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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Lower Limb Tension Test
研究概览
简要总结
- 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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •One with any systemic disease
- •Medical conditions (neurological disorders, fractures, acute inflammatory conditions, recent surgeries)
- •Foot Ulceration
- •Amputation
- •OA of Ankle or Knee Joint
结局指标
主要结局
Lower Limb Tension Test
时间窗: 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
DN-4 (Douleur Neuropathique en 4 questions)
时间窗: 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
Goniometery (Joint Range of Motion)
时间窗: 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
Manual Muscle Testing
时间窗: 12 sessions in 4 weeks
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
次要结局
未报告次要终点
研究者
MUHAMMAD MEHRAN HAIDER
Principal Investigator
Dow University of Health Sciences