NCT07695181

Brief Summary

This is a randomized controlled trial aims to evaluate the comparative effect of Pain Neuroscience Education combined with neural mobilization versus neural mobilization alone in patients with diabetic neuropathic pain. This study will Compare pain intensity between intervention groups and assess functional disability outcomes. Furthermore, this will evaluate changes in quality of life and to analyze pain-related beliefs following PNE.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Jul 2026Jan 2027

First Submitted

Initial submission to the registry

July 6, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

July 10, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2027

Expected
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2027

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

July 6, 2026

Last Update Submit

July 6, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Pain intensity

    Pain intensity will be evaluated using Numeric Pain Rating Scale

    Baseline to week 6

  • Functional disability

    Functional disability will be evaluated using Urdu version of Lower Extremity Functional Scale (LEFS)

    Baseline to week 6

  • Quality of life

    Quality of life will be evaluated by World Health Organization Quality Of Life-BREF

    Baseline to week 6

  • Central sensitization

    Central sensitization will be evaluated using Central Sensitization Inventory

    Baseline to week 6

Study Arms (2)

Group A - Pain Neurosciences Education combined with Neural Mobilization

EXPERIMENTAL

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

Other: Pain Neurosciences Education + Neural Mobilization

Group B - Neural Mobilization Alone

ACTIVE COMPARATOR

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

Other: Pain Neurosciences Education + Neural Mobilization

Interventions

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

Group A - Pain Neurosciences Education combined with Neural MobilizationGroup B - Neural Mobilization Alone

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Positive Solution Clinic, Wah Cantt

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Central Study Contacts

Somiya Naz, PhD scholar

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 parallel group; Group A - PNE + Neural Mobilization and Group B - Neural Mobilization Alone
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 10, 2026

Study Start

July 10, 2026

Primary Completion (Estimated)

January 10, 2027

Study Completion (Estimated)

January 20, 2027

Last Updated

July 10, 2026

Record last verified: 2026-07

Locations