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NCT Number: NCT00437762

Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment

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.

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Key information

Conditions

Tennis Elbow Arm Injuries Elbow Injuries Elbow Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Unité de médecine orthopédique- Hôpital Pellegrin RDC aile 2.

Bordeaux, 330076, France

About this study

  • Principal Objective : The first aim of the study is to value the effectiveness of botulinum toxin injection in the treatment of tennis elbow unrelieved by usual medical care performed during 6 months..
  • Secondary Objective : The second aim of this study is to document the tennis elbow history by a one year following after initial injection
  • Study design : It is a double blind randomized controlled trial. Principal criteria of assessment is Pain intensity three months after injection.
  • Inclusion criteria : tennis elbow during more than 6 months ; signature of consent
  • Exclusion criteria : Non inclusion criteria : less than 18 years old ; osteoarthritis elbow, referred cervical pain, fibromyalgia, pregnancy, myasthenia, polymyositis, SLA, anticoagulant treatment, aminosides ; diabetes, alcoholism
  • Study plan: randomized parallel groups
  • Number of subjects : 60

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Tennis elbow during more than 6 months
  • Signature of consent

Exclusion criteria

  • Less than 18 years old
  • Osteoarthritis elbow
  • Referred cervical pain
  • Fibromyalgia
  • Pregnancy
  • Myasthenia
  • Polymyositis
  • SLA
  • Anticoagulant treatment
  • Aminosides
  • Diabetes
  • Alcoholism
  • Previous botulinum toxin A injections

Treatment and study plan

Botulinum Toxin A Injection

Drug

Botulinum Toxin A Injection

Placebo injection

Drug

Placebo Injection

Primary outcomes

  1. Principal criteria of assessment is pain intensity three months after injection.

    Time frame: at 3 month

Secondary outcomes

  1. pain intensity

    Time frame: to day 30, 90,180, 365

  2. Number of painful days

    Time frame: to day 30, 90,180, 365

  3. Number of associated treatments.

    Time frame: to day 30, 90,180, 365

  4. Free pain grip strength

    Time frame: to day 30, 90,180, 365

  5. Rate of recidivism after initial relief

    Time frame: to day 30, 90,180, 365

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Ipsen

Registry information

Official study title

Effectiveness of Botulinum Toxin A Injection for the Treatment of Lateral Epicondylitis Unrelieved by Usual Medical Cares : A Double Blind Randomized Controlled Trial Versus Placebo

Acronym: TBA

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Feb 21, 2007
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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