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

Официальное название

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

Обзор

* 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.

Подробное описание

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.

Вмешательства

• Другое Active Neural Mobilzations
  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.
• Другое Passive Neural Mobilzations
  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.

Первичные конечные точки

• Lower Limb Tension Test [Срок оценки: 12 sessions for 4 weeks]
• DN-4 (Douleur Neuropathique en 4 questions) [Срок оценки: 12 sessions in 4 weeks]
• Goniometery (Joint Range of Motion) [Срок оценки: 12 sessions for 4 weeks]
• Manual Muscle Testing [Срок оценки: 12 sessions in 4 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Dow University of Health Sciences / Baqai Institute of Diabetology and Endocrinology — Karachi

Публикации

• 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

Идентификаторы

NCT: NCT07141992 · IRB No. 3966

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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