Clinical trial NCT05085821: Cardio-visual Stimulation in Augmented Reality for Pain Reduction
Official title: Cardio-visual Stimulation in Augmented Reality for Pain Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regional Pain Syndrome
Chronic Pain Syndrome
Lead sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Sponsor class: OTHER
Collaborators: name: Mindmaze SA
First posted: 2021-10-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in perceived pain
timeFrame: 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)
measure: Change in Heart-Rate Variability (time domain)
timeFrame: a change in heart-rate variability will be evaluated between baseline (pre), intervention, and immediately following intervention (post)
measure: Change in Heart-Rate Variability (frequency domain)
timeFrame: a change in heart-rate variability will be evaluated between baseline (pre), intervention, and immediately following intervention (post)
Secondary outcomes:
measure: Questionnaire
timeFrame: The first day of the study
measure: Questionnaire
timeFrame: The second day of the study
measure: Questionnaire
timeFrame: The third day of the study
measure: Questionnaire
timeFrame: The fourth day of the study
Other outcomes:
Locations:
city: Nancy
country: France
facility: Institut Régional de Médecine Physique et de Réadaptation
Study officials:
affiliation: UGECAM Nord Est
name: Jean Paysant, Pr
role: PRINCIPAL_INVESTIGATOR
References: