Brief Pain Exposure Therapy (BPET) For Nociplastic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Brief pain exposure therapy (BPET)
BehavioralParticipants 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.
Treatment groups
125 Participants
are divided into 1 treatment groupGroup A: Brief pain exposure therapy (BPET)Experimental treatment 1 intervention
Trial outcomes
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).
Time frame
Day 1, Day 60Secondary outcomes
1
Change in the Tampa Scale of Kinesiophobia (TSK) day 1 (T1) to day 60 (T5)
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.
Time frame
Day 1, Day 602
Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference day 1 (T1) to day 60 (T5)
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.
Time frame
Day 1, Day 603
Change in pain intensity based on the Numeric Pain Rating Scale from day 1 (T1) to day 210 (T8)
This is a one item scale that participants answer worst pain experienced from no pain (0) to worst pain imaginable (10).
Time frame
Day 1, Day 2104
Change in TSK from day 1 (T1) to day 210 (T8)
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.
Time frame
Day 1, Day 210Sponsors and contacts
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Source ClinicalTrials.gov