Rotator Cuff Related Shoulder PainNCT07293312
Optimizing the Use of Virtual Reality in Rehabilitation for Individuals With Persistent Shoulder Pain
A study testing Virtual reality unimanual distraction task, Virtual reality bimanual distraction task and Virtual reality unimanual reaching tasks with augmented visual feedback in people with Rotator Cuff Related Shoulder Pain, run by Laval University at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Related Shoulder Pain
- What is being tested?
- Virtual reality unimanual distraction task, Virtual reality bimanual distraction task and Virtual reality unimanual reaching tasks with augmented visual feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2026to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Centre for Interdisciplinary Research in Rehabilitation and Social Integration
Québec, Quebec, G1M 2S8
Jean-Sébastien Roy, PT, PhD, 418-529-9141 ext. 46005, Jean-Sebastien.Roy@fmed.ulaval.ca
About this study
Official title: Optimizing the Use of Virtual Reality in Rehabilitation for Individuals With Persistent Rotator Cuff-related Shoulder Pain
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:
Read more
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.
Read the detailed description
The use of virtual reality (VR) in rehabilitation has been shown to have positive effects on function and could enhance current rehabilitation interventions. However, the type of exercise to be performed, the specific added value of VR and the tolerance of the interventions performed remain poorly documented, which limits its clinical use. The primary objective of this project is to study the impact on function, pain, kinesiophobia and pain catastrophizing of a block of four specific VR exercises in individuals with chronic rotator cuff-related pain (RCRSP). The secondary objective is to examine participants' tolerance for different VR interventions.
Thirty adults with RCRSP will be recruited to participate in the study. Each participant will complete three assessment sessions: initial, pre-intervention, and post-intervention. The initial assessment will be conducted in person four weeks prior to the intervention to verify eligibility and provide standardized education on the neurophysiology of pain. This educational session aims to ensure a common level of understanding, improve adherence to the VR sessions, and facilitate the transfer of VR movements to daily activities.
The effect of the education will be assessed during the pre-intervention evaluation (week 4), conducted within seven days before the first VR session. The post-intervention evaluation (week 8), conducted within seven days following the 4-week intervention, will be used to address the study's primary objective. All questionnaires administered during the assessments and interventions will be completed online via REDCap.
The intervention will consist of four VR rehabilitation sessions, each involving a distinct type of task: 1)Unimanual distraction task with normal visual feedback; 2) Bimanual distraction task with normal visual feedback; 3) Unimanual reaching task with augmented visual feedback; and, 4) Unimanual reaching task with diminished visual feedback.
Outcome measures will include upper limb function, kinesiophobia, pain, participant satisfaction, sense of presence, and cybersickness.
To address the primary objective, repeated-measures ANOVAs will be conducted to compare outcomes across the three assessment time points (initial, pre-intervention [week 4], and post-intervention [week 8]). To address the secondary objective, repeated-measures ANOVAs will also be used to compare the effects of the different intervention types (unimanual vs. bimanual; augmented vs. diminished visual feedback).
This project will have an impact on both upper limb rehabilitation and the use of emerging VR technology in clinical settings. The project will provide a better understanding of the impact of VR intervention on symptoms, which is an important prerequisite for using VR in this population. It will also explore the type of intervention to be recommended in VR in complement to pain education.
- Conditions
- Rotator Cuff Related Shoulder Pain
- Being tested
- Virtual reality unimanual distraction task, Virtual reality bimanual distraction task, Virtual reality unimanual reaching tasks with augmented visual feedback, Virtual reality unimanual reaching tasks with decreased visual feedback
- Keywords
- Musculoskeletal Disorders, Virtual reality, Education, Shoulder, chronic pain intervention
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality unimanual distraction taskOther
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 bimanual distraction taskOther
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 unimanual reaching tasks with augmented visual feedbackOther
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 unimanual reaching tasks with decreased visual feedbackOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: post-intervention (week 8)
Secondary outcomes (21)
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.
Measured: baseline
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.
Measured: pre-intervention (week 4)
Functional limitations
Functional limitations related to pain will be evaluated using the Pain Interference subscale of the Brief Pain Inventory (BPI). The Pain Interference subscale (7 items) measures the level of interference with function caused by pain on a scale from 0 to 10.
Measured: baseline
Functional limitations
Functional limitations related to pain will be evaluated using the Pain Interference subscale of the Brief Pain Inventory (BPI). The Pain Interference subscale (7 items) measures the level of interference with function caused by pain on a scale from 0 to 10.
Measured: pre-intervention (week 4)
Functional limitations
Functional limitations related to pain will be evaluated using the Pain Interference subscale of the Brief Pain Inventory (BPI). The Pain Interference subscale (7 items) measures the level of interference with function caused by pain on a scale from 0 to 10.
