Back to resultsActive Prevention of Upper Limb Musculoskeletal Disorders in Thermal Environment (MUSKA). (MUSKA)
Primary Purpose
Musculoskeletal Disorders
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SPA Therapy
Sponsored by
About this trial
This is an interventional prevention trial for Musculoskeletal Disorders focused on measuring Upper limb musculoskeletal disorders, Spa treatment, Randomized controlled trials, Education, Self- management, Self-care, Exercise, Non pharmacological treatment
Eligibility Criteria
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
Sites / Locations
- Etablissement thermal
- Etablissement thermal
- Etablissement thermal
- Etablissement thermal
- Etablissement thermal
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Immediate SPA Therapy
Late SPA Therapy
Arm Description
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
Written information with physical exercises adapted to their pathology and a program of healthcare at the USB key and late 6 day SPA treatment
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Pain intensity
Pain intensity measured on a Visual Analogical Scale (VAS)
Life quality
Life quality measured by SF36 (36-item Medical Outcomes Study Short-Form Health Survey - SF-36) Survey - SF-36)
Stopping time of work
Stopping time of work by self-administered questionnaire.
Full Information
NCT ID
NCT02702466
First Posted
March 3, 2016
Last Updated
June 26, 2018
Sponsor
Association Francaise pour la Recherche Thermale
Collaborators
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT02702466
Brief Title
Active Prevention of Upper Limb Musculoskeletal Disorders in Thermal Environment (MUSKA).
Acronym
MUSKA
Official Title
Evaluation of the Effectiveness of Personalized Short and Intensive Educational SPA Therapy Prevention of Upper Limb Musculoskeletal Disorders (MSDs).
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association Francaise pour la Recherche Thermale
Collaborators
University Hospital, Clermont-Ferrand
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 (personal or professional)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Disorders
Keywords
Upper limb musculoskeletal disorders, Spa treatment, Randomized controlled trials, Education, Self- management, Self-care, Exercise, Non pharmacological treatment
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate SPA Therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Late SPA Therapy
Arm Type
Active Comparator
Arm Description
Written information with physical exercises adapted to their pathology and a program of healthcare at the USB key and late 6 day SPA treatment
Intervention Type
Other
Intervention Name(s)
SPA Therapy
Other Intervention Name(s)
Non pharmacological intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
The score from the scale Quick DASH
Description
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
Time Frame
Month 03
Secondary Outcome Measure Information:
Title
Change of Quick DASH
Description
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
Time Frame
Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06
Title
Pain intensity
Description
Pain intensity measured on a Visual Analogical Scale (VAS)
Time Frame
Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06
Title
Life quality
Description
Life quality measured by SF36 (36-item Medical Outcomes Study Short-Form Health Survey - SF-36) Survey - SF-36)
Time Frame
Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06
Title
Stopping time of work
Description
Stopping time of work by self-administered questionnaire.
Time Frame
Month 06
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel COUDEYRE, PhD
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Etablissement thermal
City
Aix-les- Bains
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
73100
Country
France
Facility Name
Etablissement thermal
City
Châtelguyon
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
63140
Country
France
Facility Name
Etablissement thermal
City
Royat
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
63408
Country
France
Facility Name
Etablissement thermal
City
Balaruc-les Bains
State/Province
Languedoc-Roussillon-Midi-Pyrénées
ZIP/Postal Code
34540
Country
France
Facility Name
Etablissement thermal
City
Saint-amand-les-eaux
State/Province
Nord-Pas-de-Calais
ZIP/Postal Code
59230
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17602991
Citation
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Results Reference
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18077092
Citation
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.
Results Reference
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PubMed Identifier
20011982
Citation
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.
Results Reference
background
PubMed Identifier
19006762
Citation
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.
Results Reference
background
PubMed Identifier
20434942
Citation
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.
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PubMed Identifier
18436467
Citation
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.
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PubMed Identifier
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Citation
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.
Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
27938361
Citation
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.
Results Reference
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Active Prevention of Upper Limb Musculoskeletal Disorders in Thermal Environment (MUSKA).
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