Status:
COMPLETED
Group-based Mindfulness for Chronic Pain in the Primary Care Setting
Lead Sponsor:
Boston Medical Center
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Chronic Pain
Back Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 l...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Age ≥ 18
- Chronic low back pain, which 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
- A score ≥ 3 on the Pain, Enjoyment of Life and General Activity (PEG)
- Willing and able to provide online or telephone informed consent
- Speak English as the intervention manual is currently written in English
Exclusion
- Do not meet the above inclusion criteria
- Red flags- recent (past month) worsening of pain, unexplained fever, unexplained weight loss
- Pregnancy
- Metastatic cancer
- First-degree relatives (parents, siblings, child) of someone who has participated or is participating in the OPTIMUM study
- Members of the same household
- Not a patient at a participating clinic or persons not planning to continue as a patient at a participating clinic for 12 or more months
Key Trial Info
Start Date :
May 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2024
Estimated Enrollment :
451 Patients enrolled
Trial Details
Trial ID
NCT04129450
Start Date
May 6 2021
End Date
November 6 2024
Last Update
December 1 2025
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118