Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-28 @ 8:27 AM
Study NCT ID:
NCT06946966
Status:
COMPLETED
Last Update Posted:
2025-08-12
First Post:
2025-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Online Mat Pilates and Face-to-Face Equipment-Based Pilates on Pain, Kinesiophobia, and Balance in Individuals With Non-Specific Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2025-04-21', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual pain scal', 'timeFrame': '12 weeks', 'description': "A 10-cm line where participants mark their pain intensity, ranging from 'no pain' to 'worst pain'."}, {'measure': 'Quebec Back Pain Disability Scale (QBPDS)', 'timeFrame': '12 weeks', 'description': 'Assesses functional disability related to back pain through 20 daily activity items. Higher scores indicate greater limitation in performing physical tasks.'}, {'measure': 'Pressure Algometer', 'timeFrame': '12 weeks', 'description': 'Measures the minimum pressure that causes pain in a specific muscle or soft tissue, helping to quantify pain sensitivity objectively.'}, {'measure': 'Y-Balance Test (YBT)', 'timeFrame': '12 weeks', 'description': 'Evaluates balance by measuring reach distance in three directions while standing on one leg. It reflects dynamic stability, core control, and lower limb function.'}, {'measure': 'Tampa Scale of Kinesiophobia (TSK)', 'timeFrame': '12 weeks', 'description': 'Assesses fear of movement and re-injury through a 17-item questionnaire. Higher scores indicate increased avoidance behavior and movement-related fear.The final score can be a minimum of 17 points and a maximum of 68 points.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Non-specific low back pain (NSLBP) is a common musculoskeletal condition that affects a significant portion of the population and often leads to limitations in daily activities, reduced quality of life, and increased levels of kinesiophobi', 'detailedDescription': 'compare the effects of online mat Pilates and face-to-face equipment-based Pilates on pain, kinesiophobia, and balance in individuals with NSLBP. While both methods emphasize neuromuscular control and alignment, differences in delivery modes and equipment usage may influence outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18 and 60 years\n* Non-specific low back pain for more than 12 weeks\n* No clear pathological diagnosis\n* Physically and cognitively capable of performing the exercises\n* Pain level between 3 and 7 on the Visual Analog Scale (VAS)\n\nExclusion Criteria:\n\n* Pregnancy\n* Spinal surgery in the last 6 months\n* Neurological or chronic systemic diseases\n* Movement restriction due to severe pain'}, 'identificationModule': {'nctId': 'NCT06946966', 'briefTitle': 'The Effects of Online Mat Pilates and Face-to-Face Equipment-Based Pilates on Pain, Kinesiophobia, and Balance in Individuals With Non-Specific Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'The Effects of Online Mat Pilates and Face-to-Face Equipment-Based Pilates on Pain, Kinesiophobia, and Balance in Individuals With Non-Specific Low Back Pain', 'orgStudyIdInfo': {'id': '2024-04/02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reformer Pilates', 'description': 'Reformer Pilates', 'interventionNames': ['Other: Reformer Pilates']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pilates control', 'description': 'Pilates control', 'interventionNames': ['Other: Pilates control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pilates online pilates', 'description': 'online pilates', 'interventionNames': ['Other: pilates online pilates']}], 'interventions': [{'name': 'Reformer Pilates', 'type': 'OTHER', 'description': 'Reformer Pilates', 'armGroupLabels': ['Reformer Pilates']}, {'name': 'Pilates control', 'type': 'OTHER', 'description': 'Pilates control', 'armGroupLabels': ['Pilates control']}, {'name': 'pilates online pilates', 'type': 'OTHER', 'description': 'pilates online pilates', 'armGroupLabels': ['pilates online pilates']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34070', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bahceşehir University Health Center', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, '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'}}}}