Clinical trial NCT05787119: Benefit of Augmented Reality Mirror Therapy in Addition to Conventional Management in Complex Regional Pain Syndrome of the Upper Extremity
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Complex Regional Pain Syndromes
Keywords: Mirror Movement Therapy
Physical Therapy Modalities
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Improvement in upper extremity motor function using ARMT versus CT alone
timeFrame: Every Monday and Thursday until study end (10 weeks)
Secondary outcomes:
measure: Improvement in clinical signs of CRPS using ARMT versus CT alone
timeFrame: Every Monday and Thursday until study end (10 weeks)
measure: Improvement in quality of life using ARMT versus CT alone
timeFrame: Every Monday and Thursday until study end (10 weeks)
measure: Improvement in global impression of change using ARMT versus CT alone
timeFrame: Every Monday and Thursday until study end (10 weeks)
measure: Improvement in deep proprioceptive sensitivity of the upper limb using ARMT versus CT alone
timeFrame: Every Monday and Thursday until study end (10 weeks)
measure: Improvement of mental imagery ability using ARMT versus CT alone
timeFrame: Every Monday and Thursday until study end (10 weeks)
measure: Improvement n perceived pain at movement and at rest using ARMT versus CT alone
timeFrame: Daily until study end (10 weeks)
measure: effectiveness of rehabilitation program adding TMRA device on cortical reactivity or Event related Potential (ERP) between pre- and post-treatment on pathological limb
timeFrame: Before Intervention (Day 0) and at the end of the study (10 weeks)
measure: evolution of cortical reactivity or event-related potential (ERP) between the healthy and pathological sides following a rehabilitation program adding a TMRA device.
timeFrame: at the end of the study (10 weeks)
measure: effectiveness of a rehabilitation program adding a TMRA device on smoothness of movement on the pathological limb between pre- and post-treatment
timeFrame: Before Intervention (Day 0) and at the end of the study (10 weeks)
measure: To compare the smoothness of movement between the healthy and pathological side following a rehabilitation programme adding a TMRA device.
timeFrame: at the end of the study (10 weeks)
measure: 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.
timeFrame: Before Intervention (Day 0) and at the end of the study (10 weeks)
measure: 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.
timeFrame: Before Intervention (Day 0) and at the end of the study (10 weeks)
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: CHU de Nimes
name: Arnaud DUPEYRON
role: PRINCIPAL_INVESTIGATOR
References: