On May 10, 2024, we hit our enrollment goal of 766 veterans in the VERDICT clinical trial. We will complete data collection in May 2025 and will share the results in summer/fall 2025.
Project Description
Funding Source: NIH/NCCIH
Grant Number: UH3-AT009761
Award Amount:$7,087,730
Performance Period: 09/15/2017 – 09/14/2022
Principal Investigators: Cynthia Long, Ph.D., Christine Goertz, D.C., Ph.D.
Co-Investigators: Erin Krebs, M.D., M.P.H., Thad Abrams, M.D., M.S., Anthony Lisi, D.C., Jon Lurie, M.D., M.S., Paul Shekelle, M.D., Ph.D., Robert Wallace, M.D., M.Sc., Stacie Salsbury, Ph.D., Robert Vining, D.C., Richard Branson, D.C., Sally Haskell, M.D., Kei-Hoi Cheung, Ph.D.
Clinical Research Specialist: Elissa Twist, D.C., M.S., CCRP
Study Coordinators: Anna Walden-Cobb, D.C., M.S., CCRC, Rebecca Rudquist, Kena McDermott, D.C., M.S., James Faria, B.S.
Description: Two linked pragmatic randomized clinical trials in four VA sites in veterans with chronic LBP; Phase 1: low dose (1-5 visits) vs. high dose (8-12 visits) over 10 weeks; Phase 2: scheduled monthly chiropractic visits vs. no chiropractic visits over 42 weeks.
Collaborating Institutions: VA Connecticut Healthcare System, Minneapolis VA Health Care System, Iowa City VA Health Care System, VA Greater LA Healthcare System, University of Iowa College of Public Health, Yale University Section of Biomedical Informatics and Data Science, The Dartmouth Institute for Health Policy & Clinical Practice, Duke Clinical Research Institute
Site Locations: VA Connecticut Healthcare System, Minneapolis VA Health Care System, Iowa City VA Health Care System
Presentations
Long C, Muller R, Cheung KH, Bathulapalli H, Vining R, Goertz C, Lisi A. Components of multimodal chiropractic care in a pragmatic clinical trial of U.S. military veterans with chronic low back pain. WFC Biennial Congress, October 11-14, 2023, Queensland, Australia.
Baca K, Salsbury S, Goertz C, Long C. Motivators, experiences, and expectations of US military veterans receiving chiropractic care: A nested qualitative study from a pragmatic trial for low back pain. WFC Biennial Congress, October 11-14, 2023, Queensland, Australia.
Roytman Gr, Cheung KH, Bathulapalli H, Goertz CM, Long CR, Lisi AJ. Preliminary analysis of chiropractic electronic record template in a multisite randomized clinical trial. ACC-RAC Conference, July 24-27, 2022, San Diego, CA.
Roytman GR, Cheung KH, Bathulapalli H, Goertz CM, Long CR, Lisi A. Use of a low back electronic health record tool in a multisite randomized pragmatic clinical trial. International Congress on Integrative Medicine & Health, May 23-26, 2022, Phoenix, AZ.
Salsbury SA, Javier S, Katsovich L, Midboe A. COVID impacts on pragmatic trials of nonpharmacological approaches to pain management: a mixed methods evaluation. International Congress on Integrative Health & Medicine, May 23-26, 2022, Phoenix, AZ.
Long CR, Lisi AJ, Vining RD, Wallace RB, Salsbury SA, Shannon ZK, Halloran S, Minkalis AL, Corber L, Shekelle PG, Krebs EE, Abrams TE, Lurie JD, Goertz CM. Veteran response to dosage in chiropractic therapy (VERDICT): Study protocol of a pragmatic randomized trial for chronic low back pain. WFC Biennial Congress, September 23-25, 2021, virtual.
Roytman G, Cheung KH, Bathulapalli H, Long C, Goertz C, Lisi A. Characteristics of virtual and face-to-face chiropractic visits in the Veterans Health Administration during the COVID-19 pandemic. WFC Biennial Congress, September 23-25, 2021, virtual.
Salsbury S, Wallace R, Lisi A, Roytman G, Twist E, McDermott K, Walden-Cobb A, Minkalis A, Kedilaya S, Vining R, Long C, Goertz C. Adapting a clinical trial protocol to support virtual chiropractic care delivery and research: planning responses to the evolving COVID-19 pandemic. WFC Biennial Congress, September 23-25, 2021, virtual.
Walden-Cobb A, Twist E, McDermott K, Kamopp C, Valle M, Rudquist R, Kedilaya S, Minkalis A, Goertz C, Long C. Development of Consent Procedure Using Multi-Modal Delivery for a Low Back Pain Study within the VA. WFC Biennial Congress, September 23-25, 2021, virtual.
