Studying Nonpharmacological Approaches for
Pain Management in Clinical Settings
Pragmatic Clinical Trials (PCTs)
The PMC Pragmatic Clinical Trials are studying nonpharmacological approaches for pain management and comorbid conditions in settings serving military personnel, veterans and their families. The 11 trials were selected based on the importance of the scientific questions, and their potential to address impediments to research within health care delivery organizations. The demonstration projects utilize a phased award UG3/UH3 mechanism, with a planning (UG3) and an implementation (UH3) phase. All projects are milestone-driven, and moving to the implementation phase (UH3) will be dependent upon the successful progress made during the planning phase (UG3).
Chiropractic Care for Veterans: A Pragmatic Randomized Trial Addressing Dose Effects for cLBP (VERDICT)
The VERDICT project will evaluate patient and clinician perceptions of non-specific treatment factors, effectiveness of study interventions, and the impact of varying doses of standard chiropractic care and chronic pain management on clinical outcomes across three VA facilities.
Christine Goertz, DC, PhD and Cynthia Long, PhD
COoperative Pain Education and Self-management: Expanding Treatment for Real-world Access (COPES ExTRA)
The overall goal of this project is to conduct a pragmatic trial to examine the real world effectiveness of an IVR-based form of CBT-CP called Co-operative Pain Education and Self-management (COPES) versus in-person CBT-CP provided by clinicians previously trained through VHA’s evidence based psychotherapy program.
Alicia Heapy, PhD and Diana Higgins, PhD
This project will test the effectiveness and cost-effectiveness of Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM). SBIRT-PM can provide an effective and cost-effective approach to reducing Veterans’ pain and risky substance use, primarily by increasing the use of nonpharmacological approaches to pain management.
Marc Rosen, MD and Steve Martino, PhD
There are critical unanswered questions surrounding best practices for addressing chronic back pain in the veteran population. This pragmatic trial compares the effectiveness of two nonpharmacological care pathways and seeks to improve access to recommended therapies, minimize utilization of higher-risk treatments such as opioids and surgery, and optimize long-term outcomes for reduced pain.
Steven George, PT, PhD and Susan Nicole Hastings, MD
The LAMP project (Learning to Apply Mindfulness to Pain) is studying two approaches for delivering nonpharmacological treatment for chronic pain—in this case, Mindfulness-Based Interventions (MBIs) that incorporate mobile application technology—that will be able to reach large numbers of Veterans.
Diana Burgess, PhD
Resolving the Burden of Low Back Pain in Military Service Members and Veterans: A Multi-Site Pragmatic Clinical Trial (RESOLVE Trial)
This multi-site PCT will compare an active CPG implementation model with the current usual physical therapy care in Service Members and Veterans with Low Back Pain (LBP) in order to evaluate an education/audit/feedback model, as well as compare it to usual care for decreasing pain and lessening reliance on analgesic medication.
Shawn Farrokhi, PT, DPT, PhD, and Christopher Dearth, PhD
The Sequential Multiple Randomization Trial for Low Back Pain (SMART LBP Trial) will enable better integration of the biopsychosocial model and improve Stepped Care management with a pragmatic, randomized controlled trial targeting chronic low back pain at four large military installations in the United States.
Julie M. Fritz, PT, PhD, FAPTA and Dan Rhon, PT, DPT, DSc, OCS, FAAOMPT
This trial seeks to identify evidence of meaningful outcomes of Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) interventions within the context of primary care settings, such as decreased opioid medication, fewer emergency room visits for pain care, and greater satisfaction with treatment plans.
CAPT Jeffrey Goodie, PhD; Don McGeary, PhD
The APPROACH Trial: Assessing Pain, Patient Reported Outcomes and Complementary and Integrative Health (A VA National Demonstration Project)
The APPROACH Trial: Assessing Pain, Patient Reported Outcomes and Complementary and Integrative Health is a Pragmatic Trial is a large-scale pragmatic clinical trial that will examine the potential for patients to benefit from a pairing of CIH self-care (yoga, tai chi, mindfulness) approaches and practitioner-delivered CIH (acupuncture, massage) versus either practitioner-delivered or self-care alone among Veterans with chronic musculoskeletal pain.
Stephanie Taylor, PhD, MPH and Steven Zeliadt, PhD, MPH
Ultrasound Guided Percutaneous Peripheral Nerve Stimulation: A Nonpharmacological Alternative for the Treatment of Postoperative Pain
In this trial, we will determine the effect of a novel, nonpharmacologic analgesic technique—percutaneous peripheral nerve stimulation (PNS)—on postoperative analgesia and opioid requirements, as well as physical and emotional functioning, the development of chronic pain, and ongoing quality of life.
Brian Ilfeld, MD, MS
Whole Health Team vs. Primary Care Group Education to Promote Non-Pharmacological Strategies to Improve Pain, Functioning, and Quality of Life in Veterans
The overarching goal of the (w)HOPE study is to establish and implement a new Whole Health paradigm for chronic pain care, emphasizing non-pharmacological pain self-management that reduces pain symptoms and improves overall functioning and quality of life in veterans.
Karen Seal, MD and William Becker, MD