Plasma Rich in Growth Factors Effectiveness for Myofascial Pain Treatment in Masticatory Muscles: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain levels 2 weeks after the procedure: Visual analog scale
研究概览
简要总结
The investigators set up a randomized controlled clinical trial to evaluate the effectiveness of plasma rich in growth factors (PRGF) injections into the masseter muscle trigger points for myofascial pain treatment. The investigators also seek to compare PRGF injections effectiveness with local anesthetic injections.
Dry needling and local anesthetics injections release trigger point by disrupting the membranes of a tout band. However, the injected substance itself does not affect the pathophysiological mechanism of the trigger point.
It is known that the platelets release growth factors who can enhance muscle regeneration processes and moreover reduce chronic pain.
The investigators raised a hypothesis that PRGF injections into the trigger points in masseter muscle can be an effective treatment method for the myofascial pain.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients.
- •Diagnosed myofascial pain syndrome in one side of the masseter muscle (diagnosis is based on diagnostic criteria described by Travell and Simons: 1) palpable taut band, 2) spot tenderness in a taut band, 3) pain recognition.
- •Patients have never had injections into their masseter muscle.
排除标准
- •Myofascial trigger points in other masticatory muscles.
- •Head and neck region inflammations that causes pain.
- •Temporomandibular joint pathology which causes pain.
- •Trigeminal nerve neuralgia.
- •Head and neck region oncological diseases.
- •Myofascial trigger points in both sides of masseter muscles.
研究组 & 干预措施
Plasma rich in growth factors group
Group of patients who will receive 1 ml of PRGF 2nd fractions injections into their trigger points in the masseter muscle.
干预措施: PRGF injection (Biological)
Lidocaine group
Group of patients who will receive 1 ml 2% Lidocaine injections into the myofascial trigger point in the masseter muscle.
干预措施: Lidocaine injection (Drug)
结局指标
主要结局
Pain levels 2 weeks after the procedure: Visual analog scale
时间窗: Patients pain levels will be measured 2 weeks after the procedure.
Patients will evaluate pain by using the Visual analog scale from 0 to 10. Where 0 means no pain and 10 means the worst possible pain
Pain levels 4 weeks after the procedure: Visual analog scale
时间窗: Patients pain levels will be measured 4 weeks after the procedure.
Patients will evaluate pain by using the Visual analog scale from 0 to 10. Where 0 means no pain and 10 means the worst possible pain
次要结局
未报告次要终点
研究者
Dovydas Šakalys
Principal Investigator
Lithuanian University of Health Sciences