Comparison of Active vs Passive Neural Mobilizations Effects in Improving Burning Pain, Muscular Strength, and Range of Motion in Patients With Diabetic Neuropathy

NCT07141992 | Enrolling By Invitation DMC

• 1 other identifier: IRB No. 3966
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

• Randomized controlled trial evaluating active and passive neurodynamic techniques for diabetic neuropathy.
• Sample size: 60 patients (30 per group), aged 40 to 65 years, diagnosed with diabetes mellitus.
• Exclusion criteria: Systemic diseases, pregnancy, fractures, foot ulceration, amputation, osteoarthritis.
• Study will be conducted at physiotherapy OPDs of Dow Ojha Hospital, DIPMR,NIDE and Baqai Institute of Diabetology and Endocrinology.
• Participants randomly assigned into two groups using a computer-generated randomization sheet. Group A: Active neurodynamics (neural flossing) - patient-controlled nerve gliding movements. Group B: Passive neurodynamics (tensioners) - therapist-applied nerve stretches.
• Standard treatment includes gait training, lower limb strengthening exercised, and stationary bike sessions.
• Treatment: 12 sessions over 4 weeks (3 sessions per week, 30 minutes each session).
• Assessments will be done at baseline and post-intervention by a blinded physical therapist.
• Outcome measures: DN-4 (pain), MMT (muscle strength), Goniometry (ROM), LLTT (nerve mobility).
• Data were analyzed using SPSS Version 27. A one-way ANOVA was performed to compare the results before and after the intervention.
• Study duration: 9 months, including approval, pilot study, data collection, and final presentation.
• Study aims to determine the most effective neurodynamic technique for pain relief, mobility, and muscle strength.
• Findings will guide better rehabilitation strategies for improved patient outcomes and quality of life.

Conditions

Neuropathy; Diabete Mellitus; Diabetic Neuropathy

Keywords

Active Neural mobilizations; Passive Neural mobilizations; diabetic neuropathy; neuropathic pain; muscle strength improvement; ROM improvement; pain reduction

Outcome Measures

Primary Outcomes (4)

• Lower Limb Tension Test

  Lower Limb Tension Test (LLTT) Purpose: Assess neural mechanosensitivity of lower limb nerves, especially sciatic, tibial, and peroneal nerves. Also Known As: Straight Leg Raise (SLR), Slump Test, Prone Knee Bend Test, etc. Indications: Radiating leg pain Suspected lumbar radiculopathy Neural tension syndromes Procedure Includes: Hip flexion, knee extension, ankle dorsiflexion, and/or foot inversion/eversion based on nerve bias Positive Sign: Reproduction of neuropathic symptoms (burning, tingling, shooting pain) Symptoms change with sensitizing maneuvers Used In: Neuropathy Sciatica Disc herniation Piriformis syndrome

  12 sessions for 4 weeks

• DN-4 (Douleur Neuropathique en 4 questions)

  DN-4 Questionnaire (Douleur Neuropathique en 4 questions) Purpose: To screen for neuropathic pain and distinguish it from nociceptive pain. Total 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) Scoring: Each "yes" = 1 point Total Score Range: 0 to 10 Score ≥ 4 indicates likely neuropathic pain Time Required: Less than 5 minutes Advantages: Quick and easy to administer Non-invasive High sensitivity and specificity Used In: Diabetic neuropathy Post-stroke pain Sciatica Postherpetic neuralgia

  12 sessions in 4 weeks

• Goniometery (Joint Range of Motion)

  Goniometry Purpose: Measure joint range of motion (ROM) accurately Instrument: Goniometer (standard) Components: Axis: Placed over the joint Stationary arm: Aligned with proximal segment Moving arm: Aligned with distal segment Procedure: Explain to patient → Proper positioning → Stabilize proximal joint → Move limb through ROM → Read measurement Used To Assess: Joint mobility limitations Effectiveness of treatment Progress tracking in rehabilitation Common Areas: Knee, hip, ankle, shoulder, elbow, wrist, cervical spine

  12 sessions for 4 weeks

• Manual Muscle Testing

  Manual Muscle Testing (MMT) Purpose: Evaluate muscle strength manually Grading Scale (0-5): 0 = No contraction 1. = Flicker/trace of contraction 2. = Full ROM in gravity-eliminated position 3. = Full ROM against gravity 4. = Full ROM with some resistance 5. = Full ROM with maximum resistance (normal) Procedure: Proper positioning → Isolate target muscle → Apply resistance gradually → Grade based on performance Used In: Neuromuscular conditions Orthopedic rehab Stroke, SCI, peripheral nerve injuries Advantages: Quick and cost-effective Useful in baseline assessment and progress monitoring

  12 sessions in 4 weeks

Study Arms (2)

Effect of Active Neural Mobilization on Pain, Strength, and ROM in Diabetic Neuropathy

EXPERIMENTAL

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: Gait 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.

Other: Active Neural Mobilzations

Effect of Passive Neural Mobilization on Pain, Strength, and ROM in Diabetic Neuropathy

EXPERIMENTAL

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: Gait 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.

Other: Passive Neural Mobilzations

Interventions

Active Neural Mobilzations OTHER

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.

Effect of Active Neural Mobilization on Pain, Strength, and ROM in Diabetic Neuropathy

Passive Neural Mobilzations OTHER

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.

Effect of Passive Neural Mobilization on Pain, Strength, and ROM in Diabetic Neuropathy

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both male and female individuals
• Aged between 40 and 65 years
• Diagnosed with Diabetes Mellitus (Type I and Type II)
• Diagnosis confirmed by a physician

You may not qualify if:

• One with any systemic disease
• Medical conditions (neurological disorders, fractures, acute inflammatory conditions, recent surgeries)
• Foot Ulceration
• Amputation
• OA of Ankle or Knee Joint

Sponsors & Collaborators

• Dow University of Health Sciences: lead
• Baqai Institute of Diabetology and Endocrinology: collaborator

Study Sites (1)

Dow University of Health Sciences / Baqai Institute of Diabetology and Endocrinology

Karachi, Sindh, 75280, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 36404825 BACKGROUND

Related Links

• 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"
• Effects of foot and ankle mobilisations combined with home stretches in people with diabetic peripheral neuropathy: a proof-of-concept RCT
• Effects of Neural Mobilization in Diabetic Peripheral Neuropathy: A Scoping Review

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Neuropathies; Neuralgia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Farhan Ishaque Khan, PhD

  Dow Institute of Physical Medicine and Rehabilitation, Dow University of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: June 4, 2025
• Primary Completion: August 23, 2025
• Study Completion: September 1, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)