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

NCT05787119 | Completed

• 1 other identifier: NIMAO/2022-AD-01
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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).

Conditions

Complex Regional Pain Syndromes

Keywords

Mirror Movement Therapy; Physical Therapy Modalities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Improvement in clinical signs of CRPS using ARMT versus CT alone

  Every Monday and Thursday until study end (10 weeks)

• Improvement in quality of life using ARMT versus CT alone

  Every Monday and Thursday until study end (10 weeks)

• Improvement in global impression of change using ARMT versus CT alone

  Every Monday and Thursday until study end (10 weeks)

• Improvement in deep proprioceptive sensitivity of the upper limb using ARMT versus CT alone

  Every Monday and Thursday until study end (10 weeks)

• Improvement of mental imagery ability using ARMT versus CT alone

  Every Monday and Thursday until study end (10 weeks)

Study Arms (3)

Group 1

EXPERIMENTAL

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

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

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

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

Interventions

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.

Group 1; Group 2; Group 3

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.

Group 1; Group 2; Group 3

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).

Group 1; Group 2; Group 3

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).

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, 30129, France

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Arnaud DUPEYRON

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 28, 2023
• Study Start: September 18, 2023
• Primary Completion: December 2, 2024
• Study Completion: March 28, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

FR (1)