CompletedNot Applicable

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

France7 participantsStarted 2023-09-18

Plain-language 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).

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Improvement in upper extremity motor function using ARMT versus CT alone

Timeframe: Every Monday and Thursday until study end (10 weeks)

Trial details

NCT IDNCT05787119

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-02

View on ClinicalTrials.gov More Complex Regional Pain Syndromes trials