Brief Pain Exposure Therapy (BPET) For Nociplastic Pain

Overview

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.

Interventions

• Behavioral Brief pain exposure therapy (BPET)
  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 painfu

Primary outcome measures

• 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]

Secondary outcome measures (9)

• Change in the Tampa Scale of Kinesiophobia (TSK) day 1 (T1) to day 60 (T5) [Time frame: Day 1, Day 60]
• 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]
• 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]
• Change in TSK from day 1 (T1) to day 210 (T8) [Time frame: Day 1, Day 210]
• Change in PROMIS Pain Interference from day 1 (T1) to day 210 (T8) [Time frame: Day 1, Day 210]
• Acceptability of intervention based on Mean scores on the Treatment Acceptability and Adherence Scale (TAAS) [Time frame: Day 29]
• Feasibility based on the number of sessions attended [Time frame: Day 29]
• Feasibility based on the number of in-session and between-session practices completed [Time frame: Day 29]
• Feasibility based on open-ended feedback at the completion of the intervention [Time frame: Day 29]

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).

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Michigan — Ann Arbor

Identifiers

NCT: NCT06208514 · HUM00238637

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