LB3P: Low Back Pain Research Study

Study Overview

The LB³P: Low Back Pain Research Study is a Mechanistic Research Center funded through a U19 award from the National Institutes of Health's HEAL (Helping to End Addiction Long-Term) Initiative, a strategic effort to combat the opioid epidemic in the United States. The LB³P Center is a member of the BACPAC (Back Pain Consortium), 13 research sites, which will work together to develop an integrated model of chronic low back pain to guide the future study and treatment of this condition. This study is conducted by researchers at the University of Pittsburgh Departments of Physical Therapy, Physical Medicine & Rehabilitation, Psychiatry, and Orthopaedic Surgery.

LB3P logo

The LB³P Center is an innovative, multidisciplinary collaboration of investigators at UPMC and the University of Pittsburgh. The Center will collect data from three key contributing domains of chronic low back pain: biological, biomechanical, and behavioral. The data will be analyzed to perform in-depth phenotyping of patients with chronic low back pain with the goal of characterizing patients and directing targeted treatments. This is a novel, integrated biopsychosocial approach to combat such a complex and multi-dimensional condition.

UPMC Press Release on the grant.

Over the next four years, the LB³P hopes to recruit 1,000 study participants to help with the collection of biological, biomechanical, and behavioral data. Participants will be asked to answer questionnaires, perform functional assessments, and submit to collecting biological samples. Testing and collection will take place at the Physical Therapy - Clinical and Translational Research Center at the University of Pittsburgh. The PT-CTRC is a state-of-the-art facility that will serve as the hub for study participation.

In the fall of 2022 BACPAC started recruiting participants for a four-arm collaborative clinical trial examining response to treatment from chronic low back pain. The University of Pittsburgh serves as one of ten sites nation-wide for the Biomarkers for Evaluating Spine Treatments (BEST) trial. Participants will be randomized into one or two of four treatment groups:

Acceptance and commitment therapy (a treatment that focuses on the whole person, their pain, health and quality of life; it also helps people learn new skills for dealing with pain);
Duloxetine (a widely used, FDA- approved medication that helps patients manage chronic low back pain);
Enhanced self-care (an online program that utilizes modules and personalized messaging to teach evidence-based strategies and lifestyle skills to help patients manage their pain); and
Evidence-based Exercise and Manual Therapy (a combination of simple exercises, such as basic stretches and strength training, and hands-on treatment by a physical therapist or chiropractor.)

Study participation lasts 38 weeks and includes a two-week online module, followed by a total of 3 in-person visits, where you will be asked to provide a blood sample, have images of your spine taken by MRI and x-ray, and undergo a physical exam and other assessments, which are described in detail during the enrollment process. Depending on which treatment(s) you receive during the trial, you might attend additional in-person visits to receive physical therapy or telehealth visits to meet with a therapist.

Principal Investigators

Gwendolyn Sowa, MD, PhD, Department of Physical Medicine & Rehabilitation

Nam Vo, PhD, Department of Orthopaedic Surgery

Core Leadership

Sara Piva, PhD, PT, Department of Physical Therapy

Anthony Delitto, PhD, PT, FAPTA, School of Health and Rehabilitation Sciences

Carol Greco, PhD, Department of Psychiatry

Michael Schneider, DC, PhD, Department of Physical Therapy

Kevin Bell, PhD, Department of Bioengineering

William Anderst, PhD, Department of Orthopaedic Surgery

Charity Patterson, PhD, MSPH, Department of Physical Therapy

Gina McKernan, PhD, Department of Physical Medicine & Rehabilitation

Study Staff

Selena Crawford, Project Manager

Jessa Darwin, Communications Manager

Marit E. Johnson, PhD, Biomechanics Core Project Manager

Corey Flynn, Clinical Core Research Project Coordinator

Lisa Bemis, Biodynamics Lab Manager

Participant Information

Interested participants must be 18 years of age and older, and have experienced low back pain for more than 3 months in the last 6 months. Visit our patient portal for more information about the study and to see if you qualify for participation in the LB ³P study or the BEST trial.

Publications

Peer-Reviewed Manuscripts

BACPAC published a supplemental issue of Pain Medicine with descriptions of the study design, harmonization efforts, and center-specific research. The LB³P team co-authored over half a dozen articles included in the supplemental, which is available online.

