Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-26 @ 10:08 AM
Study NCT ID:
NCT07141992
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-03
First Post:
2025-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Active vs Passive Neural Mobilizations Effects in Improving Burning Pain, Muscular Strength, and Range of Motion in Patients With Diabetic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2025-08-19', 'studyFirstSubmitQcDate': '2025-08-25', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lower Limb Tension Test', 'timeFrame': '12 sessions for 4 weeks', 'description': 'Lower Limb Tension Test (LLTT) Purpose: Assess neural mechanosensitivity of lower limb nerves, especially sciatic, tibial, and peroneal nerves.\n\nAlso Known As: Straight Leg Raise (SLR), Slump Test, Prone Knee Bend Test, etc.\n\nIndications:\n\nRadiating leg pain Suspected lumbar radiculopathy Neural tension syndromes\n\nProcedure Includes:\n\nHip flexion, knee extension, ankle dorsiflexion, and/or foot inversion/eversion based on nerve bias\n\nPositive Sign:\n\nReproduction of neuropathic symptoms (burning, tingling, shooting pain) Symptoms change with sensitizing maneuvers\n\nUsed In:\n\nNeuropathy Sciatica Disc herniation Piriformis syndrome'}, {'measure': 'DN-4 (Douleur Neuropathique en 4 questions)', 'timeFrame': '12 sessions in 4 weeks', 'description': 'DN-4 Questionnaire (Douleur Neuropathique en 4 questions) Purpose: To screen for neuropathic pain and distinguish it from nociceptive pain.\n\nTotal Items: 10 7 sensory descriptors (e.g., burning, electric shocks, tingling, numbness) 3 clinical examination findings (e.g., hypoesthesia to touch or pinprick, pain on brushing)\n\nScoring:\n\nEach "yes" = 1 point Total Score Range: 0 to 10 Score ≥ 4 indicates likely neuropathic pain Time Required: Less than 5 minutes\n\nAdvantages:\n\nQuick and easy to administer Non-invasive High sensitivity and specificity\n\nUsed In:\n\nDiabetic neuropathy Post-stroke pain\n\nSciatica\n\nPostherpetic neuralgia'}, {'measure': 'Goniometery (Joint Range of Motion)', 'timeFrame': '12 sessions for 4 weeks', 'description': 'Goniometry Purpose: Measure joint range of motion (ROM) accurately Instrument: Goniometer (standard)\n\nComponents:\n\nAxis: Placed over the joint Stationary arm: Aligned with proximal segment Moving arm: Aligned with distal segment\n\nProcedure:\n\nExplain to patient → Proper positioning → Stabilize proximal joint → Move limb through ROM → Read measurement\n\nUsed To Assess:\n\nJoint mobility limitations Effectiveness of treatment Progress tracking in rehabilitation Common Areas: Knee, hip, ankle, shoulder, elbow, wrist, cervical spine'}, {'measure': 'Manual Muscle Testing', 'timeFrame': '12 sessions in 4 weeks', 'description': 'Manual Muscle Testing (MMT) Purpose: Evaluate muscle strength manually\n\nGrading Scale (0-5):\n\n0 = No contraction\n\n1. = Flicker/trace of contraction\n2. = Full ROM in gravity-eliminated position\n3. = Full ROM against gravity\n4. = Full ROM with some resistance\n5. = Full ROM with maximum resistance (normal)\n\nProcedure:\n\nProper positioning → Isolate target muscle → Apply resistance gradually → Grade based on performance\n\nUsed In:\n\nNeuromuscular conditions Orthopedic rehab Stroke, SCI, peripheral nerve injuries\n\nAdvantages:\n\nQuick and cost-effective Useful in baseline assessment and progress monitoring'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Active Neural mobilizations', 'Passive Neural mobilizations', 'diabetic neuropathy', 'neuropathic pain', 'muscle strength improvement', 'ROM improvement', 'pain reduction'], 'conditions': ['Neuropathy', 'Diabete Mellitus', 'Diabetic Neuropathy']}, 'referencesModule': {'references': [{'pmid': '36404825', 'type': 'BACKGROUND', 'citation': 'Goyat M, Saxena A, Goyal M. Study Protocol titled as "Effectiveness of neural mobilization in improving the ankle ROM and plantar pressure distribution in patients with diabetic peripheral neuropathy: A single group, pre post, quasi experimental study protocol". J Diabetes Metab Disord. 2022 Aug 15;21(2):2035-2041. doi: 10.1007/s40200-022-01106-z. eCollection 2022 Dec.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/36404825/', 'label': 'Study Protocol titled as "Effectiveness of neural mobilization in improving the ankle ROM and plantar pressure distribution in patients with diabetic peripheral neuropathy: A single group, pre post, quasi experimental study protocol"'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/38057930/', 'label': 'Effects of foot and ankle mobilisations combined with home stretches in people with diabetic peripheral neuropathy: a proof-of-concept RCT'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/38205228/', 'label': 'Effects of Neural Mobilization in Diabetic Peripheral Neuropathy: A Scoping Review'}]}, 'descriptionModule': {'briefSummary': '* Randomized controlled trial evaluating active and passive neurodynamic techniques for diabetic neuropathy.