N/A
Completed N=451
Group-based Mindfulness for Chronic Pain in the Primary Care Setting
Postoperative Pain · Back Pain
Source: ClinicalTrials.gov NCT04129450 ↗
Enrolled (actual)
451
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcomePrimary: Pain Intensity and Interference at Baseline, 8 Weeks, 6 Months (Primary Timepoint), & 12 Months: Pain, Enjoyment, General Activity (PEG) Score — 6.37; 5.87; 5.21; 5.6 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity and Interference at Baseline, 8 Weeks, 6 Months (Primary Timepoint), & 12 Months: Pain, Enjoyment, General Activity (PEG) Score |
6.37; 5.87; 5.21; 5.6; 5.16; 5.28 | — |
| SECONDARY Physical Function at Baseline, 8 Weeks, 6 Months, and 12 Months |
37.9; 37.9; 38; 37.9; 39.4; 38 | — |
| SECONDARY Sleep Disturbance at Baseline, 8 Weeks, 6 Months, & 12 Months |
57.5; 56.4; 54.9; 55.6; 55.8; 55.9 | — |
| SECONDARY Opioid Prescription Use at Baseline, 8 Weeks, 6 Months, and 12 Months |
7.3; 8.4; 7.9; 8.2; 8.3; 9.8 | — |
| SECONDARY Mindfulness at Baseline, 8 Weeks, 6 Months, & 12 Months |
33.2; 32.7; 33.8; 33; 33.3; 33.3 | — |
| SECONDARY Mindfulness at 12 Months |
49.7; 47.9 | — |
| SECONDARY Patient Impression of Change at 8 Weeks, 6 Months, & 12 Months |
10; 3; 42; 7; 74; 40 | — |
| SECONDARY Pain Catastrophizing at Baseline, 8 Weeks, 6 Months, & 12 Months |
12.5; 11.8; 10.9; 10.9; 10.5; 10.6 | — |
| SECONDARY Tobacco, Alcohol, Prescription Medications, and Other Substance Use at Baseline and 12 Months |
80; 98; 144; 129; 78; 101 | — |
| SECONDARY Comorbidity at Baseline |
2.4; 2.3 | — |
| SECONDARY Anxiety at Baseline, 6 Months, & 12 Months |
80; 98; 144; 129; 26; 29 | — |
| SECONDARY Depression at Baseline, 6 Months, & 12 Months |
167; 166; 57; 61; 27; 27 | — |
| SECONDARY Sleep Duration at Baseline and 6 Months |
5.6; 5.8; 5.9; 5.6 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04129450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.