Chronic PainPRVRNCT04636177

Pain Rehabilitation Virtual Reality (PRVR): Innovations to Enhance Mobility in the Presence of Pain

A study testing Pain Rehabilitation Virtual Reality (PRVR) and Standard Physiotherapy Rehabilitation (SPR) in people with Chronic Pain and Musculoskeletal Pain, run by Stanford University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The proposed research is a single arm feasibility trial of pain rehabilitation virtual reality (PRVR) aimed at measuring feasibility, acceptability and utility of VR as well as changes in physical function and fear for adolescents with chronic musculoskeletal pain. Read more about this study

Who is it for?: Ages 10 to 17 years
Conditions the study is for: Chronic Pain, Musculoskeletal Pain, Fibromyalgia
What is being tested?: Pain Rehabilitation Virtual Reality (PRVR) and Standard Physiotherapy Rehabilitation (SPR)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 2 sitesUnited States
Study dates: 10 Mar 2022to 7 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 10 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

10 to 17 years old
Musculoskeletal pain (e.g. localized [back, limb], diffuse) not due to acute trauma (e.g. active sprain or fracture)
English Language Proficiency

Who cannot join

Significant cognitive impairment (e.g., brain injury)
Significant medical or psychiatric problem that would interfere (e.g. psychosis, suicidality)
Presents with a condition that interferes with virtual reality usage (e.g., history of seizure, facial injury precluding safe placement of headset, visual impairment, significant hearing impairment impact ability to follow audio instructions).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Pediatric Pain Management Clinic - Stanford Children's Health
Menlo Park, California, 94025
California Rehabilitation and Sports Therapy
Palo Alto, California, 94306

Other trials in United States

About this study

Conditions: Chronic Pain, Musculoskeletal Pain, Fibromyalgia, Virtual Reality
Being tested: Pain Rehabilitation Virtual Reality (PRVR), Standard Physiotherapy Rehabilitation (SPR)
Medical subject headings: Chronic Pain, Musculoskeletal Pain, Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pain Rehabilitation Virtual Reality (PRVR)Behavioural
Participants will receive approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks. Adequate dose: 75% (6 of 8 sessions).
Standard Physiotherapy Rehabilitation (SPR)Behavioural
Participants allocated to either intervention arm will receive 8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks. Adequate dose: 75% (6 of 8 sessions).

Study groups in NCT04636177
Study group	Role	What they receive
Pain Rehabilitation Virtual Reality (PRVR)	Experimental	Participants will complete VR in PT to engage participants in a series of immersive games customized to align with individual PT needs delivered over ~6-12 weeks or until clinician believes the patient is done with treatment. Patients in the PRVR arm will be given a structured HEP to practice prescribed exercises at home with integrated VR activities. PRVR participants will be allocated a VR headset for use in PT sessions and with HEP. VR will supplement treatment and be used in session (either in-person or telehealth) and at home as part of their prescribed treatment homework. Receives: Behavioral: Pain Rehabilitation Virtual Reality (PRVR)
Standard Physiotherapy Rehabilitation (SPR)	Active comparator	Sessions are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 consisting of 1) therapeutic exercise, 2) balance and proprioception, 3) strength training, and 4) use of modalities (e.g., heat/cold pack). Patients will be given a structured Home Exercise Program (HEP) with prescribed exercises for home. SPR participants will be allocated a VR headset for recreational use. Receives: Behavioral: Standard Physiotherapy Rehabilitation (SPR)

What is being measured

The primary outcome is the main question the study is designed to answer.