Nam V Vo, PhD, Sara R Piva, PhD, PT, Charity G Patterson, PhD, Gina P McKernan, PhD, Leming Zhou, PhD, DSc, Kevin M Bell, PhD, William Anderst, PhD, Carol M Greco, PhD, Michael J Schneider, PhD, DC, Anthony Delitto, PhD, PT, Brad E Dicianno, MD, Jessa Darwin, MLIS, Gwendolyn A Sowa, MD, PhD. “Toward the Identification of Distinct Phenotypes: Research Protocol for the Low Back Pain Biological, Biomechanical, and Behavioral (LB³P) Cohort Study and the BACPAC Mechanistic Research Center at the University of Pittsburgh.” Pain Medicine. 2023. https://doi.org/10.1093/pm/pnad009
Anna Batorsky, BS, Anton E Bowden, PhD, PE, Jessa Darwin, MLIS, Aaron J Fields, PhD, Carol M Greco, PhD, Richard E Harris, PhD, Trisha F Hue, PhD, MPH, Joseph Kakyomya, MS, Wolf Mehling, MD, Conor O’Neill, MD, Charity G Patterson, PhD, Sara R Piva, PT, PhD, Nico Sollmann, MD, PhD, Vincent Toups, PhD, Ajay D Wasan, MD, MSc, Ronald Wasserman, MD, FRCPC, David A Williams, PhD, Nam V Vo, PhD, Matthew A Psioda, PhD, Micah McCumber, PhD. “The BACPAC Research Program Data Harmonization: Rationale for Data Elements and Standards.” Pain Medicine. 2023. https://doi.org/10.1093/pm/pnad008
Matthew C Mauck, Jeffrey Lotz, Matthew A Psioda, Timothy S Carey, Daniel J Clauw, Sharmila Majumdar, William S Marras, Nam Vo, Ayleen Aylward, Anna Hoffmeyer, Patricia Zheng, Anastasia Ivanova, Micah McCumber, Christiane Carson, Kevin J Anstrom, Anton E Bowden, Diane Dalton, Leslie Derr, Jonathan Dufour, Aaron J Fields, Julie Fritz, Afton L Hassett, Steven E Harte, Trisha F Hue, Roland Krug, Marco L Loggia, Prasath Mageswaran, Samuel A McLean, Ulrike H Mitchell, Conor O’Neill, Valentina Pedoia, David Adam Quirk, Daniel I Rhon, Viola Rieke, Lubdha Shah, Gwendolyn Sowa, Brennan Spiegel, Ajay D Wasan, Hsiao-Ying (Monica) Wey, Lisa LaVange. “The Back Pain Consortium (BACPAC) Research Program: Structure, Research Priorities, and Methods.” Pain Medicine. 2023. https://doi.org/10.1093/pm/pnac202
Aaron J Fields, PhD, Stefan Dudli, PhD, Andrew Schrepf, PhD, Angie Kim, BS, Bernice Pham, BS, Estefania Gallego, BS, Sandra Mendoza, MA, Sharon B Meropol, MD, PhD, Jessa Darwin, MLIS, Gwendolyn Sowa, MD, PhD, Nam V Vo, PhD. “Protocol for Biospecimen Collection and Analysis within the BACPAC Research Program.” Pain Medicine. 2022. https://doi.org/10.1093/pm/pnac197
Carol M Greco, PhD, Ajay D Wasan, MD, MSc, Michael J Schneider, DC, PhD, Wolf Mehling, MD, David A Williams, PhD, Jessa Darwin, MLIS, Steven E Harte, PhD. “Biobehavioral Assessments in BACPAC: Recommendations, Rationale, and Methods.” Pain Medicine. 2022. https://doi.org/10.1093/pm/pnac175 D Adam Quirk, PhD, Marit E Johnson, PT, PhD, Dennis E Anderson, PhD, Matthew Smuck, MD, Ruopeng Sun, PhD, Robert Matthew, PhD, Jeannie Bailey, PhD, William S Marras, PhD, Kevin M Bell, PhD, Jessa Darwin, MLIS, Anton E Bowden, PhD, PE. “Biomechanical Phenotyping of Chronic Low Back Pain: Protocol for BACPAC.” Pain Medicine. 2022. https://doi.org/10.1093/pm/pnac163
Nico Sollmann, MD, PhD, Aaron J Fields, PhD, Conor O’Neill, MD, Lorenzo Nardo, MD, PhD, Sharmila Majumdar, PhD, Cynthia T Chin, MD, Duygu Tosun, PhD, Misung Han, PhD, An T Vu, PhD, Eugene Ozhinsky, PhD, Lubdha M Shah, MD, Richard E Harris, PhD, Remy Lobo, MD, William Anderst, PhD, Richard Herzog, MD, Matthew A Psioda, PhD, Christopher J Standaert, MD, River T Price, Jeffrey C Lotz, PhD, Thomas M Link, MD, Roland Krug, PhD. “Magnetic resonance imaging of the lumbar spine—recommendations for acquisition and image evaluation from the BACPAC Spine Imaging Working Group.” Pain Medicine. 2022. https://doi.org/10.1093/pm/pnac13

Tonelli Enrico V, Vo N, Methe B, Morris A, Sowa G. “An unexpected connection: A narrative review of the associations between Gut Microbiome and Musculoskeletal Pain.” Euro Spine J. 2022;31:3603-3615. doi: 10.1007/s00586-022-07429-y

Posters and Abstracts

Poster presentation at Orthopaedic Research Society's 2022 meeting, "Asymmetrical Lumbar Intervertebral Motion in Chronic Low Back Pain" by Dr. Marit Johnson