Diabetic Peripheral Neuropathy Type 2
Conditions
Brief 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.
Interventions
PROCEDUREManual 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.
PROCEDURECervical 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.
OTHERStandard Care
Participants continued to receive usual care as prescribed, including routine medical management and general physiotherapy advice.
Sponsors
Abeer Abdrabo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors were blinded to group allocation to minimize assessment bias.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | 3 months | Description: The average number of participants recruited per month during the recruitment period. |
| Retention Rate | 12 weeks | Description: The percentage of participants who complete the final assessment at 12 weeks relative to the number of participants randomized. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity (Visual Analogue Scale - VAS) | 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). |
| Quality of Life (SF-36 Questionnaire) | 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. |
| Fasting Blood Glucose (FBG) | Baseline and 12 weeks | FBG will be measured using venous blood samples to assess metabolic control. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORabeer abdrabo
Isra University, Jordan
PRINCIPAL_INVESTIGATORAmira Ezzat
Heliopolis University, Egypt
Outcome results
None listed