Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-26 @ 7:31 PM
Study NCT ID:
NCT06663592
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-10
First Post:
2024-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Adding Neural Mobilization Techniques in Patients with Cervical Radiculopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011843', 'term': 'Radiculopathy'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-03-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-07', 'studyFirstSubmitDate': '2024-10-21', 'studyFirstSubmitQcDate': '2024-10-27', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': 'At baseline, to the end of treatment at 4 weeks.', 'description': 'to measure neck pain with score extended from 0 to 10, minimum score 0 (no pain), highest score 10 (worst pain).'}, {'measure': 'The Arabic Version Of Neck Disability Index', 'timeFrame': 'At baseline, to the end of treatment at 4 weeks.', 'description': 'to assess the level of disabilities in patients with neck pain, in % points.'}, {'measure': 'Cervical Range of Motion', 'timeFrame': 'At baseline, to the end of treatment at 4 weeks.', 'description': 'to measure the full cervical rotation using CROM device in degrees'}, {'measure': 'Hand Grip Strength', 'timeFrame': 'At baseline, to the end of treatment at 4 weeks.', 'description': 'to measure hand grip strength using hydraulic dynamometer, in kilogram.'}, {'measure': 'Nerve Conduction Study', 'timeFrame': 'At baseline, to the end of treatment at 4 weeks.', 'description': 'Motor conduction study for the median nerve, to measure conduction velocity (m/second), distal latency (ms), and amplitude(mV).'}, {'measure': 'F wave', 'timeFrame': 'At baseline, to the end of treatment at 4 weeks.', 'description': 'F wave for the median nerve to measure latency (ms).'}, {'measure': 'H-Reflex', 'timeFrame': 'At baseline, to the end of treatment at 4 weeks.', 'description': 'H-Reflex for the median nerve to measure latency (ms), amplitude (mV), H-R ratio (%).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Radiculopathy', 'Neuromobılızatıon', 'Median Nerve', 'Electromyography', 'Nerve Conduction']}, 'referencesModule': {'references': [{'pmid': '9620187', 'type': 'BACKGROUND', 'citation': 'Abrams RA, Butler JM, Bodine-Fowler S, Botte MJ. 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Epub 2004 Dec 21.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled trial is to investigate the effects of adding slider neural mobilization technique compared to tensioner neural mobilization technique to conventional physical therapy treatment on pain, function, cervical range of motion, hand grip strength, and electrophysiological parameters of the median nerve in patients with cervical radiculopathy.', 'detailedDescription': 'Cervical radiculopathy (CR) is a condition where the nerve root of a spinal nerve is compressed or impaired, causing the pain and symptoms to spread beyond the neck, radiating to the shoulder, and upper limb. Cervical radiculopathy primarily results from an impingement and inflammation of a nerve root induced by a space-occupying lesion that reduces the size of the intervertebral foramen, as a degenerative lesion of the zygapophyseal joint or it is associated with a cervical disc derangement.\n\nPatients presenting with CR complain of neck, periscapular, and radicular pain into the hand and arm. As well as neurologic symptoms such as sensory disturbances (paresthesia or numbness), muscle weakness with a reduced tendon reflexes in the affected nerve root or combination of these signs and symptoms .\n\nThe reported annual incidence of CR is 85 cases per 100,000 people in the population, while the prevalence is 3.5/1000 persons. The C7 nerve root is most frequently impacted, with more than half of all cases affecting this level.\n\nSeveral studies utilized therapeutic exercises, manual therapy, other modalities cervical collar, cervical traction, postural education and different medications such as drugs and steroid injections in the conservative management for cervical radiculopathy in its different stages.\n\nThe neural mobilization (NM) is a manual therapy method that improves neural flexibility, lowers dynamic sensitivity of the nervous system, increases blood flow, and relief pain; for that, improved neural mobility and alleviated pain increases joint range of motion (ROM).\n\nThe neural mobilization techniques (NM) are delivered by two techniques, "sliding/gliding" and "tensioning". Tensioner technique generate tension from both ends of the nerve, while sliders involve gliding of the nerve relative to its surrounding structures by performing joint movements that elongate the nerve bed with minimal strain. In addition, sliders are usually less aggressive than tensioners and their use might be indicated at early disease stages.