Online therapy for managing pain in fibromyalgia and lupus patients
Brief Pain Exposure Therapy (BPET) For Nociplastic Pain
NA · University of Michigan · NCT06208514
This study is testing an online therapy called Brief Pain Exposure Therapy to see if it can help adults with fibromyalgia and lupus manage their pain and improve their overall well-being.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan (other) |
| Drugs / interventions | prednisone |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06208514 on ClinicalTrials.gov |
What this trial studies
This study tests a brief, Zoom-based behavioral treatment called Brief Pain Exposure Therapy (BPET) aimed at helping adults with fibromyalgia and systemic lupus erythematosus. Participants will learn effective strategies to reduce pain and associated issues such as disability, depression, and anxiety. The study is conducted by the University of Michigan and includes specific eligibility criteria for participants based on their medical diagnoses and pain experiences.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with fibromyalgia or systemic lupus erythematosus who have access to the internet and can participate in Zoom meetings.
Not a fit: Patients who do not have a diagnosis of fibromyalgia or lupus, or those unable to participate in telehealth sessions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide patients with effective tools to manage their pain and improve their quality of life.
How similar studies have performed: Other studies have shown promise in using telehealth-based behavioral interventions for pain management, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to read, write and speak English * Internet access and audio-visual conferencing capability (e.g., Zoom meetings by phone or computer) in the home Fibromyalgia participants must have: * Physician diagnosis of fibromyalgia * OR: meet 2016 American College of Rheumatology (ACR) Criteria for FM: Widespread pain index score is ≥ 7 and symptom severity scale score is ≥ 5, or widespread pain index score is 4 to 6 and symptom severity score is ≥ 9 * OR: have pain self-reported in 4 out of 7 body regions in the General Sensory Sensitivity (GSS)-brief body map AND Opioid Use Disorder diagnosis by a physician. Lupus participants must have: * Physician diagnosis of systemic lupus erythematosus * AND: Have pain self-reported in 4 out of 7 body regions in the GSS-brief body map * AND: No change in medications or steroid dose for one month prior to entry (to avoid oscillation of steroid dosing during the study due to active disease). Chronic Low Back Pain participants must have: * Low Back Pain for at least half the days over the past 6 months * Over the past 7 days, an average pain intensity of at least 4 out of 10 Exclusion Criteria: * Indication of a co-occurring (non-fibromyalgia OR non-lupus) cause of chronic pain (e.g., inflammatory arthritis, other autoimmune disorders, spinal cord injury, cancer) * Currently receiving cognitive-behavioral therapy or other psychological therapies for pain * Open litigation regarding chronic pain in the past 1 year, as assessed in preliminary study screening. * Inability to provide informed consent and complete study procedures (e.g., indications of suspected major cognitive impairment via observations of study staff during consenting) that would preclude comprehension or participation in study protocols. * Pregnant or breastfeeding * Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators. * Lupus group only: taking \>10 mg prednisone (or equivalent steroid) dose per day as an indicator of ongoing disease activity (with no other strict exclusions based on medications) * Chronic Pelvic Pain group only: surgery for any chronic pelvic pain related condition in the past 6 months * Chronic low back pain only: scheduled back surgery; leg pain that is greater than your back pain
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
Study contacts
- Principal investigator: John Sturgeon, PhD — University of Michigan
- Study coordinator: Beth Banner
- Email: eledward@med.umich.edu
- Phone: 734-998-5837
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fibromyalgia, Lupus Erythematosus, Systemic, Chronic Pelvic Pain, Chronic Low Back Pain, Pain exposure therapy, Telehealth-based behavioral intervention