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

Dow University of Health Sciences

Status: Invitation-only

Conditions: Diabetic Neuropathy; Diabete Mellitus; Neuropathy

Treatments: Other: Passive Neural Mobilzations; Other: Active Neural Mobilzations

Study type: Interventional

Funder types: Other

Identifiers

NCT07141992

IRB No. 3966

Details and patient eligibility

About

• 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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

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

Experimental group

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: 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.

Treatment:

Other: Active Neural Mobilzations

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

Experimental group

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: 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.

Treatment:

Other: Passive Neural Mobilzations