Electrical Dry Needling Versus Sham Dry Needling in Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Pain Intensity (Visual Analogue Scale, VAS)
研究概览
简要总结
This study will evaluate the effectiveness of electrical dry needling (EDN) compared to sham dry needling (SDN) in patients with chronic low back pain (CLBP). CLBP is a common musculoskeletal condition associated with persistent pain, functional limitations, and reduced quality of life. Myofascial trigger points (MTrPs) are often implicated in CLBP and represent a key therapeutic target.
Dry needling is a minimally invasive procedure where fine needles are inserted into trigger points to release muscle tension and alleviate pain. Electrical dry needling is an advanced variation that applies low-frequency electrical stimulation through the inserted needles, potentially enhancing therapeutic effects. However, evidence is limited regarding its superiority over sham procedures.
In this randomized controlled trial, 70 adult participants with CLBP persisting for at least three months will be randomly assigned to one of two groups:
Group A (EDN + Conventional Therapy): Patients will receive electrical dry needling at active MTrPs combined with a structured physiotherapy program.
Group B (SDN + Conventional Therapy): Patients will receive sham dry needling at the same anatomical sites (using superficial or blunt needle placement without penetration) alongside the same physiotherapy program.
Interventions will be delivered weekly for six weeks. Assessments will occur at baseline, third week, and sixth week.
Primary outcomes include:
Pain intensity (Visual Analogue Scale, VAS)
Functional disability (Roland-Morris Disability Questionnaire, RMDQ)
Kinesiophobia (Tampa Scale of Kinesiophobia, TSK)
This trial is designed to clarify the clinical value of EDN beyond placebo effects, providing evidence to guide management of CLBP.
详细描述
Chronic low back pain (CLBP) affects approximately 7-8% of the global population and remains a leading cause of disability and healthcare burden. Conventional management strategies, including medication, manual therapy, and exercise, often provide partial or temporary relief. Myofascial trigger points (MTrPs) are highly prevalent in CLBP and contribute to persistent pain and movement restrictions.
Dry needling has emerged as a widely used intervention to deactivate MTrPs. The technique produces a local twitch response, improves blood flow, and reduces muscle tightness. Electrical dry needling (EDN) enhances this effect by delivering low-frequency electrical stimulation through the inserted needles, which may result in improved neuromuscular relaxation and pain modulation.
Despite encouraging findings from prior studies, the literature lacks rigorous trials comparing EDN with sham dry needling (SDN) controls. Sham procedures are critical to distinguish specific treatment effects from placebo or expectancy effects. This study aims to fill that gap.
Study Design:
Randomized controlled trial (parallel groups, single-blind).
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)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both male and female gender will be included (Fernández-Carnero, 2021).
- •Clinically diagnosed of chronic low back pain persisting for at least three months (Tüzün et al., 2017)
- •Identifiable active myofascial trigger points in the lower back muscles, confirmed through palpation or another standardized method (Donohoe, 2016).
- •Moderate to severe pain intensity, measured by a visual analog scale (VAS) (Tüzün et al., 2017)
- •Sufficient cognitive and physical ability to engage in assessments and interventions (Tüzün et al., 2017)
排除标准
- •Known hypersensitivity to needles, history of severe bleeding disorders, or any condition that contraindicates dry needling (Tüzün et al., 2017)
- •Use of other physical therapy interventions or dry needling treatments in the last three months for low back pain (Fernández-Carnero, 2021).
- •Presence of specific spinal conditions (e.g., disc herniation, spinal stenosis, fractures, or recent spinal surgeries) (Tüzün et al., 2017)
- •History of neurological conditions affecting movement, sensation, or pain perception, such as multiple sclerosis or peripheral neuropathy (Donohoe, 2016)
- •Pregnant women will be excluded due to potential risks associated with the interventions (Tüzün et al., 2017)
- •Unstable psychiatric conditions or active substance abuse that could interfere with participation or adherence to study procedures
研究组 & 干预措施
Electrical Dry Needling with Conventional Therapy
Participants will receive electrical dry needling (EDN) applied to active myofascial trigger points in lumbar muscles (quadratus lumborum, multifidus, iliocostalis lumborum) once weekly for six weeks. Fine monofilament needles will be inserted into trigger points and connected to a low-frequency electrical stimulator (2-10 Hz) for 10-15 minutes per session. In addition, participants will follow a standardized physiotherapy program including core strengthening, lumbar and hamstring stretching, posture education, and a home-based exercise plan.
干预措施: Electrical Dry Needling (EDN) (Procedure)
Sham Dry Needling with Conventional Therapy
Participants will receive sham dry needling (SDN) once weekly for six weeks. Needles will be applied superficially or with blunt instruments at the same anatomical points as the experimental arm, but without penetration into muscle tissue and without electrical stimulation. Alongside SDN, participants will receive the same standardized physiotherapy program as the experimental group, including core strengthening, stretching, posture education, and a home-based exercise plan.
干预措施: Sham Dry Needling (SDN) (Procedure)
结局指标
主要结局
Pain Intensity (Visual Analogue Scale, VAS)
时间窗: Baseline, 3rd week, and 6th week
Pain will be assessed using a 10-cm Visual Analogue Scale, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." This provides a validated, subjective measure of current pain intensity.
Functional Disability (Roland-Morris Disability Questionnaire, RMDQ)
时间窗: Baseline, 3rd week, and 6th week
Functional disability will be evaluated using the 24-item Roland-Morris Disability Questionnaire. Scores range from 0 to 24, with higher scores indicating greater disability and functional limitations due to low back pain.
Kinesiophobia (Tampa Scale of Kinesiophobia, TSK)
时间窗: Baseline, 3rd week, and 6th week
Fear of movement will be measured using the 17-item Tampa Scale of Kinesiophobia (TSK). Items are scored on a 4-point Likert scale (range 17-68), with higher scores indicating greater fear of movement and injury.
次要结局
未报告次要终点
研究者
Ammar Sanaullah
Student
University of Lahore