Optimizing the Use of Virtual Reality in Rehabilitation for Individuals With Persistent Shoulder Pain

NCT07293312 | Not Yet Recruiting

• 1 other identifier: 2025-3292
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this clinical trial is to investigate the effect of a block of four specific virtual reality (VR) exercises on upper limb function, pain, kinesiophobia, and pain catastrophizing in individuals with rotator cuff-related shoulder pain (RCRSP). The secondary objective is to examine participants' tolerability of different VR interventions. Study Procedures: Participants will:

• Attend a face-to-face assessment to confirm eligibility and receive a standardized pain neurophysiology education session (week 0).
• Visit the clinic once weekly for four weeks to undergo the VR interventions and review pain education concepts (Weeks 5 to 8).
• Complete online questionnaires evaluating upper limb function, kinesiophobia, pain, sense of presence, and cybersickness. Interventions Four VR interventions will be tested:
• Unimanual distraction task with normal visual feedback
• Bimanual distraction task with normal visual feedback
• Unimanual reaching task with augmented visual feedback
• Unimanual reaching task with diminished visual feedback Findings will guide clinicians in selecting the most effective VR interventions for shoulder impairment and assess the feasibility of implementing VR in a private physiotherapy clinic for individuals with RCRSP.

Conditions

Rotator Cuff Related Shoulder Pain

Keywords

Musculoskeletal Disorders; Virtual reality; Education; Shoulder; chronic pain intervention

Outcome Measures

Primary Outcomes (1)

• Symptoms and functional limitations specific to the upper limbs

  The QuickDASH is an 11-item questionnaire, validated in individuals with rotator cuff-related shoulder pain, addressing the level of difficulty in performing daily activities and the severity of the symptoms of the upper limbs. Higher scores indicate greater pain and functional limitations.

  post-intervention (week 8)

Secondary Outcomes (21)

• Symptoms and functional limitations specific to the upper limbs

  baseline

• Symptoms and functional limitations specific to the upper limbs

  pre-intervention (week 4)

• Functional limitations

  baseline

• Functional limitations

  pre-intervention (week 4)

• Functional limitations

  post-intervention (week 8)

Study Arms (1)

Virtual reality interventions

EXPERIMENTAL

All participants will complete a four-week intervention, performing one of the four types of virtual reality (VR) exercises per week, so that each participant experiences all four exercises: 1. Unimanual distraction task with normal visual feedback 2. Bimanual distraction task with normal visual feedback 3. Unimanual reaching task with augmented visual feedback 4. Unimanual reaching task with diminished visual feedback During each session, participants will reach 18 targets positioned at heights of 60°, 90°, and 120° across three planes of motion (flexion, scaption, and abduction). Target positions will be adjusted to accommodate each participant's arm length and size. To ensure participant comfort, the session will end if repetitions are not completed within 2 minutes. The order of interventions will be randomized for each participant.

Other: Virtual reality unimanual distraction task; Other: Virtual reality bimanual distraction task; Other: Virtual reality unimanual reaching tasks with augmented visual feedback; Other: Virtual reality unimanual reaching tasks with decreased visual feedback

Interventions

Virtual reality bimanual distraction task OTHER

Bimanual tasks with unaltered visual feedback (targets positioned based on the affected limb) will involve distraction exercises in which participants move a tray toward targets while keeping a ball balanced on the tray. Three trials with varying levels of friction between the ball and tray will be presented to adjust task difficulty.

Virtual reality interventions

Virtual reality unimanual distraction task OTHER

Unimanual tasks (performed with the affected limb) with unaltered visual feedback will involve distraction exercises in which participants move a tray toward targets while keeping a ball balanced on the tray. Three trials with varying levels of friction between the ball and tray will be presented to manipulate the task's difficulty.

Virtual reality interventions

Virtual reality unimanual reaching tasks with augmented visual feedback OTHER

Three trials with varying levels of visual feedback alteration will be performed, corresponding to a 0%, 25%, or 50% amplification of movement in the virtual environment compared to the real world. While virtual targets will appear farther apart, the actual movement required to reach them will remain the same across all trials.

Virtual reality interventions

Virtual reality unimanual reaching tasks with decreased visual feedback OTHER

Three trials with varying levels of visual feedback alteration will be performed, corresponding to a 0%, 17%, or 33% reduction in movement in the virtual environment compared to the real world. Although the virtual targets will appear closer together, the actual movement required to reach them will remain the same across all trials.

Virtual reality interventions

Eligibility Criteria

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

You may qualify if:

• Rotator cuff-related shoulder pain (screen by phone and then confirmed by the physiotherapist at the initial evaluation: pain over the deltoid and/or upper arm region, pain associated with arm movement \[painful arc of movement\], and familiar pain reproduced with loading or resisted testing during external rotation of the arm) for at least 6 months
• Minimum score of 15/100 on the shortened version of the Disabilities of the Arm, Shoulder, and Hand (1.5 times the minimally clinically important difference)

You may not qualify if:

• Unavailable for the 4 weeks intervention
• Cannot understand or read French
• Have a diagnosis of rheumatoid, inflammatory or neurodegenerative diseases
• Have received a corticosteroid injection or any other type of injection (e.g., platelet-rich plasma, prolotherapy, hyaluronic acid) in the past three months for their current condition
• Have bilateral shoulder pain
• Have pain in another upper limb joint
• Have signs of upper (e.g., bilateral paresthesia, hyperreflexia, or spasticity) or lower (e.g., decreased sensation or strength in dermatomes and myotomes, hypotonia, or hyporeflexia) motor neuron lesions
• History of shoulder surgery, dislocation, or fracture
• Presence of severe osteoarthritis, symptomatic acromioclavicular joint pathology, or adhesive capsulitis (defined as restriction of passive glenohumeral movement of at least 30% for two or more directions)
• Full thickness rotator cuff tear, identified by imaging or clinical tests (lag signs and gross weakness)

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Centre for Interdisciplinary Research in Rehabilitation and Social Integration

Québec, Quebec, G1M 2S8, Canada

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• Catherine Mercier, OT,PhD

  Centre for Interdisciplinary Research in Rehabilitation and Social Integration (Cirris)

  STUDY DIRECTOR

• Jean-Sébastien Roy, PT, PhD

  Centre for Interdisciplinary Research in Rehabilitation and Social Integration (Cirris)

  STUDY DIRECTOR

Central Study Contacts

Félix Fiset, PT, MSc

CONTACT

418-649-3735; felix.fiset.1@ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will be blinded to the specific VR interventions they will perform to prevent anticipation or adjustment of their movements based on the intervention. For instance, they will not know whether their movements will be amplified or diminished compared to real-life motion.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 19, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

CA (1)