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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
75
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 techniques were applied at the cervical spine to modulate neural function and potentially influence systemic outcomes. Sessions were conducted twice weekly for 12 weeks.
Participants continued to receive usual care as prescribed, including routine medical management and general physiotherapy advice.
Department of Physical Therapy, King Abdullah University Hospital
Amman, Jordan
Recruitment Rate
Description: The average number of participants recruited per month during the recruitment period.
Time frame: 3 months
Retention Rate
Description: The percentage of participants who complete the final assessment at 12 weeks relative to the number of participants randomized.
Time frame: 12 weeks
Pain Intensity (Visual Analogue Scale - VAS)
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).
Time frame: Baseline, 6 weeks, and 12 weeks
Quality of Life (SF-36 Questionnaire)
The Short Form-36 (SF-36) scores range from 0 to 100. Higher scores represent better physical and mental health status.
Time frame: Baseline and 12 weeks
Fasting Blood Glucose (FBG)
FBG will be measured using venous blood samples to assess metabolic control.
Time frame: Baseline and 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.