Comparison of Electrical Dry Needling and Therapeutic Exercise Versus Therapeutic Exercise in Patients With Nonspecific Chronic Neck Pain: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Neck disability index
研究概览
简要总结
To compare the effectiveness of electrical dry needling combined with therapeutic exercise versus therapeutic exercise alone in patients with nonspecific chronic mechanical neck pain.
详细描述
Neck pain is highly prevalent, affecting 203 million people worldwide in 2020 and ranking eleventh in terms of years lived with disability. More than 50% of individuals will not recover from an acute episode and will experience recurrent neck pain within 1 to 5 years, leading to a persistent and chronic problem. Chronic neck pain can originate from a traumatic episode, such as whiplash, or it may not have a traumatic origin. In the latter case, in the absence of an identifiable pathoanatomic cause, it is classified as nonspecific chronic neck pain (NSNP). The GBD 2021 study acknowledges that the burden of neck pain has not been reduced in the past three decades and projects a significant increase in this absolute burden by 2050. Several studies have highlighted the urgency of prioritizing future research on preventing and treating this condition.
Clinical practice guidelines for the management of NSNP advocate for the use of exercise. Specifically, it has been shown that specific neck exercises are more effective than other types of alternative exercises in reducing pain and disability in patients with NSNP. In recent years, treatment based on electrical Dry Needling (DN) has gained popularity and has become an alternative to conventional treatment for soft tissue injuries, noted for its low incidence of significant side effects. This technique seeks to induce a local mechanical and microtraumatic response, optimizing the release of endogenous opioids, decreasing cortisol, improving microcirculation, and reducing proinflammatory mediators. All of this can contribute to improved motor control and pain relief. Additionally, the advent of ultrasound technology has provided new opportunities to improve the safety of this invasive approach.
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
- 30 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged between 30 and 65 years with chronic cervical pain lasting 3 months or more and not receiving any other type of physiotherapy treatment.
排除标准
- •Patients with sensory and/or coagulation disorders, history of spine surgery, cardiac complications, severe concurrent central or peripheral nervous system disease, epilepsy, needle phobia, disc pathology, or serious pathologies that may be the primary cause of chronic cervical pain (e.g., tumors, Arnold Chiari disease, vertigo syndrome, etc.) will be excluded, as they are contraindicated for transcutaneous electrical nerve stimulation (TENS).
研究组 & 干预措施
Electrical Dry Needling and Therapeutic exercise
The group receiving dry needling combined with therapeutic exercise (n=35) will receive up to 6 sessions of stimulation at the active trigger points in the cervical region, according to Travell and Simons: occipitofrontalis, sternocleidomastoid, splenius capitis, anterior, middle, and posterior scalene muscles, upper, middle, and lower trapezius, and multifidus at the C6 level. Using ultrasound guidance, 0.25 mm x 25 mm needles will be inserted into the active. The needles will be connected to a TENS (transcutaneous electrical nerve stimulation) device (TensMed S82-Enraf Nonius), applying an asymmetric biphasic square wave current, low frequency (8 Hz), pulse duration of 250 μs, with an intensity perceived as mild to moderate, for 30 minutes. In addition, this group will undergo a protocol of specific therapeutic exercises for the cervical spine during the same electropuncture session and immediately afterward.
干预措施: Electrical Dry Needling and Therapeutic exercise (Other)
Therapeutic Exercise
The therapeutic exercise group (n=35) will perform progressive exercises for the cervical flexor and extensor muscles, once a week for 6 weeks (6 sessions in total, with each session lasting 30 minutes). The protocol includes activation and recruitment of the deep cervical flexor muscles, isometric co-contraction exercises for both deep and superficial flexors, and eccentric and isokinetic exercises for both flexors and extensors. Each week's session will include the exercises for that week, along with the exercises from previous weeks, as detailed in the specific cervical spine exercise table, which indicates sets, repetitions, contraction time, and rest periods.
干预措施: Therapeutic exercise (Other)
结局指标
主要结局
Neck disability index
时间窗: At baseline, at 6 weeks and at 2 months
The neck disability index consists of 10 questions addressing functional activities such as personal care, lifting, reading, work, driving, sleeping, recreational, pain intensity, concentration and headache.
次要结局
- Pain (Visual Analog Scale)(At baseline, at 6 weeks and at 2 months)
- McGill Pain Questionnaire(At baseline, at 6 weeks and at 2 months)
- Quality of Life (SF-36 quality of life questionnaire)(At baseline, at 6 weeks and at 2 months)
- Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)(At baseline, at 6 weeks and at 2 months)
- Tampa scale for kinesiophobia(At baseline, at 6 weeks and at 2 months)
- Pain Catastrophizing Scale(At baseline, at 6 weeks and at 2 months)
- Treatment expectations(At baseline, at 6 weeks and at 2 months)
- Expectations regarding cervical pain(At baseline, at 6 weeks and at 2 months)
- Cervical Range of Motion (Pro Motion Capture. Werium)(At baseline, at 6 weeks and at 2 months)
- Active and Latent Myofascial Trigger Points (Number of trigger Points)(At baseline, at 6 weeks and at 2 months)
研究者
Adelaida María Castro-Sánchez
PhD
Universidad de Almeria