Contribution of Immersive Virtual Reality to a Standardized Rehabilitation Program for Upper Limb Chronic Pain: A Single-Case Experimental Design Study (ReVIDoC)

University Hospital, Angers

Status: Not yet enrolling

Conditions: Complex Regional Pain Syndrome Type I of the Upper Limb

Treatments: Device: H'ability

Study type: Interventional

Funder types: Other

Identifiers

NCT06523361

49RC24_0066

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

introduction of the intervention phase before session 4 with occupational therapist

Other group

Description:

The first "group" will be repeated three times. For each participant, the beginning of the intervention will be randomized. All participants will undergo a baseline phase, intervention phase, and follow-up phase. During the baseline phase, participants serve as controls. As the randomized beginning of the intervention varies across subjects, the length of the baseline phase also varies. The objective is to identify a change in the outcome measure when the intervention starts, despite the differing lengths of the baseline phases across participants.

Treatment:

Device: H'ability

introduction of the intervention phase before session 5 with occupational therapist

Other group

Description:

The second "group" will be repeated three times. For each participant, the beginning of the intervention will be randomized. All participants will undergo a baseline phase, intervention phase, and follow-up phase. During the baseline phase, participants serve as controls. As the randomized beginning of the intervention varies across subjects, the length of the baseline phase also varies. The objective is to identify a change in the outcome measure when the intervention starts, despite the differing lengths of the baseline phases across participants.

Treatment:

Device: H'ability

introduction of the intervention phase before session 6 with occupational therapist

Other group

Description:

The third "group" will be repeated three times. For each participant, the beginning of the intervention will be randomized. All participants will undergo a baseline phase, intervention phase, and follow-up phase. During the baseline phase, participants serve as controls. As the randomized beginning of the intervention varies across subjects, the length of the baseline phase also varies. The objective is to identify a change in the outcome measure when the intervention starts, despite the differing lengths of the baseline phases across participants.

Treatment:

Device: H'ability

introduction of the intervention phase before session 7 with occupational therapist

Other group

Description:

The fourth "group" will be repeated three times. For each participant, the beginning of the intervention will be randomized. All participants will undergo a baseline phase, intervention phase, and follow-up phase. During the baseline phase, participants serve as controls. As the randomized beginning of the intervention varies across subjects, the length of the baseline phase also varies. The objective is to identify a change in the outcome measure when the intervention starts, despite the differing lengths of the baseline phases across participants.

Treatment:

Device: H'ability