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

Sponsor

Association Francaise pour la Recherche Thermale (Other)

Overall Status

Completed

CT.gov ID

NCT02702466

Collaborator

University Hospital, Clermont-Ferrand (Other)

150

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Musculoskeletal Disorders	Other: SPA Therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

May 1, 2018

Arms and Interventions

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

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

Other Names:

Non pharmacological intervention

Outcome Measures

Primary Outcome Measures

The score from the scale Quick DASH [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

Secondary Outcome Measures

Change of Quick DASH [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
Pain intensity [Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06]
Pain intensity measured on a Visual Analogical Scale (VAS)
Life quality [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)
Stopping time of work [Month 06]
Stopping time of work by self-administered questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Etablissement thermal	Aix-les- Bains	Auvergne-Rhône-Alpes	France	73100
2	Etablissement thermal	Châtelguyon	Auvergne-Rhône-Alpes	France	63140
3	Etablissement thermal	Royat	Auvergne-Rhône-Alpes	France	63408
4	Etablissement thermal	Balaruc-les Bains	Languedoc-Roussillon-Midi-Pyrénées	France	34540
5	Etablissement thermal	Saint-amand-les-eaux	Nord-Pas-de-Calais	France	59230