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

NCT ID: NCT06523361

Last Updated: 2026-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-04
• Study Completion Date: 2027-05-04

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.

Conditions

Complex Regional Pain Syndrome Type I of the Upper Limb

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

introduction of the intervention phase before session 4 with occupational therapist

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.

Group Type: OTHER

H'ability

Intervention Type: DEVICE

H'ability is introduced depending the randomization result, during the baseline (before session 4, 5, 6 or 7 with occupational therapist

introduction of the intervention phase before session 5 with occupational therapist

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.

Group Type: OTHER

H'ability

Intervention Type: DEVICE

H'ability is introduced depending the randomization result, during the baseline (before session 4, 5, 6 or 7 with occupational therapist

introduction of the intervention phase before session 6 with occupational therapist

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.

Group Type: OTHER

H'ability

Intervention Type: DEVICE

H'ability is introduced depending the randomization result, during the baseline (before session 4, 5, 6 or 7 with occupational therapist

introduction of the intervention phase before session 7 with occupational therapist

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.

Group Type: OTHER

H'ability

Intervention Type: DEVICE

H'ability is introduced depending the randomization result, during the baseline (before session 4, 5, 6 or 7 with occupational therapist

Interventions

H'ability

H'ability is introduced depending the randomization result, during the baseline (before session 4, 5, 6 or 7 with occupational therapist

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Angers

Angers, , France

Site Status: RECRUITING

CH LAVAL

Laval, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Pauline ALi, Doctor

Role: CONTACT

pauline.ali@chu-angers.fr

33678874242

Viviane CASSISA

Role: CONTACT

vicassisa@chu-angers.fr

33241356831

Facility Contacts

Pauline ALI, Doctor

Role: primary

pauline.ali@chu-angers.fr

Romain Champagne Doctor Champagne Romain

Role: primary

Romain.CHAMPAGNE@chlaval.fr

Other Identifiers

49RC24_0066

Identifier Type: -

Identifier Source: org_study_id