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Active (not recruiting) Not applicable NCT07537270

Neural Mobilization vs Cervical Neuromodulation in DPN

No applicable phase (e.g. observational)
Conditions: Diabetic Peripheral Neuropathy Type 2

Sponsor: Abeer Abdrabo

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
Interventions
Manual Neural Mobilization
PROCEDURE
Cervical Neuromodulatory Intervention
PROCEDURE
Standard Care
OTHER
Locations 1
Egypt (1)
Cairo University Hospitals, Kasr Al-Ainy
Cairo
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
05.02.2026
Completion date
01.06.2026
Registry ID
NCT07537270
Source
clinicaltrials.gov
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