An interventional study of Virtual reality unimanual distraction task and Virtual reality bimanual distraction task in Rotator Cuff Related Shoulder Pain, sponsored by Laval University. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Laval University · Not applicable, Interventional, and Treatment
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:
Interventions
Four VR interventions will be tested:
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.
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.
657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.
This study's planned enrollment of 30 is below the median of 73 across 438 interventional studies indexed under Musculoskeletal Diseases.
Browse Musculoskeletal Diseases studies →Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
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
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.
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.
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.
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.
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.
Time frame: post-intervention (week 8)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: post-intervention (week 8)
Plan to share: 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.
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