Autonomic Recalibration

Not Applicable

Completed

• Conditions: Chronic Pain (Back / Neck); Autonomic Dysregulation
• Interventions: Other: Autonomic Recalibration Treatment

• Registration Number: NCT06603168
• Lead Sponsor: Edward Via Virginia College of Osteopathic Medicine

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.

Study Timeline

• Study Start: 2023-04-27
• Primary Completion: 2023-08-24
• Study Completion: 2024-02-27
• Status Verified: 2024-09
• Study First Submitted: 2024-09-17
• Study First Submitted QC: 2024-09-17
• Last Update Submitted: 2024-09-17
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autonomic Recalibration Treatment	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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Edward Via College of Osteopathic Medicine, Auburn Campus; 🇺🇸 Auburn, Alabama, United States