\n\nBoth techniques aid in preventing the formation of adhesions, to reduce endoneurial pressure reduce intraneural oedema increase nerve oxygenation, and decrease the ischemic pain.\n\nStudies which used sliders and tensioners NM techniques in their clinical studies, showed significant changes in biomechanical factors such as patients\' self-reports of pain, disability, ROM, endurance and muscle strength in management of musculoskeletal neck disorders with nerve-related symptoms.\n\nTherefore, What are the possible effects of adding tensioner neural mobilization technique versus slider neural mobilization technique to conventional physical treatment in treating patients with cervical radiculopathy?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Current continuous or intermittent pain that has persisted for more than 3 months.\n2. Motor, reflex, and/ or sensory changes in the upper limb.\n3. Diminished deep tendon reflexes in the affected arm.\n4. Paresthesia or numbness along the course of the nerve.\n5. A positive Upper Limb Neural Tension 1 (ULNT) test for the median nerve, Spurlings test, compression test, cervical distraction test, less than 60° cervical rotation towards the symptomatic side, and Valsalva maneuver.\n6. Unilateral affection in the upper limb.\n\nExclusion Criteria:\n\n1. History of surgical procedures for pathologies giving rise to neck pain or CTS.\n2. Clinical signs or symptoms of medical red flags; (infection, cancer, and cardiac involvement).\n3. Patients with neck pain for signs and symptoms of serious pathology, upper cervical ligamentous insufficiency, unexplained cranial nerve dysfunction, and fracture.\n4. Any systematic disease such as rheumatism and tuberculosis, cervical myelopathy, or multiple sclerosis.\n5. Systemic disease is known to cause generalized peripheral neuropathy as diabetes mellitus.\n6. Upper Motor neuron disease such as stroke and amyotrophic lateral sclerosis (ALS).\n7. Complete loss of sensation along the involved nerve root.\n8. Primary report of bilateral radiating arm pain.\n9. Inability to tolerate the planned intervention.\n10. Pregnant woman.\n11. Thoracic outlet syndrome\n12. Pronator teres syndrome'}, 'identificationModule': {'nctId': 'NCT06663592', 'briefTitle': 'Efficacy of Adding Neural Mobilization Techniques in Patients with Cervical Radiculopathy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effectiveness of Slider and Tensioner Neurodynamic Mobilization Techniques in Patients with Cervical Radiculopathy: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005270'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group A (conventional treatment)', 'description': 'Conventional treatment, including hot pack, stretching of the neck muscles, cervical isometrics exercise.', 'interventionNames': ['Other: Conventional treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group B (Tensioning neural mobilization with addition to conventional treatment)', 'description': 'Median nerve neural tensioning mobilization with addition to conventional treatment', 'interventionNames': ['Other: Tensioner Neuro Dynamic Mobilization']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group C (Sliding neural mobilization with addition to conventional treatment)', 'description': 'Median nerve sliding neural mobilization with addition to conventional treatment', 'interventionNames': ['Other: Slider Neuro Dynamic Mobilization']}], 'interventions': [{'name': 'Conventional treatment', 'type': 'OTHER', 'description': 'hot pack, stretching of the neck muscles, cervical isometrics exercise', 'armGroupLabels': ['Control group A (conventional treatment)']}, {'name': 'Tensioner Neuro Dynamic Mobilization', 'type': 'OTHER', 'description': 'Median nerve tensioner neural mobilization with addition to conventional treatment', 'armGroupLabels': ['Experimental group B (Tensioning neural mobilization with addition to conventional treatment)']}, {'name': 'Slider Neuro Dynamic Mobilization', 'type': 'OTHER', 'description': 'Median nerve neural sliding mobilization with addition to conventional treatment', 'armGroupLabels': ['Experimental group C (Sliding neural mobilization with addition to conventional treatment)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hiba M. Hasan', 'role': 'CONTACT', 'email': 'dr.hibahasan95@gmail.com', 'phone': '+96170519123'}, {'name': 'Marihan Z. Aziz Makary, Lecturer', 'role': 'CONTACT', 'email': 'marihan_aziz@cu.edu.eg', 'phone': '+201201227971'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hiba Mohammad Hasan', 'investigatorAffiliation': 'Cairo University'}}}}