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

Centre Hospitalier Universitaire de Nīmes

Status: Enrolling

Conditions: Complex Regional Pain Syndromes

Treatments: Other: Conventional therapy; Other: ARMT; Other: cortical reactivity; Other: Fluidity of movement

Study type: Interventional

Funder types: Other

Identifiers

NCT05787119

NIMAO/2022-AD-01

Details and patient eligibility

About

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).

Enrollment: 7 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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7 participants in 3 patient groups

Group 1

Experimental group

Description:

2 weeks Conventional therapy / 1 month ARMT / 4 weeks Conventional therapy

Treatment:

Other: Fluidity of movement

Other: cortical reactivity

Other: ARMT

Other: Conventional therapy

Group 2

Experimental group

Description:

3 weeks Conventional therapy / 1 month ARMT / 3 weeks Conventional therapy

Treatment:

Other: Fluidity of movement

Other: cortical reactivity

Other: ARMT

Other: Conventional therapy

Group 3

Experimental group

Description:

2.5 weeks Conventional therapy / 1 month ARMT / 3.5 weeks Conventional therapy

Treatment:

Other: Fluidity of movement

Other: cortical reactivity

Other: ARMT

Other: Conventional therapy