Can a Novel Manual Therapy Technique Help Relieve Stress? Assessing Effects of Primal Reflex Release on the Body's Stress Response

NCT ID: NCT06305585

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2025-03-31

Brief Summary

Stress, when left unmanaged, can have detrimental effects on both physical and mental health, contributing to conditions such as high blood pressure, anxiety, and even cardiovascular disease. Effective stress management therapies may help maintain overall well-being and reduce the risk of long-term health complications. The Primal Reflex Release Technique (PRRT) is a novel manual therapy that may reduce markers related to stress such as heart rate variability (HRV) and patient-reported outcomes (PROs). Therefore, the purpose of this study is to elucidate the potential for PRRT to improve HRV and PROs.

Detailed Description

This randomized, controlled experimental intervention study evaluates acute impacts of a reflex-targeted manual therapy called Primal Reflex Release Technique (PRRT) on cardiovascular indices of stress and sympathetic tone. After consenting and baseline characteristics, subjects are allocated to receive either the PRRT or the control condition.

Continuous electrocardiography (ECG) and impedance cardiography (ICG) monitoring will be used to track heart rate variability (HRV) changes across three phases:

1. Pre-intervention during a 5-minute video of aquatic nature scenes to establish resting baseline

2. 5 minutes of a practitioner administering targeted spinal manipulation PRRT protocol in the treatment group to stimulate innate protective reflexes OR continued relaxation video viewing for control group

3. Post-intervention repeat of the standardized video to assess changes after PRRT session without ongoing manipulation

The PRRT targets precise anatomical locations and neural pathways including stimulating facial muscles, upper spinal reflexes and traction of the suboccipital muscles. Brief, reversible sensations will occur without expected harm or lasting effects.

Psychological state assessed via paper mood scales pre/post tracks subjective stress correlates. Analysis using linear mixed effects models contrast whether indices of cardiovascular reactivity and psychological responses shift acutely with PRRT versus control video. Findings could provide physiological validation for integration as stress-alleviating treatment.

Conditions

Psychological Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Primal Reflex Release Technique

The subject will lay on their back with their eyes closed. Palmar Reflex Release The subject will actively raise arms overhead (palm facing the floor) with a pen squeezed between their fingers.

Epicranial Release The clinician will grasp the subject's hair near the front of the hairline with one hand, just above the ear on the right side and gently pull.

Frontalis Release The clinician will instruct the subject to raise their eyebrows and keep them raised. The clinician will use their thumbs to gently flick downward on the inside portion of the subject's eyebrows.

Orbicularis Oculi Release The clinician will place their thumb below the eye resting on the cheek bone and with the other hand will lightly rest on the subject's eyelid The clinician will then gently and lightly attempt to quickly open the subject's eyelids

Suboccipital Release The participant will rest their head in clinicians hands while they provide a slight traction at the base of the skull

Group Type: EXPERIMENTAL

Primal Reflex Release Technique (PRRT)

Intervention Type: OTHER

Primal Reflex Release Technique (PRRT) is a non-invasive complementary hands-on treatment method intended to help relax the central nervous system by gently stimulating innate protective reflexes. A certified practitioner applies light tactile stimulation to targeted areas in a structured sequence postulated to help release hypertonic muscles, restore regulation of automatic responses, and enable a calm, parasympathetic state.

Control

For the control, the subject will watch another 5-minute video of fish in an aquarium.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Primal Reflex Release Technique (PRRT)

Primal Reflex Release Technique (PRRT) is a non-invasive complementary hands-on treatment method intended to help relax the central nervous system by gently stimulating innate protective reflexes. A certified practitioner applies light tactile stimulation to targeted areas in a structured sequence postulated to help release hypertonic muscles, restore regulation of automatic responses, and enable a calm, parasympathetic state.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subject can refrain from caffeinated beverages in the 6 hours prior to data collection
• Subject is not currently taking any beta blockers
• Subject is comfortable with a manual therapy technique where the clinician touches your face and head

Exclusion Criteria

• Subject has had caffeine within 6 hours
• Subject is currently taking any beta blockers

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CJ Brush

UNKNOWN

Sponsor Role: collaborator

Jayme Baker

UNKNOWN

Sponsor Role: collaborator

Sydney Leverett

UNKNOWN

Sponsor Role: collaborator

University of Idaho

OTHER

Sponsor Role: lead

Responsible Party

Nickolai Martonick

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

ISMaRT Clinic

Moscow, Idaho, United States

Countries

United States

Central Contacts

Nickolai J Martonick, PhD

Role: CONTACT

nmartonick@uidaho.edu

(208) 885-8749

CJ Brush, PhD

Role: CONTACT

cbrush@uidaho.edu

(208) 885-2970

Facility Contacts

Jayme Baker, DPT

Role: primary

jaymeb@uidaho.edu

208-885-1055

Other Identifiers

IRB# 23-214

Identifier Type: -

Identifier Source: org_study_id