Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-24 @ 7:52 PM
Study NCT ID:
NCT02702466
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
2016-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Active Prevention of Upper Limb Musculoskeletal Disorders in Thermal Environment (MUSKA).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-26', 'studyFirstSubmitDate': '2016-03-03', 'studyFirstSubmitQcDate': '2016-03-07', 'lastUpdatePostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The score from the scale Quick DASH', 'timeFrame': 'Month 03', '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'}], 'secondaryOutcomes': [{'measure': 'Change of Quick DASH', 'timeFrame': 'Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06', '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'}, {'measure': 'Pain intensity', 'timeFrame': 'Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06', 'description': 'Pain intensity measured on a Visual Analogical Scale (VAS)'}, {'measure': 'Life quality', 'timeFrame': 'Day 06, Month 01, Month 02, Month 03, Month 04, Month 05, Month 06', 'description': 'Life quality measured by SF36 (36-item Medical Outcomes Study Short-Form Health Survey - SF-36) Survey - SF-36)'}, {'measure': 'Stopping time of work', 'timeFrame': 'Month 06', 'description': 'Stopping time of work by self-administered questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Upper limb musculoskeletal disorders', 'Spa treatment', 'Randomized controlled trials', 'Education', 'Self- management', 'Self-care', 'Exercise', 'Non pharmacological treatment'], 'conditions': ['Musculoskeletal Disorders']}, 'referencesModule': {'references': [{'pmid': '17602991', 'type': 'BACKGROUND', '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.'}, {'pmid': '18077092', 'type': 'BACKGROUND', '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.'}, {'pmid': '20011982', 'type': 'BACKGROUND', '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.'}, {'pmid': '19006762', 'type': 'BACKGROUND', '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.'}, {'pmid': '20434942', 'type': 'BACKGROUND', '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.'}, {'pmid': '18436467', 'type': 'BACKGROUND', '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.'}, {'pmid': '17983829', 'type': 'BACKGROUND', '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.'}, {'pmid': '24708552', 'type': 'RESULT', '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.'}, {'pmid': '22818516', 'type': 'RESULT', '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.'}, {'pmid': '38479114', 'type': 'DERIVED', 'citation': 'Lanhers C, Grolier M, Dutheil F, Gay C, Goldstein A, Mourgues C, Levyckyj C, Pereira B, Coudeyre E. Comparison of self-management and spa therapy for upper-extremity musculoskeletal disorders: A randomized controlled trial. Ann Phys Rehabil Med. 2024 Apr;67(3):101813. doi: 10.1016/j.rehab.2023.101813. Epub 2024 Mar 12.'}, {'pmid': '27938361', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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)', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* TMS latent or symptomatic of the upper limbs according to the European Consensus SALTSA / Q score with INRS Nordic \\> 2\n* With or without a history of work stoppage and occupation at the time of inclusion\n* Age: \\> 18 years \\< 65 years\n* Patient affiliated to a social security scheme ( beneficiary entitled )\n* Patient has given its consent in writing to participate in the study\n\nExclusion Criteria:\n\n* Contraindication to the spa therapy\n* Spa achieved in the last 12 months\n* Trouble behavior or understanding making it impossible to assess'}, 'identificationModule': {'nctId': 'NCT02702466', 'acronym': 'MUSKA', 'briefTitle': 'Active Prevention of Upper Limb Musculoskeletal Disorders in Thermal Environment (MUSKA).', 'organization': {'class': 'OTHER', 'fullName': 'Association Francaise pour la Recherche Thermale'}, 'officialTitle': 'Evaluation of the Effectiveness of Personalized Short and Intensive Educational SPA Therapy Prevention of Upper Limb Musculoskeletal Disorders (MSDs).', 'orgStudyIdInfo': {'id': 'MUSKA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate SPA Therapy', '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', 'interventionNames': ['Other: SPA Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Late SPA Therapy', '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', 'interventionNames': ['Other: SPA Therapy']}], 'interventions': [{'name': 'SPA Therapy', 'type': 'OTHER', 'otherNames': ['Non pharmacological 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', 'armGroupLabels': ['Immediate SPA Therapy', 'Late SPA Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73100', 'city': 'Aix-les-Bains', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Etablissement thermal', 'geoPoint': {'lat': 45.69173, 'lon': 5.90863}}, {'zip': '63140', 'city': 'Châtel-Guyon', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Etablissement thermal', 'geoPoint': {'lat': 45.92258, 'lon': 3.06423}}, {'zip': '63408', 'city': 'Royat', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Etablissement thermal', 'geoPoint': {'lat': 45.76497, 'lon': 3.05013}}, {'zip': '59230', 'city': 'Saint-Amand-les-Eaux', 'state': 'Hauts-de-France', 'country': 'France', 'facility': 'Etablissement thermal', 'geoPoint': {'lat': 50.44718, 'lon': 3.43076}}, {'zip': '34540', 'city': 'Balaruc-les-Bains', 'state': 'Occitanie', 'country': 'France', 'facility': 'Etablissement thermal', 'geoPoint': {'lat': 43.4417, 'lon': 3.6778}}], 'overallOfficials': [{'name': 'Emmanuel COUDEYRE, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association Francaise pour la Recherche Thermale', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}