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

Complex Regional Pain Syndromes Clinical Trial

— REFLEXION  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05787119
• Other study ID #: NIMAO/2022-AD-01
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Arnaud DUPEYRON
• Phone: 04.66.68.34.59
• Email: arnaud.DUPEYRON[@]umontpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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". 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

Other:
• Conventional therapy
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
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
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
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).

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Every Monday and Thursday until study end (10 weeks)
Secondary	Improvement in clinical signs of CRPS using ARMT versus CT alone	Change in Complex regional pain syndrome Severity Score (CSS); score out of 16	Every Monday and Thursday until study end (10 weeks)
Secondary	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).	Every Monday and Thursday until study end (10 weeks)
Secondary	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.	Every Monday and Thursday until study end (10 weeks)
Secondary	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.	Every Monday and Thursday until study end (10 weeks)
Secondary	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	Every Monday and Thursday until study end (10 weeks)
Secondary	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	Daily until study end (10 weeks)
Secondary	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	Before Intervention (Day 0) and at the end of the study (10 weeks)
Secondary	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	at the end of the study (10 weeks)
Secondary	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)	Before Intervention (Day 0) and at the end of the study (10 weeks)
Secondary	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)	at the end of the study (10 weeks)
Secondary	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)	Before Intervention (Day 0) and at the end of the study (10 weeks)
Secondary	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)	Before Intervention (Day 0) and at the end of the study (10 weeks)