Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT06198660
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRT Versus CBT on Chronic Non Specific LBP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-10', 'studyFirstSubmitDate': '2023-12-18', 'studyFirstSubmitQcDate': '2024-01-08', 'lastUpdatePostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pressure algometer', 'timeFrame': 'pre intervention and immediately after intervention', 'description': 'change in pain pressure threshold .with unit of measurement kg/cm2'}], 'secondaryOutcomes': [{'measure': 'the arabic version of oswestry disability questionnaire', 'timeFrame': 'pre intervention and immediately after intervention', 'description': 'the patients choose one out of six senteces 10 multiple choise questions for back pain higher scores indicate great pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['positional release', 'cognitive behavioral therapy'], 'conditions': ['Chronic Non Specific Mechanical Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare between the effect of positional release technique and cognitive behavioral therapy in patients with chronic non specific low back pain.\n\nThe main question aims to answer :Is there any differences of using positional release techniques versus cognitive behavioral therapy on patients with chronic low back pain?', 'detailedDescription': 'Design of the study :\n\nPretest-posttest randomized controlled trial.\n\nSubjects selection :\n\nsixty patients their age between 25-45 years of both genders with chronic non specific low back pain will participate in this study according tosample size calculation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients will be clinically diagnosed with chronic non specific low back pain .\n* Their ages will range from 20to40years old.\n* body mass index will range from 18 to 30 kg/cm².\n* Cognitive score will be 23 or above .\n* Voluntary acceptance of participation in this study.\n\nExclusion Criteria:\n\n* Lumbar canal stenosis\n* Lumbar discogenic lesions\n* Lumbar infections,tumors.arthiritis\n* Patients with decreased range of motion due to congenital anamolies.\n* Cognitive and emotional disturbances'}, 'identificationModule': {'nctId': 'NCT06198660', 'briefTitle': 'PRT Versus CBT on Chronic Non Specific LBP', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Positional Release Technique Versus Cognitive Behavioral Therapy on Chronic Non Specific Low Back Pain', 'orgStudyIdInfo': {'id': 'PRT V CBT IN CNLBP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'positional release', 'description': 'positional release techniques in addition to conventional physical therapy', 'interventionNames': ['Other: positional release technique']}, {'type': 'EXPERIMENTAL', 'label': 'cognitive behavioral therapy', 'description': 'cognitive behavioral therapy in addition to conventional physical therapy', 'interventionNames': ['Other: cognitive behavioral therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional physical therapy', 'description': 'conventional physical therapy in control group', 'interventionNames': ['Other: positional release technique', 'Other: cognitive behavioral therapy', 'Other: conventional therapy only']}], 'interventions': [{'name': 'positional release technique', 'type': 'OTHER', 'description': 'positional release techniques in addition to conventional therapy two sessions per week for 6 weeks', 'armGroupLabels': ['conventional physical therapy', 'positional release']}, {'name': 'cognitive behavioral therapy', 'type': 'OTHER', 'description': 'cognitive behavioral therapy in addition to conventional therapy two sessions per week for 6 weeks', 'armGroupLabels': ['cognitive behavioral therapy', 'conventional physical therapy']}, {'name': 'conventional therapy only', 'type': 'OTHER', 'description': 'conventional therapy two sessions for 6 weeks', 'armGroupLabels': ['conventional physical therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Damietta', 'state': 'New Damietta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Nosaiba Eissa', 'role': 'CONTACT', 'email': 'neissa@horus.edu.eg', 'phone': '01005305615'}], 'facility': 'Horus University', 'geoPoint': {'lat': 31.41648, 'lon': 31.81332}}], 'centralContacts': [{'name': 'Nosaiba Eissa', 'role': 'CONTACT', 'email': 'neissa@horus.edu.eg', 'phone': '01005305615'}], 'overallOfficials': [{'name': 'Nosaiba Eissa', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Nosaiba Ahmed fahmy Eissa', 'investigatorAffiliation': 'Cairo University'}}}}