Mindfulness to Improve Functional Outcomes in Patients With Fibromyalgia or Central Sensitization

Vanderbilt University Medical Center

Status: Terminated

Conditions: Fibromyalgia; Chronic Pain; Central Sensitisation

Treatments: Behavioral: BreathAware for Pain Management

Study type: Interventional

Funder types: Other

Identifiers

NCT03693274

180985

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Mindfulness Course

Experimental group

Description:

Patient will be provided usual care for chronic pain at the Interventional Pain Clinic at Vanderbilt University Medical Center and will also be given access to BreatheAware for Pain Management, a 16- week web-based mindfulness course.

Treatment:

Behavioral: BreathAware for Pain Management

Usual Care

No Intervention group

Description:

Patient will be provided usual care for chronic pain at the Interventional Pain Clinic at Vanderbilt University Medical Center.