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

NCT ID: NCT03693274

Last Updated: 2020-08-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-02
• Study Completion Date: 2020-08-25

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.

Conditions

Chronic Pain; Fibromyalgia; Central Sensitisation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mindfulness Course

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.

Group Type: EXPERIMENTAL

BreathAware for Pain Management

Intervention Type: BEHAVIORAL

Patients will be given access to a BreathAware, a 16- week web-based mindfulness course, which will be initiated at their enrollment. BreathAware is a self-paced course comprised of 2-3 minute lessons delivered via video, audio and technology-based guided instruction, and is available on a phone or tablet.

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

BreathAware for Pain Management

Patients will be given access to a BreathAware, a 16- week web-based mindfulness course, which will be initiated at their enrollment. BreathAware is a self-paced course comprised of 2-3 minute lessons delivered via video, audio and technology-based guided instruction, and is available on a phone or tablet.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jenna Walters

Assistant Professor of Anesthesiology and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jenna Walters, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

180985

Identifier Type: -

Identifier Source: org_study_id