"Analgesic Effects of Capacitive Resistive Monopolar Radio-frequency (448 kHz) in Patients With Myofascial Chronic Neck Pain: A Pilot Randomized Controlled Trial."
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Visual analogue scale (VAS).
研究概览
简要总结
The aim of this study was to evaluate the potential clinical benefits of Monopolar Capacitive Resistive Radio-frequency (448 kHz) (MCRR)F for the treatment of myofascial chronic neck pain.
详细描述
A randomized, double-blind, placebo-controlled trial. Setting: University community.
Patients with myofascial chronic neck pain with active MTrP in one upper trapezius muscle were involved. The patients were randomly divided into two groups: a radiofrequency group (RFG), who (14 patients) received 8 sessions of a monopolar capacitive resistive radiofrequency (MCRRF) application over the upper trapezius muscle and ten patients received 8 sessions of placebo radiofrequency (PG) over the same muscle. Main outcome measures: Visual analog scale (VAS), neck disability index (NDI) and cervical range of motion (pre-treatment, immediately post-first session treatment and post-treatment.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 60 years with myofascial chronic neck pain. The area of neck pain was defined as the cervical region, possibly with referred or radiating pain into the occiput, nuchal muscles, shoulders and upper limbs. Symptoms had to have been present for at least six months before. At least one active MTrP in one upper trapezius muscle had to be present. For bilateral neck pain, the most painful side was designated for treatment.
排除标准
- •Severe disorders of the cervical spine, such as spinal stenosis, disk prolapse, postoperative conditions of the neck and shoulder areas, history of severe trauma, whiplash, spasmodic torticollis, instability, migraine, peripheral nerve entrapment, fibromyalgia, shoulder diseases, inflammatory rheumatic diseases, severe psychiatric illness and pregnancy.
结局指标
主要结局
Visual analogue scale (VAS).
时间窗: 1 month
Pain intensity was measured using a 100-mm visual analogue scale (VAS). This scale consists of a 100-mm horizontal line with pain descriptors ranging from "no pain" marked on the left side to "the worst pain imaginable" on the right side. The perceived pain level of the patients was measured at rest, by marking the VAS with a perpendicular line. This is a valid method to measure pain level, and psychometric properties of the VAS have been reported widely. The minimal important difference of the VAS is based on detecting an 8.6-mm difference (based on a previous study for a score \< 40 mm with a pain onset of greater than 12 weeks) immediately after treatment The VAS has been documented in previous studies as having good reliability and validity.
次要结局
- Cervical Range of Motion(1 month)
- Neck disability(1 month)
研究者
Josue Fernandez Carnero
PhD
Universidad Rey Juan Carlos