NCT07537270

Neural Mobilization vs Cervical Neuromodulation in DPN

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Isra University, Jordan · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Diabetic Peripheral Neuropathy Type 2

Interventions

Type	Name	Description
PROCEDURE	Manual Neural Mobilization	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.
PROCEDURE	Cervical Neuromodulatory Intervention	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.
OTHER	Standard Care	Participants continued to receive usual care as prescribed, including routine medical management and general physiotherapy advice.

Timeline

• Start date: 2026-02-05
• Primary completion: 2026-05-30
• Completion: 2026-06-01
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: Jordan