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Completed

NCT Number: NCT00497913

Dysport® Injection in the Treatment of Chronic Lateral Epicondylitis

The purpose of this study is to determine whether a single injection of Dysport with a new protocol at forearm is effective in the management of chronic lateral epicondylitis.

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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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Imam Khomeini Hospital

Tehran, Tehran Province, 1419173341, Iran

About this study

Some studies valued the effectiveness of botulinum toxin. There is a great amount of controversy on the amount of botulinum toxin injected and the location of the injection. The purpose of the study is to compare the effectiveness of botulinum toxin injection with placebo at a new injection site at the forearm in the treatment of chronic tennis elbow unrelieved by corticosteroid injection and physiotherapy. It is a double blind randomized controlled trial.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pain: pain will be assessed as the physician touches lateral epicondyle or passively flexing the patient's wrist and while the patient extends his/her wrist or 3rd finger against resistance. Individuals who fulfill two or more of above will be considered to have lateral epicondylitis.
  • Symptom duration: should be at least 6 months.
  • Previous trial of complete course of physiotherapy and corticosteroid injection.

Exclusion criteria

  • Rheumatoid arthritis
  • Generalized polyarthritis
  • Local elbow arthritis
  • Simultaneous medial epicondylalgia
  • Bilateral lateral epicondylitis
  • Neurologic deficits (abnormal light touch sensation, deep tendon reflexes abnormality, radicular pain, radial nerve entrapment, signs of nerve root compression, decreased muscle force, multiple sclerosis, seizures)
  • The use of corticosteroid in last 30 days
  • Simultaneous use of drugs other than acetaminophen or physical therapy in the course of study
  • Pregnancy
  • Breast-feeding
  • Previous hand surgery
  • Having a hobby or job that needs finger extension

Treatment and study plan

NaCl 0.9%

Drug

Botulinum toxin A

Drug

Other names: Dysport

Primary outcomes

  1. Pain score on VAS at maximal grip, at maximal pinch, and during previous month at rest

    Time frame: 4 months

Secondary outcomes

  1. Patients subjective feeling of improvement.

    Time frame: 4 months

  2. Tenderness on lateral epicondyle

    Time frame: 4 months

  3. Pain sensation on resisted wrist extension, and passive wrist flexion

    Time frame: 4 months

  4. Pain-free grip strength, and pinch strength

    Time frame: 4 months

  5. Maximal grip strength, and pinch strength

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Acronym: DCLE

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 9, 2007
Registry last updated
Apr 23, 2008

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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