Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-25 @ 9:41 PM
Study NCT ID:
NCT05041751
Status:
WITHDRAWN
Last Update Posted:
2022-05-17
First Post:
2021-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Myofascial Release or Trigger Point Injections for the Reduction of Post-Mastectomy Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'D015669', 'term': 'Acupuncture Points'}, {'id': 'D008405', 'term': 'Massage'}], 'ancestors': [{'id': 'D016740', 'term': 'Meridians'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI Left Institution', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-10', 'studyFirstSubmitDate': '2021-02-03', 'studyFirstSubmitQcDate': '2021-09-08', 'lastUpdatePostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain response', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Defined by score differences (using the pain numerical rating scale). an 11-point scale (0-none to 10-worst) Pain responders will be defined as patients demonstrating an equal or lower pain score relative to baseline. The 2-week post-treatment assessment will be used to assess the primary endpoint.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breast Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial studies the effect of myofascial release in decreasing post-mastectomy pain compared to standard of care trigger point injections in patients with post-mastectomy pain syndrome. Patients who have mastectomies often experience pain that does not go away after time. This is known as post-mastectomy pain syndrome. Myofascial release is a form of physical therapy in which pressure is applied to the affected areas. Myofascial release may be an effective way of decreasing pain in patients with post-mastectomy pain syndrome without the use of medication.', 'detailedDescription': "PRIMARY OBJECTIVE:\n\nI. To evaluate the change in pain score using the Numerical Rating Scale for pain on an 11-point scale (0-none to 10-worst) from implementation of myofascial release (MFR) versus trigger point injections (TPI) in the treatment of myofascial trigger points (MTP) as noninvasive therapies for post mastectomy pain syndrome (PMPS).\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate the change in medications, particularly opiate medications in the treatment of post mastectomy pain.\n\nII. To evaluate a patient's satisfaction with therapy or treatment throughout the course of the study at each consecutive encounter or follow up.\n\nIII. To evaluate a patient's range of motion with therapy or treatment beginning at time of screening and until the end of the study.\n\nIV. To evaluate a patient's degree of lymphedema both subjectively and objectively in the affected extremity(ies) unilateral to the site(s) of mastectomy in response to the various forms of treatment throughout the study.\n\nV. To evaluate quality of life measure changes with treatments used throughout the study.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients receive standard of care trigger point injections at baseline.\n\nARM II: Patients perform myofascial release for 10 minutes each day."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic post-mastectomy pain syndrome (\\>= 3 months)\n* Able to perform MFR techniques and follow basic instructions\n* \\>= 18 years old\n\nExclusion Criteria:\n\n* Current chemotherapy\n* Pending surgery during treatment\n* Active infection\n* Active debilitating disease\n* Pregnant\n* Other chronic pain diagnosis beside PMPS\n* Untreated psychiatric diagnosis (not receptive to taking precautions and interventions by treating psychiatrist/psychologist/physician i.e. taking necessary medications)\n* Morbid obesity (body mass index \\[BMI\\] \\> 40)\n* Allergy history of bupivacaine and/or lidocaine'}, 'identificationModule': {'nctId': 'NCT05041751', 'briefTitle': 'Myofascial Release or Trigger Point Injections for the Reduction of Post-Mastectomy Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'A Pilot Study Assessing the Benefits of Fascial Freedom for the Win (MFR Versus TPI)', 'orgStudyIdInfo': {'id': '2020-0498'}, 'secondaryIdInfos': [{'id': 'NCI-2020-13900', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2020-0498', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I (trigger point injections)', 'description': 'Patients receive standard of care trigger point injections at baseline', 'interventionNames': ['Procedure: Acupuncture Point Injection', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (myofascial release)', 'description': 'Patients perform myofascial release for 10 minutes each day.', 'interventionNames': ['Procedure: Massage Therapy', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Acupuncture Point Injection', 'type': 'PROCEDURE', 'description': 'Receive trigger point injections', 'armGroupLabels': ['Arm I (trigger point injections)']}, {'name': 'Massage Therapy', 'type': 'PROCEDURE', 'otherNames': ['Massage'], 'description': 'Perform myofascial release', 'armGroupLabels': ['Arm II (myofascial release)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (trigger point injections)', 'Arm II (myofascial release)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (trigger point injections)', 'Arm II (myofascial release)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Christina Le-Short', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}