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

Musculoskeletal Disorders Clinical Trial

— MUSKA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702466
• Other study ID #: MUSKA
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: May 2018

Study information

• Verified date: June 2018
• Source: Association Francaise pour la Recherche Thermale
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (personal or professional)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Musculoskeletal Diseases
• Musculoskeletal Disorders

Intervention

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

Locations

Country	Name	City	State
France	Etablissement thermal	Aix-les- Bains	Auvergne-Rhône-Alpes
France	Etablissement thermal	Balaruc-les Bains	Languedoc-Roussillon-Midi-Pyrénées
France	Etablissement thermal	Châtelguyon	Auvergne-Rhône-Alpes
France	Etablissement thermal	Royat	Auvergne-Rhône-Alpes
France	Etablissement thermal	Saint-amand-les-eaux	Nord-Pas-de-Calais

Sponsors (2)

Lead Sponsor	Collaborator
Association Francaise pour la Recherche Thermale	University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

References & Publications (9)

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. — View Citation

Fayad F, Lefevre-Colau MM, Gautheron V, Macé 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. — View Citation

Fayad F, Lefevre-Colau MM, Macé 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. Epub 2007 Aug 30. — View Citation

Kamaleri Y, Natvig B, Ihlebaek CM, Bruusgaard D. Localized or widespread musculoskeletal pain: does it matter? Pain. 2008 Aug 15;138(1):41-6. Epub 2008 Feb 20. — View Citation

McBeth J, Jones K. Epidemiology of chronic musculoskeletal pain. Best Pract Res Clin Rheumatol. 2007 Jun;21(3):403-25. Review. — View Citation

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. — View 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. — View 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. — View 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. Epub 2009 Dec 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Month 03
Secondary	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	Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06
Secondary	Pain intensity	Pain intensity measured on a Visual Analogical Scale (VAS)	Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06
Secondary	Life quality	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
Secondary	Stopping time of work	Stopping time of work by self-administered questionnaire.	Month 06