Regional Pain SyndromeHEARTNCT05085821
Cardio-visual Stimulation in Augmented Reality for Pain Reduction
A study testing HEART in people with Regional Pain Syndrome and Chronic Pain Syndrome, run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Regional Pain Syndrome, Chronic Pain Syndrome
- What is being tested?
- HEART
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 20 Apr 2021to 29 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Régional de Médecine Physique et de Réadaptation
Nancy, 54000
About this study
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.
Read the 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.
- Conditions
- Regional Pain Syndrome, Chronic Pain Syndrome
- Being tested
- HEART, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEARTDevice
In an augmented reality environment, the patient receives visual feedback in synchrony with their cardiac-cycle (HEART)
PlaceboDevice
In an augmented reality environment, the patient receives visual feedback out-of-synchrony with their cardiac cycle (Placebo)
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1: HEART - Placebo - HEART - Placebo | Experimental | 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) Receives: Device: HEART; Device: Placebo |
| Experimental 2: HEART - Placebo - Placebo - HEART | Experimental | 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) Receives: Device: HEART; Device: Placebo |
| Experimental 3: Placebo - HEART - Placebo - HEART | Experimental | 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) Receives: Device: HEART; Device: Placebo |
| Experimental 4: Placebo - HEART - HEART - Placebo | Experimental | 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) Receives: Device: HEART; Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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]
Measured: 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)
Measured: a change in heart-rate variability will be evaluated between baseline (pre), intervention, and immediately following intervention (post)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The fourth day of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start20 Apr 2021
- Primary completion29 Jun 2023
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
- Sponsor type
- University, hospital or other
- Collaborators
- Mindmaze SA
- Responsible party
- Principal investigator, Amélie Touillet, Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
- Investigators
- Jean Paysant, Pr, Principal investigator, UGECAM Nord Est
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085821
- Sponsor's protocol ID
- IRR-CLP-2019-4
- Acronym
- HEART
- Status last verified
- Dec 2022
- First submitted
- 3 May 2021
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardio-visual Stimulation in Augmented Reality for Pain Reduction
- ClinicalTrials.gov ID
- NCT05085821
- Acronym / sponsor ID
- HEART / IRR-CLP-2019-4
- Conditions
- Regional Pain Syndrome, Chronic Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord EstUniversity, hospital or other
- Collaborators
- Mindmaze SA
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental 1: HEART - Placebo - HEART - Placebo | Experimental | Device: HEART, Device: PlaceboThe 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) |
| Experimental 2: HEART - Placebo - Placebo - HEART | Experimental | Device: HEART, Device: PlaceboThe 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) |
| Experimental 3: Placebo - HEART - Placebo - HEART | Experimental | Device: HEART, Device: PlaceboThe 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) |
| Experimental 4: Placebo - HEART - HEART - Placebo | Experimental | Device: HEART, Device: PlaceboThe 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEARTIn an augmented reality environment, the patient receives visual feedback in synchrony with their cardiac-cycle (HEART) | Device | Experimental 1: HEART - Placebo - HEART - Placebo, Experimental 2: HEART - Placebo - Placebo - HEART, Experimental 3: Placebo - HEART - Placebo - HEART, Experimental 4: Placebo - HEART - HEART - Placebo |
| PlaceboIn an augmented reality environment, the patient receives visual feedback out-of-synchrony with their cardiac cycle (Placebo) | Device | Experimental 1: HEART - Placebo - HEART - Placebo, Experimental 2: HEART - Placebo - Placebo - HEART, Experimental 3: Placebo - HEART - Placebo - HEART, Experimental 4: Placebo - HEART - HEART - Placebo |
Primary outcome
Change in perceived pain
Time frame: 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)
Time frame: 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)
Time frame: 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)
4 secondary outcomes
Questionnaire
Time frame: The first day of the study
Questionnaire
Time frame: The second day of the study
Questionnaire
Time frame: The third day of the study
Questionnaire
Time frame: The fourth day of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Paysant, Pr principal investigator
UGECAM Nord Est
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEART in people with Regional Pain Syndrome and Chronic Pain Syndrome, run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived pain (time frame: 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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.