Manual Neural Mobilization Versus Cervical Neuromodulatory Intervention for Glycemic Control in Adults With Diabetic Peripheral Neuropathy: Pilot RCT - Hypothesis-generating Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors were blinded to group allocation to minimize assessment bias.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically confirmed diabetic peripheral neuropathy
- •Ability to attend twice-weekly intervention sessions for 12 weeks
- •Stable medication regimen for at least 3 months
排除标准
- •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
研究组 & 干预措施
Manual Neural Mobilization (MNM)
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.
干预措施: Manual Neural Mobilization (Procedure)
Cervical Neuromodulatory Intervention (CNI)
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.
干预措施: Cervical Neuromodulatory Intervention (Procedure)
Standard Care
Participants in this group received standard medical and physiotherapy care without additional manual therapy interventions over a 12-week period.
干预措施: Standard Care (Other)
结局指标
主要结局
Recruitment Rate
时间窗: 3 months
Description: The average number of participants recruited per month during the recruitment period.
Retention Rate
时间窗: 12 weeks
Description: The percentage of participants who complete the final assessment at 12 weeks relative to the number of participants randomized.
次要结局
- Pain Intensity (Visual Analogue Scale - VAS)(Baseline, 6 weeks, and 12 weeks)
- Quality of Life (SF-36 Questionnaire)(Baseline and 12 weeks)
- Fasting Blood Glucose (FBG)(Baseline and 12 weeks)
研究者
Abeer Abdrabo
Principal Investigator
Isra University, Jordan