Clinical trial NCT02702466: Active Prevention of Upper Limb Musculoskeletal Disorders in Thermal Environment (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
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Disorders
Keywords: Upper limb musculoskeletal disorders
Spa treatment
Randomized controlled trials
Education
Self- management
Self-care
Exercise
Non pharmacological treatment
Lead sponsor: Association Francaise pour la Recherche Thermale
Sponsor class: OTHER
Collaborators: name: University Hospital, Clermont-Ferrand
First posted: 2016-03-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The score from the scale Quick DASH
timeFrame: Month 03
Secondary outcomes:
measure: Change of Quick DASH
timeFrame: Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06
measure: Pain intensity
timeFrame: Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06
measure: Life quality
timeFrame: Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06
measure: Stopping time of work
timeFrame: Month 06
Other outcomes:
Locations:
city: Aix-les- Bains
country: France
facility: Etablissement thermal
state: Auvergne-Rhône-Alpes
city: Châtelguyon
country: France
facility: Etablissement thermal
state: Auvergne-Rhône-Alpes
city: Royat
country: France
facility: Etablissement thermal
state: Auvergne-Rhône-Alpes
city: Balaruc-les Bains
country: France
facility: Etablissement thermal
state: Languedoc-Roussillon-Midi-Pyrénées
city: Saint-amand-les-eaux
country: France
facility: Etablissement thermal
state: Nord-Pas-de-Calais
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Emmanuel COUDEYRE, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.