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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.

Contemporary clinical trials
October 1, 2021
Carol M Greco et al. (23 authors)
Journal ArticleRandomized Controlled TrialResearch Support, N.I.H., ExtramuralHuman StudyClinical
Study Details

Study Goal

The researchers aimed to evaluate the effectiveness of an online mindfulness-based intervention combined with medical group visits for treating chronic low back pain in primary care settings.

Results Summary

The study protocol outlines a randomized trial comparing mindfulness-based stress reduction (MBSR) delivered via telehealth alongside medical group visits to usual primary care. Outcomes include pain reduction, psychological function, healthcare utilization, and opioid prescriptions, with results pending as it is a protocol.

Population

Adults with chronic low back pain in diverse US healthcare settings, including safety net hospitals and federally qualified health centers.

Effective Dosage

Not specified (intervention modeled on MBSR, typically 8 weeks with weekly sessions).

Duration

8-week program with follow-ups at 6 and 12 months.

Interactions

None mentioned

Extracted Claims (11)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Mindfulness-based stress reduction (MBSR)
decrease
chronic low back pain (cLBP)
-
-
is an evidence-based non-pharmacological approach for
#1
OPTIMUM (Optimizing Pain Treatment In Medical settings Using Mindfulness)
neutral
-
persons with cLBP
-
is offered
#2
OPTIMUM
neutral
-
persons with cLBP
-
includes
#3
medical group visits (MGV) with a PCP and a mindfulness meditation intervention modeled on MBSR
neutral
-
persons with cLBP
-
is included in
#4
MGV + MBSR
neutral
-
450 patients
-
will be assigned randomly to
#5
usual PCP care alone
neutral
-
450 patients
-
will be assigned randomly to
#6
self-report surveys
neutral
-
participants
-
will be completed at
#7
Health care utilization data
neutral
-
-
-
will be obtained through
#8
brief monthly surveys
neutral
-
participants
-
will be completed by
#9
OPTIMUM trial
increase
primary care treatment of cLBP
-
-
has the potential to enhance
#10
OPTIMUM
increase
scalable and accessible
underserved patients
-
is expected to be
#11
Abstract

Mindfulness-based stress reduction (MBSR) is an evidence-based non-pharmacological approach for chronic low back pain (cLBP), yet it is not readily available or reimbursable within primary care clinics. Primary care providers (PCPs) who wish to avoid prescribing opioids and other medications typically have few options for their cLBP patients. We present the protocol of a pragmatic clinical trial entitled OPTIMUM (Optimizing Pain Treatment In Medical settings Using Mindfulness). OPTIMUM is offered online via telehealth and includes medical group visits (MGV) with a PCP and a mindfulness meditation intervention modeled on MBSR for persons with cLBP. In diverse health-care settings in the US, such as a safety net hospital, federally qualified health centers, and a large academic health system, 450 patients will be assigned randomly to the MGV + MBSR or to usual PCP care alone. Participants will complete self-report surveys at baseline, following the 8-week program, and at 6- and 12-month follow-up. Health care utilization data will be obtained through electronic health records and via brief monthly surveys completed by participants. The primary outcome measure is the PEG (Pain, enjoyment, and general activity) at the 6-month follow-up. Additionally, we will assess psychological function, healthcare resource use, and opioid prescriptions. This trial, which is part of the NIH HEAL Initiative, has the potential to enhance primary care treatment of cLBP by combining PCP visits with a non-pharmacological treatment modeled on MBSR. Because it is offered online and integrated into primary care, it is expected to be scalable and accessible to underserved patients. Clinical Trials.gov: NCT04129450.

Medical Subject Headings (MeSH)
Analgesics, OpioidChronic PainHumansLow Back PainMeditationMindfulnessStress, PsychologicalTelemedicineTreatment Outcome
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations12
Citations/Year3.0
Relative Citation Ratio1.49
NIH Percentile64.8%
Research Impact Scores
APT Score0.75
Weight Score2.60
Normalized Score0.67
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