Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:55 AM
Study NCT ID:
NCT07329205
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-09
First Post:
2025-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Femoral Nerve Mobilization for Patients With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-02-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-28', 'studyFirstSubmitDate': '2025-12-15', 'studyFirstSubmitQcDate': '2025-12-28', 'lastUpdatePostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain intensity', 'timeFrame': 'after 4 weeks', 'description': 'The pain was assessed by the numerical rating scale (NRS) where zero indicating no pain and 10 indicating maximal pain'}, {'measure': 'central sensitization', 'timeFrame': 'after 4 weeks', 'description': 'The CSI is a validated questionnaire designed to identify symptoms associated with central sensitization. It has two components: Scale A assesses 25 common symptoms in individuals with central sensitization, resulting in a score ranging from 0 to 100. This score was interpreted as follows: subclinical (0-29), mild (30-39), moderate (40-49), severe (50-59), and extreme (60-100). Scale B, which is not scored, collects information on previous diagnoses of specific diseases'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NEURAL MOBILIZATION', 'Knee osteoarthritis', 'conventional physical therapy'], 'conditions': ['Knee Osteoarthristis']}, 'referencesModule': {'references': [{'pmid': '31675184', 'type': 'RESULT', 'citation': 'Pedersini P, Valdes K, Cantero-Tellez R, Cleland JA, Bishop MD, Villafane JH. Effects of Neurodynamic Mobilizations on Pain Hypersensitivity in Patients With Hand Osteoarthritis Compared to Robotic Assisted Mobilization: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2021 Feb;73(2):232-239. doi: 10.1002/acr.24103. Epub 2021 Jan 3.'}, {'pmid': '39597042', 'type': 'RESULT', 'citation': 'Serrano-Garcia B, Martinez-Cepa CB, Forriol F, Zuil-Escobar JC. Active Neurodynamic Technique at Home in Patients with Knee Osteoarthritis: An Open Single Arm Clinical Trial. Medicina (Kaunas). 2024 Nov 12;60(11):1857. doi: 10.3390/medicina60111857.'}, {'pmid': '37892772', 'type': 'RESULT', 'citation': 'Serrano-Garcia B, Forriol-Campos F, Zuil-Escobar JC. Active Neurodynamics at Home in Patients with Knee Osteoarthritis: A Feasibility Study. J Clin Med. 2023 Oct 20;12(20):6635. doi: 10.3390/jcm12206635.'}]}, 'descriptionModule': {'briefSummary': 'Background: Knee osteoarthritis (KO) is considered as a cause of disability among the elderly, causing pain, reduced quality of life, and decreased functionality. There is a limited knowledge about using femoral nerve mobilization in treating patients with arthritic changes.\n\nObjectives: This study will be designed to determine the efficacy of adding of femoral nerve mobilization on pain intensity, function, quality of life and central sensitization in patients with knee osteoarthritis Methods: Thirty patients (aged ≥50 years with KO Kellgren-Lawrence grades I-II) will be included in this study: Patients will randomly be assigned into two groups: group A will receive traditional physical therapy while group B will receive femoral nerve mobilization in addition to traditional physical therapy. Three sessions will be performed for four weeks by 3 session /week. Patients will be evaluated for pain intensity using the numerical rating scale (NRS), knee function by WOMAC scale, quality of life by 12-item Short Form Survey questionnaire (SF-12) and central sensitization by the Arabic version of central sensitization inventory (CSI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients aged 50 years or older, diagnosed with KO according to theAmerican College of Rheumatology's criteria with knee pain, and grade I or II on the Kellgren-Lawrence radiographic scale\n\nExclusion Criteria:\n\n* individuals suffering from chronic conditions considered to be perpetuating factors (e.g., fibromyalgia)\n* those with conditions causing lower extremity pain\n* individuals who had taken analgesics within 24 h before evaluations\n* those who had undergone corticosteroid or local anesthetic infiltration in the year prior to the study or during the follow-up period\n* those using substances that could interfere with treatment\n* those with a previous diagnosis of neuropathy (lumbosacral plexus) or myopathy\n* those with contraindications to mobilization or exercise, and those with cognitive deficits (dementia, Alzheimer's)."}, 'identificationModule': {'nctId': 'NCT07329205', 'acronym': 'RCT', 'briefTitle': 'Femoral Nerve Mobilization for Patients With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Prince Sattam Bin Abdulaziz University'}, 'officialTitle': 'Effects of Femoral Nerve Mobilization on Pain Intensity, Function, Quality of Life and Central Sensitization in Patients With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'RHPT/025/015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Traditional physical therapy', 'interventionNames': ['Other: traditional physical therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Neural mobilization group', 'description': 'traditional physical therapy plus femoral nerve mobilization', 'interventionNames': ['Other: traditional physical therapy', 'Other: Femoral nerve mobilization']}], 'interventions': [{'name': 'traditional physical therapy', 'type': 'OTHER', 'description': 'stretching exercises for hamstring, calf muscles and iliotibial band in addition to isotonic exercise for hip extensors and abductors and isometric quadriceps exercise', 'armGroupLabels': ['Control group', 'Neural mobilization group']}, {'name': 'Femoral nerve mobilization', 'type': 'OTHER', 'description': 'A physiotherapist guided the patients in performing active mobilization of the femoral nerve. The prescribed method for active neural mobilization involved assuming a prone position supported by the forearms with a slight extension of the spine, flexion of the knee, and extension of the cervical spine. This was followed by performing the opposite movement', 'armGroupLabels': ['Neural mobilization group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16242', 'city': 'Al Kharj', 'country': 'Saudi Arabia', 'facility': 'Prince Sattam bin Abdulaziz University', 'geoPoint': {'lat': 24.15541, 'lon': 47.33457}}], 'centralContacts': [{'name': 'Mohammed Hegazy, Phd', 'role': 'CONTACT', 'email': 'mohamed.mostafa@pt.cu.edu.eg', 'phone': '00966566169893', 'phoneExt': '00966115886387'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prince Sattam Bin Abdulaziz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assisstant professor , department of health and rehabilitation sciences, college of applied medical siences', 'investigatorFullName': 'Mohammad Moustafa Aldosoukki Hegazy', 'investigatorAffiliation': 'Prince Sattam Bin Abdulaziz University'}}}}