Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
NCT ID:
NCT07141992
Brief Summary:
* 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.
Detailed 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.
Study:
NCT07141992
Study Brief:
Protocol Section:
NCT07141992