Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT05813002
Status:
UNKNOWN
Last Update Posted:
2023-04-14
First Post:
2023-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Order of Movement on Nerve Root Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "The assessor, who took the measurements for all groups will be blinded to the subject's group."}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to one of three different groups. One group will receive the standard neural mobilization, the second group will receive Distal-Proximal neural mobilization, and the third group will receive Proximal-Distal neural mobilization, all targeting the median nerve.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-01', 'studyFirstSubmitDate': '2023-04-01', 'studyFirstSubmitQcDate': '2023-04-01', 'lastUpdatePostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in dermatomal somatosensory evoked potentials.', 'timeFrame': 'baseline (pre-treatment) and immediately after the treatment', 'description': "In all dermatomes, 2 complete recording runs will be undertaken during each session with averages of 250 to 1200 cortical responses from scalp surface recording electrodes (C3'-C4' in a 10-20 electrode configuration) of the contralateral scalp to the stimulated dermatomes being stimulated. The impedance of ground and scalp electrodes will be maintained at \\< 5 k Cutaneous areas of C5,C6,C7 sensory roots will be stimulated in lower limb with the electrical impulses of 0.2 ms duration, frequency of 3.3 Hz and intensity 3 times higher than the sensory threshold will be determined individually for each subject."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Randomized controlled trial', 'Neurodynamics', 'Evoked potential', 'Somatosensory'], 'conditions': ['Physical and Rehabilitation Medicine']}, 'descriptionModule': {'briefSummary': 'the main objective of this study is to investigate if different neurodynamic test sequencing of the median nerve has a different impact on median nerve root function. We hypothesized that the order of median nerve neurodynamic movements would influence peak-to-peak amplitude and latency.', 'detailedDescription': 'Neurodynamic concept is used clinically to normalize nerve mobility. It has been manifested in previous studies that neurodynamics have increased mobility by floss like movement of the nerve. Whereas in other studies it has been concluded that neurodynamic techniques has an effect in decreasing fibrous and adhesions between neural tissues and the surrounding tissues therefore giving an outcome of improved infrafasicular gliding.\n\nThe upper limb neurodynamic test has an effect to alter the mechanical loads on the nerve by changing its dimensions. For neurodynamic to be more effective, it requires a certain sequence.\n\nThe different order of movements will induce different duration of tension in which it will influence the nerve root function, which is needed to be investigated to check for the effectiveness. A previous study has found that the difference of sequence on median nerve, had caused a change on the distribution of the sensory response on the asymptomatic participants. The sensory responses were more prevalent during the neurodynamic of the median nerve when it was applied from a distal to proximal sequence . One of the main purposes of the order of sequences is to add more strain to the nerve segment to increase the sensitivity of the test.\n\nClinically it has been assumed that the different order of movements could possibly influence the level of strain on a certain nerve segment. When the standard sequence was compared with the distal-to-proximal sequence for the median nerve, there was no physiological difference obtained at the end of the test. In comparison, there was a larger strain in the distal-to-proximal sequence in comparison to the proximal-to-distal sequence observed. However, the longitudinal excursion collected data indicated that the start and end positions for all the three sequences were alike.\n\nIn terms of neurophysiological outcomes, in this study we will use the dermatomal somatosensory evoked potential as a primary outcome due to its reliability in comparison with other physiological outcomes. There is a literature gap in regard to the effect of the order of sequence on the median nerve on the nerve root function and this is what the study will focus on. We hypothesized that the order of movements of the median nerve neurodynamic will influence the peak-to-peak amplitude and the latency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* not currently experiencing any neck or dominant upper extremity symptoms.\n* do not have a history significant for a chronic painful condition.\n* do not using pain relievers.\n\nExclusion Criteria:\n\n* inflammatory joint disease or other systemic pathologies.\n* prior history of overt injury and surgery relating to the musculoskeletal system.\n* disorder related to the spine and extremities.\n* musculoskeletal pain in the last three months'}, 'identificationModule': {'nctId': 'NCT05813002', 'briefTitle': 'Impact of Order of Movement on Nerve Root Function', 'organization': {'class': 'OTHER', 'fullName': 'University of Sharjah'}, 'officialTitle': 'Impact of Order of Movement on Nerve Root Function: A Neurophysiological Study With Implications for Neurodynamic Test Sequencing', 'orgStudyIdInfo': {'id': 'REC-22-06-04-S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard neurodynamic sequence', 'description': 'Participants in the first group will receive the standard neurodynamic sequence. The starting position for this sequence will be shoulder in extension with lateral rotation, elbow in full flexion and wrist in neutral position. Passively the shoulder is abducted till 90 degrees followed by wrist extension then ended by elbow extension. Ipsilateral movement of the head bending till 45 degrees with movement of the wrist towards the body for 10 repetitions', 'interventionNames': ['Other: standard neural mobilization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Distal to proximal neurodynamic sequence', 'description': 'The second group participants will receive the distal to proximal neurodynamic sequence. For this sequence the starting position will be shoulder in full extension with lateral rotation, elbow fully extended and wrist in neutral position. the sequence will start with wrist extension, going to elbow extension, and ending with shoulder abduction. Ipsilateral movement of the head bending till 45 degrees with movement of the wrist towards the body for 10 repetitions', 'interventionNames': ['Other: Distal to proximal neural mobilization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'proximal to distal neurodynamic sequence', 'description': 'The participants in the third experimental group will receive the proximal to distal sequence which will start with shoulder abduction, elbow extension and then wrist extension. The starting position is shoulder in extension and laterally rotated, elbow in full flexion, and wrist in neutral position. The shoulder will be passively mobilized to 90 degrees of abduction, elbow into full extension and wrist in full extension. Ipsilateral movement of the head bending till 45 degrees with movement of the wrist towards the body for 10 repetitions', 'interventionNames': ['Other: proximal to distal neural mobilization']}], 'interventions': [{'name': 'standard neural mobilization', 'type': 'OTHER', 'description': 'is a movement-based intervention aimed at restoring the homeostasis in and around the nervous system.', 'armGroupLabels': ['standard neurodynamic sequence']}, {'name': 'Distal to proximal neural mobilization', 'type': 'OTHER', 'description': 'is a distal to proximal movement-based intervention aimed at restoring the homeostasis in and around the nervous system.', 'armGroupLabels': ['Distal to proximal neurodynamic sequence']}, {'name': 'proximal to distal neural mobilization', 'type': 'OTHER', 'description': 'is a proximal to distal movement-based intervention aimed at restoring the homeostasis in and around the nervous system.', 'armGroupLabels': ['proximal to distal neurodynamic sequence']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ibrahim M [imoustafa], Professor', 'role': 'CONTACT', 'email': 'iabuamr@sharjah.ac.ae', 'phone': '+971502180024', 'phoneExt': '7513'}], 'overallOfficials': [{'name': 'Ibrahim M moustafa, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sharjah'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no plan to make individual participant data (IPD) available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sharjah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor-chair of Physiotherapy Department', 'investigatorFullName': 'Ibrahim Moustafa', 'investigatorAffiliation': 'University of Sharjah'}}}}