Measured: post-intervention (week 8)
Pain Severity
Pain severity will be evaluated using the Pain Severity subscale of the Brief Pain Inventory. The Pain Severity subscale of the BPI includes four items that measure pain intensity from 0 to 10.
Measured: baseline
Pain Severity
Pain severity will be evaluated using the Pain Severity subscale of the Brief Pain Inventory. The Pain Severity subscale of the BPI includes four items that measure pain intensity from 0 to 10.
Measured: pre-intervention (week 4)
Pain Severity
Pain severity will be evaluated using the Pain Severity subscale of the Brief Pain Inventory. The Pain Severity subscale of the BPI includes four items that measure pain intensity from 0 to 10.
Measured: post-intervention (week 8)
Pain-related fear
The Tampa Scale for Kinesiophobia will be used to evaluate pain-related fear. This scale is a 11-item scale designed to assess beliefs and behaviours associated with pain. Higher scores indicate a higher level of kinesiophobia.
Measured: baseline
Pain-related fear
The Tampa Scale for Kinesiophobia will be used to evaluate pain-related fear. This scale is a 11-item scale designed to assess beliefs and behaviours associated with pain. Higher scores indicate a higher level of kinesiophobia.
Measured: pre-intervention (week 4)
Pain-related fear
The Tampa Scale for Kinesiophobia will be used to evaluate pain-related fear. This scale is a 11-item scale designed to assess beliefs and behaviours associated with pain. Higher scores indicate a higher level of kinesiophobia.
Measured: post-intervention (week 8)
Pain catastrophizing
The Pain Catastrophizing Scale will be used to evaluate pain catastrophizing. This scale is a 13-item scale designed to identify catastrophic thoughts about pain. Higher scores indicate a higher level of pain catastrophizing.
Measured: baseline
Pain catastrophizing
The Pain Catastrophizing Scale will be used to evaluate pain catastrophizing. This scale is a 13-item scale designed to identify catastrophic thoughts about pain. Higher scores indicate a higher level of pain catastrophizing.
Measured: pre-intervention (week 4)
Pain catastrophizing
The Pain Catastrophizing Scale will be used to evaluate pain catastrophizing. This scale is a 13-item scale designed to identify catastrophic thoughts about pain. Higher scores indicate a higher level of pain catastrophizing.
Measured: post-intervention (week 8)
Participants' satisfaction with their condition
The Patient Acceptable Symptom State (PASS) will be used to assess participants' satisfaction with their condition. It asks patients whether they are satisfied with their current state and to rate their satisfaction on a 0-10 numeric scale.
Measured: baseline
Participants' satisfaction with their condition
The Patient Acceptable Symptom State (PASS) will be used to assess participants' satisfaction with their condition. It asks patients whether they are satisfied with their current state and to rate their satisfaction on a 0-10 numeric scale.
Measured: pre-intervention (week 4)
Participants' satisfaction with their condition
The Patient Acceptable Symptom State (PASS) will be used to assess participants' satisfaction with their condition. It asks patients whether they are satisfied with their current state and to rate their satisfaction on a 0-10 numeric scale.
Measured: post-intervention (week 8)
Pain severity related to the intervention
Pain severity related to the intervention will be evaluated using the Pain Severity subscale of the Brief Pain Inventory. The Pain Severity subscale of the BPI includes four items that measure pain intensity from 0 to 10.
Measured: Immediately before, after and two days after each intervention (weeks 5 to 8)
Cybersickness
Cybersickness will be assess with the Simulator Sickness Questionnaire. This questionnaire contain questions about the intensity of symptoms related to the virtual reality intervention received.
Measured: Immediately after each intervention (weeks 5 to 8)
Sense of presence
The Presence Questionnaire will be used to assess the sense of presence. This questionnaire contains questions about different aspects of the sense of presence with regard to the experienced virtual environment and the task being completed.
Measured: Immediately after each intervention (weeks 5 to 8)
Satisfaction with interventions received
Participants will rate their satisfaction with treatment received ("not satisfied'', "satisfied'', "very much satisfied''), with the duration of treatments ("too short'', "long enough'', "too long''), with the frequency of treatments and with the time spent with the health professional during treatments ("not enough'', "just right'', "too much'') using a 3-item Likert scale.
Measured: post-intervention (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start15 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Related Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Sébastien Roy, Laval University
- Investigators
- Catherine Mercier, OT,PhD, Study director, Centre for Interdisciplinary Research in Rehabilitation and Social Integration (Cirris)Jean-Sébastien Roy, PT, PhD, Study director, Centre for Interdisciplinary Research in Rehabilitation and Social Integration (Cirris)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293312
- Sponsor's protocol ID
- 2025-3292
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are awaiting confirmation from the ethics research committee regarding permission to share individual participant data with other researchers. Once confirmed, we will outline the plan.