Clinical trial NCT06208514: Brief Pain Exposure Therapy (BPET) For Nociplastic Pain
Official title: Brief Pain Exposure Therapy (BPET) For Nociplastic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Lupus Erythematosus, Systemic
Keywords: Pain exposure therapy
Telehealth-based behavioral intervention
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The enrollment numbers were increased to 70 (from 50) after the University of Michigan Medical School Institutional Review Board approved the amendment.
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

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)

Primary outcomes:
measure: Change in pain intensity based on the Numeric Pain Rating Scale between day 1 (T1) and day 60 (T5)
timeFrame: Day 1, Day 60
Secondary outcomes:
measure: Change in the Tampa Scale of Kinesiophobia (TSK) day 1 (T1) to day 60 (T5)
timeFrame: Day 1, Day 60
measure: Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference day 1 (T1) to day 60 (T5)
timeFrame: Day 1, Day 60
measure: Change in pain intensity based on the Numeric Pain Rating Scale from day 1 (T1) to day 210 (T8)
timeFrame: Day 1, Day 210
measure: Change in TSK from day 1 (T1) to day 210 (T8)
timeFrame: Day 1, Day 210
measure: Change in PROMIS Pain Interference from day 1 (T1) to day 210 (T8)
timeFrame: Day 1, Day 210
measure: Acceptability of intervention based on Mean scores on the Treatment Acceptability and Adherence Scale (TAAS)
timeFrame: Day 29
measure: Feasibility based on the number of sessions attended
timeFrame: Day 29
measure: Feasibility based on the number of in-session and between-session practices completed
timeFrame: Day 29
measure: Feasibility based on open-ended feedback at the completion of the intervention
timeFrame: Day 29
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: John Sturgeon, PhD
role: PRINCIPAL_INVESTIGATOR
References: