Cardio-visual Stimulation in Augmented Reality for Pain Reduction

Chronic Pain Syndrome Clinical Trial

— HEART  

Official title:

Cardio-visual Stimulation in Augmented Reality for Pain Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05085821
• Other study ID #: IRR-CLP-2019-4
• Status: Completed
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: June 29, 2023

Study information

• Verified date: December 2022
• Source: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 29, 2023
• Est. primary completion date: June 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome
• Regional Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Device:
• HEART
In an augmented reality environment, the patient receives visual feedback in synchrony with their cardiac-cycle (HEART)
• Placebo
In an augmented reality environment, the patient receives visual feedback out-of-synchrony with their cardiac cycle (Placebo)

Locations

Country	Name	City	State
France	Institut Régional de Médecine Physique et de Réadaptation	Nancy

Sponsors (2)

Lead Sponsor	Collaborator
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est	Mindmaze SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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