Chronic Pain Syndrome, Regional Pain Syndrome
Conditions
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.
Interventions
DEVICEHEART
In an augmented reality environment, the patient receives visual feedback in synchrony with their cardiac-cycle (HEART)
DEVICEPlacebo
In an augmented reality environment, the patient receives visual feedback out-of-synchrony with their cardiac cycle (Placebo)
Sponsors
Mindmaze SA
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in perceived pain | 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) | 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 Heart-Rate Variability (time domain) | a change in heart-rate variability will be evaluated between baseline (pre), intervention, and immediately following intervention (post) | time-domain metrics of heart-rate variability \[ms\] |
| Change in Heart-Rate Variability (frequency domain) | a change in heart-rate variability will be evaluated between baseline (pre), intervention, and immediately following intervention (post) | frequency-domain metric of heart-rate variability (power) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire | The first day of the study | 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. |
Countries
France
Outcome results
None listed