Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03693274
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Jenna Walters, Vanderbilt University Medical Center

Tracking Information
First Submitted Date  ICMJE September 30, 2018
First Posted Date  ICMJE October 2, 2018
Last Update Posted Date January 11, 2019
Actual Study Start Date  ICMJE January 2, 2019
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2018)
Feasibility: Number of participants who complete the study [ Time Frame: 17 weeks ]
Number of participants who complete the study
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03693274 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2018)
  • Change in mean Five Facet Mindfulness Questionnaire (FFMQ) score [ Time Frame: Baseline and 17 weeks ]
    Comparison of mean score of FFMQ at baseline and 17 weeks of study participation. FFMQ is a self administered 39 item validated comprehensive instrument for assessing different aspects of mindfulness. Respondents rate statements according to how true the statement is to them on a scale of 1 (never or very rarely true) to 5 (very often or always true). Total scores are between 39 and 195 and higher scores indicate greater mindfulness.
  • Change in median Patient Reported Outcomes Measurement Information Systems-29 (PROMIS_29) score [ Time Frame: Baseline and 17 weeks ]
    Comparison of mean PROMIS-29 score at baseline and 17 weeks of study participation. The PROMIS-29 (version 2) is a self administered validated instrument to assess seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and ability to participate in social roles and activities. Each of the seven domains has four questions which are scored on a five-point Likert scale. In addition, pain intensity is measured with a single item on an 11-point numeric scale (NPRS) that ranges from 0 to 10. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores mean more of the specific scale's construct, which may indicate a desirable or an undesirable outcome.
  • Change in Pain Catastrophizing Scale (PCS) [ Time Frame: Baseline and 17 weeks ]
    Comparison of mean PCS score at baseline and 17 weeks of study participation. The PCS is measured with a self-administered questionnaire. The Pain Catastrophizing Scale is a 13-item inventory that measures 3 elements of the perception of the intensity of pain (rumination, magnification, feeling helpless). Participants indicate the degree to which they agree with statements related their pain by selecting 0 = not at all, 1 = to a slight degree, 2 = to a moderate degree, 3 = to a great degree, 4 = all the time. There are three subscale scores assessing rumination, magnification and helplessness. All subscales are summed to produce a total score ranging from 0 to 52 with higher scores indicating the participant is having more thoughts about the pain they feel helplessness. All subscales are summed to produce a total score ranging from 0 to 52 with higher scores indicating the participant is having more thoughts about the pain they feel.
  • Global Change [ Time Frame: 17 weeks ]
    Global change measured by Patient Global Impression of Change (PGIC). The PGIC evaluates aspects of patients health and assesses if there has been an improvement or decline. The patient reports change in activity limitations, symptoms, emotions, and overall quality of life on scale from 1 (No change) to 7 (a great deal better), and the degree of change on a scale from 0 (much better) to 10 (much worse).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindfulness to Improve Functional Outcomes in Patients With Fibromyalgia or Central Sensitization
Official Title  ICMJE Mindfulness to Improve Functional Outcomes in Patients With Fibromyalgia or Central Sensitization: A Pilot Feasibility Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Chronic Pain
  • Fibromyalgia
  • Central Sensitisation
Intervention  ICMJE Behavioral: 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: BreathAware for Pain Management
  • No Intervention: Usual Care
    Patient will be provided usual care for chronic pain at the Interventional Pain Clinic at Vanderbilt University Medical Center.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 30, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jenna Walters, MD 615-3322-4311 jenna.l.walters@vumc.org
Contact: Gail Mayo, RN 615-936-1705 gail.mayo@vumc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03693274
Other Study ID Numbers  ICMJE 180985
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jenna Walters, Vanderbilt University Medical Center
Study Sponsor  ICMJE Vanderbilt University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jenna Walters, MD Vanderbilt University Medical Center
PRS Account Vanderbilt University Medical Center
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP