Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
Study NCT ID:
NCT07286760
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effects of MAT Pilates and MIHA Combined Exercise Programs on Pain, Quality of Life, Anxiety, and Endurance in Patients With Nonspecific Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-12-02', 'studyFirstSubmitQcDate': '2025-12-03', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Assessment', 'timeFrame': '12 weeks', 'description': 'An algometer will be used to measure pain levels. We have identified three muscle groups for the algometer: Gluteus Medius, Erector Spinae, and Quadratus Lumborum. A low level indicates greater sensitivity and weakness.'}, {'measure': 'Quality of Life Assessment', 'timeFrame': '12 weeks', 'description': 'Quality of life will be assessed using the Oswestry Disability Index. It is used to evaluate the effect of the MAT Pilates and EMS-assisted exercise programs applied in the study on daily living activities. The lower the total score, the less the disability.'}, {'measure': 'Anxiety Assessment', 'timeFrame': '12 weeks', 'description': "Individuals' anxiety levels are assessed using the Beck Anxiety Scale. This assessment aims to compare individuals' anxiety levels before and after intervention. A high score on the Beck Anxiety Scale indicates a higher level of anxiety."}, {'measure': 'Endurance Assessment', 'timeFrame': '12 weeks', 'description': ': Individual endurance is assessed using three movements: the Plank, Bridge Movement, and V-Sit position. These selected movements target the anterior, posterior, and lateral core muscle groups, enabling an assessment of overall endurance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Comparison of the Effects of MAT Pilates and MIHA Combined Exercise Programs on Pain, Quality of Life, Anxiety, and Endurance in Patients with Nonspecific Back Pain'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBeing between 25 and 45 years of age Having had back pain for the last 3 months The back pain not being due to a structural, traumatic, infectious, or tumor-related cause (i.e., no specific cause has been identified) Not having any serious cardiovascular, neurological, or orthopedic conditions that would prevent participation in a physical exercise program Not having participated in a regular physical exercise program in the past 6 months Not having any contraindications to the use of a wearable EMS device (e.g., not having a pacemaker)\n\nExclusion Criteria:\n\nThe back pain is associated with a specific pathology (e.g., spinal stenosis, fracture, tumor, infection, etc.) Being within the first 6 months of pregnancy or postpartum History of neurological disease (e.g., multiple sclerosis, peripheral neuropathy, spinal cord injury, etc.) Having a pacemaker or other electronic device in the body Pre-existing intolerance to EMS'}, 'identificationModule': {'nctId': 'NCT07286760', 'briefTitle': 'Comparison of the Effects of MAT Pilates and MIHA Combined Exercise Programs on Pain, Quality of Life, Anxiety, and Endurance in Patients With Nonspecific Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'Comparison of the Effects of MAT Pilates and MIHA Combined Exercise Programs on Pain, Quality of Life, Anxiety, and Endurance in Patients With Nonspecific Back Pain', 'orgStudyIdInfo': {'id': 'E-78097791-020-4745'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MIHA Combined Exercise Programs', 'interventionNames': ['Other: MIHA Combined Exercise Programs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MAT Pilates', 'interventionNames': ['Other: MAT Pilates']}], 'interventions': [{'name': 'MIHA Combined Exercise Programs', 'type': 'OTHER', 'description': 'MIHA Combined Exercise Programs', 'armGroupLabels': ['MIHA Combined Exercise Programs']}, {'name': 'MAT Pilates', 'type': 'OTHER', 'description': 'MAT Pilates', 'armGroupLabels': ['MAT Pilates']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34353', 'city': 'Istanbul', 'state': 'None Selected', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Hazal GENÇ', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Hazal GENÇ', 'role': 'CONTACT', 'email': 'hazaloksuz@gmail.com', 'phone': '05413204291'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'hazal genc', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}