Brief Pain Exposure Therapy (BPET) For Nociplastic Pain

University of Michigan

Status

Enrolling

Conditions

Lupus Erythematosus, Systemic

Fibromyalgia

Chronic Low Back Pain (CLBP)

Chronic Pelvic Pain

Treatments

Behavioral: Brief pain exposure therapy (BPET)

Study type

Interventional

Funder types

Other

Identifiers

NCT06208514

HUM00238637

Details and patient eligibility

About

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).

Full description

This project was amended and approved by the University of Michigan Medical School Institutional Review Board. These changes include adding chronic pelvic pain and chronic low back pain participants on to the study.

Enrollment

125 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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