Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT04936451
Status:
TERMINATED
Last Update Posted:
2023-08-01
First Post:
2021-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electrotherapy in the Management of Myofascial Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-08-29', 'releaseDate': '2025-08-13'}], 'estimatedResultsFirstSubmitDate': '2025-08-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Monocentric, randomized in cross over in two arms, open'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'lack of recrutment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-31', 'studyFirstSubmitDate': '2021-06-15', 'studyFirstSubmitQcDate': '2021-06-15', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The main objective is to evaluate the effectiveness of TENS and TENS ECOMODYN® on the management of chronic breast pain after surgery.', 'timeFrame': '16,5 months', 'description': 'Chronic pain is assessed using the Digital Pain Rating Scale (0 worse outcome to 10 better outcome) before and after using the method (TENS and TENS ECOMODYN®) at M0, M2, M2.5 and M4.5.'}], 'secondaryOutcomes': [{'measure': 'Evaluate the changes made by the treatment felt by the patient', 'timeFrame': '16.5 months', 'description': "The intensity of The patient's feelings will be evaluated by the Patient Global Impression of Change questionnaire: at M2 and M4.5"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Surgery', 'Myofascial syndrome'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Myofascial syndrome is defined as "musculoskeletal pain characterized by local and referred pain perceived to be deep and constant, and by the presence of myofascial trigger points in any part of the body" Post-breast surgery myofascial syndrome affects up to 44.7% of operated women, mainly on the muscles of the greater shoulder girdle. The repercussions are significant, functional, somatic, psychological and socio-professional affecting the quality of life. The treatments offered may or may not be medicinal. Transcutaneous electrical nerve stimulation (TENS) is a therapy that uses low voltage electrical current to provide pain relief. A TENS unit consists of a battery-powered device that delivers electrical impulses through electrodes placed on the surface of your skin. The electrodes are placed at or near nerves where the pain is located or at trigger points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female who had first breast cancer surgery, regardless of the type of surgery\n* Age ≥ 18 years\n* Patients with refractory pain with myofascial syndrome, with a numerical scale ≥ 4\n* Topical treatment for refractory pain completed more than 30 days ago\n* Healthy, non-irritated skin on painful areas to treat\n* Patient with a third party who can attend visits M0 and M2.5\n* Obtaining the signed written consent of the patient\n* Major patient affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Patient who has used TENS before on the muscles affected by the myofascial syndrome\n* Post-surgery management of the affected area by a physiotherapist\n* Person with venous thrombosis\n* Contraindications specific to the treatments studied'}, 'identificationModule': {'nctId': 'NCT04936451', 'acronym': 'MODYMYO', 'briefTitle': 'Electrotherapy in the Management of Myofascial Syndrome', 'organization': {'class': 'OTHER', 'fullName': "Institut Cancerologie de l'Ouest"}, 'officialTitle': 'Contribution of an Electrotherapy Technique Such as TENS ECOMODYN® vs Electrotherapy Only Type TENS in the Management of Myofascial Syndrome After Breast Surgery', 'orgStudyIdInfo': {'id': 'ICO-A-2020-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'TENS / TENS ECOMODYN', 'description': 'Patients who have signed their consent receive, after randomization, the trial treatments assigned to them. Arm TENS / TENS ECOMODYN Patients first start with TENS during 2 months puis change with TENS ECOMODYN during 2 months with a wash-out period of 15 days', 'interventionNames': ['Device: TENS (transcutaneous electrical nerve stimulation)', 'Device: TENS (transcutaneous electrical nerve stimulation) ECOMODYN']}, {'type': 'OTHER', 'label': 'TENS ECOMODYN / TENS', 'description': 'Patients who have signed their consent receive, after randomization, the trial treatments assigned to them. Arm TENS ECOMODYN / TENS Patients first start with TENS ECOMODYN during 2 months puis change with TENS during 2 months with a wash-out period of 15 days', 'interventionNames': ['Device: TENS (transcutaneous electrical nerve stimulation)', 'Device: TENS (transcutaneous electrical nerve stimulation) ECOMODYN']}], 'interventions': [{'name': 'TENS (transcutaneous electrical nerve stimulation)', 'type': 'DEVICE', 'description': 'Patients will benefit from screening for refractory pain, neuropathic or not, with myofascial syndrome, between 3 and 12 months after surgery.\n\nThe healthcare professional will determine 4 trigger points. TENS is applied twice 45 min every day for 2 months. Pain treatment will be done by using the P6 program in alternative mode: 2hz / 100Hz.\n\nThe time between 2 electrostimulations will be a minimum of 4 hours and a maximum of 15 hours.', 'armGroupLabels': ['TENS / TENS ECOMODYN', 'TENS ECOMODYN / TENS']}, {'name': 'TENS (transcutaneous electrical nerve stimulation) ECOMODYN', 'type': 'DEVICE', 'description': 'TENS ECOMODYN® is applied to 4 treatment points, 5 minutes per point 2 times a day for 2 months.\n\nA minimum rest period of 4 hours between 2 sessions on the same point must be respected Stimulation is performed directly with the bipolar probe of the TENS ECOMODYN® device on the painful area by fixed stimulation of 4 active pain points in 77Hz mode.', 'armGroupLabels': ['TENS / TENS ECOMODYN', 'TENS ECOMODYN / TENS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'facility': "Institut de Cancerologie de l'Ouest", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}], 'overallOfficials': [{'name': 'EVA KERROUAULT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut de Cancérologie de l'Ouest"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Cancerologie de l'Ouest", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-13', 'type': 'RELEASE'}, {'date': '2025-08-29', 'type': 'RESET'}], 'unpostedResponsibleParty': "Institut Cancerologie de l'Ouest"}}}}