Neural Mobilization vs Cervical Neuromodulation in DPN

NCT07537270 | Active Not Recruiting DMC

• 1 other identifier: DPN-MNM-CNI-2026-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a three-arm, assessor-blinded, randomized controlled pilot feasibility trial. The primary goal is to evaluate the feasibility and acceptability of conducting a full-scale randomized controlled trial (RCT) comparing two manual therapy techniques: Manual Neural Mobilization (MNM) and Cervical Neuromodulatory Intervention (CNI) in individuals with Diabetic Peripheral Neuropathy (DPN). While glycemic control is a central part of managing type 2 diabetes, this study explores whether non-pharmacological manual therapies can serve as adjunctive interventions to improve metabolic outcomes. A total of 75 participants were assigned to either MNM, CNI, or standard care for 12 weeks. The study focuses on recruitment rates, adherence, and safety, while also exploring secondary outcomes like blood glucose levels (HbA1c, FBG) and pain intensity.

Conditions

Diabetic Peripheral Neuropathy Type 2

Outcome Measures

Primary Outcomes (2)

• Recruitment Rate

  Description: The average number of participants recruited per month during the recruitment period.

  3 months

• Retention Rate

  Description: The percentage of participants who complete the final assessment at 12 weeks relative to the number of participants randomized.

  12 weeks

Secondary Outcomes (3)

• Pain Intensity (Visual Analogue Scale - VAS)

  Baseline, 6 weeks, and 12 weeks

• Quality of Life (SF-36 Questionnaire)

  Baseline and 12 weeks

• Fasting Blood Glucose (FBG)

  Baseline and 12 weeks

Study Arms (3)

Manual Neural Mobilization (MNM)

EXPERIMENTAL

Participants in this group received manual neural mobilization techniques targeting the peripheral nerves of the lower limb. The intervention was administered twice weekly for 12 weeks in addition to standard care.

Procedure: Manual Neural Mobilization

Cervical Neuromodulatory Intervention (CNI)

EXPERIMENTAL

Participants in this group received cervical neuromodulatory intervention aimed at influencing neural function via cervical spine techniques. The intervention was delivered twice weekly for 12 weeks in addition to standard care.

Procedure: Cervical Neuromodulatory Intervention

Standard Care

ACTIVE COMPARATOR

Participants in this group received standard medical and physiotherapy care without additional manual therapy interventions over a 12-week period.

Other: Standard Care

Interventions

Manual Neural Mobilization PROCEDURE

Manual neural mobilization techniques were applied to improve neural mobility and reduce mechanosensitivity in the lower extremities. Treatment sessions were conducted twice weekly over a 12-week period.

Manual Neural Mobilization (MNM)

Cervical Neuromodulatory Intervention PROCEDURE

Cervical neuromodulatory techniques were applied at the cervical spine to modulate neural function and potentially influence systemic outcomes. Sessions were conducted twice weekly for 12 weeks.

Cervical Neuromodulatory Intervention (CNI)

Standard Care OTHER

Participants continued to receive usual care as prescribed, including routine medical management and general physiotherapy advice.

Standard Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically confirmed diabetic peripheral neuropathy
• Ability to attend twice-weekly intervention sessions for 12 weeks
• Stable medication regimen for at least 3 months

You may not qualify if:

• Severe cardiovascular, neurological, or musculoskeletal disorders
• Recent surgery (\<6 months) in lower limbs or cervical spine
• Pregnancy or breastfeeding
• Cognitive impairment preventing informed consent or compliance

Sponsors & Collaborators

• Abeer Abdrabo: lead

Study Sites (1)

Cairo University Hospitals, Kasr Al-Ainy

Cairo, Egypt

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• abeer abdrabo

  Isra University, Jordan

  PRINCIPAL INVESTIGATOR

• Amira Ezzat

  Heliopolis University, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blinded to group allocation to minimize assessment bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 17, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)