Complex Regional Pain SyndromesREFLEXIONNCT05787119
Benefit of Augmented Reality Mirror Therapy in Addition to Conventional Management in Complex Regional Pain Syndrome of the Upper Extremity
A study testing Conventional therapy, ARMT and cortical reactivity in people with Complex Regional Pain Syndromes, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Complex Regional Pain Syndrome (CRPS) is a "polymorphic joint and periarticular pain syndrome associated with various changes in sensitivity, vasomotor, sudomotor, muscular and trophic changes". Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Complex Regional Pain Syndromes
- What is being tested?
- Conventional therapy, ARMT and cortical reactivity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 18 Sep 2023to 28 Mar 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Patient with CRPS of the upper limb according to the Budapest criteria.
- Patient newly treated at the Centre d'Evaluation et de Traitement de la Douleur of the CHU of Nîmes.
- Patient with a diagnosis of CRPS for more than 3 months
Who cannot join
- The subject is participating in a therapeutic study, or is in a period of exclusion determined by a previous study
- The subject unable to express consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient is pregnant, parturient or breastfeeding
- Patient with medically significant visual impairment that is incompatible with the practice of ARMT
Show all 11Show fewer
- Patient with CRPS secondary to a stroke
- Patient with cognitive disorders (Montreal Cognitive Assessment scale less than 26)
- Patient with Unilateral Spatial Negligence according to the Bell's test
- Patient with arthrodesis of one of the joints of the upper limbs.
- Patient with an unhealed fracture of one of the upper limbs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefit of Augmented Reality Mirror Therapy in Addition to Conventional Management in Complex Regional Pain Syndrome of the Upper Extremity: a Single Case Experimental Design (SCED) Study.
Complex Regional Pain Syndrome (CRPS) is a "polymorphic joint and periarticular pain syndrome associated with various changes in sensitivity, vasomotor, sudomotor, muscular and trophic changes". The diagnostic criteria of the disease follow the Budapest criteria, namely (i) vasomotor disorders (temperature asymmetry, color changes), (ii) sudomotor/oedema (sweating changes, edema), (iii) sensory (hyperesthesia, allodynia, hyperalgesia) and (iv) motor/trophic (reduced joint mobility, weakness, tremor, dystonia, trophic disorders of skin, nails, hair).
Of the many treatments, augmented reality mirror therapy (ARMT), is novel in substituting a virtual environment for part of the real environment. This type of device has never been studied from a clinical point of view in the treatment of upper limb CRPS, whereas fMRI and clinical dissertation studies have suggested an improvement in neuroplasticity.
The aim of this study is to establish the clinical effects of ARMT on CRPS, and to evaluate its benefit within a conventional rehabilitation treatment (physiotherapy and occupational therapy).
- Conditions
- Complex Regional Pain Syndromes
- Being tested
- Conventional therapy, ARMT, cortical reactivity, Fluidity of movement
- Keywords
- Mirror Movement Therapy, Physical Therapy Modalities
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional therapyOther
The CT consists of 1 session of 30 minutes of physical therapy (type of re-education established according to the pain at rest and during movement assessed every day) and 1 session of 30 minutes of occupational therapy (type of re-education established according to the pain at rest and during movement assessed every day). CT is performed 5 days a week.
ARMTOther
The ARMT consists of 1 session of 30 minutes (type of rehabilitation established according to the pain at rest and during movement evaluated daily). ARMT is performed 5 days a week for 1 month.
cortical reactivityOther
An electroencephalogram was taken at the start and end of the study to study cortical reactivity during the performance of 3 different tasks repeated 30 times: a resting task (consisting of looking at a cross on a screen), a motor imagery task (consisting of imagining performing wrist flexions/extensions) and a motor execution task (consisting of performing wrist flexions/extensions).
Fluidity of movementOther
Motion capture at the start and end of the study to study the fluidity of movement during 3 different tasks repeated 30 times: a resting task (looking at a cross on a screen), a motor imagery task (imagining wrist flexions/extensions) and a motor execution task (performing wrist flexions/extensions).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 2 weeks Conventional therapy / 1 month ARMT / 4 weeks Conventional therapy Receives: Other: Conventional therapy; Other: ARMT; Other: cortical reactivity; Other: Fluidity of movement |
| Group 2 | Experimental | 3 weeks Conventional therapy / 1 month ARMT / 3 weeks Conventional therapy Receives: Other: Conventional therapy; Other: ARMT; Other: cortical reactivity; Other: Fluidity of movement |
| Group 3 | Experimental | 2.5 weeks Conventional therapy / 1 month ARMT / 3.5 weeks Conventional therapy Receives: Other: Conventional therapy; Other: ARMT; Other: cortical reactivity; Other: Fluidity of movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in upper extremity motor function using ARMT versus CT alone
Change in Box and Block Test (BBT) score. The score will be compared between the right and left hand and against reference values according to age and sex.
