VR-Assisted Rehabilitation in Partial Supraspinatus Tears
Effects of Virtual Reality-Assisted Rehabilitation on Pain, Kinesiophobia, Quality of Life, and Supraspinatus Tendon Thickness in Patients With Partial Supraspinatus Tears: A Randomized Controlled Trial
This randomized controlled trial investigated the effects of virtual reality-assisted rehabilitation in patients with partial supraspinatus tendon tears. Partial supraspinatus tears are a common cause of shoulder pain, functional limitation, restricted range of motion, and fear of movement. Conservative rehabilitation is commonly used as first-line treatment, while evidence regarding immersive virtual reality rehabilitation in this patient population remains limited.
Participants were randomly allocated to either a virtual reality-assisted rehabilitation group or a conventional rehabilitation group. Both groups received the same physical therapy modalities, including hot pack, therapeutic ultrasound, and transcutaneous electrical nerve stimulation. The control group subsequently performed conventional therapeutic shoulder exercises, whereas the virtual reality group performed approximately equal-duration immersive VR-based exercises instead of the conventional exercise component. Outcomes included pain, shoulder range of motion, disability, kinesiophobia, health-related quality of life, and supraspinatus tendon thickness.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
This randomized controlled trial investigated the effects of immersive virtual reality-assisted rehabilitation in patients with partial supraspinatus tendon tears.
Partial supraspinatus tendon tears are a common cause of shoulder pain and functional impairment and may be associated with restricted shoulder range of motion, reduced quality of life, and increased fear of movement. Conservative rehabilitation is commonly used as first-line treatment and typically includes physical therapy modalities together with exercises aimed at restoring shoulder mobility, rotator cuff function, and scapular control.
Virtual reality allows patients to perform repetitive, task-oriented upper-extremity movements within an interactive environment. Such systems may support active participation and provide visual feedback during movement; however, evidence regarding immersive virtual reality rehabilitation specifically in patients with partial supraspinatus tendon tears remains limited.
Participants with MRI-confirmed partial supraspinatus tendon tears were randomly allocated to either a virtual reality-assisted rehabilitation group or a conventional rehabilitation group. Both groups received a standardized physical therapy program consisting of hot pack, therapeutic ultrasound, and transcutaneous electrical nerve stimulation.
Following these physical therapy modalities, participants in the control group performed approximately 30 minutes of supervised conventional therapeutic exercises targeting shoulder mobility, stretching, strengthening, and scapular stabilization. Participants in the virtual reality group instead performed approximately 30 minutes of immersive virtual reality-based upper-extremity exercise. Thus, the virtual reality intervention replaced the conventional therapeutic exercise component rather than being added as an additional treatment, and the scheduled exercise duration was approximately equivalent between groups.
The intervention was delivered over 15 sessions during three weeks, with five sessions per week. Evaluations were performed at baseline and after completion of treatment.
The study evaluated pain intensity, passive shoulder range of motion, shoulder pain and disability, kinesiophobia, health-related quality of life, and supraspinatus tendon thickness measured by ultrasonography. The aim was to compare immersive virtual reality-based exercise with conventional therapeutic exercise when delivered within an otherwise similar rehabilitation program.
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Çorum
-
Çorum, Çorum, Turkey (Türkiye), 19000
- Hitit University Erol Olçok Research Hospital Physical Medicine and Rehabilitation Clinic
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18 to 65 years
- Shoulder pain persisting for more than four weeks
- Partial supraspinatus tendon tear confirmed by shoulder magnetic resonance imaging
Exclusion Criteria:
- Physiotherapy treatment within the previous six months
- Shoulder injection within the previous six months
- History of tendon repair surgery
- Communication or cognitive impairment
- Vertigo, vestibular disorder, or another condition causing balance instability
- History of epilepsy or seizures
- Photosensitivity
- Diagnosed psychiatric condition, including an anxiety disorder or claustrophobia
- Additional orthopedic condition affecting the same shoulder
- Neurological, vascular, or cardiac disorder restricting functional capacity
- Pregnancy or breastfeeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: virtual reality group
Participants received the same physical therapy modalities as the control group, consisting of hot pack, therapeutic ultrasound, and transcutaneous electrical nerve stimulation.
