Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-26 @ 9:43 AM
Study NCT ID:
NCT04830566
Status:
COMPLETED
Last Update Posted:
2022-11-02
First Post:
2021-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Myofascial Technique on Biomechanical Properties of the Lumbar Myofascia of Chronic Low Back Pain Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089803', 'term': 'Myofascial Release Therapy'}], 'ancestors': [{'id': 'D008405', 'term': 'Massage'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2021-03-19', 'studyFirstSubmitQcDate': '2021-04-01', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in elastography features of the myofascial unit', 'timeFrame': 'Baseline (before treatment), post-treatment (immediately after treatment)', 'description': 'Evaluated with a shear wave sonoelastography device.'}], 'secondaryOutcomes': [{'measure': 'Changes in ultrasonography features of the myofascial unit', 'timeFrame': 'Baseline (before treatment) post-treatment (immediately after treatment)', 'description': 'Evaluated with a B-mode ultrasound imaging device'}, {'measure': 'Changes in myometry features of the myofascial unit', 'timeFrame': 'Baseline (before treatment) post-treatment (immediately after treatment)', 'description': 'Evaluated with a myotonometer'}, {'measure': 'Changes in pain intensity', 'timeFrame': 'Baseline (before treatment) post-treatment (immediately after treatment), at day 2 and at day 7 after the intervention', 'description': 'Numeric rating Scale (0 to 10; minimum = 0; maximum = 10; higher score means worst outcome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low back pain', 'Fascia properties', 'Thoracolumbar fascia', 'Myofascial release', 'Manual therapy', 'Osteopathy', 'Ultrasound imaging', 'Sonoelastography'], 'conditions': ['Chronic Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Non-specific low back pain is a worldwide health issue that remains poorly understood. Some authors have shown that the thoracolumbar fascia of low back pain adults presents changes in biomechanical properties. As it is richly endowed with pain receptors, the thoracolumbar fascia could therefore be a key contributor to this chronic pain condition. Myofascial techniques (MFTs) are commonly used in manual therapy by practitioners of various backgrounds to address fascia biomechanical properties, but there is a paucity of objective evidence on their effects on tissue state. Musculoskeletal ultrasonography, sonoelastography and myometry are emerging imaging techniques that can quantify the biomechanical properties of fascia and underlying muscle. These innovative techniques could in turn contribute to a better understanding of MFTs effects on fascial properties.\n\nThe main objective of this study is to evaluate the immediate effect of a standardized MFT on the elastography features of the lumbar paraspinal muscle and fascia (i.e. myofascial unit). The secondary objectives are to evaluate the immediate effects of a MFT on: i) ultrasonography features of the myofascial unit; ii) myometry features of the myofascial unit; ii) pain intensity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults over 18 years of age,\n* lumbar pain and/or referred pain above or below the gluteal fold , with intensity \\> 3/10, persisting for \\> 6 months and presenting during the day \\> 50% of the time.\n\nExclusion Criteria:\n\n* history of serious spinal or lower extremity injury or surgery in the last year\n* identifiable back pain or known pathology\n* known rheumatological condition\n* oral or injectable corticosteroids in the lumbar spine within the last 3 months\n* psychiatric disorder\n* pregnancy\n* manual treatment of the lumbo-sacral region 1 month prior to the experimentation and during the week of the study'}, 'identificationModule': {'nctId': 'NCT04830566', 'briefTitle': 'Effects of a Myofascial Technique on Biomechanical Properties of the Lumbar Myofascia of Chronic Low Back Pain Adults', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Effects of a Myofascial Technique on Biomechanical Properties of the Lumbar Paraspinal Muscle and Thoracolumbar Fascia in Chronic Low Back Pain Adults Assessed by Elastography, Ultrasonography and Myometry', 'orgStudyIdInfo': {'id': '2021-3572'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Myofascial release technique group', 'interventionNames': ['Other: Myofascial release technique']}, {'type': 'SHAM_COMPARATOR', 'label': 'Simulated myofascial release technique group', 'interventionNames': ['Other: Simulated Myofascial Release technique']}], 'interventions': [{'name': 'Myofascial release technique', 'type': 'OTHER', 'description': 'Myofascial technique on the thoracolumbar fascia and lumbar paraspinal muscles', 'armGroupLabels': ['Myofascial release technique group']}, {'name': 'Simulated Myofascial Release technique', 'type': 'OTHER', 'description': 'Superficial hands contact on the lumbar area', 'armGroupLabels': ['Simulated myofascial release technique group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Nathaly Gaudreault, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Université de Sherbrooke'}, {'name': 'Mélanie Morin, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Université de Sherbrooke'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research director', 'investigatorFullName': 'Mélanie Morin', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}