
Other Names:
  • Non pharmacological intervention
Active Comparator: Late SPA Therapy
Written information with physical exercises adapted to their pathology and a program of healthcare at the USB key and late 6 day SPA treatment
Other: SPA Therapy
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
Other Names:
  • Non pharmacological intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The score from the scale Quick DASH
Time Frame: Month 03
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
Month 03

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Quick DASH
Time Frame: Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06
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
Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06
Pain intensity
Time Frame: Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06
Pain intensity measured on a Visual Analogical Scale (VAS)
Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06
Life quality
Time Frame: Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06
Life quality measured by SF36 (36-item Medical Outcomes Study Short-Form Health Survey - SF-36) Survey - SF-36)
Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06
Stopping time of work
Time Frame: Month 06
Stopping time of work by self-administered questionnaire.
Month 06

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Francaise pour la Recherche Thermale

Collaborators

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Emmanuel COUDEYRE, PhD, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

March 3, 2016

First Submitted That Met QC Criteria

March 7, 2016

First Posted (Estimate)

March 8, 2016

Study Record Updates

Last Update Posted (Actual)

June 27, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUSKA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Musculoskeletal Disorders

Clinical Trials on SPA Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe