Cardio-visual Stimulation in Augmented Reality for Pain Reduction (HEART)

The objective of this study is to evaluate the feasibility and efficacy of an Augmented Reality (AR) biofeedback intervention to alleviate pain symptoms in individuals suffering from chronic pain of the hand and/or the forearm.

Study Overview

• Status: Completed
• Conditions: Regional Pain Syndrome; Chronic Pain Syndrome
• Intervention / Treatment: Device: HEART; Device: Placebo

Detailed Description

Chronic pain is a major public health problem with implications for high health care costs, lost productivity and an estimated financial burden of $500 billion. Individuals with chronic pain are also at an increased risk of developing an opioid use disorder.

Chronic pain has previously been associated with a distorted body representation, in particular of the affected body parts. Virtual Reality (VR) studies using embodiment-, respiration-, and heart-beat related feedback have demonstrated positive effects for induced pain in healthy participants (e.g., increased pain thresholds) and chronic pain in patient populations (e.g., decreased subjective pain, improved functionality, improved physiological markers of pain). Based on these studies, the AR intervention evaluated here aims to alleviate subjective pain symptoms and improve physiological pain markers in chronic pain patients using heartbeat-related feedback.

This within-subject study will compare subjective pain ratings before, during, and after an AR intervention that provides visual feedback of participants' on-going heartbeat in relation to their affected limb. Primary outcomes include subjective reports from participants (perceived efficacy, acceptability, and demand) and the intervention's clinical feasibility, including reports from therapists. Secondary outcomes include changes in heart rate and variability.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • Institut Régional de Médecine Physique et de Réadaptation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Be over 18 years of age
• Present permanent chronic pain (for more than 3 months), secondary to a peripheral pathology (traumatic, orthopedic or neurological), located in the hand or forearm.

Exclusion Criteria:

• Pregnant women
• People in emergency situations
• Persons unable to give informed consent
• Persons who are mentally or linguistically unable to understand the research test instructions
• Individuals who are not available to complete the entire study protocol
• Cognitive impairments that prevent the use of the equipment
• Psychiatric disorders
• Patients with seizure disorders
• Patients with central hemineglect
• Pain secondary to central nervous system pathology
• Patients with arrhythmia
• Patients with head tremors or head shaking.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental 1: HEART - Placebo - HEART - Placebo; The patient receives visual feedback in an augmented reality environment in four session, over two weeks. Week 1: HEART, Placebo (after >24hour washout) Week 2: HEART, Placebo (after >24hour washout)	Device: HEART; In an augmented reality environment, the patient receives visual feedback in synchrony with their cardiac-cycle (HEART); Device: Placebo; In an augmented reality environment, the patient receives visual feedback out-of-synchrony with their cardiac cycle (Placebo)
Experimental: Experimental 2: HEART - Placebo - Placebo - HEART; The patient receives visual feedback in an augmented reality environment in four session, over two weeks. Week 1: HEART, Placebo (after >24hour washout) Week 2: Placebo, HEART (after >24hour washout)	Device: HEART; In an augmented reality environment, the patient receives visual feedback in synchrony with their cardiac-cycle (HEART); Device: Placebo; In an augmented reality environment, the patient receives visual feedback out-of-synchrony with their cardiac cycle (Placebo)
Experimental: Experimental 3: Placebo - HEART - Placebo - HEART; The patient receives visual feedback in an augmented reality environment in four session, over two weeks. Week 1: Placebo, HEART (after >24hour washout) Week 2: Placebo, HEART (after >24hour washout)	Device: HEART; In an augmented reality environment, the patient receives visual feedback in synchrony with their cardiac-cycle (HEART); Device: Placebo; In an augmented reality environment, the patient receives visual feedback out-of-synchrony with their cardiac cycle (Placebo)
Experimental: Experimental 4: Placebo - HEART - HEART - Placebo; The patient receives visual feedback in an augmented reality environment in four session, over two weeks. Week 1: HEART, Placebo (after >24hour washout) Week 2: Placebo, HEART (after >24hour washout)	Device: HEART; In an augmented reality environment, the patient receives visual feedback in synchrony with their cardiac-cycle (HEART); Device: Placebo; In an augmented reality environment, the patient receives visual feedback out-of-synchrony with their cardiac cycle (Placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perceived pain	The patient moves a cursor on a Visual Analog Scale to indicate their currently perceived level of pain. The gauge ranges from "no pain" (0) to "worst pain imaginable" (10).	change in pain rating will be evaluated when participants first wear the Head-Mounted Display (baseline), after 3 minutes of video-passthrough (Pre), after 3 minutes of cardio-visual stimulation (post), after 3 minutes of video-passthrough (final)
Change in Heart-Rate Variability (time domain)	time-domain metrics of heart-rate variability [ms]	a change in heart-rate variability will be evaluated between baseline (pre), intervention, and immediately following intervention (post)
Change in Heart-Rate Variability (frequency domain)	frequency-domain metric of heart-rate variability (power)	a change in heart-rate variability will be evaluated between baseline (pre), intervention, and immediately following intervention (post)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire	Questionnaire on the sensations, usability, and satisfaction with the augmented reality stimulation using a Visual Analog Scale (0-10) where higher scores indicate agreement with the questionnaire item.	The first day of the study
Questionnaire	Questionnaire on the sensations, usability, and satisfaction with the augmented reality stimulation using a Visual Analog Scale (0-10) where higher scores indicate agreement with the questionnaire item.	The second day of the study
Questionnaire	Questionnaire on the sensations, usability, and satisfaction with the augmented reality stimulation using a Visual Analog Scale (0-10) where higher scores indicate agreement with the questionnaire item.	The third day of the study
Questionnaire	Questionnaire on the sensations, usability, and satisfaction with the augmented reality stimulation using a Visual Analog Scale (0-10) where higher scores indicate agreement with the questionnaire item.	The fourth day of the study

Collaborators and Investigators

• Sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
• Collaborators: Mindmaze SA
• Investigators: Principal Investigator: Jean Paysant, Pr, UGECAM Nord Est

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Actual): June 29, 2023
• Study Completion (Actual): June 29, 2023

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Pain; Neurologic Manifestations; Disease; Syndrome; Chronic Pain; Somatoform Disorders
• Other Study ID Numbers: IRR-CLP-2019-4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No