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Die klinische Studie NCT06208514 (BPET) für Fibromyalgie, Systemischer Lupus erythematodes, Chronische Beckenschmerzen, Chronic Low Back Pain (CLBP) ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
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Universität MichiganBrief Pain Exposure Therapy (BPET) For Nociplastic Pain 125
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Die klinische Studie NCT06208514 (BPET) ist eine interventionsstudie zur Untersuchung von Fibromyalgie, Systemischer Lupus erythematodes, Chronische Beckenschmerzen, Chronic Low Back Pain (CLBP) und hat den Status offene rekrutierung. Die Studie startete am 4. März 2024 und soll 125 Teilnehmer aufnehmen. Durchgeführt von Universität Michigan ist der Abschluss für 1. Juli 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 10. Dezember 2025 aktualisiert.
Kurzbeschreibung
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).
Ausführliche Beschreibung
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.
Offizieller Titel
Brief Pain Exposure Therapy (BPET) For Nociplastic Pain
Erkrankungen
FibromyalgieSystemischer Lupus erythematodesChronische BeckenschmerzenChronic Low Back Pain (CLBP)Weitere Studien-IDs
- BPET
- HUM00238637
NCT-Nummer
Studienbeginn (tatsächlich)
2024-03-04
Zuletzt aktualisiert
2025-12-10
Studienende (vorauss.)
2026-07
Geplante Rekrutierung
125
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
Pain exposure therapy
Telehealth-based behavioral intervention
Telehealth-based behavioral intervention
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellBrief pain exposure therapy (BPET) | 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, mindfuln...Mehr anzeigen |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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. | Day 1, Day 60 |
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. | Day 1, Day 60 |
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). | Day 1, Day 210 |
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. | Day 1, Day 210 |
Change in PROMIS Pain Interference from day 1 (T1) to day 210 (T8) | 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. | Day 1, Day 210 |
Acceptability of intervention based on Mean scores on the Treatment Acceptability and Adherence Scale (TAAS) | 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). | Day 29 |
Feasibility based on the number of sessions attended | Higher number of sessions attended shows higher level of feasibility. | Day 29 |
Feasibility based on the number of in-session and between-session practices completed | Higher number of sessions and between-sessions completed shows higher level of feasibility. | Day 29 |
Feasibility based on open-ended feedback at the completion of the intervention | Participants will complete the open-ended feedback form that has 4 questions regarding the intervention and will be summarized. | Day 29 |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- 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
- 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
Universität Michigan489 aktive klinische Studien zum ErkundenVerantwortliche Partei
John Sturgeon, Hauptprüfer, Assistant Professor of Anesthesiology, University of Michigan
Zentrale Studienkontakte
Kontakt: Beth Banner, 734-998-5837, [email protected]
1 Studienstandorte in 1 Ländern
Michigan
University of Michigan, Ann Arbor, Michigan, 48109, United States
Beth Banner, Kontakt, 734-998-5837, [email protected]
John Sturgeon, PhD, Hauptprüfer
Offene Rekrutierung