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Spinal Manipulative Therapy vs. Prescription Drug Therapy for Care of Aged Medicare Beneficiaries with Neck Pain

Award Number: R15AT010035
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2018
PERIOD OF PERFORMANCE END DATE: 04/30/2025

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Spinal Manipulative Therapy vs. Prescription Drug Therapy for Care of Aged Medicare Beneficiaries with Neck Pain - An estimated 3.9 million older US adults suffer from Neck Pain (NP), the fourth leading cause of disability worldwide. However, little is known about the comparative value of current treatment approaches to NP. The management of spine pain in the United States is inefficient, costly, and sometimes hazardous. Thus, there is an acute need to evaluate non-pharmaceutical treatment alternatives and identify safe, high-value management strategies. The need is critical for older adults with NP, who tend to be comorbid, vulnerable to adverse events, and prone to the utilization of high-cost interventions. Prescription drug therapy (PDT) and spinal manipulative therapy (SMT) are widely used treatment strategies for NP, but their comparative value for NP is uncertain. Because NP is often persistent, many patients feel compelled to seek ongoing care, but the chronic use of PDT (primarily opioids and NSAIDs) for NP raises safety concerns, particularly for the elderly. The utilization of SMT - which shows similar effectiveness to other interventions in systematic reviews - is often limited by insurers because the value of prolonged treatment is also uncertain. There is, therefore, a pressing need to compare the long-term value of these two approaches (SMT and PDT) for management of NP in Medicare beneficiaries. The overall objective of this project is to assess both short- and long-term value of SMT as compared to PDT for management of NP in older Medicare beneficiaries. With active engagement of students, this project is also intended to strengthen the research environment at Southern California University of Health Sciences. The central hypothesis is that utilization of SMT for NP offers superior value as compared to PDT. The central hypothesis will be tested objectively by pursuing three related but independent specific aims: (1) compare the short- and long-term safety of SMT vs. PDT as measured by the likelihood of adverse outcomes, (2) compare the short- and long-term efficiency of SMT vs. PDT as measured by rates of escalation of care for NP, and (3) compare the short- and long-term costs of SMT vs. PDT as measured by payer expenditures and patient cost sharing. Rigorous methods intended to reduce risk of bias and confounding will include weighted propensity scoring and instrumental variable methodology. The approach to this research is innovative because relatively little is known about the value of non-pharmacological treatment approaches for NP among older adults. This project promises to challenge the status quo by assessing the value of a non- pharmacologic alternative to high-risk prescription drugs. Evidence of the superior value of SMT for care of NP will facilitate an innovative shift away from the hazards of chronic analgesic use and toward non- pharmacological interventions. The project also includes a practical plan for introducing large-scale health services research – with student participation - to two educational institutions that train complementary and integrative healthcare clinicians. The research contribution is expected to be significant because evidence favoring SMT promises to improve the safety, efficiency, and value of care for older adults with NP.


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: 2025 ( Subtotal = $0 )
2025	2022	SOUTHERN CALIFORNIA UNIVERSITY OF HEALTH SCIENCES	16200 AMBER VALLEY DR	WHITTIER	CA	90604	LOS ANGELES	USA	Research and Training in Complementary and Integrative Health	000	2	9/11/2025	COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	SOUTHERN CALIFORNIA UNIVERSITY OF HEALTH SCIENCES	16200 AMBER VALLEY DR	WHITTIER	CA	90604	LOS ANGELES	USA	Research and Training in Complementary and Integrative Health	000	2	9/16/2024	COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = -$1 )
2023	2018	SOUTHERN CALIFORNIA UNIVERSITY OF HEALTH SCIENCES	16200 AMBER VALLEY DR	WHITTIER	CA	90604	LOS ANGELES	USA	Research and Training in Complementary and Integrative Health	000	1	11/21/2022	NEW	-$1
														Subtotal = -$1

Issue Date FY: 2022 ( Subtotal = $459,595 )
2022	2022	SOUTHERN CALIFORNIA UNIVERSITY OF HEALTH SCIENCES	16200 AMBER VALLEY DR	WHITTIER	CA	90604	LOS ANGELES	USA	Research and Training in Complementary and Integrative Health	001	2	8/29/2022	COMPETING CONTINUATION	$459,595
2022	2018	SOUTHERN CALIFORNIA UNIVERSITY OF HEALTH SCIENCES	16200 AMBER VALLEY DR	WHITTIER	CA	90604	LOS ANGELES	USA	Research and Training in Complementary and Integrative Health	000	1	11/30/2021	NEW	$0
														Subtotal = $459,595

Issue Date FY: 2018 ( Subtotal = $437,831 )
2018	2018	SOUTHERN CALIFORNIA UNIVERSITY OF HEALTH SCIENCES	16200 E AMBER VALLEY DR	WHITTIER	CA	90604	LOS ANGELES	USA	Research and Training in Complementary and Integrative Health	000	1	7/18/2018	NEW	$437,831
														Subtotal = $437,831

Grand Total All Awards = $897,425

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Spinal Manipulative Therapy vs. Prescription Drug Therapy for Care of Aged Medicare Beneficiaries with Neck Pain

Award Number: R15AT010035

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/01/2018

PERIOD OF PERFORMANCE END DATE: 04/30/2025

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