An interventional study of Autonomic Recalibration Treatment in Chronic Pain (Back / Neck) and Autonomic Dysregulation, sponsored by Edward Via Virginia College of Osteopathic Medicine. Completed at 1 site in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Edward Via Virginia College of Osteopathic Medicine · Not applicable, Interventional, and Treatment
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.
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.
166 studies on the registry are indexed under Autonomic Nervous System Diseases; 36 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 107 interventional studies indexed under Autonomic Nervous System Diseases.
Browse Autonomic Nervous System Diseases studies →Edward Via Virginia College of Osteopathic Medicine is the lead sponsor of 24 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participant receives Autonomic Recalibration Treatment. Measurements: Pre/post shear wave elastography Pre/post myonometry Pre/post motion capture HRV/GSR during ART Pre/post pain ratings Pre/post trigger point log
Other: Autonomic 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.
Pain Intensity (NRS Pain Scale)
0-10 Pain Rating. 0=no pain to 10=pain as intense as you can imagine
Time frame: Pre/Post for each day of treatment. 2 days total.
Heart Rate Variability
Changes in HRV (ms) pre/post and Day 1/Day 2.
Time frame: Pre/Post for each day of treatment. 2 days total.
Galvanic Skin Response (GSR)
Comparison of GSR peak counts pre/post and Day 1/Day 2.
Time frame: Pre/Post for each day of treatment. 2 days total.
Muscle Stiffness using Shear Wave Elastography
Changes in muscle stiffness (kPa) measured by Ultrasound.
Time frame: Pre/Post for each day of treatment. 2 days total.
Nociceptive Trigger Points
Log of reported trigger points during nociceptive start exam. Taken Pre, Middle, and Post ART on Day 1 and Day 2.
Time frame: Pre/Middle/Post for each day of treatment. 2 days total.
Changes in mobility
Posture/mobility changes using multivariate morphometric analysis.
Time frame: Pre/Post for each day of treatment. 2 days total.
Plan to share: No
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Autonomic Nervous System Diseases→
Edward Via Virginia College of Osteopathic Medicine