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Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment

Study acronym: TBA
StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study Status, References

    v6

  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

    Study Status, Sponsor/Collaborators, Study Design, Contacts/Locationsv5

  3. Minor

    Primary completion date: Mar 2011 to Jul 2011

    Completion date: Dec 2011 to Jun 2012

    Study Statusv4

  4. Notable

    Primary completion date: Mar 2009 to Mar 2011

    Completion date: Dec 2009 to Dec 2011; Eligibility criteria expanded, about 5 words; Site contact updated

    Show what changed: Eligibility criteria
    [...] s SLA Anticoagulant treatment Aminosides Diabetes Alcoholism Previous botulinum toxin A injections

    Study Identification, Study Status, Eligibility, Contacts/Locationsv3

  5. Notable

    Phase: Phase 4 to Phase 3

    Trial status: Not Yet Recruiting to Recruiting; Primary endpoint revised; Primary completion date: Mar 2009; and 9 more

    Show all 13 changes in this update
    • Notable Phase: Phase 4 to Phase 3
    • Notable Trial status: Not Yet Recruiting to Recruiting
    • Notable Primary endpoint revised
      Show what changed
      Principal criteria of assessementassessment is Painpain intensity three months after injection.
    • Minor Primary completion date: Mar 2009
    • Minor Completion date: Dec 2009
    • Minor Start date: Mar 2007 to Apr 2007
    • Minor Interventions: Dysport (Botulinum A Toxin) (Drug) to Botulinum Toxin A Injection (Drug), Placebo injection (Drug)
    • Minor Eligibility criteria revised
      Show what changed
      Inclusion Criteria: Tennis elbow during more than 6 months CignatureSignature of consent Exclusion Criteria: Less than 18 years old Osteo [...]
    • Minor Secondary endpoints: 1 to 5
      Show what changed
      secondary criteria of assessment are : pain intensity to day 30, 180, 365 ; Number of painful days ; Number of associated treatments. Free pain grip strength ; Rate of recidivism after initial relief
    • Minor Study description revised
      Show what changed
      [...] care performed during 6 months.. Secondary Objective : The secundsecond aim of this study is to documentedocument the tennis elbow history by a one year following after init [...] le blind randomized controlled trial. Principal criteria of assessementassessment is Pain intensity three months after injection. Inclusion c [...]
    • Minor Site details revised
    • Minor Study title revised
      Show what changed
      Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment.
    • Minor Study arms: 0 to 2

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locationsv2

  6. Minor

    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.
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 Tennis Elbow
Enrollment 61 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov