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临床试验/NCT06603168
NCT06603168已完成不适用

Autonomic Recalibration Approach to Myofascial Pain Elimination

Edward Via Virginia College of Osteopathic Medicine2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年4月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Pain Intensity (NRS Pain Scale)

研究概览

简要总结

The goal of this clinical trial is to learn if Autonomic Recalibration works to reduce sympathetic dominance to alleviate dysfunctional myofascial pain. The main questions it aims to answer are:

How is the Autonomic Nervous System (ANS) affected during Autonomic Recalibration Treatment (ART)? How are myofascial tissue properties impacted from ART?

Participants will:

Have 2 treatments of ART on consecutive days. Wear sensors to track HRV (heart rate variability) and GSR to verify autonomic recalibration.

Measure changes in range of motion by wearing a Rokoko motion capture suit. Measure changes in muscle stiffness through shear wave elastography.

详细描述

Myofascial pain contributes to opioid misuse and opioid use disorder. Alternative non-drug therapies for myofascial pain, such as osteopathic manipulative treatment, are critical areas of research. An unexplored approach in osteopathic manipulative treatment is recruiting the regulatory assistance of the autonomic nervous system (ANS) to alleviate myofascial pain. Autonomic Recalibration Technique (ART) is a manual and behavioral approach that employs osteopathic principles in addressing the neurobiological mechanisms that regulate myofascial pain. Our central hypothesis is that ART utilizes ANS regulation to restore myofascial function and alleviate chronic myofascial pain. The scientific premise of this proposal is the need to document mechanistic evidence that the ANS can be recruited to alleviate and eliminate pain by employing osteopathic principles. While elements of this approach have been employed by various practitioners, including manual and integrative clinicians including osteopaths, the innovation is to combine a manual bottom-up approach to shut down sympathetic tone, and a top-down approach to address trauma-based triggers that propagate pain. If successful, these preclinical data will be used in future grants to propose a clinical trial of ART as an additional technique in osteopathic manipulative treatment to provide an alternative to surgical or drug treatment of chronic myofascial pain.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • dysfunctional myofascial pain, i.e., ongoing pain not relevant to an acute perturbation (e.g., recent injury) or known underlying condition (e.g., cancer).

排除标准

  • known skin allergies to gel as found in common cosmetic or household products
  • can't make treatment appointments on two consecutive days
  • myofascial pain is deemed functional (normal response to acute injury or ongoing pathology)
  • lacking a COVID-19 vaccination and a booster shot.

结局指标

主要结局

Pain Intensity (NRS Pain Scale)

时间窗: Pre/Post for each day of treatment. 2 days total.

0-10 Pain Rating. 0=no pain to 10=pain as intense as you can imagine

Heart Rate Variability

时间窗: Pre/Post for each day of treatment. 2 days total.

Changes in HRV (ms) pre/post and Day 1/Day 2.

Galvanic Skin Response (GSR)

时间窗: Pre/Post for each day of treatment. 2 days total.

Comparison of GSR peak counts pre/post and Day 1/Day 2.

Muscle Stiffness using Shear Wave Elastography

时间窗: Pre/Post for each day of treatment. 2 days total.

Changes in muscle stiffness (kPa) measured by Ultrasound.

Nociceptive Trigger Points

时间窗: Pre/Middle/Post for each day of treatment. 2 days total.

Log of reported trigger points during nociceptive start exam. Taken Pre, Middle, and Post ART on Day 1 and Day 2.

Changes in mobility

时间窗: Pre/Post for each day of treatment. 2 days total.

Posture/mobility changes using multivariate morphometric analysis.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

William Pearson

Discipline Chair for Anatomy

Edward Via Virginia College of Osteopathic Medicine

研究点 (2)

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