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OpenTrials
Completed

NCT Number: NCT06603168

Autonomic Recalibration

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.

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Key information

Conditions

Chronic Pain (Back / Neck) Autonomic Dysregulation Autonomic Nervous System Diseases Chronic Pain Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Primary Dysautonomias Signs and Symptoms

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edward Via College of Osteopathic Medicine, Auburn Campus

Auburn, Alabama, 36832, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autonomic Recalibration Treatment

Other

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Changes in mobility

    Time frame: Pre/Post for each day of treatment. 2 days total.

    Posture/mobility changes using multivariate morphometric analysis.

Sponsors and collaborators

Lead sponsor

Edward Via Virginia College of Osteopathic Medicine

Other

Registry information

Official study title

Autonomic Recalibration Approach to Myofascial Pain Elimination

Acronym: ART

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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