Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603168
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Autonomic Recalibration
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Autonomic Recalibration Approach to Myofascial Pain Elimination
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ART
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None