Clinical trial NCT03693274: Mindfulness to Improve Functional Outcomes in Patients With Fibromyalgia or Central Sensitization
Official title: Mindfulness to Improve Functional Outcomes in Patients With Fibromyalgia or Central Sensitization: A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Pain
Fibromyalgia
Central Sensitisation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary aim of the study will be to determine the feasibility of utilizing a web-based mindfulness program in adult patients with chronic pain with a diagnosis of fibromyalgia or central sensitization.

Detailed description: Chronic pain has a substantial economic cost and rate of impairment. Patients who suffer from fibromyalgia and other pain conditions leading to central sensitization have limited treatment options. The only medications currently approved by the Food and Drug Administration (FDA) for the treatment of fibromyalgia includes pregabalin, milnacipran and duloxetine. The International Association for the Study of Pain (IASP) also recommends the implementation of an exercise program and cognitive behavioral therapy. A previous meta-analysis found weak evidence to support Mindfulness-Based Stress Reductions (MBSR) in fibromyalgia patients, however more robust clinical studies are needed. In the midst of an opioid crisis, MBSR provides a safer alternative for the treatment of chronic pain. Unfortunately, an instructor lead MBSR program is both costly and largely unavailable in rural areas of the country. This web-based mindfulness program provides a treatment option for patients who would otherwise, not have access to alternative medicine therapies.

Eligibility criteria: Inclusion Criteria:

* Age from 30-65
* Patients with a diagnosis of fibromyalgia or central sensitization for greater than 6 months who are referred to the Interventional Pain Clinic

Exclusion Criteria:

* Patients on greater than 120 morphine equivalents per day
* Patients with untreated psychological illness
* Patients already enrolled in ongoing trials involving pain management and treatment interventions
* Patients currently undergoing treatment at the Osher Center for Integrative Health or patients with previous or current training in mindfulness.

Primary outcomes:
measure: Feasibility: Number of participants who complete the study
timeFrame: 17 weeks
Secondary outcomes:
measure: Change in mean Five Facet Mindfulness Questionnaire (FFMQ) score
timeFrame: Baseline and 17 weeks
measure: Change in median Patient Reported Outcomes Measurement Information Systems-29 (PROMIS_29) score
timeFrame: Baseline and 17 weeks
measure: Change in Pain Catastrophizing Scale (PCS)
timeFrame: Baseline and 17 weeks
measure: Global Change
timeFrame: 17 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Jenna Walters, MD
role: PRINCIPAL_INVESTIGATOR
References: