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Group-based Mindfulness for Patients With Chronic Low Back Pain in the Primary Care Setting
The purpose of this pragmatic clinical trial (PCT) research is to determine whether a group-visit approach modeled on Mindfulness-Based Stress Reduction can improve function for persons with chronic low back pain. This will be done by an embedded PCT within the evidence-based "OPTIMUM" (Optimizing Pain Treatment In Medical settings Using Mindfulness) program.
The research will be conducted with three health care system (HCS) sites: Boston Medical Center (BMC), MA, a safety net health system; University of Pittsburgh Medical Center (UPMC), Pittsburgh, PA, a large health system; and Piedmont Health Services, NC, a network of federally funded health centers in partnership with the University of North Carolina (UNC), Chapel Hill. As per NIH protocol for the funding, the first 12 month (Phase 1) of this PCT will be a pilot to plan and test the group-based mindfulness program for chronic pain program in each of the three sites with 5 participants/site. Once completed the Phase 2 will be conducted to integrate and test the group-based mindfulness program compared to standard of care for patients with chronic low back pain (cLBP) in the primary care setting at each collaborating site. Eligible consenting participants will be randomized to either: the primary care providers (PCP) usual care group, or the group with both PCP usual care and the 8 weeks mindfulness clinical pain group. Participants will be asked to complete baseline and follow-up surveys about pain, function, pain medicine use, mood and anxiety symptoms, and quality of life. The surveys will take up to an hour to complete.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Boston Medical Center
Boston, Massachusetts, United States
Start Date
May 6, 2021
Primary Completion Date
November 6, 2024
Completion Date
November 6, 2024
Last Updated
December 1, 2025
451
ACTUAL participants
Group medical visits with mindfulness-based stress reduction
OTHER
Usual PCP care
OTHER
Lead Sponsor
Boston Medical Center
Collaborators
NCT06661850
NCT03836248
NCT04379115
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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