VR Duration of Use Per Week
This outcome is to assess Feasibility, Acceptability, and Utility of VR.
Measured: Baseline to end of treatment across 6-8 weeks, on average
Participant Rated Ease of Use
This outcome is to assess Feasibility, Acceptability, and Utility of VR.
Measured: End of treatment at 6-8 weeks, on average
Participant Rated Enjoyment
This outcome is to assess Feasibility, Acceptability, and Utility of VR.
Measured: End of treatment at 6-8 weeks, on average

Secondary outcomes (3)

Pain-related Fear and Avoidance
Fear of Pain Questionnaire Short Form (FOPQ- SF): a 10-item validated patient-reported measure of pain-related fear and avoidance. Total score range: Min=0, Max=40; lower score indicates less fear and avoidance/better outcomes.
Measured: Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment
Physical Function: Lower Extremity
Lower Extremity Functional Scale (LEFS): a 20-item validated patient-reported measure of lower extremity function. Overall score range: Min=0, Max=80; lower score indicates greater disability/worse outcomes.
Measured: Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment
Physical Function: Upper Extremity
Upper Extremity Functional Index (UEFI): a 20- item validated patient-reported measures of upper extremity functioning. Overall score range: 0 to 80, with greater scores indicating increased upper extremity functioning.
Measured: Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Mar 20227 Dec 2024

First posted19 Nov 2020
Study start10 Mar 2022
Primary completion7 Dec 2024
Study completion7 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04636177
Sponsor's protocol ID: 68669
Other IDs: R21AR079140
Acronym: PRVR
Status last verified: Oct 2025
First submitted: 13 Nov 2020
Last updated: 14 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data (text, tables, figures, appendices) that underlie the results reported in an article related to this trial will, after de-identification, be shared with researchers who provide a methodologically sound proposal.

Publications

Simons LE, Hess CW, Choate ES, Van Orden AR, Tremblay-McGaw AG, Menendez M, Boothroyd DB, Parvathinathan G, Griffin A, Caruso TJ, Stinson J, Weisman A, Liu T, Koeppen K. Virtual Reality-Augmented Physiotherapy for Chronic Pain in Youth: Protocol for a Randomized Controlled Trial Enhanced With a Single-Case Experimental Design. JMIR Res Protoc. 2022 Dec 12;11(12):e40705. doi: 10.2196/40705.
PubMed 36508251

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain

All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pain Rehabilitation Virtual Reality (PRVR): Innovations to Enhance Mobility in the Presence of Pain
ClinicalTrials.gov ID: NCT04636177
Acronym / sponsor ID: PRVR / 68669
Conditions: Chronic Pain, Musculoskeletal Pain, Fibromyalgia, Virtual Reality
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study start: 10 Mar 2022 (actual)
Primary completion: 7 Dec 2024 (actual)
Study completion: 7 Dec 2024 (actual)
First posted: 19 Nov 2020 (actual)
Results: Posted 14 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Pain Rehabilitation Virtual Reality (PRVR)	Experimental	Behavioral: Pain Rehabilitation Virtual Reality (PRVR)Participants will complete VR in PT to engage participants in a series of immersive games customized to align with individual PT needs delivered over ~6-12 weeks or until clinician believes the patient is done with treatment. Patients in the PRVR arm will be given a structured HEP to practice prescribed exercises at home with integrated VR activities. PRVR participants will be allocated a VR headset for use in PT sessions and with HEP. VR will supplement treatment and be used in session (either in-person or telehealth) and at home as part of their prescribed treatment homework.
Standard Physiotherapy Rehabilitation (SPR)	Active comparator	Behavioral: Standard Physiotherapy Rehabilitation (SPR)Sessions are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 consisting of 1) therapeutic exercise, 2) balance and proprioception, 3) strength training, and 4) use of modalities (e.g., heat/cold pack). Patients will be given a structured Home Exercise Program (HEP) with prescribed exercises for home. SPR participants will be allocated a VR headset for recreational use.

Who may qualify

Ages: 10 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

10 to 17 years old
Musculoskeletal pain (e.g. localized [back, limb], diffuse) not due to acute trauma (e.g. active sprain or fracture)
English Language Proficiency

Key exclusion criteria (3 listed)

Significant cognitive impairment (e.g., brain injury)
Significant medical or psychiatric problem that would interfere (e.g. psychosis, suicidality)
Presents with a condition that interferes with virtual reality usage (e.g., history of seizure, facial injury precluding safe placement of headset, visual impairment, significant hearing impairment impact ability to follow audio instructions).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pain Rehabilitation Virtual Reality (PRVR)Participants will receive approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks. Adequate dose: 75% (6 of 8 sessions).	Behavioural	Pain Rehabilitation Virtual Reality (PRVR)
Standard Physiotherapy Rehabilitation (SPR)Participants allocated to either intervention arm will receive 8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks. Adequate dose: 75% (6 of 8 sessions).	Behavioural	Standard Physiotherapy Rehabilitation (SPR)

Primary outcome

VR Duration of Use Per Week
Time frame: Baseline to end of treatment across 6-8 weeks, on average
This outcome is to assess Feasibility, Acceptability, and Utility of VR.
Participant Rated Ease of Use
Time frame: End of treatment at 6-8 weeks, on average
This outcome is to assess Feasibility, Acceptability, and Utility of VR.
Participant Rated Enjoyment
Time frame: End of treatment at 6-8 weeks, on average
This outcome is to assess Feasibility, Acceptability, and Utility of VR.

3 secondary outcomes

Pain-related Fear and Avoidance
Time frame: Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment
Physical Function: Lower Extremity
Time frame: Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment
Physical Function: Upper Extremity
Time frame: Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment

Results and safety

Results posted to the registry on 14 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pain Rehabilitation Virtual Reality (PRVR)	4	3
Standard Physiotherapy Rehabilitation (SPR)	6	4

Primary outcome: VR Duration of Use Per Week

Time frame: Baseline to end of treatment across 6-8 weeks, on average. Mean (Standard Deviation). Unit: Minutes per week

Measure	Pain Rehabilitation Virtual Reality (PRVR) n = 25	Standard Physiotherapy Rehabilitation (SPR) n = 4
Value	30.5 (39.52)	17.0 (6.36)

Population analysed: Participants who completed the protocol

Primary outcome: Participant Rated Ease of Use

Time frame: End of treatment at 6-8 weeks, on average. Count of participants. Unit: Participants

Measure	Pain Rehabilitation Virtual Reality (PRVR) n = 25	Standard Physiotherapy Rehabilitation (SPR) n = 4
Very easy	13	0
Easy	6	3
A little easy	4	0
Not at all easy	0	0
No Response	2	1

Population analysed: Participants who completed the protocol

Primary outcome: Participant Rated Enjoyment

Time frame: End of treatment at 6-8 weeks, on average. Count of participants. Unit: Participants

Measure	Pain Rehabilitation Virtual Reality (PRVR) n = 25	Standard Physiotherapy Rehabilitation (SPR) n = 4
Enjoyed very much	5	0
Enjoyed	10	0
Enjoyed a little	5	3
Not at all	0	0
No response	5	1

Population analysed: Participants who completed the protocol

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pain Rehabilitation Virtual Reality (PRVR)	0 of 28 (0%)	1 of 28 (3.6%)	0 of 28
Standard Physiotherapy Rehabilitation (SPR)	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36508251Simons LE, Hess CW, Choate ES, Van Orden AR, Tremblay-McGaw AG, Menendez M, Boothroyd DB, Parvathinathan G, Griffin A, Caruso TJ, Stinson J, Weisman A, Liu T, Koeppen K. Virtual Reality-Augmented Physiotherapy for Chronic Pain in Youth: Protocol for a Randomized Controlled Trial Enhanced With a Single-Case Experimental Design. JMIR Res Protoc. 2022 Dec 12;11(12):e40705. doi: 10.2196/40705.
Individual participant dataSharing planned: Yes. Individual participant data (text, tables, figures, appendices) that underlie the results reported in an article related to this trial will, after de-identification, be shared with researchers who provide a methodologically sound proposal.

Related trials for Chronic Pain

Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laura Simons, PhD principal investigator

Stanford School of Medicine

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VR Duration of Use Per Week (time frame: Baseline to end of treatment across 6-8 weeks, on average). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04636177, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.