Wallace R, Walden-Cobb A, Salsbury S, Roytman G, McDermott K, Lisi A, Goertz C. Benefits and Challenges of going Virtual: The Future of Research and Clinical Approaches to Musculoskeletal Care in US Military. WFC Biennial Congress, September 23-25, 2021, virtual.
Long CR, Lisi AJ, Vining RD, Wallace RB, Salsbury SA, Shannon ZK, Halloran S, Minkalis AL, Corber L, Shekelle PG, Krebs EE, Abrams TE, Lurie JD, Goertz CM. Veteran response to dosage in chiropractic therapy (VERDICT): study protocol of a pragmatic randomized trial for chronic low back pain. WFC Biennial Congress, September 23-25, 2021, virtual.
Roytman G, Cheung KH, Bathulapalli H, Long C, Goertz C, Lisi A. Characteristics of virtual and face-to-face chiropractic visits in the Veterans Health Administration during the COVID-19 pandemic. WFC Biennial Congress, September 23-25, 2021, virtual.
Salsbury S, Twist E, Wallace R, Vining R, Goertz C, Long C. Veteran perceptions of a single-arm pilot of chiropractic care for low back pain: a qualitative analysis. WFC Biennial Congress, September 23-25, 2021, virtual.
Salsbury S, Wallace R, Lisi A, Roytman G, Twist E, McDermott K, Walden-Cobb A, Minkalis A, Kedilaya S, Vining R, Long C, Goertz C. Adapting a clinical trial protocol to support virtual chiropractic care delivery and research: planning responses to the evolving COVID-19 pandemic. WFC Biennial Congress, September 23-25, 2021, virtual.
Twist E, Walden-Cobb AL, McDermott K, Karnopp C, Valle M, Rudquist R, Kedilaya S, Minkalis AL, Goertz CM, Long CR. Development of a consent procedure using a multi-modal delivery for a low back pain study within the VA Healthcare System. WFC Biennial Congress, September 23-26, 2021, virtual.
Wallace R, Walden-Cobb A, Salsbury S, Roytman G, McDermott K, Vining R, Lisi A, Goertz C. Benefits and challenges of going virtual: the future of research and clinical approaches to musculoskeletal care in US military Veterans. WFC Biennial Congress, September 23-25, 2021, virtual
Roytman G, Coleman B, Corcoran K, Goertz C, Long C, Lisi A. Rapid widespread adoption of telehealth for chiropractic care in the Department of Veterans Affairs during the COVID-19 pandemic. Association of Chiropractic Colleges Research Agenda Conference. March, 25-27, 2021. NBCE Research Award Winner
Vining R, Shannon Z, Corber L, Salsbury S, Minkalis A, Goertz C. A Chiropractic Decision Aid for Managing Low Back Pain in US Veterans Affairs Healthcare Facilities. WFC-ECU Congress, March 20-23, 2019, Berlin, Germany.
Publications
Yu Q, George SZ, Kyriakides TC, Rhon DI, Morasco BJ, Dziura J, Fritz JM, Geda M, Peduzzi P, Long CR. Adapting to change: Experiences and recommendations from the Pain Management Collaboratory on modifying statistical analysis plans. Pain Med, 2024;25(S1):S49-S53.
Dziura J, Gilstad-Hayden K, Coffman CJ, Long CR, Yu Q, Buta E, Coggeshall S, Geda M, Peduzzi P, Kyriakides TC. Recommendations for monitoring adherence and fidelity in pragmatic trials based on experiences in the Pain Management Collaboratory. Pain Med, 2024;25(S1):S41-S48.
Peduzzi P, Brandt C, Dearth CL, Dziura J, Farrakhi S, George SZ, Kyriakides TC, Long CR, Mascha EJ, Patterson CG, Rhon DI, Kerns RD. Utility of the PICOTS framework to assess clinical trial disruptions: Monitoring the impact of COVID-19 in the Pain Management Collaboratory. Pain Med, 2024;25(S1):S34-S40.
Burns A, Young-McCaughan S, Davis AF, Vining R, Ali J, Fritz JM, Morasco BJ, Rhon DI, Roogow R, Kyriakides TC, Kerns RD. Monitoring and reporting adverse events in pragmatic clinical trials testing nonpharmacological pain management interventions. Pain Med, 2024;25(S1):S64-S67).
Rhon DI, Davis AF, Ali J, Brand C, Burns A, Lucio W, Vining R, Young-McCaughan S. Ambiguity in care delivery terminology: Implications that affect pragmatic clinical trials using nonpharmacological interventions. BMJ Evid-Based Med. 2024 Sep 20;29(5):296-299.