Measured: Every Monday and Thursday until study end (10 weeks)
Secondary outcomes (12)
Improvement in clinical signs of CRPS using ARMT versus CT alone
Change in Complex regional pain syndrome Severity Score (CSS); score out of 16
Measured: Every Monday and Thursday until study end (10 weeks)
Improvement in quality of life using ARMT versus CT alone
Change in EQ-5D-3L questionnaire score. The first part is a score out of 15 total (scoring out of 3 per item). The second part is a scale numbered 0 to 100 (0 being the worst health imaginable to 100 being the best health imaginable).
Measured: Every Monday and Thursday until study end (10 weeks)
Improvement in global impression of change using ARMT versus CT alone
Change in Patient Global Impression of Change (PGIC) Questionnaire score. The measurement is between 1 and 7. It is a qualitative scale converted into a numerical scale.
Measured: Every Monday and Thursday until study end (10 weeks)
Improvement in deep proprioceptive sensitivity of the upper limb using ARMT versus CT alone
Change in proprioceptive section of the Rivermead Assessment of Somatosensory Performance questionnaire score. 5 joints are tested 6 times. Thus for each joint, the score is out of 6, for a total score of 30.
Measured: Every Monday and Thursday until study end (10 weeks)
Improvement of mental imagery ability using ARMT versus CT alone
Change in mental chronometry. Measured using a modified Box and Block Test to give a ratio = (real task time - imagined task time) / real task time
Measured: Every Monday and Thursday until study end (10 weeks)
Improvement n perceived pain at movement and at rest using ARMT versus CT alone
Change in pain, reported on a 0-10 visual analog scale
Measured: Daily until study end (10 weeks)
effectiveness of rehabilitation program adding TMRA device on cortical reactivity or Event related Potential (ERP) between pre- and post-treatment on pathological limb
Measurement of signal power amplitude (in microVolts) in motor imagery task and motor execution task compared with a resting task
Measured: Before Intervention (Day 0) and at the end of the study (10 weeks)
evolution of cortical reactivity or event-related potential (ERP) between the healthy and pathological sides following a rehabilitation program adding a TMRA device.
Amplitude of signal power (in microVolts) in motor imagery task and motor execution task compared with a resting task
Measured: at the end of the study (10 weeks)
effectiveness of a rehabilitation program adding a TMRA device on smoothness of movement on the pathological limb between pre- and post-treatment
Leap Motion Control motion capture device from Ultraleap Company (description)
Measured: Before Intervention (Day 0) and at the end of the study (10 weeks)
To compare the smoothness of movement between the healthy and pathological side following a rehabilitation programme adding a TMRA device.
Amplitude of signal power in motor imagery task and motor execution task compared with a resting task (descriptive, adimentional)
Measured: at the end of the study (10 weeks)
Correlate the power of cortical reactivity with fluidity of movement, function, mental chronometry, quality of life, global impression of change, proprioceptive sensitivity and clinical criteria of severity.
Correlation between 2 signals: cortical and motor for motor execution tasks (adimentional)
Measured: Before Intervention (Day 0) and at the end of the study (10 weeks)
Correlate fluidity of movement with the power of cortical reactivity, function, mental chronometry, quality of life, global impression of change, proprioceptive sensitivity and clinical criteria of severity.
Multiple correlation (adimentional)
Measured: Before Intervention (Day 0) and at the end of the study (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start18 Sep 2023
- Primary completion2 Dec 2024
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain SyndromesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud DUPEYRON, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787119
- Sponsor's protocol ID
- NIMAO/2022-AD-01
- Acronym
- REFLEXION
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2023
- Last updated
- 18 Mar 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 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Augmented Reality Mirror Therapy in Addition to Conventional Management in Complex Regional Pain Syndrome of the Upper Extremity: a Single Case Experimental Design (SCED) Study.
- ClinicalTrials.gov ID
- NCT05787119
- Acronym / sponsor ID
- REFLEXION / NIMAO/2022-AD-01
- Conditions
- Complex Regional Pain Syndromes
- Keywords
- Mirror Movement Therapy, Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 28 Mar 2023 (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.
Complex Regional Pain Syndrome (CRPS) is a "polymorphic joint and periarticular pain syndrome associated with various changes in sensitivity, vasomotor, sudomotor, muscular and trophic changes". The diagnostic criteria of the disease follow the Budapest criteria, namely (i) vasomotor disorders (temperature asymmetry, color changes), (ii) sudomotor/oedema (sweating changes, edema), (iii) sensory (hyperesthesia, allodynia, hyperalgesia) and (iv) motor/trophic (reduced joint mobility, weakness, tremor, dystonia, trophic disorders of skin, nails, hair).
Of the many treatments, augmented reality mirror therapy (ARMT), is novel in substituting a virtual environment for part of the real environment. This type of device has never been studied from a clinical point of view in the treatment of upper limb CRPS, whereas fMRI and clinical dissertation studies have suggested an improvement in neuroplasticity.
