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Low-Intensity Focused Ultrasound and the Complex Patient

A legfontosabb adatok

Ki végzi
Virginia Polytechnic Institute and State University
Hol
Roanoke (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Visszavonva
Kezdés
2024. dec. 4.
Befejezés
2026. okt. 31.
A vizsgálat típusa
Beavatkozással járó
A vizsgált kezelések
  • Low-Intensity Focused Ultrasound
  • Low-Intensity Focused Ultrasound - sham
A regiszteradat frissítve
2026. november 9.
Miért állt le
Unable to recruit any eligible participants.

Ki vehet részt

Életkor
18 év – 65 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 18 feltétel megnézéseKevesebb

Ki vehet részt

  • Males and females aged 18-65 years
  • Current diagnosis of Chronic Back Pain as defined by pain duration of at least three months, with back pain being an ongoing problem for at least half the days of the last six months
  • Have evidence of central sensitization (CS) as measured by the Widespread Pain/Symptom Severity Index (WPSSI) with a score of Widespread Pain Index (WPI) ≥ 7 and Symptom Severity (SS) ≥ 5 or WPI = 3-6 and SS ≥ 9
  • Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current opiate use disorder as diagnosed by the Structured Clinical Interview for DSM-5
  • Be in treatment for opioid use disorder (OUD) including buprenorphine or methadone
  • Meet the DSM-5 criteria for a current anxiety disorder: generalized anxiety disorder, post-traumatic stress disorder or social anxiety disorder as diagnosed by the Structured Clinical Interview for DSM-5

Ki nem vehet részt

  • Previous spine surgery
  • Ferromagnetic implants or other contraindications for magnetic resonance imaging (MRI)
  • Current substance use disorder other than OUD or tobacco use disorder
  • Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder
  • Chronic Pain Conditions other than chronic back pain
  • History of head injury, seizures, neurologic disorders including cerebrovascular disease, stroke, brain surgery, brain tumor, multiple sclerosis, or neurodegenerative diseases
  • History of metastasizing cancers, inflammatory disorder (rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus or polymyositis), unintended weight loss of 20 pounds or more in the last year, or cauda equina syndrome
  • Unstable medical conditions such as congestive heart failure, unstable angina, poorly controlled arrhythmia active system infection end stage renal disease
  • Evidence of arteriovenous malformation, aneurysm, infarct, meningioma, parenchymal brain tumor or evidence of neurodegenerative processes and/or white matter lesions greater than that expected for age as determined by the study neuroradiologist
  • Evidence of neuropathic pain
  • Daily opiate use other than buprenorphine/methadone for OUD/pain control
  • Pregnant or breastfeeding

Helyszínek itt: Egyesült Államok

  • Fralin Biomedical Research Institute at VTCRoanoke, Egyesült Államok

A vizsgálatról

Mit akar kideríteni a vizsgálat

Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.

A vizsgálat csoportja

  • Pain, Craving, and Anxiety measuresA vizsgált kezelés

    Multi visit - LIFU/Sham. Participants will complete pain, craving, and anxiety measures pre and post intervention.

    Kezelés: Low-Intensity Focused Ultrasound és Low-Intensity Focused Ultrasound - sham

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Investigations of Low-Intensity Focused Ultrasound Towards Treatment for the Complex Patient
A regiszteradat frissítve
2026. november 9.