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Active, Not Recruiting

NCT Number: NCT07537270

Neural Mobilization vs Cervical Neuromodulation in DPN

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetic Peripheral Neuropathy Type 2

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Hospitals, Kasr Al-Ainy

Cairo, Egypt

About this study

Background:

Diabetic peripheral neuropathy (DPN) often leads to pain and reduced quality of life. Manual therapy techniques such as Manual Neural Mobilization (MNM) and Cervical Neuromodulatory Intervention (CNI) are typically used for musculoskeletal relief, but their impact on systemic glycemic control in DPN patients is not yet well-established.

Objectives:

To assess the feasibility of the trial protocol (recruitment, retention, and adherence).

To provide preliminary data on the effects of MNM and CNI on glycemic parameters (HbA1c, FBG) and clinical symptoms (pain intensity, functional mobility).

Methodology:

Participants (n=75) with type 2 diabetes and clinically confirmed DPN were randomized into three equal groups:

Group 1 (MNM): Received manual neural mobilization targeting the lower limbs (2 sessions/week for 12 weeks).

Group 2 (CNI): Received cervical neuromodulatory techniques aimed at influencing the autonomic nervous system (2 sessions/week for 12 weeks).

Group 3 (Control): Received standard medical and physiotherapy care.

Outcome Assessment:

Feasibility was measured by tracking recruitment success and participant retention. Secondary exploratory outcomes included laboratory tests for HbA1c and Fasting Blood Glucose, and clinical scales for pain (VAS) and quality of life (SF-36). As this is a pilot study, the results are intended to inform the design and sample size of future definitive trials rather than to establish final clinical efficacy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Standard care

Other

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

Primary outcomes

  1. Recruitment Rate

    Time frame: 3 months

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

  2. Retention Rate

    Time frame: 12 weeks

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

Secondary outcomes

  1. Pain Intensity (Visual Analogue Scale - VAS)

    Time frame: Baseline, 6 weeks, and 12 weeks

    Description: Participants rate their pain on a scale from 0 to 10, where 0 represents "no pain" and 10 represents "worst imaginable pain". Lower scores indicate a better outcome (reduction in pain).

  2. Quality of Life (SF-36 Questionnaire)

    Time frame: Baseline and 12 weeks

    The Short Form-36 (SF-36) scores range from 0 to 100. Higher scores represent better physical and mental health status.

  3. Fasting Blood Glucose (FBG)

    Time frame: Baseline and 12 weeks

    FBG will be measured using venous blood samples to assess metabolic control.

Sponsors and collaborators

Lead sponsor

Abeer Abdrabo

Other

Registry information

Official study title

Manual Neural Mobilization Versus Cervical Neuromodulatory Intervention for Glycemic Control in Adults With Diabetic Peripheral Neuropathy: Pilot RCT - Hypothesis-generating Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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