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New treatment option for Fibromyalgia
Official title Brief Pain Exposure Therapy (BPET) For Nociplastic Pain
ClinicalTrials.gov ID: NCT06208514
What this study is testing
- What it's testing
- This study is intended to test whether a brief Zoom-based behavioral treatment can help adults with fibromyalgia (FM), Lupus, chronic pelvic pain, and chronic low back pain learn effective strategies for reducing pain, disability and other problems that can come with fibromyalgia, Lupus, chronic pelvic pain, and chronic low back pain (such as depression or anxiety).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- Indication of a co-occurring (non-fibromyalgia OR non-lupus) cause of chronic pain (e.g., inflammatory arthritis, other autoimmune disorders, spinal...
- 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...
- Pregnant or breastfeeding
- Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators.
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.