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

Primary Purpose

Chronic Pain, Musculoskeletal Pain, Fibromyalgia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pain Rehabilitation Virtual Reality (PRVR)
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Sites / Locations

  • Pediatric Pain Management Clinic - Stanford Children's HealthRecruiting
  • California Rehabilitation and Sports TherapyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pain Rehabilitation Virtual Reality (PRVR)

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility, Acceptability, and Utility of VR
Acceptability will be assessed via collected use metrics (e.g. how long the app was played each day) and will also qualitatively at the end of treatment through interview questions related to acceptability, ease of use, comprehensibility, and suggestions for improvement. Qualitative responses will be described and summarized.

Secondary Outcome Measures

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. (score Min=0, Max=40; lower score indicates less fear and avoidance/better outcomes).
Physical Function: Lower Extremity
Lower Extremity Functional Scale (LEFS): a 20-item validated patient-reported measure of lower extremity function. (score Min=0, Max=80; lower score indicates greater disability/worse outcomes).
Physical Function: Upper Extremity
Upper Extremity Functional Index (UEFI): a 20- item validated patient-reported measures of

Full Information

First Posted
November 13, 2020
Last Updated
September 20, 2023
Sponsor
Stanford University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT04636177
Brief Title
Pain Rehabilitation Virtual Reality (PRVR): Innovations to Enhance Mobility in the Presence of Pain
Acronym
PRVR
Official Title
Pain Rehabilitation Virtual Reality (PRVR): Innovations to Enhance Mobility in the Presence of Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. The intervention includes standard physiotherapy treatment including functional goal setting and progressive exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Musculoskeletal Pain, Fibromyalgia, Virtual Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pain Rehabilitation Virtual Reality (PRVR)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pain Rehabilitation Virtual Reality (PRVR)
Intervention Description
Participants will receive approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks. Adequate dose: 75% (6 of 8 sessions).
Primary Outcome Measure Information:
Title
Feasibility, Acceptability, and Utility of VR
Description
Acceptability will be assessed via collected use metrics (e.g. how long the app was played each day) and will also qualitatively at the end of treatment through interview questions related to acceptability, ease of use, comprehensibility, and suggestions for improvement. Qualitative responses will be described and summarized.
Time Frame
Baseline to end of treatment at 6-8 weeks, on average
Secondary Outcome Measure Information:
Title
Pain-related Fear and Avoidance
Description
Fear of Pain Questionnaire Short Form (FOPQ- SF): a 10-item validated patient-reported measure of pain-related fear and avoidance. (score Min=0, Max=40; lower score indicates less fear and avoidance/better outcomes).
Time Frame
Baseline to end of treatment at 6-8 weeks, on average
Title
Physical Function: Lower Extremity
Description
Lower Extremity Functional Scale (LEFS): a 20-item validated patient-reported measure of lower extremity function. (score Min=0, Max=80; lower score indicates greater disability/worse outcomes).
Time Frame
Baseline to end of treatment at 6-8 weeks, on average
Title
Physical Function: Upper Extremity
Description
Upper Extremity Functional Index (UEFI): a 20- item validated patient-reported measures of
Time Frame
Baseline to end of treatment at 6-8 weeks, on average

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Jehl, BS
Phone
(650) 725-8111
Email
njehl@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lab Manager
Email
pedspainlab@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Simons, PhD
Organizational Affiliation
Stanford School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Pain Management Clinic - Stanford Children's Health
City
Menlo Park
State/Province
California
ZIP/Postal Code
94025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Jehl, BS
Phone
650-725-8111
Email
njehl@stanford.edu
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
650-665-3253
Email
pedspainlab@stanford.edu
First Name & Middle Initial & Last Name & Degree
Laura E Simons, PhD
Facility Name
California Rehabilitation and Sports Therapy
City
Palo Alto
State/Province
California
ZIP/Postal Code
94306
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kurt Koeppen, PT
Email
kkoeppen@prnpt.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Proposals should be directed to Dr. Laura Simons at lesimons@stanford.edu. To gain access, data requestors will need to sign a data access agreement with Stanford University.

Learn more about this trial

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

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