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NCT Number: NCT07141992

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

* 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.

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Key information

Conditions

Neuropathy Diabete Mellitus Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Diabetic Neuropathy Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Karachi, Sindh, 75280, Pakistan

About this study

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.

Neural 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.

This 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.

Each 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:

Neuropathic pain using the DN-4 questionnaire

Muscle strength using manual muscle testing (MMT)

Joint range of motion using goniometry

The 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.

Limitations 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Lower Limb Tension Test

    Time frame: 12 sessions for 4 weeks

    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

  2. DN-4 (Douleur Neuropathique en 4 questions)

    Time frame: 12 sessions in 4 weeks

    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

  3. Goniometery (Joint Range of Motion)

    Time frame: 12 sessions for 4 weeks

    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

  4. Manual Muscle Testing

    Time frame: 12 sessions in 4 weeks

    Manual Muscle Testing (MMT) Purpose: Evaluate muscle strength manually

    Grading Scale (0-5):

    0 = No contraction

    • = Flicker/trace of contraction
    • = Full ROM in gravity-eliminated position
    • = Full ROM against gravity
    • = Full ROM with some resistance
    • = 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

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Collaborators

  • Baqai Institute of Diabetology and Endocrinology

Registry information

Official study title

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

Acronym: RCT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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