Complex Regional Pain Syndrome Type I of the Upper LimbReVIDoCNCT06523361
Contribution of Immersive Virtual Reality to a Standardized Rehabilitation Program for Upper Limb Chronic Pain: A Single-Case Experimental Design Study
A study testing H'ability in people with Complex Regional Pain Syndrome Type I of the Upper Limb, run by University Hospital, Angers at 2 sites in France.
Trial summary
Background: Chronic pain represents a significant public health concern, given its high prevalence and the substantial impact it has on the quality of life of many individuals affected. There is no single, universally effective medical treatment for chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Complex Regional Pain Syndrome Type I of the Upper Limb
- What is being tested?
- H'ability
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Nov 2024to 10 Jun 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic pain in the upper limb, predominantly in one or both upper limbs, for more than 3 months
- Age between 18 and 65
- Patient affiliated with or benefiting from a social security organization
- Person able to tolerate the virtual reality device
- Informed consent form signed
Who cannot join
- Upper limb surgery < 6 months
- Infection or pathology of the central nervous system or active cancer
- Fibromyalgia
- Severe psychiatric or cognitive disorders
- Diabetes mellitus complicated by peripheral neuropathy
- Neurogenic paraosteoarthropathy or recent fracture
Show all 13Show fewer
- Pregnancy or breast-feeding.
- Poor understanding of the French language.
- Person deprived of liberty by judicial or administrative decision
- Psychiatric disorder
- Person subject to a legal protection measure
- Person unable to give consent
- In connection with the virtual reality device: unstabilized epilepsy, facial trauma < 3 months, hearing or visual impairment, pain, dizziness or nausea caused by the use of virtual reality.
Trial locations and contacts
2 sites in 1 country.
About this study
Background: Chronic pain represents a significant public health concern, given its high prevalence and the substantial impact it has on the quality of life of many individuals affected. There is no single, universally effective medical treatment for chronic pain. The gold standard for treatment is a multidisciplinary rehabilitation program. Immersive virtual reality (IVR) represents a novel and promising approach to do rehabilitation, offering the potential to enhance engagement and perception of movement.
The objective of this study was to investigate the improvement of upper limb function in chronic pain patients using an IVR device in occupational therapy sessions during a rehabilitation program.
Read more
Methods: The study use a single-case experimental design (SCED) to investigate the efficacy of IVR device in improving upper limb function in patients with upper limb chronic pain. The study was conducted in three phases: baseline, intervention, and follow-up. The SCED will be with multiple baseline across subjects, whereby the patient serves as his own control. A total of 12 participants will be included. The virtual reality sessions will be conducted exclusively during the intervention phase. The primary outcome measure will be the upper limb function, as assessed by the Quick DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire. Furthermore, the intensity of pain will be quantified using a numeric scale, and the pain self-efficacy will be evaluated using the Pain Self-Effacity Short Form Questionnaire.
Expected results: This method will allow for the comparison of phases within and between subjects to determine whether the IVR sessions improve the function assessed by the Quick DASH.
Conclusion: Further investigation is required to determine the potential benefits of using IVR for upper limb chronic pain rehabilitation, with a particular focus on the development of precise protocols for its use in clinical settings.
- Being tested
- H'ability
- Medical subject headings
- Reflex Sympathetic Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H'abilityDevice
H'ability is introduced depending the randomization result, during the baseline (before session 4, 5, 6 or 7 with occupational therapist
| Study group | Role | What they receive |
|---|---|---|
| introduction of the intervention phase before session 4 with occupational therapist | Other | The first "group" will be repeated three times. For each participant, the beginning of the intervention will be randomized. All participants will undergo a baseline phase, intervention phase, and follow-up phase. During the baseline phase, participants serve as controls. As the randomized beginning of the intervention varies across subjects, the length of the baseline phase also varies. The objective is to identify a change in the outcome measure when the intervention starts, despite the differing lengths of the baseline phases across participants. Receives: Device: H'ability |
| introduction of the intervention phase before session 5 with occupational therapist | Other | The second "group" will be repeated three times. For each participant, the beginning of the intervention will be randomized. All participants will undergo a baseline phase, intervention phase, and follow-up phase. During the baseline phase, participants serve as controls. As the randomized beginning of the intervention varies across subjects, the length of the baseline phase also varies. The objective is to identify a change in the outcome measure when the intervention starts, despite the differing lengths of the baseline phases across participants. Receives: Device: H'ability |
| introduction of the intervention phase before session 6 with occupational therapist | Other | The third "group" will be repeated three times. For each participant, the beginning of the intervention will be randomized. All participants will undergo a baseline phase, intervention phase, and follow-up phase. During the baseline phase, participants serve as controls. As the randomized beginning of the intervention varies across subjects, the length of the baseline phase also varies. The objective is to identify a change in the outcome measure when the intervention starts, despite the differing lengths of the baseline phases across participants. Receives: Device: H'ability |
| introduction of the intervention phase before session 7 with occupational therapist | Other | The fourth "group" will be repeated three times. For each participant, the beginning of the intervention will be randomized. All participants will undergo a baseline phase, intervention phase, and follow-up phase. During the baseline phase, participants serve as controls. As the randomized beginning of the intervention varies across subjects, the length of the baseline phase also varies. The objective is to identify a change in the outcome measure when the intervention starts, despite the differing lengths of the baseline phases across participants. Receives: Device: H'ability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick DASH (Quick Disabilities of the Arm, Shoulder and Hand) self-questionnaire
The self-questionnaire contains 11 items to assess the patient's ability to perform certain activities of daily living, the severity of the pain, the impact of the condition on social or professional life, etc. rated on a scale of 1 (no difficulty or inability) to 5 (unable to do)
Measured: 5 times per week for 7 weeks
Secondary outcomes (10)
self-assessment of pain using the Numerical Scale (EN)
numerical scale from 1 to 10
Measured: 5 times per week for 7 weeks
subjective assessment of pain via the PSEQ-2 self-questionnaire
PSEQ-2 (Pain Self Efficacy Questionnaire). measure patients' confidence in their ability to perform tasks despite pain-scale from 0 to 6.
Measured: 5 times per week for 7 weeks
functional assessment of the shoulder using the C-test
measurement of the thoracohumeral angle during active elbow elevation
Measured: 5 times per week for 7 weeks
self-evaluation of performance and feeling of satisfaction associated with the difficulties identified by the patient with MCRO questionnaire
Mesure Canadienne du Rendement Occupationnel (MCRO). Scale from 1 to 10
Measured: One time between day 7 and day 14 + one time between week 6 and week 7.
Measure of Constant score:composite score allowing to assess pain, level of daily activities, level of hand work, shoulder mobility and strength.
composite score allowing to assess pain, level of daily activities, level of hand work, shoulder mobility and strength.
Measured: One time between day 7 and day 14 + one time between week 6 and week 7.
assessment of kinesiophobia with the Tampa Scale for Kinesiophobia (TSK)
reliable and validated self-questionnaire in French which assesses through 17 items the fear of movement in connection with the fear of being injured during a movement (25). Each question is scored between 1 (strongly disagree) and 4 (strongly agree) with the exception of items 4, 8, 12 and 16 which are inversely scored with 1 (strongly agree ) and 4 (strongly disagree). A total score greater than or equal to 40 confirms significant kinesiophobia and the higher the score, the greater the kinesiophobia.
Measured: once at inclusion + one time between week 6 and week 7.
assessing grip strength with the Jamar test
This is a quick and simple test that requires squeezing a hydraulic dynanometer to its fullest extent. 3 repeated measurements are taken on one side then the other and only the highest value is retained for each side. It has been shown in the literature that grip strength is a good indicator of overall upper limb strength and that muscle strength in a chronically painful limb is reduced.
Measured: One time between day 7 and day 14 + one time between week 6 and week 7.
assessing dexterity with the Box and Block Test (BBT)
It consists of 150 cubes placed in a wooden box with two equal-sized compartments. The patient must move, with one hand, a maximum of cubes from one compartment to another, one by one, in 1 minute. The score obtained corresponds to the number of cubes moved for each hand in one minute.
