The Efficacy of Ultrasound Guided Transcutaneous Pulsed Radiofrequency for Cervical Radiculopathy: a Randomized, Sham-controlled, Double-blind Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Numeric Rating Scale (NRS)
研究概览
简要总结
Cervical radiculopathy (CR) is a painful condition caused by irritation of the cervical nerve roots, often leading to neck, shoulder, and arm pain, sometimes with numbness or weakness. These symptoms can reduce quality of life and place a burden on healthcare systems. Current treatments, such as physical therapy, cervical traction, and medication, are often not fully effective. Pulsed radiofrequency (PRF) has shown benefits for nerve-related pain, but because it requires an invasive procedure, its use is limited.
Transcutaneous pulsed radiofrequency (TCPRF) is a non-invasive version of PRF. It has shown promising results in animal studies and in clinical research for knee and shoulder conditions, but has not been tested for CR. Recent improvements in ultrasound allow more precise targeting of cervical nerve roots, making ultrasound-guided TCPRF a potentially safe and accessible treatment option.
This pilot study will evaluate the efficacy and safety of ultrasound-guided TCPRF in patients with CR compared to a sham treatment. A total of 32 participants with CR lasting more than six weeks will be randomly assigned to either TCPRF or sham treatment. Both groups will receive 12 treatment sessions over four weeks, combined with a standard rehabilitation program.
The main outcome is pain intensity measured by the Numeric Rating Scale (NRS). Secondary outcomes include neck-related disability, medication use, and any side effects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 75 years old.
- •Clinical diagnosis of cervical radiculopathy, defined by:
- •Presence of neck pain or paresthesia radiating to the unilateral upper extremity with radicular and dermatomal pattern;
- •Positive Spurling's test;
- •Positive cervical distraction test
- •Symptoms lasting for over 6 weeks
- •Numeric Rating Scale (NRS) for arm pain ≥ 4 out of 10
- •MRI or CT-confirmed nerve root compression, corresponding to clinical symptoms.
- •Able to provide written informed consent and comply with study procedures
排除标准
- •History of cervical spine surgery.
- •Motor deficit on involving limb
- •Presence of axial neck pain without radicular symptoms
- •Symptoms from shoulder, elbow, or wrist joint or other musculoskeletal co-morbidity such as rheumatologic disease or carpal tunnel syndrome
- •Evidence of serious underlying pathology (e.g., tumor, infection, fracture, or myelopathy)
- •Prior exposure to epidural steroid injection or pulsed radiofrequency therapy within the past 6 months
- •Presence of pregnancy or breastfeeding.
- •History of epilepsy or electronic devices implanted in the body
- •Active infection or skin disease at the stimulator contact site
- •Allergy to electrode patch
- •Unable to understand the study protocol or provide written
研究组 & 干预措施
true transcutaneous pulsed radiofrequency group
干预措施: true transcutaneous pulsed radiofrequency (Device)
Sham transcutaneous pulsed radiofrequency group
干预措施: Sham device (Device)
结局指标
主要结局
Numeric Rating Scale (NRS)
时间窗: baseline, at the end of week 2, at the end of week 4 (post-treatment), and at a 3-month follow-up after the intervention
Participants will rate their average pain over the past week on a scale from 0 (no pain) to 10 (worst imaginable pain).
次要结局
- Neck Disability Index (NDI)(baseline, at the end of week 2, at the end of week 4 (post-treatment), and at a 3-month follow-up after the intervention)
- medication usage(baseline, at the end of week 2, at the end of week 4 (post-treatment), and at a 3-month follow-up after the intervention)