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| Name | Class |
|---|---|
| Baqai Institute of Diabetology and Endocrinology | OTHER |
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Group A: Active neurodynamics (neural flossing) - patient-controlled nerve gliding movements.
Group B: Passive neurodynamics (tensioners) - therapist-applied nerve stretches.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farhan Ishaque Khan, PhD | Dow Institute of Physical Medicine and Rehabilitation, Dow University of Health Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dow University of Health Sciences / Baqai Institute of Diabetology and Endocrinology | Karachi | Sindh | 75280 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36404825 | Background | 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. |
| Label | URL |
|---|---|
| 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" | View source |
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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.
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| 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. |
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Manual Muscle Testing (MMT) Purpose: Evaluate muscle strength manually
Grading Scale (0-5):
0 = No contraction
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 |
| Effects of foot and ankle mobilisations combined with home stretches in people with diabetic peripheral neuropathy: a proof-of-concept RCT | View source |
| Effects of Neural Mobilization in Diabetic Peripheral Neuropathy: A Scoping Review | View source |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 13, 2026 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003929 | Diabetic Neuropathies |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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