Neural Mobilization vs Cervical Neuromodulation in DPN

Abeer Abdrabo

Status: Active, not recruiting

Conditions: Diabetic Peripheral Neuropathy Type 2

Treatments: Other: Standard Care; Procedure: Cervical Neuromodulatory Intervention; Procedure: Manual Neural Mobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT07537270

DPN-MNM-CNI-2026-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

Manual Neural Mobilization (MNM)

Experimental group

Description:

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.

Treatment:

Procedure: Manual Neural Mobilization

Cervical Neuromodulatory Intervention (CNI)

Experimental group

Description:

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.

Treatment:

Procedure: Cervical Neuromodulatory Intervention

Standard Care

Active Comparator group

Description:

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

Treatment:

Other: Standard Care