CompletedNot Applicable

Group-based Mindfulness for Chronic Pain in the Primary Care Setting

United States451 participantsStarted 2021-05-06

Plain-language 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 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Pain Intensity and Interference at Baseline, 8 Weeks, 6 Months (Primary Timepoint), & 12 Months: Pain, Enjoyment, General Activity (PEG) Score

Timeframe: Baseline, 8 weeks, 6 months (primary timepoint), 12 months

Trial details

NCT IDNCT04129450

SponsorBoston Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-06

Results submitted2025-10-14