Wednesday, April 24, 2024 4/24/2024

Randomized-controlled trial of virtual reality for chronic low back pain to improve patient-reported outcomes and physical activity

Award Number: UH3AR076573
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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PROJECT SUMMARY Chronic low back pain (cLBP) is a prevalent and costly condition that markedly impairs physical, emotional, and social function. Despite its overwhelming burden of illness, with one in four adults reporting frequent back pain, available drug therapies are limited in their ability to provide lasting benefits and improve health-related quality of life (HRQOL). Patients with cLBP frequently turn to opioids when other pharmacotherapies fail to provide adequate analgesia, yet often discover that opioids also fall short in delivering meaningful pain reduction or improving HRQOL. Hence, there is a critical gap in pain management in cLBP; it is vital to address this evidence gap in a way that maximizes benefits for patients while minimizing harms from medical therapy. Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for musculoskeletal pain, including cLBP. Users of VR wear a pair of goggles with a close-proximity stereoscopic screen that creates a sensation of being transported into lifelike, three-dimensional worlds. By stimulating the visual cortex while engaging other senses, VR modulates the user’s processing of nociceptive stimuli. Functional magnetic resonance imaging (fMRI) of the brain reveals that VR has similar effects on the sensory and insular cortex as opioids, and head-to-head trials show that VR achieves similar or greater analgesia as hydromorphone. However, there are few data regarding long-term efficacy and safety of VR in cLBP. To date, VR has been limited to short-term clinical trials. In addition, limited research exists on VR modalities beyond mere distraction, such as VR therapy that teaches exportable skills using cognitive behavioral therapy (CBT), guided meditation, and biofeedback-based breathing exercises. To address these gaps, we propose to measure patient-reported outcomes (PROs), biometric outcomes, and opioid use in 360 nonspecific cLBP patients randomized among 3 groups and followed for 90 days: (1) immersive skills-based VR therapy; (2) immersive distraction VR therapy; and (3) non-immersive sham VR using 2D videos displayed in a VR headset. The results will inform best practices for implementing VR in cLBP and identify patient-level predictors of efficacy.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	WEST HOLLYWOOD	CA	90048	LOS ANGELES	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	5	12/15/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $785,247 )
2023	2023	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	WEST HOLLYWOOD	CA	90048	LOS ANGELES	USA	Arthritis, Musculoskeletal and Skin Diseases Research	002	5	8/29/2023	SUPPLEMENT FOR EXPANSION	$81,760
2023	2023	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	WEST HOLLYWOOD	CA	90048	LOS ANGELES	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	5	8/4/2023	NON-COMPETING CONTINUATION	$621,894
2023	2023	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	WEST HOLLYWOOD	CA	90048	LOS ANGELES	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	4	5/25/2023	SUPPLEMENT FOR EXPANSION	$81,593
														Subtotal = $785,247

Issue Date FY: 2022 ( Subtotal = $1,009,520 )
2022	2022	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	WEST HOLLYWOOD	CA	90048	LOS ANGELES	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	4	8/11/2022	NON-COMPETING CONTINUATION	$837,772
2022	2022	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	WEST HOLLYWOOD	CA	90048	LOS ANGELES	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	4	8/12/2022	SUPPLEMENT FOR EXPANSION	$171,748
														Subtotal = $1,009,520

Issue Date FY: 2021 ( Subtotal = $1,372,989 )
2021	2021	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	LOS ANGELES	CA	90048	LOS ANGELES	USA	Arthritis, Musculoskeletal and Skin Diseases Research	002	3	9/21/2021	SUPPLEMENT FOR EXPANSION	$137,134
2021	2021	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	LOS ANGELES	CA	90048	LOS ANGELES	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	3	9/17/2021	SUPPLEMENT FOR EXPANSION	$398,083
2021	2021	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	LOS ANGELES	CA	90048	LOS ANGELES	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	8/20/2021	NON-COMPETING CONTINUATION	$837,772
														Subtotal = $1,372,989

Issue Date FY: 2020 ( Subtotal = $1,199,516 )
2020	2020	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	LOS ANGELES	CA	90048	LOS ANGELES	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	9/21/2020	EXTENSION WITH OR WITHOUT FUNDS	$1,199,516
														Subtotal = $1,199,516

Grand Total All Awards = $4,367,272

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Randomized-controlled trial of virtual reality for chronic low back pain to improve patient-reported outcomes and physical activity

Award Number: UH3AR076573

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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