Brief Pain Exposure Therapy (BPET) For Nociplastic Pain

NCT06208514 | Recruiting

• 1 other identifier: HUM00238637
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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).

Conditions

Fibromyalgia; Lupus Erythematosus, Systemic; Chronic Pelvic Pain; Chronic Low Back Pain (CLBP)

Keywords

Pain exposure therapy; Telehealth-based behavioral intervention

Outcome Measures

Primary Outcomes (1)

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

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

  Day 1, Day 60

Secondary Outcomes (9)

• Change in the Tampa Scale of Kinesiophobia (TSK) day 1 (T1) to day 60 (T5)

  Day 1, Day 60

• 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 pain intensity based on the Numeric Pain Rating Scale from day 1 (T1) to day 210 (T8)

  Day 1, Day 210

• Change in TSK from day 1 (T1) to day 210 (T8)

  Day 1, Day 210

• Change in PROMIS Pain Interference from day 1 (T1) to day 210 (T8)

  Day 1, Day 210

Study Arms (1)

Brief pain exposure therapy (BPET)

EXPERIMENTAL

Behavioral: Brief pain exposure therapy (BPET)

Interventions

Brief pain exposure therapy (BPET) BEHAVIORAL

Participants will complete daily logs for 7-days pre-treatment baseline, along with 21 days during the intervention protocol (fibromyalgia participants only will complete the daily logs), and 7 for days post-treatment. Brief Pain Exposure Therapy will be given for 3 weeks, 1.5 hours per week, telehealth-based behavioral intervention for chronic pain. Session content will include pain neuroscience education, mindfulness meditation, and graded exposure techniques for improving tolerance of painful or feared activities. Participants will also be provided handouts and pre-recorded meditation and imagery scripts that participants can use to facilitate between-session practices. In addition, participants will complete surveys through-out the study.

Brief pain exposure therapy (BPET)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• John Sturgeon, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth Banner

CONTACT

734-998-5837; eledward@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Model Details: The enrollment numbers were increased to 125 (from 70) after the University of Michigan Medical School Institutional Review Board approved the amendment.

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 17, 2024
• Study Start: March 4, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)