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

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05787119

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Complex Regional Pain Syndromes	Other: Conventional therapy Other: ARMT	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

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.

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 2 weeks Conventional therapy / 1 month ARMT / 4 weeks Conventional therapy	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. Other: 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.
Experimental: Group 2 3 weeks Conventional therapy / 1 month ARMT / 3 weeks Conventional therapy	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. Other: 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.
Experimental: Group 3 2.5 weeks Conventional therapy / 1 month ARMT / 3.5 weeks Conventional therapy	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. Other: 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.

Arm

Intervention/Treatment

Experimental: Group 1

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

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.

Other: 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.

Experimental: Group 2

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

Other: Conventional therapy

Other: 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.

Experimental: Group 3

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

Other: Conventional therapy

Other: 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.

Outcome Measures

Primary Outcome Measures

Improvement in upper extremity motor function using ARMT versus CT alone [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 Outcome Measures

Improvement in clinical signs of CRPS using ARMT versus CT alone [Every Monday and Thursday until study end (10 weeks)]
Change in Complex regional pain syndrome Severity Score (CSS); score out of 16
Improvement in quality of life using ARMT versus CT alone [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).
Improvement in global impression of change using ARMT versus CT alone [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.
Improvement in deep proprioceptive sensitivity of the upper limb using ARMT versus CT alone [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.
Improvement of mental imagery ability using ARMT versus CT alone [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
Improvement n perceived pain at movement and at rest using ARMT versus CT alone [Daily until study end (10 weeks)]
Change in pain, reported on a 0-10 visual analog scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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