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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Neural Mobilization (MNM) | Experimental | 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. |
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| Cervical Neuromodulatory Intervention (CNI) | Experimental | 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. |
|
| Standard Care | Active Comparator | Participants in this group received standard medical and physiotherapy care without additional manual therapy interventions over a 12-week period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Neural Mobilization | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Description: The average number of participants recruited per month during the recruitment period. | 3 months |
| Retention Rate | Description: The percentage of participants who complete the final assessment at 12 weeks relative to the number of participants randomized. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, 6 weeks, and 12 weeks |
| Quality of Life (SF-36 Questionnaire) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| abeer abdrabo | Isra University, Jordan | Principal Investigator |
| Amira Ezzat | Heliopolis University, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University Hospitals, Kasr Al-Ainy | Cairo | Egypt |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Outcome assessors were blinded to group allocation to minimize assessment bias.
| Cervical Neuromodulatory Intervention | Procedure | 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. |
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| Standard Care | Other | Participants continued to receive usual care as prescribed, including routine medical management and general physiotherapy advice. |
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The Short Form-36 (SF-36) scores range from 0 to 100. Higher scores represent better physical and mental health status. |
| Baseline and 12 weeks |
| Fasting Blood Glucose (FBG) | FBG will be measured using venous blood samples to assess metabolic control. | Baseline and 12 weeks |