Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT07079202
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-22
First Post:
2025-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Kinetic Control in Lumbosacral Radiculopathy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-13', 'studyFirstSubmitDate': '2025-07-13', 'studyFirstSubmitQcDate': '2025-07-13', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ELECTROMYOGRAPHIC ACTIVITY OF TRUNK MUSCLES', 'timeFrame': '6 Weeks'}], 'secondaryOutcomes': [{'measure': 'lumbar proprioception', 'timeFrame': '6 Weeks'}, {'measure': 'Pain intensity level', 'timeFrame': '6 weeks'}, {'measure': 'Trunk Rang Of Motion', 'timeFrame': '6 Weeks'}, {'measure': 'Functional disability level', 'timeFrame': '6 Weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['LUMBOSACRAL RADICULOPATHY', 'Chronic Low Back Pain']}, 'descriptionModule': {'briefSummary': '-This study would answer the following question: Is there an effect of kinetic control retraining on electromyographic activity of trunk and lumbar proprioception in patients with lumbosacral radiculopathy?\n\nThe aims of this study are:\n\n1. To investigate the effect of kinetic control retraining on electromyographic activity of trunk in patients with lumbosacral radiculopathy\n2. To investigate the effect of kinetic control retraining on lumbar proprioception in patients with lumbosacral radiculopathy.\n3. To investigate the effect of kinetic control retraining on trunk Range of motion (ROM) in patients with lumbosacral radiculopathy.\n4. To investigate the effect of kinetic control retraining on pain intensity in patients with lumbosacral radiculopathy. 5 -To investigate the effect of kinetic control retraining on functional disability in patients with lumbosacral radiculopathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients will be from both sexes.\n2. The age of patients will range from 35- 50 years old.\n3. The Body Mass Index (BMI) of patients will be less than 30Kg/m2\n4. All patients represent chronic low back pain (at least 3 months).\n5. Patients with unilateral lumbosacral radiculopathy (L4-5, L5-S1) due to Posterolateral disc prolapse.\n6. Patients have been diagnosed by MRI.\n7. Patients with sufficient cognitive abilities that enables them to understand and follow instructions (Mini-Mental State Examination (MMSE) scale \\>24).\n\nExclusion Criteria:\n\n1. Previous spinal surgeries\n2. Another Causes of the lumbosacral radiculopathy\n3. Pain that persists less than 3 months\n4. Spinal tumors\n5. Lumbar instability due to structural problems, for example: ligament tear or spondylolythesis.\n6. Cognitive impairment (a score less than 24 according to MMSE).'}, 'identificationModule': {'nctId': 'NCT07079202', 'acronym': 'KC', 'briefTitle': 'Effect of Kinetic Control in Lumbosacral Radiculopathy.', 'organization': {'class': 'OTHER', 'fullName': 'Nahda University'}, 'officialTitle': 'EFFECT OF KINETIC CONTROL RETRAINING ON ELECTROMYOGRAPHIC ACTIVITY OF TRUNK MUSCLES IN PATIENTS WITH LUMBOSACRAL RADICULOPATHY.', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004918'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kinetic control', 'description': 'This group received kinetic control retraining protocol in addition to conventional physical therapy. ( TENS, hot backs, Ultrasound,Nerve mobilization ) three sessions per week for 6 weeks.', 'interventionNames': ['Other: kinetic control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional physical therapy', 'description': 'This group received only conventional physical therapy. ( TENS, hot backs, Ultrasound, Nerve mobilization ) three sessions per week for 6 weeks.', 'interventionNames': ['Other: Conventional physical therapy.']}], 'interventions': [{'name': 'kinetic control', 'type': 'OTHER', 'description': 'Kinetic Control uses the Movement Control Rating System based on motor tests, the purpose of which is to identify the place and direction of uncontrolled movements and exercises to re-educate motor control', 'armGroupLabels': ['Kinetic control']}, {'name': 'Conventional physical therapy.', 'type': 'OTHER', 'description': 'This group received only conventional physical therapy. ( TENS, hot backs, Ultrasound,Nerve mobilization ) three sessions per week for 6 weeks.', 'armGroupLabels': ['Conventional physical therapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Madonna Maher Ezzat', 'role': 'CONTACT', 'email': 'madonna.maher@nub.edu.eg', 'phone': '01204511549'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Madonna Maher Ezzat Yassa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Teaching Assistant', 'investigatorFullName': 'Madonna Maher Ezzat Yassa', 'investigatorAffiliation': 'Nahda University'}}}}