Autonomic Recalibration (ART)

September 17, 2024 updated by: William Pearson, Edward Via Virginia College of Osteopathic Medicine

Autonomic Recalibration Approach to Myofascial Pain Elimination

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Auburn, Alabama, United States, 36832
        • Edward Via College of Osteopathic Medicine, Auburn Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autonomic Recalibration Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity (NRS Pain Scale)
Time Frame: 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
Pre/Post for each day of treatment. 2 days total.
Heart Rate Variability
Time Frame: Pre/Post for each day of treatment. 2 days total.
Changes in HRV (ms) pre/post and Day 1/Day 2.
Pre/Post for each day of treatment. 2 days total.
Galvanic Skin Response (GSR)
Time Frame: Pre/Post for each day of treatment. 2 days total.
Comparison of GSR peak counts pre/post and Day 1/Day 2.
Pre/Post for each day of treatment. 2 days total.
Muscle Stiffness using Shear Wave Elastography
Time Frame: Pre/Post for each day of treatment. 2 days total.
Changes in muscle stiffness (kPa) measured by Ultrasound.
Pre/Post for each day of treatment. 2 days total.
Nociceptive Trigger Points
Time Frame: 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.
Pre/Middle/Post for each day of treatment. 2 days total.
Changes in mobility
Time Frame: Pre/Post for each day of treatment. 2 days total.
Posture/mobility changes using multivariate morphometric analysis.
Pre/Post for each day of treatment. 2 days total.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edward Via Virginia College of Osteopathic Medicine

Investigators

  • Principal Investigator: William G Pearson, PhD, Edward Via College of Osteopathic Medicine, Auburn Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2023

Primary Completion (Actual)

August 24, 2023

Study Completion (Actual)

February 27, 2024

Study Registration Dates

First Submitted

September 17, 2024

First Submitted That Met QC Criteria

September 17, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 17, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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