Measured: One time between day 7 and day 14 + one time between week 6 and week 7.
assessing dexterity with the Purdue Pegboard Test (PPT)
The test involves taking small metal pegs and placing them in the small holes of a standardized board for 30 seconds
Measured: One time between day 7 and day 14 + one time between week 6 and week 7.
self-assessment of the H'ability© device according to healthcare professionals and patients using the SUS scale (System Usability Scale)
questionnaire for measuring the usability of interactive systems, validated in French, which includes 10 items associated with a 5-point Likert scale (from 1 = Completely disagree to 5 = Completely agree). The overall score is obtained by subtracting 1 from the score checked for items 1, 3, 5, 7 and 9, then calculating 5 minus the score checked for items 2, 4, 6, 8 and 10 (items whose wording is negative and reverse rating). The 10 scores thus calculated are added and multiplied by 2.5, to obtain a total score between 0 and 100 (a higher score means better usability).
Measured: one time between week 6 anD week 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start4 Nov 2024
- Primary completion28 Apr 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain Syndrome Type I of the Upper LimbStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Sequential
- Model description
- Single case experimental design, with sequential introduction of the intervention and comparison within subject (between phases) and between subjects
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523361
- Sponsor's protocol ID
- 49RC24_0066
- Acronym
- ReVIDoC
- Status last verified
- Jun 2026
- First submitted
- 4 Jul 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Immersive Virtual Reality to a Standardized Rehabilitation Program for Upper Limb Chronic Pain: A Single-Case Experimental Design Study
- ClinicalTrials.gov ID
- NCT06523361
- Acronym / sponsor ID
- ReVIDoC / 49RC24_0066
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 26 Jul 2024 (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.
Background: Chronic pain represents a significant public health concern, given its high prevalence and the substantial impact it has on the quality of life of many individuals affected. There is no single, universally effective medical treatment for chronic pain. The gold standard for treatment is a multidisciplinary rehabilitation program. Immersive virtual reality (IVR) represents a novel and promising approach to do rehabilitation, offering the potential to enhance engagement and perception of movement.
The objective of this study was to investigate the improvement of upper limb function in chronic pain patients using an IVR device in occupational therapy sessions during a rehabilitation program.
Methods: The study use a single-case experimental design (SCED) to investigate the efficacy of IVR device in improving upper limb function in patients with upper limb chronic pain. The study was conducted in three phases: baseline, intervention, and follow-up. The SCED will be with multiple baseline across subjects, whereby the patient serves as his own control. A total of 12 participants will be included. The virtual reality sessions will be conducted exclusively during the intervention phase. The primary outcome measure will be the upper limb function, as assessed by the Quick DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire. Furthermore, the intensity of pain will be quantified using a numeric scale, and the pain self-efficacy will be evaluated using the Pain Self-Effacity Short Form Questionnaire.
Expected results: This method will allow for the comparison of phases within and between subjects to determine whether the IVR sessions improve the function assessed by the Quick DASH.
Conclusion: Further investigation is required to determine the potential benefits of using IVR for upper limb chronic pain rehabilitation, with a particular focus on the development of precise protocols for its use in clinical settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Single case experimental design, with sequential introduction of the intervention and comparison within subject (between phases) and between subjects
| Arm | Type | Receives |
|---|---|---|
| introduction of the intervention phase before session 4 with occupational therapist | Other | Device: H'abilityThe first "group" will be repeated three times. For each participant, the beginning of the intervention will be randomized. All participants will undergo a baseline phase, intervention phase, and follow-up phase. During the baseline phase, participants serve as controls. As the randomized beginning of the intervention varies across subjects, the length of the baseline phase also varies. The objective is to identify a change in the outcome measure when the intervention starts, despite the differing lengths of the baseline phases across participants. |
| introduction of the intervention phase before session 5 with occupational therapist | Other | Device: H'abilityThe second "group" will be repeated three times. For each participant, the beginning of the intervention will be randomized. All participants will undergo a baseline phase, intervention phase, and follow-up phase. During the baseline phase, participants serve as controls. As the randomized beginning of the intervention varies across subjects, the length of the baseline phase also varies. The objective is to identify a change in the outcome measure when the intervention starts, despite the differing lengths of the baseline phases across participants. |
| introduction of the intervention phase before session 6 with occupational therapist | Other | Device: H'abilityThe third "group" will be repeated three times. For each participant, the beginning of the intervention will be randomized. All participants will undergo a baseline phase, intervention phase, and follow-up phase. During the baseline phase, participants serve as controls. As the randomized beginning of the intervention varies across subjects, the length of the baseline phase also varies. The objective is to identify a change in the outcome measure when the intervention starts, despite the differing lengths of the baseline phases across participants. |
| introduction of the intervention phase before session 7 with occupational therapist | Other | Device: H'abilityThe fourth "group" will be repeated three times. For each participant, the beginning of the intervention will be randomized. All participants will undergo a baseline phase, intervention phase, and follow-up phase. During the baseline phase, participants serve as controls. As the randomized beginning of the intervention varies across subjects, the length of the baseline phase also varies. The objective is to identify a change in the outcome measure when the intervention starts, despite the differing lengths of the baseline phases across participants. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic pain in the upper limb, predominantly in one or both upper limbs, for more than 3 months
- Age between 18 and 65
- Patient affiliated with or benefiting from a social security organization
- Person able to tolerate the virtual reality device
- Informed consent form signed
Key exclusion criteria (13 listed)
- Upper limb surgery < 6 months
- Infection or pathology of the central nervous system or active cancer
- Fibromyalgia
- Severe psychiatric or cognitive disorders
- Diabetes mellitus complicated by peripheral neuropathy
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 |
|---|---|---|
| H'abilityH'ability is introduced depending the randomization result, during the baseline (before session 4, 5, 6 or 7 with occupational therapist | Device | introduction of the intervention phase before session 4 with occupational therapist, introduction of the intervention phase before session 5 with occupational therapist, introduction of the intervention phase before session 6 with occupational therapist, introduction of the intervention phase before session 7 with occupational therapist |
Primary outcome
Quick DASH (Quick Disabilities of the Arm, Shoulder and Hand) self-questionnaire
Time frame: 5 times per week for 7 weeks
The self-questionnaire contains 11 items to assess the patient's ability to perform certain activities of daily living, the severity of the pain, the impact of the condition on social or professional life, etc. rated on a scale of 1 (no difficulty or inability) to 5 (unable to do)
10 secondary outcomes
self-assessment of pain using the Numerical Scale (EN)
Time frame: 5 times per week for 7 weeks
subjective assessment of pain via the PSEQ-2 self-questionnaire
Time frame: 5 times per week for 7 weeks
functional assessment of the shoulder using the C-test
Time frame: 5 times per week for 7 weeks
self-evaluation of performance and feeling of satisfaction associated with the difficulties identified by the patient with MCRO questionnaire
Time frame: One time between day 7 and day 14 + one time between week 6 and week 7.
Measure of Constant score:composite score allowing to assess pain, level of daily activities, level of hand work, shoulder mobility and strength.
Time frame: One time between day 7 and day 14 + one time between week 6 and week 7.
assessment of kinesiophobia with the Tampa Scale for Kinesiophobia (TSK)
Time frame: once at inclusion + one time between week 6 and week 7.
assessing grip strength with the Jamar test
Time frame: One time between day 7 and day 14 + one time between week 6 and week 7.
assessing dexterity with the Box and Block Test (BBT)
Time frame: One time between day 7 and day 14 + one time between week 6 and week 7.
assessing dexterity with the Purdue Pegboard Test (PPT)
Time frame: One time between day 7 and day 14 + one time between week 6 and week 7.
self-assessment of the H'ability© device according to healthcare professionals and patients using the SUS scale (System Usability Scale)
Time frame: one time between week 6 anD week 7.
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 17 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H'ability in people with Complex Regional Pain Syndrome Type I of the Upper Limb, run by University Hospital, Angers at 2 sites 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 5 inclusion and 13 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 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Quick DASH (Quick Disabilities of the Arm, Shoulder and Hand) self-questionnaire (time frame: 5 times per week for 7 weeks). 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 17 Jun 2026.