They subsequently performed approximately 30 minutes of immersive virtual reality-based upper-extremity exercise using a Meta Quest Pro headset instead of the conventional therapeutic exercise component.
The virtual reality exercise was therefore a replacement rather than an additional treatment.
|
Participants received physical therapy modalities consisting of hot pack, therapeutic ultrasound, and transcutaneous electrical nerve stimulation.
They subsequently performed approximately 30 minutes of immersive virtual reality-based upper-extremity exercise using a Meta Quest Pro headset instead of the conventional therapeutic shoulder exercise component.
The virtual reality activities involved repetitive, task-oriented shoulder and upper-extremity movements within an interactive three-dimensional environment.
The intervention was delivered five days per week for three weeks, for a total of 15 sessions.
|
|
Active Comparator: Control Group
Participants received physical therapy modalities consisting of hot pack, therapeutic ultrasound, and transcutaneous electrical nerve stimulation.
They subsequently performed approximately 30 minutes of supervised conventional therapeutic shoulder exercises targeting shoulder mobility, stretching, strengthening, and scapular stabilization.
|
After receiving physical therapy modalities consisting of hot pack, therapeutic ultrasound, and transcutaneous electrical nerve stimulation, participants performed approximately 30 minutes of supervised conventional therapeutic shoulder exercise.
The program included scapular mobilization; stretching exercises for shoulder flexion, abduction, internal rotation, and external rotation; and strengthening exercises for the shoulder and scapular stabilizer muscles.
Exercises were performed in three sets of 10 repetitions.
The intervention was delivered five days per week for three weeks, for a total of 15 sessions.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity measured by the Numeric Rating Scale (NRS)
Time Frame: Baseline and after 3 weeks of treatment
|
Pain intensity at rest and during shoulder movement was assessed separately using an 11-point Numeric Rating Scale, ranging from 0 (no pain) to 10 (the worst pain imaginable).
Higher scores indicated greater pain intensity.
|
Baseline and after 3 weeks of treatment
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Passive range of motion (ROM) of the affected shoulder
Time Frame: Baseline and after 3 weeks of treatment
|
Passive range of motion of the affected shoulder, including flexion, extension, abduction, internal rotation, and external rotation, was measured in degrees using a Saehan goniometer.
Higher values indicated greater range of motion.
|
Baseline and after 3 weeks of treatment
|
|
Shoulder pain and disability measured using the Shoulder Pain and Disability Index (SPADI)
Time Frame: Baseline and after 3 weeks of treatment
|
The Shoulder Pain and Disability Index is a 13-item questionnaire comprising a five-item pain subscale and an eight-item disability subscale.
Pain, disability, and total scores are expressed on a scale from 0 to 100, with higher scores indicating greater pain and disability.
|
Baseline and after 3 weeks of treatment
|
|
Health-related quality of life measured using the Short Form-36 (SF-36)
Time Frame: Baseline and after 3 weeks of treatment
|
The Short Form-36 is a 36-item questionnaire comprising eight domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health.
Each domain is scored from 0 to 100, with higher scores indicating better health status.
|
Baseline and after 3 weeks of treatment
|
|
Kinesiophobia measured using the Tampa Scale of Kinesiophobia
Time Frame: Baseline and after 3 weeks of treatment
|
The Tampa Scale of Kinesiophobia is a 17-item questionnaire scored using a four-point Likert scale.
Total scores range from 17 to 68, with higher scores indicating greater fear of movement or reinjury.
|
Baseline and after 3 weeks of treatment
|
|
Supraspinatus tendon thickness measured using ultrasonography (USG)
Time Frame: Baseline and after 3 weeks of treatment
|
Supraspinatus tendon thickness was measured with the participant seated and the affected arm placed in the modified Crass position.
Using a Logiq V2 portable ultrasound device, the transducer was positioned longitudinally over the supraspinatus tendon, and tendon thickness was measured at the point of maximal thickness and recorded in centimeters.
The measurement procedure was based on the EURO-MUSCULUS shoulder scanning protocol.
|
Baseline and after 3 weeks of treatment
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2024-144
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.