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NCT Number: NCT06208514

Brief Pain Exposure Therapy (BPET) For Nociplastic Pain

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Beth Banner

CONTACT

[email protected]

734-998-5837

John Sturgeon, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

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

    Time frame: Day 1, Day 60

    This is a 17-item survey that participants answer strongly disagree (1) to strongly agree (4).

    Total scores are between 17-68 with a higher value indicating higher kinesiophobia.

  2. Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference day 1 (T1) to day 60 (T5)

    Time frame: Day 1, Day 60

    Four questions are included in the PROMIS for pain interference. Participants will answer from not at all (1) to very much (5). Scores range from 4-20 with a higher score indicating more interference.

  3. Change in pain intensity based on the Numeric Pain Rating Scale from day 1 (T1) to day 210 (T8)

    Time frame: Day 1, Day 210

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

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

    Time frame: Day 1, Day 210

    This is a 17-item survey that participants answer strongly disagree (1) to strongly agree (4).

    Total scores are between 17-68 with a higher value indicating higher kinesiophobia.

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

    Time frame: Day 1, Day 210

    Four questions are included in the PROMIS for pain interference. Participants will answer from not at all (1) to very much (5). Scores range from 4-20 with a higher score indicating more interference.

  6. Acceptability of intervention based on Mean scores on the Treatment Acceptability and Adherence Scale (TAAS)

    Time frame: Day 29

    This is a 10-item survey that participant will complete after final intervention. Questions are answered from strongly disagree (1), neither agree or disagree (4), to agree (7). Scores above the midpoint - 35 out of 70 - will denote moderate acceptability of the intervention).

  7. Feasibility based on the number of sessions attended

    Time frame: Day 29

    Higher number of sessions attended shows higher level of feasibility.

  8. Feasibility based on the number of in-session and between-session practices completed

    Time frame: Day 29

    Higher number of sessions and between-sessions completed shows higher level of feasibility.

  9. Feasibility based on open-ended feedback at the completion of the intervention

    Time frame: Day 29

    Participants will complete the open-ended feedback form that has 4 questions regarding the intervention and will be summarized.

Study contacts

Contact information is provided by the study sponsor or research team.

Beth Banner

CONTACT

[email protected]

734-998-5837

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Acronym: BPET

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 17, 2024
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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