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.
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:
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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);
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Duloxetine (a widely used, FDA- approved medication that helps patients manage chronic low back pain);
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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
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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
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Gwendolyn Sowa, MD, PhD, Department of Physical Medicine & Rehabilitation
Nam Vo, PhD, Department of Orthopaedic Surgery
- Core Leadership
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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
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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 LB3P study or the BEST trial.
Publications
Poster presentation at Orthopaedic Research Society's 2022 meeting, "Asymmetrical Lumbar Intervertebral Motion in Chronic Low Back Pain" by Dr. Marit Johnson