Evaluation of the Efficacy and Neurological Effects of Dry Needling in the Treatment of Myofascial Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Analgesic effects of dry needling
研究概览
简要总结
AIM OF INVESTIGATION: To evaluate in a prospective, randomized, sham-controlled study the pattern of analgesic efficacy of trigger point dry needling in Myofascial Pain Syndrome (MPS) patients.
详细描述
This study will be performed in patients with shoulder pain due to excess of nociception associated with chronic Myofascial Pain Syndrome in asymmetrical unilateral trapezius muscle trigger points.
Patients will be randomly assigned to two treatment arms: Active (A) (n=20) and Sham (S) (n=21). Group A will receive actual treatment with trigger point dry needling. Group S will receive a sham treatment, with the needle inserted superficially in the skin, without reaching the muscle underneath it.
The duration and pain elicited during active and sham dry needling will be controlled for. Patients will be evaluated one week before needling (D-7), on the day of dry needling (D0) and seven days after the procedure (D+7).
Patients will fill out the Brazilian version of the Douleur Neuropathique 4, Beck Depression Inventory, Brief Pain Inventory (BPI), McGill Pain Questionnaire-SF (SFMPQ), Hospital Anxiety and Depression Scale and Global Impression of Change, and also a 14-day Carnet to more accurately evaluate their daily pain before and after the treatment.
For the evaluation of neurologic changes, we will evaluate local hyperalgesia, tactile, mechanical, static and thermal sensitivity with thermal quantitative sensorial testing (TQS), and also mapping of the painful area, before and after treatment in both D0 and D+7.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Assymetric shoulder pain (VAS on painful side : VAS on non painful side > 2:1)
- •Pain due to unilateral Myofascial Pain Syndrome of the trapezius muscle.
- •Chronic pain, with duration of at least 3 months and VAS > 40/100
- •Patients with pain at least 4 days in a week
- •Patients without neurological pain, as in DN4 score less than 4
- •Age over 18 years
- •Patients with stable drug treatment over at least 15 days, without any acute pharmacological changes during the study
- •Patients who read, understood and signed the Free and Clarified Consent Term
排除标准
- •Patients with major depression, according to DSM-IV criteria
- •History of bipolar mood disorder, panic syndrome or psychosis
- •Intermittent pain history
- •Refusal to sing the Consent Term
- •Patients not able to attend all the follow-ups
- •Patients with another pain syndrome in shoulders
研究组 & 干预措施
Dry needling
Dry needling for myofascial pain syndrome, in the trapezius muscle.
干预措施: Dry needling (Procedure)
Dry needling
Dry needling for myofascial pain syndrome, in the trapezius muscle.
干预措施: acupuncture needle 0,25 x 40mm (Device)
Sham needling
Superficial dry needling in the trapezius muscle
干预措施: Dry needling (Procedure)
结局指标
主要结局
Analgesic effects of dry needling
时间窗: Within the first 7 days after treatment
Maximum, average and lowest pain will be evaluated daily 7 days before the treatment, on the day of the treatment, and also 7 days after the treatment is done.
次要结局
- Neurologic effects of dry needling(Within the first 7 days after treatment)