Hays RD, Shannon ZK, Long CR, Spritzer KL, Vining RD, Coulter I, Pohlman KA, Walter J, Goertz CM. Health-related quality of life among United States service members with low back pain receiving usual care plus chiropractic care plus usual care vs usual care alone: secondary outcomes of a pragmatic clinical trial. Pain Med. 2022 Aug 1;23(9):1550-1559
Kerns RD, Burgess DJ, Coleman BC, Cook CE, Farrokhi S, Fritz JM, Goertz C, Heapy A, Lisi AJ, Rhon DI, Vining R. Chronic pain self-management: psychologically guided core competencies for providers. Pain Med. 2022 OCT;23(11):1815-1819.
Ali J, Antonelli M, Bastian L, Becker W, Brandt CA, Burgess DJ, Burns A, Cohen SP, Davis AF, Dearth CL, Dziura J, Edwards R, Erdos J, Farrokhi S, Fritz J, Geda M, George SZ, Goertz C, Goodie J, Hastings SN, Heapy A, Ilfeld BM, Katsovich L, Kerns RD, Kyriakides T, Lee A, Long CR, et.al. Optimizing the impact of pragmatic clinical trials for veteran and military populations: lessons from the Pain Management Collaboratory. Mil. Med. 2021 Nov 13;187(7-8):179-185.
Ali J, Davis AF, Burgess DJ, Rhon DI, Vining R, Young-McCaughan S, Green S, Kerns RD. Justice and equity in pragmatic clinical trials: considerations for pain research within integrated health systems. Learn. Health Syst. 2021;6(2): e10291.
Coleman BC, Purcell N, Geda M, Luther SL, Peduzzi P, Kerns RD, Seal KH, Burgess DJ, Rosen MI, Sellinger J, Salsbury SA, Gelman H, Brandt CA, Edwards RR. Assessing the impact of the COVID-19 pandemic on pragmatic clinical trial participants. Contemp. Clin. Trials Commun 2021; 111:106619.
Halloran SM, Coleman BC, Kawecki T, Long CR, Goertz C, Lisi A. Characteristics and practice patterns of Us Veteran Health Administration doctors of chiropractic: a cross-sectional survey. J Manipulative Physiol Ther 2021;44(7):535-545.
Roytman GR, Coleman BC, Corcoran KL, Goertz CM, Long CR, Lisi A. Changes in the use of telehealth and face-to-face chiropractic care in the Department of Veterans Affairs before and after the COVID-19 pandemic. J Manipulative Physiol Ther 2021;44(7):584-590.
Bastian LA, Cohen SP, Katsovich L, Becker WC, Brummett BR, Burgess DJ, Crunkhorn AE, Denneson LM, Frank JW, Goertz C, Ilfeld B, Kanzler KE, Krishnaswamy A, LaChappelle K, Martino S, Mattocks K, McGeary CA, Seal KH, Semiatin AM, Shin MH, Simon CB, Teyhen DS, Zamora K, Kerns RD. Stakeholder engagement in pragmatic clinical trials: emphasizing relationships to improve pain management delivery and outcomes. Pain Med 2020;21(S2): S13-S20.
Long CR, Lisi AJ, Vining RD, Wallace RB, Salsbury SA, Shannon ZK, Halloran S, Minkalis AL, Corber L, Shekelle PG, Krebs EE, Abrams TE, Lurie JD, Goertz CM. Veteran response to dosage in chiropractic therapy (VERDICT): study protocol of a pragmatic randomized trial for chronic low back pain. Pain Med 2020;21(S2): S37-S44.
Vining R, Shannon Z, Salsbury S, Corber L, Minkalis A, Goertz C. Development of a clinical decision aid for chiropractic management of common conditions causing low back pain in Veterans: results of a consensus process. J Manipulative Physiol Ther 2019;42(9):677-693.
Kerns RD, Brandt CA, Peduzzi P, Ali J, Antonelli M, Becker W, Burgess D, Burns A, Cohen SP, Dearth C, Dziura J, Erdos J, Farrokhi S, Fritz J, Geda M, George SZ, Goertz C, Goodie J, Hastings S, Heapy A, Houston J, Ilfeld B, Johnson G, Kerns R, Kyriakides T, Lee A, Long C. NIH-DoD-VA pain management collaboratory. Pain Med 2019;202336-2345.
Roytman GR, Cheung KH, Bathulapalli H, Goertz CM, Long CR, Lisi AJ. Characteristics of chiropractic patients in the Veterans Health Administration during the COVID-19 pandemic: A cross-sectional analysis. J manipulative Physiol Ther. 2023 Nov-Dec;45(9):615-622.