\n* Sample size: 60 patients (30 per group), aged 40 to 65 years, diagnosed with diabetes mellitus.\n* Exclusion criteria: Systemic diseases, pregnancy, fractures, foot ulceration, amputation, osteoarthritis.\n* Study will be conducted at physiotherapy OPDs of Dow Ojha Hospital, DIPMR,NIDE and Baqai Institute of Diabetology and Endocrinology.\n* Participants randomly assigned into two groups using a computer-generated randomization sheet.\n\nGroup A: Active neurodynamics (neural flossing) - patient-controlled nerve gliding movements.\n\nGroup B: Passive neurodynamics (tensioners) - therapist-applied nerve stretches.\n\n* Standard treatment includes gait training, lower limb strengthening exercised, and stationary bike sessions.\n* Treatment: 12 sessions over 4 weeks (3 sessions per week, 30 minutes each session).\n* Assessments will be done at baseline and post-intervention by a blinded physical therapist.\n* Outcome measures: DN-4 (pain), MMT (muscle strength), Goniometry (ROM), LLTT (nerve mobility).\n* Data were analyzed using SPSS Version 27. A one-way ANOVA was performed to compare the results before and after the intervention.\n* Study duration: 9 months, including approval, pilot study, data collection, and final presentation.\n* Study aims to determine the most effective neurodynamic technique for pain relief, mobility, and muscle strength.\n* Findings will guide better rehabilitation strategies for improved patient outcomes and quality of life.', 'detailedDescription': 'Diabetic neuropathy is a common complication of diabetes mellitus that presents with neuropathic pain, muscle weakness, and restricted mobility in the lower limbs. These impairments negatively affect quality of life and increase the risk of falls, foot ulcers, and amputations. Pharmacological treatments are available but frequently provide incomplete symptom relief and may cause adverse effects, creating the need for effective non-pharmacological interventions.\n\nNeural mobilization techniques have been reported to improve nerve mobility and decrease pain sensitivity. Two forms will be applied in this trial: active neural mobilization (neural flossing) and passive neural mobilization (tensioners). Both approaches aim to restore normal neural dynamics but differ in their application principles.\n\nThis randomized controlled trial will be conducted in the physiotherapy outpatient departments of Dow Ojha Hospital, the National Institute of Diabetology and Endocrinology (NIDE), and the Baqai Institute of Diabetology and Endocrinology (BIDE). A total of 60 participants with clinically diagnosed diabetic neuropathy, aged 40-65 years, will be recruited and randomly assigned to either an active neural mobilization group or a passive neural mobilization group.\n\nEach group will receive 12 treatment sessions over a 4-week period. Both groups will additionally perform conventional physiotherapy, including gait training, strengthening exercises, and stationary cycling. Outcomes will be assessed at baseline and post-intervention. Measures will include:\n\nNeuropathic pain using the DN-4 questionnaire\n\nMuscle strength using manual muscle testing (MMT)\n\nJoint range of motion using goniometry\n\nThe primary objective of the study will be to compare the effectiveness of active versus passive neural mobilization in reducing neuropathic pain and improving muscle strength and joint mobility. Secondary objectives will include determining clinical applicability and the potential role of these interventions in rehabilitation protocols for diabetic neuropathy.\n\nLimitations of the trial will include the inability to blind participants, possible variability in treatment adherence, and potential influence of external factors such as concurrent analgesic use. Randomization and standardized intervention protocols will be employed to minimize bias.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both male and female individuals\n* Aged between 40 and 65 years\n* Diagnosed with Diabetes Mellitus (Type I and Type II)\n* Diagnosis confirmed by a physician\n\nExclusion Criteria:\n\n* One with any systemic disease\n* Medical conditions (neurological disorders, fractures, acute inflammatory conditions, recent surgeries)\n* Foot Ulceration\n* Amputation\n* OA of Ankle or Knee Joint'}, 'identificationModule': {'nctId': 'NCT07141992', 'acronym': 'RCT', 'briefTitle': 'Comparison of Active vs Passive Neural Mobilizations Effects in Improving Burning Pain, Muscular Strength, and Range of Motion in Patients With Diabetic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Dow University of Health Sciences'}, 'officialTitle': 'Comparison of Active vs Passive Neural Mobilizations Effects in Improving Burning Pain, Muscular Strength, and Range of Motion in Patients With Diabetic Neuropathy: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'IRB No. 3966'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Effect of Active Neural Mobilization on Pain, Strength, and ROM in Diabetic Neuropathy', 'description': 'Participants in the active neural mobilization group will receive neural flossing techniques, aimed at improving nerve mobility and reducing neuropathic symptoms. Along with neural mobilization, participants will follow a standardized physiotherapy protocol, including:\n\nGait training on both smooth and rough surfaces Strengthening exercises: leg press, ankle press, isometric exercises for knee and ankle extensors, bridging, and pelvic rolling All exercises will be performed in 3 sets of 12 repetitions, with 30 seconds of rest between sets Stationary cycling will be included as part of cardiovascular conditioning The intervention will be delivered over 12 sessions, scheduled three times per week for four weeks. This program aims to reduce burning pain, and enhance muscle strength and range of motion in patients with diabetic neuropathy.', 'interventionNames': ['Other: Active Neural Mobilzations']}, {'type': 'EXPERIMENTAL', 'label': 'Effect of Passive Neural Mobilization on Pain, Strength, and ROM in Diabetic Neuropathy', 'description': 'Participants in the passive neural mobilization group will receive neural tensioning techniques, which involve therapist-guided passive movements to mobilize the neural structures. In addition to passive mobilization, participants will undergo the same standardized physiotherapy protocol, which includes:\n\nGait training on both smooth and rough surfaces Strengthening exercises: leg press, ankle press, isometric exercises for knee and ankle extensors, bridging, and pelvic rolling Exercises will be performed in 3 sets of 12 repetitions, with 30 seconds of rest between sets Stationary cycling will be used for cardiovascular conditioning This group will also receive 12 treatment sessions, conducted three times per week over four weeks, with the goal of improving pain, strength, and mobility in individuals with diabetic neuropathy.', 'interventionNames': ['Other: Passive Neural Mobilzations']}], 'interventions': [{'name': 'Active Neural Mobilzations', 'type': 'OTHER', 'description': 'Participants in this group will receive active neural mobilization in the form of neural flossing techniques. These involve controlled, repeated movements performed actively by the patient to mobilize peripheral nerves without placing them under excessive tension. The goal is to restore neural mobility, reduce mechanosensitivity, and relieve neuropathic symptoms such as burning pain.', 'armGroupLabels': ['Effect of Active Neural Mobilization on Pain, Strength, and ROM in Diabetic Neuropathy']}, {'name': 'Passive Neural Mobilzations', 'type': 'OTHER', 'description': 'Participants in this group will receive passive neural mobilization using neural tensioning techniques. These techniques involve therapist-applied passive limb movements that place a controlled tensile load on the neural structures. The objective is to improve neural gliding, reduce nerve compression, and decrease neuropathic pain, particularly in cases of restricted neural tissue mobility.', 'armGroupLabels': ['Effect of Passive Neural Mobilization on Pain, Strength, and ROM in Diabetic Neuropathy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75280', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Dow University of Health Sciences / Baqai Institute of Diabetology and Endocrinology', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Farhan Ishaque Khan, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dow Institute of Physical Medicine and Rehabilitation, Dow University of Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual Participant Data (IPD) will not be shared due to confidentiality concerns. Protecting the privacy and anonymity of participants is a top priority, and sharing IPD may risk breaching this confidentiality. Additionally, the data is securely stored and intended solely for use within the scope of this study; therefore, it will not be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dow University of Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baqai Institute of Diabetology and Endocrinology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'MUHAMMAD MEHRAN HAIDER', 'investigatorAffiliation': 'Dow University of Health Sciences'}}}}