Brief Pain Exposure Therapy (BPET) for Nociplastic Pain

Last updated: March 12, 2025
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Fibromyalgia

Systemic Lupus Erythematosus

Lupus

Treatment

Brief pain exposure therapy (BPET)

Clinical Study ID

NCT06208514
HUM00238637
  • Ages > 18
  • All Genders

Study Summary

This study is intended to test whether a brief Zoom-based behavioral treatment can help adults with fibromyalgia (FM) and Lupus learn effective strategies for reducing pain, disability and other problems that can come with fibromyalgia and Lupus (such as depression or anxiety).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Able to read, write and speak English

  • Internet access and audio-visual conferencing capability (e.g., Zoom meetings byphone or computer) in the home

Fibromyalgia participants must have:

  • Physician diagnosis of fibromyalgia

  • OR: meet 2016 American College of Rheumatology (ACR) Criteria for FM: Widespreadpain index score is ≥ 7 and symptom severity scale score is ≥ 5, or widespread painindex 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 SensorySensitivity (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 avoidoscillation of steroid dosing during the study due to active disease).

Exclusion

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 therapiesfor pain

  • Open litigation regarding chronic pain in the past 1 year, as assessed inpreliminary study screening.

  • Inability to provide informed consent and complete study procedures (e.g.,indications of suspected major cognitive impairment via observations of study staffduring consenting) that would preclude comprehension or participation in studyprotocols.

  • Pregnant or breastfeeding

  • Any other diseases or conditions that would make a patient unsuitable for studyparticipation as determined by the site principal investigators.

  • Lupus group only: taking >10 mg prednisone (or equivalent steroid) dose per day asan indicator of ongoing disease activity (with no other strict exclusions based onmedications)

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Brief pain exposure therapy (BPET)
Phase:
Study Start date:
March 04, 2024
Estimated Completion Date:
July 31, 2026

Study Description

This project was amended and approved by the University of Michigan Medical School Institutional Review Board. These changes include a title update and adding Lupus participants on to the study.

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

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