- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07695181
Effectiveness of Pain Neuroscience Education Along With Neural Mobilization Versus Neural Mobilization Alone on Pain, Functional Disability And Quality of Life In Patients With Diabetic Neuropathic Pain
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Roshan Farman, MSPT
- Phone Number: +923188108470
- Email: 5012324032@student.iiui.edu.pk
Study Contact Backup
- Name: Somiya Naz, PhD scholar
- Phone Number: +923315163093
- Email: somiyanaz@uipt.iiui.edu.pk
Study Locations
-
-
Punjab Province
-
Rawalpindi, Punjab Province, Pakistan, 46000
- Positive Solution Clinic, Wah Cantt
-
Contact:
- Mahjabeen Farooqui, MSPT
- Phone Number: 3313666898
- Email: mahafarooqui0@gmail.com
-
Contact:
- Somiya Asif, MSPT
- Phone Number: 3435322291
- Email: sumaiya.asif92@gmail.com
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Principal Investigator:
- Roshan Farman, MSPT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Age ≥ 40 years (WHO 2016 criteria) Diagnosed Type II diabetes mellitus Lower limb neuropathic pain ≥ 3 months Pain intensity ≥ 4/10 on NPRS Able to walk independently and follow instructions
Exclusion Criteria:
Neurological disorders (e.g. stroke, Guillain-Barré) Lumbar disc herniation with radiculopathy Lower limb surgery or spinal fracture within 6 months Active diabetic foot ulcer Diagnosed cognitive impairment or severe infection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A - Pain Neurosciences Education combined with Neural Mobilization
Pain neuroscience education (PNE) will be delivered through structured educational sessions focusing on pain physiology, neural sensitization, and pain modulation.
PNE: 20-30 min (weeks 1-2) → 10 min reinforcement (weeks 3-6) Methods: Simple diagrams, patient-friendly metaphors, video demonstrations.
Neural mobilization techniques will be applied following standardized neurodynamic principles and patients' tolerance.
Target nerves: Sciatic, tibial & common peroneal Technique: Slider neurodynamic mobilization Dosage: 10-15 reps × 2-3 sets | Rest: 30-60 sec between sets Session duration: 15-20 minutes
|
In Group A pain neuroscience Education will be given in adjunct with neural mobilization techniques Target nerves: Sciatic, tibial & common peroneal Technique: Slider neurodynamic mobilization Dosage: 10-15 reps × 2-3 sets | Rest: 30-60 sec between sets Session duration: 15-20 minutes PNE: 20-30 min (weeks 1-2) → 10 min reinforcement (weeks 3-6) Methods: Simple diagrams, patient-friendly metaphors, video demonstrations
|
|
Active Comparator: Group B - Neural Mobilization Alone
Neural mobilization techniques will be applied following standardized neurodynamic principles and patients' tolerance.
Target nerves: Sciatic, tibial & common peroneal Technique: Slider neurodynamic mobilization Dosage: 10-15 reps × 2-3 sets | Rest: 30-60 sec between sets Session duration: 15-20 minutes
|
In Group A pain neuroscience Education will be given in adjunct with neural mobilization techniques Target nerves: Sciatic, tibial & common peroneal Technique: Slider neurodynamic mobilization Dosage: 10-15 reps × 2-3 sets | Rest: 30-60 sec between sets Session duration: 15-20 minutes PNE: 20-30 min (weeks 1-2) → 10 min reinforcement (weeks 3-6) Methods: Simple diagrams, patient-friendly metaphors, video demonstrations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: Baseline to week 6
|
Pain intensity will be evaluated using Numeric Pain Rating Scale
|
Baseline to week 6
|
|
Functional disability
Time Frame: Baseline to week 6
|
Functional disability will be evaluated using Urdu version of Lower Extremity Functional Scale (LEFS)
|
Baseline to week 6
|
|
Quality of life
Time Frame: Baseline to week 6
|
Quality of life will be evaluated by World Health Organization Quality Of Life-BREF
|
Baseline to week 6
|
|
Central sensitization
Time Frame: Baseline to week 6
|
Central sensitization will be evaluated using Central Sensitization Inventory
|
Baseline to week 6
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IIUI/RERC/ADT/2026/05/265
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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