Clinical trial NCT04129450: Group-based Mindfulness for Chronic Pain in the Primary Care Setting
Official title: Group-based Mindfulness for Patients With Chronic Low Back Pain in the Primary Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Back Pain
Keywords: Mindfulness-Based Stress Reduction
Medical group visits
Primary care setting
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-10-16
Enrollment: 451
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Detailed description: 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.

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 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

Primary outcomes:
measure: Pain intensity and interference at Baseline, 8 weeks, 6 months (primary timepoint), & 12 months: PEG score
timeFrame: Baseline, 8 weeks, 6 months (primary timepoint), 12 months
Secondary outcomes:
measure: Physical function at Baseline, 8 weeks, 6 months, and 12 months
timeFrame: Baseline, 8 weeks, 6 months, 12 months
measure: Sleep Disturbance at Baseline, 8 weeks, 6 months, & 12 months
timeFrame: Baseline, 8 weeks, 6 months, 12 months
measure: Quality of Life at Baseline, 8 weeks, 6 months, & 12 months
timeFrame: Baseline, 8 weeks, 6 months,12 months
measure: Opioid prescription use at Baseline, 8 weeks, 6 months, and 12 months
timeFrame: Baseline, 8 weeks, 6 months, 12 months
measure: Mindfulness at Baseline, 8 weeks, 6 months, & 12 months
timeFrame: Baseline, 8 weeks, 6 months,12 months
measure: Mindfulness at 12 months
timeFrame: 12 months
measure: Patient Impression of Change at 8 weeks, 6 months, & 12 months
timeFrame: 8 weeks, 6 months,12 months
measure: Pain Catastrophizing at Baseline, 8 weeks, 6 months, & 12 months
timeFrame: Baseline, 8 weeks, 6 months, 12 months
measure: Tobacco, Alcohol, Prescription medications, and other Substance use at Baseline and 12 months
timeFrame: Baseline and 12 months
measure: Comorbidity at baseline
timeFrame: Baseline
measure: Treatment expectation at baseline
timeFrame: Baseline
measure: Telehealth Usability at Baseline and 8 weeks
timeFrame: Baseline, 8 weeks
measure: Anxiety at Baseline
timeFrame: Baseline
measure: Depression at Baseline
timeFrame: Baseline
measure: Sleep duration at Baseline and 6 months
timeFrame: Baseline, 6 months
measure: Classes of back pain medication
timeFrame: Baseline, 8 weeks, 6 months, 12 months
measure: Amount of opioid pain medication
timeFrame: Baseline, 8 weeks, 6 months, 12 months
measure: Trauma at 8 weeks
timeFrame: 8 weeks
measure: Chronic overlapping pain at 8 weeks
timeFrame: 8 weeks
measure: Dietary supplement and natural products use at 1 month
timeFrame: Once at any timepoint
measure: Use of healthcare resources by participants as documented in the EHR
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Natalia Morone, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greco CM, Gaylord SA, Faurot K, Weinberg JM, Gardiner P, Roth I, Barnhill JL, Thomas HN, Dhamne SC, Lathren C, Baez JE, Lawrence S, Neogi T, Lasser KE, Castro MG, White AM, Simmons SJ, Ferrao C, Binda DD, Elhadidy N, Eason KM, McTigue KM, Morone NE. The design and methods of the OPTIMUM study: A multisite pragmatic randomized clinical trial of a telehealth group mindfulness program for persons with chronic low back pain. Contemp Clin Trials. 2021 Oct;109:106545. doi: 10.1016/j.cct.2021.106545. Epub 2021 Aug 27.