Influence of Induced Expectations on the Autonomic Nervous System During a Dry Needling Intervention for Patients With Neck Pain. A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Skin conductance (µS).
研究概览
简要总结
Objectives The aim of this study is to compare the effects of inducing positive expectations against negative or neutral induced expectations on the activation of the Autonomic Nervous System and the analgesic response, after a dry needling technique in upper trapezius fibers in patients with unspecific neck pain.
Summary Theoretical framework: Dry needling has proven its efficacy for the treatment of myofascial trigger points. Moreover, it has proven its effects over the Central Nervous System and the Autonomic Nervous System (ANS). Despite that previous studies have researched the role of patient's expectations and their relationship with the results of treatment, there is insufficient information concerning the effects of inducing expectations and the activation of the ANS during the application of widely used therapies, such as dry needling.
详细描述
The aim of this study will be to research the effects of induced expectations combined with a dry needling technique on the activation of the ANS and on the results of the treatment.
Hypothesis
The induction of a positive expectation shall cause a greater analgesic response associated with a response in the ANS compared to the induction of neutral or negative expectations.
Methods: Patients with neck pain will participated in this randomized clinical trial, which will be randomly assigned into 3 groups in order to receive positive, neutral or negative expectations concerning the treatment, by means of an individual informative talk. All subjects will received treatment using dry needling in the upper trapezius fibers. The main variables measured will be the following: Analogic Visual Scale, Pressure Pain Threshold using a mechanical Force Gage (before and after) and the activation of the ANS measuring the skin conductance, skin temperature, heart rate and breathing rate (monitored for 5 minutes before the intervention, during and 20 minutes afterwards).
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Neck pain.
- •Hiperalgesic point in Upper trapezius muscle.
排除标准
- •Pain Irradiation toward upper limb
- •Psychological disorders
- •Whiplash.
- •Neuropathic symptoms
- •Cervical and / or Shoulder Spine Surgery
研究组 & 干预措施
• Group 1. Positive expectation
"Dry needling is a very effective tool used in the treatment of nonspecific neck pain, which we hope will reduce your neck pain."
干预措施: Positive expectation AND dry needling in the upper trapezius fibers, at the most painful point (Other)
• Group 2. Neutral Expectation
"Dry needling is an indicated tool used in the treatment of nonspecific neck pain, but its efficacy is unknown".
干预措施: Neutral expectation AND dry needling in the upper trapezius fibers, at the most painful point (Other)
• Group 3. Negative Expectation
"Dry needling is not a very effective treatment tool for nonspecific neck pain, so we expect your neck pain to increase a bit."
干预措施: Negative expectation AND dry needling in the upper trapezius fibers, at the most painful point (Other)
结局指标
主要结局
Skin conductance (µS).
时间窗: Change from baseline at twenty minutes
It is the measure of the variations in the electrical resistance of the skin, caused by the excitation of the sweat glands, controlled by the Sympathetic Nervous System (SNS)
次要结局
- Heart rate variability(Change from baseline at twenty minutes)
- Pain intensity(Change from baseline at twenty minutes)
- Pressure pain threshold(Change from baseline at twenty minutes.)
研究者
Prof. Dr. Daniel Pecos Martín
PhD. Daniel Pecos Martín
University of Alcala