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

NCT03693274 | Terminated

• 1 other identifier: 180985
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Fibromyalgia; Central Sensitisation

Outcome Measures

Primary Outcomes (1)

• Feasibility: Number of participants who complete the study

  Number of participants who complete the study

  17 weeks

Secondary Outcomes (4)

• Change in mean Five Facet Mindfulness Questionnaire (FFMQ) score

  Baseline and 17 weeks

• Change in median Patient Reported Outcomes Measurement Information Systems-29 (PROMIS_29) score

  Baseline and 17 weeks

• Change in Pain Catastrophizing Scale (PCS)

  Baseline and 17 weeks

• Global Change

  17 weeks

Study Arms (2)

Mindfulness Course

EXPERIMENTAL

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.

Behavioral: BreathAware for Pain Management

Usual Care

NO INTERVENTION

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

Interventions

BreathAware for Pain Management 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.

Mindfulness Course

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Chronic Pain; Fibromyalgia

Interventions

Pain Management

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Disease Management; Patient Care Management; Health Services Administration

Study Officials

• Jenna Walters, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology and Pain Medicine

Study Record Dates

• First Submitted: September 30, 2018
• First Posted: October 2, 2018
• Study Start: January 2, 2019
• Primary Completion: August 25, 2020
• Study Completion: August 25, 2020
• Last Updated: August 27, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)