Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment

Study acronym: TBA
StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Study Status, Referencesv6
  2. Notable Primary completion date changed from estimate of Jul 2011 to Jun 2012
    • Trial status: Recruiting to Completed
    • Enrollment target: estimated 60 to confirmed 61
    • Site details revised
    v5
  3. Minor Primary completion date: Mar 2011 to Jul 2011
    • Study completion date: Dec 2011 to Jun 2012
    v4
  4. Notable Primary completion date: Mar 2009 to Mar 2011
    • Study completion date: Dec 2009 to Dec 2011
    • Site contact updated
    • Eligibility criteria expanded, about 5 words
    v3
  5. Notable Phase: Phase 4 to Phase 3v2 Show 12 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary endpoint revised
    • Primary completion date: Mar 2009
    • Study completion date: Dec 2009
    • Start date: Mar 2007 to Apr 2007
    • Interventions: Dysport (Botulinum A Toxin) (Drug) to Botulinum Toxin A Injection (Drug), Placebo injection (Drug)
    • Eligibility criteria revised
    • Secondary endpoints: 1 to 5
    • Study description revised
    • Site details revised
    • Study title revised
    • Study arms: 0 to 2
  6. Study First Submitted
  • 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.
Some studies valued the effectiveness of botulinum toxin. Results are contradictory and we need more studies. The purpose of the study is to compare the effectiveness of botulinum toxin injection with placebo in the treatment of tennis elbow unrelieved by usual medical care performed during 6 months. Method : It is a double blind randomized controlled trial. Principal criteria of assessment is Pain intensity three months after injection.
Trial Details
NCT Number NCT00437762
Lead Sponsor University Hospital, Bordeaux
Collaborators: Ipsen
Conditions
(from sponsor)
Tennis Elbow
Related terms Tennis Elbow
Enrollment 61 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov