Contribution of Immersive Virtual Reality to a Standardized Rehabilitation Program for Upper Limb… (NCT06523361) | Clinical Trial Compass
CompletedNot Applicable
Contribution of Immersive Virtual Reality to a Standardized Rehabilitation Program for Upper Limb Chronic Pain: A Single-Case Experimental Design Study
France13 participantsStarted 2024-11-04
Plain-language summary
Background: Chronic pain represents a significant public health concern, given its high prevalence and the substantial impact it has on the quality of life of many individuals affected. There is no single, universally effective medical treatment for chronic pain. The gold standard for treatment is a multidisciplinary rehabilitation program. Immersive virtual reality (IVR) represents a novel and promising approach to do rehabilitation, offering the potential to enhance engagement and perception of movement.
The objective of this study was to investigate the improvement of upper limb function in chronic pain patients using an IVR device in occupational therapy sessions during a rehabilitation program.
Methods: The study use a single-case experimental design (SCED) to investigate the efficacy of IVR device in improving upper limb function in patients with upper limb chronic pain. The study was conducted in three phases: baseline, intervention, and follow-up. The SCED will be with multiple baseline across subjects, whereby the patient serves as his own control. A total of 12 participants will be included. The virtual reality sessions will be conducted exclusively during the intervention phase. The primary outcome measure will be the upper limb function, as assessed by the Quick DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire. Furthermore, the intensity of pain will be quantified using a numeric scale, and the pain self-efficacy will be evaluated using the Pain Self-Effacity Short Form Questionnaire.
Expected results: This method will allow for the comparison of phases within and between subjects to determine whether the IVR sessions improve the function assessed by the Quick DASH.
Conclusion: Further investigation is required to determine the potential benefits of using IVR for upper limb chronic pain rehabilitation, with a particular focus on the development of precise protocols for its use in clinical settings.
Who can participate
Age range
18 Years – 65 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:
* Chronic pain in the upper limb, predominantly in one or both upper limbs, for more than 3 months
* Age between 18 and 65
* Patient affiliated with or benefiting from a social security organization
* Person able to tolerate the virtual reality device
* Informed consent form signed
Exclusion Criteria:
* Upper limb surgery \< 6 months
* Infection or pathology of the central nervous system or active cancer
* Fibromyalgia
* Severe psychiatric or cognitive disorders
* Diabetes mellitus complicated by peripheral neuropathy
* Neurogenic paraosteoarthropathy or recent fracture
* Pregnancy or breast-feeding.
* Poor understanding of the French language.
* Person deprived of liberty by judicial or administrative decision
* Psychiatric disorder
* Person subject to a legal protection measure
* Person unable to give consent
* In connection with the virtual reality device: unstabilized epilepsy, facial trauma \< 3 months, hearing or visual impairment, pain, dizziness or nausea caused by the use of virtual reality.
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.
1This study used immersive virtual reality as part of a rehabilitation program for Complex Regional Pain Syndrome Type I in the upper limb — how does adding virtual reality to standard rehab actually work for CRPS, and is that something worth considering in my own treatment plan?
2The trial measured outcomes using the Quick DASH questionnaire, which tracks disability in the arm, shoulder, and hand — based on what this study found, did patients with CRPS Type I show meaningful improvements in day-to-day arm function, and how does that compare to standard rehab alone?
3Since this trial is listed as Phase NA and used a single-case experimental design, what does that mean for how much confidence we can have in the results, and should I be looking for larger studies before considering this approach?
4This study has already been completed — do you know whether the results have been published, and if so, what did they actually show about whether virtual reality helped with chronic upper limb pain?
5Given that this was a small-scale experimental design study, would you recommend I try a more established rehabilitation approach for my CRPS first, or does the evidence here suggest virtual reality therapy is worth pursuing now?
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
1
Quick DASH (Quick Disabilities of the Arm, Shoulder and Hand) self-questionnaire