Wednesday, February 5, 2025 2/5/2025

Physical Therapy Integrated with Mindfulness for Patients with Chronic Musculoskeletal Pain and Long-Term Opioid Treatment

Award Number: R01AT012229
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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PROJECT SUMMARY/ABSTRACT An estimated 20%–30% of persons with chronic musculoskeletal pain (CMP) use opioids for pain management. In recent years, the prevalence of long-term opioid treatment (LTOT) has increased in patients with musculoskeletal pain. Particularly concerning are the significant LTOT-related risks (e.g., opioid-related abuse, overdose, and death). Physical therapy (PT) is a common nonpharmacologic management strategy recommended for CMP. The majority of patients in outpatient PT clinics have musculoskeletal pain, and at least one in three use prescription opioids. Combining exercise-based interventions with mindfulness practices is effective for patients with CMP, and engaging in mindfulness practices leads to a reduction in opioid dose in patients with chronic pain and LTOT. However, the impact of physical therapist-led mindfulness-based interventions integrated with evidence-based PT (I-EPT) to manage patients with CMP and LTOT has not been elucidated. Our overall goal is to develop effective, scalable strategies to manage patients with CMP and LTOT in the PT setting. In response to the FOA PAR-21-241 for multisite feasibility clinical trials of mind and body interventions, this proposal focuses on evaluating the feasibility of conducting a fully-powered clinical trial that tests I-EPT. In preparation for a fully-powered trial, we propose a before and after multi-site feasibility clinical trial conducted in PT clinics located in an academic health care system in the Intermountain West and PT clinics that are part of a rehabilitation system in the Southeast. We will evaluate the feasibility of providing I- EPT to patients with CMP and LTOT by carrying 3 Specific Aims. Aim 1: Refine and manualize the I-EPT treatment protocol for patients with CMP and LTOT. Our approach will use semi-structured interviews of patients and physical therapists to refine I-EPT. Using the results of the semi-structured interviews, we will manualize the I-EPT treatment protocol. Aim 2: Evaluate different intensities of a physical therapist training programs for the refined I-EPT treatment protocol. Our approach will be to randomize physical therapists 2:1 to training and no training groups. The training group will include a high intensity training (HighIT) program and a low intensity training program (LowIT). Following the training programs, we will examine immediate post- training competency in providing I-EPT using a standardized patient simulation. Aim 3: Evaluate the feasibility of the I-EPT intervention across domains of the RE-AIM framework. Our approach will be to pilot test the refined I-EPT treatment protocol in patients managed by physical therapists randomized to training and no training arms. We will use mixed-methods to assess feasibility outcomes. The results of this feasibility study will inform the design and execution of our planned fully powered clinical trial and could lead to improved management of patients with CPM and LTOT.


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 = $479,708 )
2025	2025	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Research and Training in Complementary and Integrative Health	000	3	11/27/2024	NON-COMPETING CONTINUATION	$479,708
														Subtotal = $479,708

Issue Date FY: 2024 ( Subtotal = $524,036 )
2024	2024	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Research and Training in Complementary and Integrative Health	000	2	11/17/2023	NON-COMPETING CONTINUATION	$481,258
2024	2024	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Research and Training in Complementary and Integrative Health	002	2	5/10/2024	NON-COMPETING CONTINUATION	$42,778
2024	2024	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Research and Training in Complementary and Integrative Health	003	2	6/6/2024	NON-COMPETING CONTINUATION	$0
2024	2024	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Research and Training in Complementary and Integrative Health	001	2	3/4/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $524,036

Issue Date FY: 2023 ( Subtotal = $534,213 )
2023	2023	UNIVERSITY OF UTAH, THE	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Research and Training in Complementary and Integrative Health	000	1	12/26/2022	NEW	$534,213
														Subtotal = $534,213

Grand Total All Awards = $1,537,957

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Physical Therapy Integrated with Mindfulness for Patients with Chronic Musculoskeletal Pain and Long-Term Opioid Treatment

Award Number: R01AT012229

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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