Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT01478451
Status:
COMPLETED
Last Update Posted:
2012-02-28
First Post:
2011-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Effect of Massage and Exercise on Muscle Tenderness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D008405', 'term': 'Massage'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-27', 'studyFirstSubmitDate': '2011-10-28', 'studyFirstSubmitQcDate': '2011-11-21', 'lastUpdatePostDateStruct': {'date': '2012-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived tenderness of the trapezius muscle on a numerical rating scale of 0-10', 'timeFrame': 'change from before to after the acute intervention (average of 0, 10, 20 and 60 min after the intervention)', 'description': 'Perceived tenderness where 0 is no tenderness and 10 is worst imaginable tenderness'}, {'measure': 'Pressure pain threshold of the trapezius muscle', 'timeFrame': 'change from before to after the acute intervention (average of 0, 10, 20 and 60 min after the intervention)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DOMS'], 'conditions': ['Musculoskeletal Disorders']}, 'referencesModule': {'references': [{'pmid': '23524365', 'type': 'DERIVED', 'citation': 'Andersen LL, Jay K, Andersen CH, Jakobsen MD, Sundstrup E, Topp R, Behm DG. Acute effects of massage or active exercise in relieving muscle soreness: randomized controlled trial. J Strength Cond Res. 2013 Dec;27(12):3352-9. doi: 10.1519/JSC.0b013e3182908610.'}], 'seeAlsoLinks': [{'url': 'http://arbejdsmiljoforskning.dk', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Many people experience pain, tenderness and soreness of joint and muscles, both in sport and working life. Pain killers can provide acute relief of pain, but may not be a feasible solution for all people. Here the investigators examine the acute effect of massage and exercise on induced muscle tenderness (delayed onset muscular soreness).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '67 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* working age adults\n\nExclusion Criteria:\n\n* blood pressure above 160/100\n* disease of the cervical spine'}, 'identificationModule': {'nctId': 'NCT01478451', 'briefTitle': 'Acute Effect of Massage and Exercise on Muscle Tenderness', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Research Centre for the Working Environment, Denmark'}, 'officialTitle': 'Danish: Integreret Motion på Arbejdspladsen (IRMA) English: Implementation of Exercise at the Workplace', 'orgStudyIdInfo': {'id': 'IRMA02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Massage', 'description': 'massage will be provided for 10 minutes at the left or right trapezius (randomized)', 'interventionNames': ['Other: Massage']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': 'exercise (shoulder shrugs with elastic resistance) will be performed for 10 minutes at the left or right trapezius (randomized)', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'control shoulder (randomized)'}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'Exercise will be performed for 10 minutes at the left or right trapezius (randomized)', 'armGroupLabels': ['Exercise']}, {'name': 'Massage', 'type': 'OTHER', 'description': 'massage will be provided for 10 minutes at the left or right trapezius (randomized)', 'armGroupLabels': ['Massage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'National Research Centre for the Working Environment', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Lars L Andersen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Senior Researcher'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Research Centre for the Working Environment, Denmark', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lars L. Andersen', 'investigatorAffiliation': 'National Research Centre for the Working Environment, Denmark'}}}}