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UltraSound-Guided Versus Non-Ultrasound-Guided Botulinum Toxin Injections in Cervical Dystonia [CUSTODY]

Study acronym: CUSTODY
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Secondary endpoints: details revised at 4 of 7 entriesv3
  2. Secondary endpoints: details revised at 2 of 7 entries
    • Study title shortened, about 8 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cervical dystonia is a condition that causes the neck muscles to tighten or spasm, leading to abnormal head positions and pain. The main questions it aims to answer are: * Do ultrasound-guided BoNT injections improve quality of life more than injections without ultrasound? * Are ultrasound-guided injections as safe as injections without ultrasound? Researchers will compare: * BoNT injections with ultrasound guidance * BoNT injections without ultrasound guidance (based only on body landmarks) Participants will: * Receive both types of injections during the study (one first, then the other) * Complete questionnaires about quality of life, movement, pain, and mood * Attend follow-up visits over about 8 months About 37 adults with cervical dystonia will take part. The study will take place at the Fondazione IRCCS Istituto Neurologico Carlo Besta in Milan, Italy.
Trial Details
NCT Number NCT07233993
Lead Sponsor Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Conditions
(from sponsor)		 Idiopathic Cervical Dystonia
Related terms Torticollis
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov