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Completed

NCT Number: NCT05787119

Benefit of Augmented Reality Mirror Therapy in Addition to Conventional Management in Complex Regional Pain Syndrome of the Upper Extremity

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).

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Key information

Conditions

Complex Regional Pain Syndromes Autonomic Nervous System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes

Nîmes, 30129, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Conventional Therapy

Other

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.

ARMT

Other

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 reactivity

Other

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 movement

Other

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Improvement in clinical signs of CRPS using ARMT versus CT alone

    Time frame: Every Monday and Thursday until study end (10 weeks)

    Change in Complex regional pain syndrome Severity Score (CSS); score out of 16

  2. Improvement in quality of life using ARMT versus CT alone

    Time frame: Every Monday and Thursday until study end (10 weeks)

    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).

  3. Improvement in global impression of change using ARMT versus CT alone

    Time frame: Every Monday and Thursday until study end (10 weeks)

    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.

  4. 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)

    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.

  5. Improvement of mental imagery ability using ARMT versus CT alone

    Time frame: Every Monday and Thursday until study end (10 weeks)

    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

  6. Improvement n perceived pain at movement and at rest using ARMT versus CT alone

    Time frame: Daily until study end (10 weeks)

    Change in pain, reported on a 0-10 visual analog scale

  7. 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)

    Measurement of signal power amplitude (in microVolts) in motor imagery task and motor execution task compared with a resting task

  8. 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)

    Amplitude of signal power (in microVolts) in motor imagery task and motor execution task compared with a resting task

  9. 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)

    Leap Motion Control motion capture device from Ultraleap Company (description)

  10. 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)

    Amplitude of signal power in motor imagery task and motor execution task compared with a resting task (descriptive, adimentional)

  11. 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)

    Correlation between 2 signals: cortical and motor for motor execution tasks (adimentional)

  12. 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)

    Multiple correlation (adimentional)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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.

Acronym: REFLEXION

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 28, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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