Purpose

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, MA, a safety net health system; 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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Chronic low back pain, that is pain that persists for at least 3-months and has resulted in pain on at least half the days in the past 6 months. - Willing and able to provide informed consent. - Speak English as the intervention manual is currently written in English.

Exclusion Criteria

  • In the past month, worsening of pain, unexplained fever, unexplained weight loss - Back injury in the past 3 months - Pregnancy - Metastatic cancer

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Mindfulness Pain Program + Usual PCP Care
Participants will undergo 8 weekly 90 minute sessions of Mindfulness-Based Stress Reduction in addition to receiving usual PCP care for chronic lower back pain.
  • Other: Group medical visits with mindfulness-based stress reduction
    Eight weekly 90 minute sessions of mindfulness-based stress reduction in group medical visits
  • Other: Usual PCP care
    Usual one on one PCP care for chronic lower back pain
Active Comparator
Usual PCP Care
Participants will receive usual PCP care for chronic lower back pain.
  • Other: Group medical visits with mindfulness-based stress reduction
    Eight weekly 90 minute sessions of mindfulness-based stress reduction in group medical visits
  • Other: Usual PCP care
    Usual one on one PCP care for chronic lower back pain

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Natalia Morone, MD, MS
617-414-6652
natalie.morone@bmc.org

More Details

Status
Recruiting
Sponsor
Boston Medical Center

Study Contact

Natalia Morone, MD, MS
617-414-6652
natalia.morone@bmc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.