Clinical trial NCT06603168: Autonomic Recalibration
Official title: Autonomic Recalibration Approach to Myofascial Pain Elimination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain (Back / Neck)
Autonomic Dysregulation
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
Lead sponsor: Edward Via Virginia College of Osteopathic Medicine
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This pilot study design is a pretest-posttest cohort study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Intensity (NRS Pain Scale)
timeFrame: Pre/Post for each day of treatment. 2 days total.
measure: Heart Rate Variability
timeFrame: Pre/Post for each day of treatment. 2 days total.
measure: Galvanic Skin Response (GSR)
timeFrame: Pre/Post for each day of treatment. 2 days total.
measure: Muscle Stiffness using Shear Wave Elastography
timeFrame: Pre/Post for each day of treatment. 2 days total.
measure: Nociceptive Trigger Points
timeFrame: Pre/Middle/Post for each day of treatment. 2 days total.
measure: Changes in mobility
timeFrame: Pre/Post for each day of treatment. 2 days total.
Secondary outcomes:
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Edward Via College of Osteopathic Medicine, Auburn Campus
state: Alabama
Study officials:
affiliation: Edward Via College of Osteopathic Medicine, Auburn campus
name: William G Pearson, PhD
role: PRINCIPAL_INVESTIGATOR
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