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

NCT06523361 | Recruiting

• 1 other identifier: 49RC24_0066
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Quick DASH (Quick Disabilities of the Arm, Shoulder and Hand) self-questionnaire

  The self-questionnaire contains 11 items to assess the patient's ability to perform certain activities of daily living, the severity of the pain, the impact of the condition on social or professional life, etc. rated on a scale of 1 (no difficulty or inability) to 5 (unable to do)

  5 times per week for 7 weeks

Secondary Outcomes (10)

• self-assessment of pain using the Numerical Scale (EN)

  5 times per week for 7 weeks

• subjective assessment of pain via the PSEQ-2 self-questionnaire

  5 times per week for 7 weeks

• functional assessment of the shoulder using the C-test

  5 times per week for 7 weeks

• self-evaluation of performance and feeling of satisfaction associated with the difficulties identified by the patient with MCRO questionnaire

  One time between day 7 and day 14 + one time between week 6 and week 7.

• Measure of Constant score:composite score allowing to assess pain, level of daily activities, level of hand work, shoulder mobility and strength.

  One time between day 7 and day 14 + one time between week 6 and week 7.

Study Arms (4)

introduction of the intervention phase before session 4 with occupational therapist

OTHER

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.

Device: H'ability

introduction of the intervention phase before session 5 with occupational therapist

OTHER

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.

Device: H'ability

introduction of the intervention phase before session 6 with occupational therapist

OTHER

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.

Device: H'ability

introduction of the intervention phase before session 7 with occupational therapist

OTHER

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.

Device: H'ability

Interventions

H'ability 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 4 with occupational therapist; introduction of the intervention phase before session 5 with occupational therapist; introduction of the intervention phase before session 6 with occupational therapist; introduction of the intervention phase before session 7 with occupational therapist

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (2)

CHU Angers

Angers, 49933, France

RECRUITING

CH LAVAL

Laval, 53000, France

RECRUITING

MeSH Terms

Conditions

Reflex Sympathetic Dystrophy

Condition Hierarchy (Ancestors)

Complex Regional Pain Syndromes; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Central Study Contacts

Pauline ALi, Doctor

CONTACT

33678874242; pauline.ali@chu-angers.fr

Viviane CASSISA

CONTACT

33241356831; vicassisa@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Single case experimental design, with sequential introduction of the intervention and comparison within subject (between phases) and between subjects

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 26, 2024
• Study Start: November 4, 2024
• Primary Completion (Estimated): July 4, 2026
• Study Completion (Estimated): September 4, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

FR (2)