Tuesday, December 30, 2025 12/30/2025

Feasibility Trial of a Novel Integrated Mindfulness and Acupuncture Program to Improve Outcomes after Spine Surgery (I-MASS)

Award Number: R34AT012082
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: 02/21/2023
PERIOD OF PERFORMANCE END DATE: 05/31/2026

Group Awards By:

View Award Description

Feasibility Trial of a Novel Integrated Mindfulness and Acupuncture Program to Improve Outcomes after Spine Surgery (I-MASS) - ABSTRACT Spine pain consistently ranks first or near the top in global rankings of disease burden, and epidemiological data suggest the burden is worsening. The number of low back surgeries has increased by 300% over the past 2 decades, accounting for approximately 30% of spine-related costs in the US. While it can provide cost- effective pain relief to some patients, up to 25% of those who undergo spine surgery will develop persistent pain requiring additional surgery, imaging, or other invasive interventions. Moreover, many patients will experience persistent opioid use, which carries significant risks of misuse, addiction, and overdose. Clinical practice guidelines strongly recommend the use of multimodal – or ‘mind and body’ – treatments for effective pain management after surgery. This approach combines interventions with analgesic or physical therapeutic inputs alongside interventions with psychological or behavioral inputs to better address the multifaceted risk factors for persistent pain and opioid use following surgery. Integration of Mindfulness delivered via mobile app (mHealth) with auricular Acupuncture (AA) in individuals undergoing Spine Surgery (I-MASS) is a highly promising multimodal treatment approach given the distinct yet complementary mechanisms by which mindfulness and AA influence pain after surgery. Establishing the effectiveness of I-MASS requires a rigorously designed pragmatic trial comparing it to usual medical care in adults who undergo spine surgery. However, trials of this size and scope require careful preparation. This proposed mixed methods R34 project is designed to answer important preparatory questions regarding the feasibility and acceptability of I-MASS through the following Specific Aims: 1) Conduct interviews with patient and care delivery stakeholders to refine and finalize the I-MASS intervention protocol by integrating mHealth mindfulness training and AA for use in patients age 18-80 undergoing spine surgery; 2) Conduct a single-site, exploratory randomized controlled clinical trial to assess the feasibility and acceptability of I-MASS in patients undergoing single-level laminectomy, discectomy or fusion; and 3) Use feasibility trial results to develop and submit a competitive research proposal to NIH for a multi-site, pragmatic, randomized comparative effectiveness clinical trial designed to rigorously evaluate I-MASS compared to mHealth mindfulness, AA, and usual care augmented with standard education. The results of this R34 project will provide the information needed to successfully execute on such a study and create new knowledge regarding the feasibility and acceptability of a highly innovative non-pharmacological multimodal approach designed to improve the lives of patients undergoing spine surgery.


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: 2026 ( Subtotal = $0 )
2026	2025	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Research and Training in Complementary and Integrative Health	000	3	10/7/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $217,350 )
2025	2025	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Research and Training in Complementary and Integrative Health	002	3	5/16/2025	NON-COMPETING CONTINUATION	$0
2025	2025	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Research and Training in Complementary and Integrative Health	001	3	11/19/2024	NON-COMPETING CONTINUATION	$217,350
2025	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Research and Training in Complementary and Integrative Health	000	2	10/21/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $217,350

Issue Date FY: 2024 ( Subtotal = $236,670 )
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Research and Training in Complementary and Integrative Health	000	2	11/17/2023	NON-COMPETING CONTINUATION	$217,350
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Research and Training in Complementary and Integrative Health	001	2	6/25/2024	NON-COMPETING CONTINUATION	$19,320
														Subtotal = $236,670

Issue Date FY: 2023 ( Subtotal = $241,500 )
2023	2023	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Research and Training in Complementary and Integrative Health	000	1	2/21/2023	NEW	$241,500
														Subtotal = $241,500

Grand Total All Awards = $695,520

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Feasibility Trial of a Novel Integrated Mindfulness and Acupuncture Program to Improve Outcomes after Spine Surgery (I-MASS)

Award Number: R34AT012082

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: 02/21/2023

PERIOD OF PERFORMANCE END DATE: 05/31/2026

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer