Clinical trial NCT06523361: Contribution of Immersive Virtual Reality to a Standardized Rehabilitation Program for Upper Limb Chronic Pain: A Single-Case Experimental Design Study
Official title: Contribution of Immersive Virtual Reality to a Standardized Rehabilitation Program for Upper Limb Chronic Pain: A Single-Case Experimental Design Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Complex Regional Pain Syndrome Type I of the Upper Limb
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2024-07-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Single case experimental design, with sequential introduction of the intervention and comparison within subject (between phases) and between subjects
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Quick DASH (Quick Disabilities of the Arm, Shoulder and Hand) self-questionnaire
timeFrame: 5 times per week for 7 weeks
Secondary outcomes:
measure: self-assessment of pain using the Numerical Scale (EN)
timeFrame: 5 times per week for 7 weeks
measure: subjective assessment of pain via the PSEQ-2 self-questionnaire
timeFrame: 5 times per week for 7 weeks
measure: functional assessment of the shoulder using the C-test
timeFrame: 5 times per week for 7 weeks
measure: self-evaluation of performance and feeling of satisfaction associated with the difficulties identified by the patient with MCRO questionnaire
timeFrame: One time between day 7 and day 14 + one time between week 6 and week 7.
measure: Measure of Constant score:composite score allowing to assess pain, level of daily activities, level of hand work, shoulder mobility and strength.
timeFrame: One time between day 7 and day 14 + one time between week 6 and week 7.
measure: assessment of kinesiophobia with the Tampa Scale for Kinesiophobia (TSK)
timeFrame: once at inclusion + one time between week 6 and week 7.
measure: assessing grip strength with the Jamar test
timeFrame: One time between day 7 and day 14 + one time between week 6 and week 7.
measure: assessing dexterity with the Box and Block Test (BBT)
timeFrame: One time between day 7 and day 14 + one time between week 6 and week 7.
measure: assessing dexterity with the Purdue Pegboard Test (PPT)
timeFrame: One time between day 7 and day 14 + one time between week 6 and week 7.
measure: self-assessment of the H'ability© device according to healthcare professionals and patients using the SUS scale (System Usability Scale)
timeFrame: one time between week 6 anD week 7.
Other outcomes:
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