The aim of this study is to establish the clinical effects of ARMT on CRPS, and to evaluate its benefit within a conventional rehabilitation treatment (physiotherapy and occupational therapy).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Conventional therapy, Other: ARMT, Other: cortical reactivity, Other: Fluidity of movement2 weeks Conventional therapy / 1 month ARMT / 4 weeks Conventional therapy |
| Group 2 | Experimental | Other: Conventional therapy, Other: ARMT, Other: cortical reactivity, Other: Fluidity of movement3 weeks Conventional therapy / 1 month ARMT / 3 weeks Conventional therapy |
| Group 3 | Experimental | Other: Conventional therapy, Other: ARMT, Other: cortical reactivity, Other: Fluidity of movement2.5 weeks Conventional therapy / 1 month ARMT / 3.5 weeks Conventional therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Patient with CRPS of the upper limb according to the Budapest criteria.
- Patient newly treated at the Centre d'Evaluation et de Traitement de la Douleur of the CHU of Nîmes.
- Patient with a diagnosis of CRPS for more than 3 months
Key exclusion criteria (11 listed)
- The subject is participating in a therapeutic study, or is in a period of exclusion determined by a previous study
- The subject unable to express consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient is pregnant, parturient or breastfeeding
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 |
|---|---|---|
| Conventional therapyThe CT consists of 1 session of 30 minutes of physical therapy (type of re-education established according to the pain at rest and during movement assessed every day) and 1 session of 30 minutes of occupational therapy (type of re-education established according to the pain at rest and during movement assessed every day). CT is performed 5 days a week. | Other | Group 1, Group 2, Group 3 |
| ARMTThe ARMT consists of 1 session of 30 minutes (type of rehabilitation established according to the pain at rest and during movement evaluated daily). ARMT is performed 5 days a week for 1 month. | Other | Group 1, Group 2, Group 3 |
| cortical reactivityAn electroencephalogram was taken at the start and end of the study to study cortical reactivity during the performance of 3 different tasks repeated 30 times: a resting task (consisting of looking at a cross on a screen), a motor imagery task (consisting of imagining performing wrist flexions/extensions) and a motor execution task (consisting of performing wrist flexions/extensions). | Other | Group 1, Group 2, Group 3 |
| Fluidity of movementMotion capture at the start and end of the study to study the fluidity of movement during 3 different tasks repeated 30 times: a resting task (looking at a cross on a screen), a motor imagery task (imagining wrist flexions/extensions) and a motor execution task (performing wrist flexions/extensions). | Other | Group 1, Group 2, Group 3 |
Primary outcome
Improvement in upper extremity motor function using ARMT versus CT alone
Time frame: Every Monday and Thursday until study end (10 weeks)
Change in Box and Block Test (BBT) score. The score will be compared between the right and left hand and against reference values according to age and sex.
12 secondary outcomes
Improvement in clinical signs of CRPS using ARMT versus CT alone
Time frame: Every Monday and Thursday until study end (10 weeks)
Improvement in quality of life using ARMT versus CT alone
Time frame: Every Monday and Thursday until study end (10 weeks)
Improvement in global impression of change using ARMT versus CT alone
Time frame: Every Monday and Thursday until study end (10 weeks)
Improvement in deep proprioceptive sensitivity of the upper limb using ARMT versus CT alone
Time frame: Every Monday and Thursday until study end (10 weeks)
Improvement of mental imagery ability using ARMT versus CT alone
Time frame: Every Monday and Thursday until study end (10 weeks)
Improvement n perceived pain at movement and at rest using ARMT versus CT alone
Time frame: Daily until study end (10 weeks)
effectiveness of rehabilitation program adding TMRA device on cortical reactivity or Event related Potential (ERP) between pre- and post-treatment on pathological limb
Time frame: Before Intervention (Day 0) and at the end of the study (10 weeks)
evolution of cortical reactivity or event-related potential (ERP) between the healthy and pathological sides following a rehabilitation program adding a TMRA device.
Time frame: at the end of the study (10 weeks)
effectiveness of a rehabilitation program adding a TMRA device on smoothness of movement on the pathological limb between pre- and post-treatment
Time frame: Before Intervention (Day 0) and at the end of the study (10 weeks)
To compare the smoothness of movement between the healthy and pathological side following a rehabilitation programme adding a TMRA device.
Time frame: at the end of the study (10 weeks)
Correlate the power of cortical reactivity with fluidity of movement, function, mental chronometry, quality of life, global impression of change, proprioceptive sensitivity and clinical criteria of severity.
Time frame: Before Intervention (Day 0) and at the end of the study (10 weeks)
Correlate fluidity of movement with the power of cortical reactivity, function, mental chronometry, quality of life, global impression of change, proprioceptive sensitivity and clinical criteria of severity.
Time frame: Before Intervention (Day 0) and at the end of the study (10 weeks)
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 18 Mar 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.
Arnaud DUPEYRON principal investigator
CHU de Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional therapy, ARMT and cortical reactivity in people with Complex Regional Pain Syndromes, run by Centre Hospitalier Universitaire de Nīmes 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 5 inclusion and 11 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 18 Mar 2026. 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?
Improvement in upper extremity motor function using ARMT versus CT alone (time frame: Every Monday and Thursday until study end (10 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 18 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.