Brief Pain Exposure Therapy (BPET) For Nociplastic Pain

University of Michigan1 site in 1 country125 target enrollmentMarch 4, 2024

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: University of Michigan
Enrollment: 125
Locations: 1
Primary Endpoint: Change in pain intensity based on the Numeric Pain Rating Scale between day 1 (T1) and day 60 (T5)
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Detailed 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.

Registry

clinicaltrials.gov

Start Date

March 4, 2024

End Date

July 1, 2026

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Michigan

Responsible Party

Principal Investigator

John Sturgeon

Assistant Professor of Anesthesiology

University of Michigan

Eligibility 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).

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

Outcomes

Primary Outcomes

Change in pain intensity based on the Numeric Pain Rating Scale between day 1 (T1) and day 60 (T5)

Time Frame: Day 1, Day 60

This is a one item scale that participants answer worst pain experienced from no pain (0) to worst pain imaginable (10).

Secondary Outcomes

Acceptability of intervention based on Mean scores on the Treatment Acceptability and Adherence Scale (TAAS)(Day 29)
Feasibility based on open-ended feedback at the completion of the intervention(Day 29)
Change in PROMIS Pain Interference from day 1 (T1) to day 210 (T8)(Day 1, Day 210)
Feasibility based on the number of in-session and between-session practices completed(Day 29)
Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference day 1 (T1) to day 60 (T5)(Day 1, Day 60)
Change in the Tampa Scale of Kinesiophobia (TSK) day 1 (T1) to day 60 (T5)(Day 1, Day 60)
Change in pain intensity based on the Numeric Pain Rating Scale from day 1 (T1) to day 210 (T8)(Day 1, Day 210)
Feasibility based on the number of sessions attended(Day 29)
Change in TSK from day 1 (T1) to day 210 (T8)(Day 1, Day 210)