Autonomic Dysregulation, Chronic Pain (Back / Neck)
Conditions
Keywords
chronic pain, autonomic nervous system, sympathetic dominance, myofascial pain, Sympathetic tone, dysfunctional pain, Primal Reflex Release Technique, shear wave elastography, heart rate variability, galvanic skin response, Rokoko, motion capture, range of motion, posture
Brief summary
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.
Detailed description
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.
Interventions
OTHERAutonomic Recalibration Treatment
An initial history to r/o pathology and document a chief complaint relevant to pain is conducted. An initial head to toe assessment of withdrawal or startle reflex behavior in response to palpation is performed to identify trigger points and establish patterns of sympathetic dominance throughout the myofascial system. The pattern of sympathetic dominance (pattern of trigger point) is addressed during treatment by Primal Reflex Release Technique Protocol to inhibit somatic afferent feedback loops and rebalance the autonomic nervous system towards a state of parasympathetic dominance. The absence of a trigger point indicates that the treatment is complete.
Sponsors
Edward Via Virginia College of Osteopathic Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This pilot study design is a pretest-posttest cohort study.
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* dysfunctional myofascial pain, i.e., ongoing pain not relevant to an acute perturbation (e.g., recent injury) or known underlying condition (e.g., cancer).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity (NRS Pain Scale) | 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 | 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) | 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 | Pre/Post for each day of treatment. 2 days total. | Changes in muscle stiffness (kPa) measured by Ultrasound. |
| Nociceptive Trigger Points | 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 | Pre/Post for each day of treatment. 2 days total. | Posture/mobility changes using multivariate morphometric analysis. |
Countries
United States
Outcome results
None listed