Mindfulness to Improve Functional Outcomes in Patients With Fibromyalgia or Central Sensitization
Purpose
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
Eligibility
- Eligible Ages
- Between 30 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
No Intervention Usual Care |
Patient will be provided usual care for chronic pain at the Interventional Pain Clinic at Vanderbilt University Medical Center. |
|
More Details
- Status
- Terminated
- Sponsor
- Vanderbilt University Medical Center
Study Contact
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.