Pain Rehabilitation Virtual Reality (PRVR): Innovations t... | NCT04636177

ID	Type	Description	Link
R21AR079140	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	NIH

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.	Behavioral: Standard Physiotherapy Rehabilitation (SPR)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pain Rehabilitation Virtual Reality (PRVR)	Behavioral	Participants will receive approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks. Adequate dose: 75% (6 of 8 sessions).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VR Duration of Use Per Week	This outcome is to assess Feasibility, Acceptability, and Utility of VR.	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.	End of treatment at 6-8 weeks, on average
Participant Rated Enjoyment	This outcome is to assess Feasibility, Acceptability, and Utility of VR.	End of treatment at 6-8 weeks, on average

Secondary Outcomes

Measure	Description	Time Frame
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.	Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Laura Simons, PhD	Stanford School of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Pain Management Clinic - Stanford Children's Health		Menlo Park	California	94025	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36508251	Derived	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.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Pain Rehabilitation Virtual Reality (PRVR)	PRVR participants are allocated a VR headset for use in their physical therapy sessions and as part of their home exercise program (approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks).
FG001	Standard Physiotherapy Rehabilitation (SPR)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 3, 2023

Arm/Group Information

ID	Title	Description
BG000	Pain Rehabilitation Virtual Reality (PRVR)	PRVR participants are allocated a VR headset for use in their physical therapy sessions and as part of their home exercise program (approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks).
BG001	Standard Physiotherapy Rehabilitation (SPR)	SPR participants are allocated to sessions that are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 as part of their home exercise program (8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks).
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00028 BG0016 BG00234

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG00028 BG0016 BG00234
Between 18 and 65 years

Sex/Gender, Customized

Count of Participants

Participants

Title

Denominators

Categories

Female

Title	Measurements
	BG00012 BG0014 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0002 BG0011 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00028 BG0016 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

VR Duration of Use Per Week

This outcome is to assess Feasibility, Acceptability, and Utility of VR.

Participants who completed the protocol

Posted

Mean

Standard Deviation

Minutes per week

Baseline to end of treatment across 6-8 weeks, on average

ID	Title	Description
OG000	Pain Rehabilitation Virtual Reality (PRVR)	PRVR participants are allocated a VR headset for use in their physical therapy sessions and as part of their home exercise program (approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks).
OG001	Standard Physiotherapy Rehabilitation (SPR)	SPR participants are allocated to sessions that are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 as part of their home exercise program (8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks).

Units	Counts
Participants	OG00025 OG0014

Title

Denominators

Categories

Title	Measurements
	OG00030.5± 39.52 OG00117.0± 6.36

Primary

Participant Rated Ease of Use

This outcome is to assess Feasibility, Acceptability, and Utility of VR.

Participants who completed the protocol

Posted

Count of Participants

Participants

End of treatment at 6-8 weeks, on average

ID	Title	Description
OG000	Pain Rehabilitation Virtual Reality (PRVR)	PRVR participants are allocated a VR headset for use in their physical therapy sessions and as part of their home exercise program (approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks).
OG001	Standard Physiotherapy Rehabilitation (SPR)	SPR participants are allocated to sessions that are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 as part of their home exercise program (8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks). Participants receive standard VR headset with relaxing games.

Units	Counts
Participants	OG000

Primary

Participant Rated Enjoyment

This outcome is to assess Feasibility, Acceptability, and Utility of VR.

Participants who completed the protocol

Posted

Count of Participants

Participants

End of treatment at 6-8 weeks, on average

ID	Title	Description
OG000	Pain Rehabilitation Virtual Reality (PRVR)	PRVR participants are allocated a VR headset for use in their physical therapy sessions and as part of their home exercise program (approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks).
OG001	Standard Physiotherapy Rehabilitation (SPR)	SPR participants are allocated to sessions that are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 as part of their home exercise program (8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks). Participants receive standard VR headset with relaxing games.

Units	Counts
Participants	OG000

Secondary

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.

Participants who were enrolled in the study were analyzed at baseline and those who completed treatment and 3-month follow-up surveys were analyzed at those timepoints.

Posted

Mean

Standard Deviation

score on a scale

Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment

ID	Title	Description
OG000	Pain Rehabilitation Virtual Reality (PRVR)	PRVR participants are allocated a VR headset for use in their physical therapy sessions and as part of their home exercise program (approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks).
OG001	Standard Physiotherapy Rehabilitation (SPR)	SPR participants are allocated to sessions that are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 as part of their home exercise program (8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks). Participants receive standard VR headset with relaxing games.

Secondary

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.

Participants who were enrolled in the study were analyzed at baseline and those who completed treatment and 3-month follow-up surveys were analyzed at those timepoints.

Posted

Mean

Standard Deviation

score on a scale

Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment

ID	Title	Description
OG000	Pain Rehabilitation Virtual Reality (PRVR)	PRVR participants are allocated a VR headset for use in their physical therapy sessions and as part of their home exercise program (approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks).
OG001	Standard Physiotherapy Rehabilitation (SPR)	SPR participants are allocated to sessions that are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 as part of their home exercise program (8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks). Participants receive standard VR headset with relaxing games.

Secondary

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.

Participants who were enrolled in the study were analyzed at baseline and those who completed treatment and 3-month follow-up surveys were analyzed at those timepoints.

Posted

Mean

Standard Deviation

score on a scale

Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment

ID	Title	Description
OG000	Pain Rehabilitation Virtual Reality (PRVR)	PRVR participants are allocated a VR headset for use in their physical therapy sessions and as part of their home exercise program (approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks).
OG001	Standard Physiotherapy Rehabilitation (SPR)	SPR participants are allocated to sessions that are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 as part of their home exercise program (8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks). Participants receive standard VR headset with relaxing games.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pain Rehabilitation Virtual Reality (PRVR)	PRVR participants are allocated a VR headset for use in their physical therapy sessions and as part of their home exercise program (approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks).	0	28	0	28	1	28
EG001	Standard Physiotherapy Rehabilitation (SPR)	SPR participants are allocated to sessions that are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 as part of their home exercise program (8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks).	0	6	0	6	0	6

ID	Term
D059350	Chronic Pain
D059352	Musculoskeletal Pain
D005356	Fibromyalgia

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases