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Dysport® Injection in the Treatment of Chronic Lateral Epicondylitis (DCLE)

This study has been completed.
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00497913
First received: July 6, 2007
Last updated: April 22, 2008
Last verified: April 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Tennis Elbow
 Drug: NaCl 0.9%
Drug: Botulinum Toxin A
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Pain score on VAS at maximal grip, at maximal pinch, and during previous month at rest [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients subjective feeling of improvement. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Tenderness on lateral epicondyle [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Pain sensation on resisted wrist extension, and passive wrist flexion [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Pain-free grip strength, and pinch strength [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Maximal grip strength, and pinch strength [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: August 2007
Study Completion Date: April 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Botulinum Toxin A
Other Name: Dysport
Placebo Comparator: B Drug: NaCl 0.9%

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00497913

Locations
Iran, Islamic Republic of
Imam Khomeini Hospital
Tehran, Iran, Islamic Republic of, 1419173341
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Study Director: Seyed Mohammad J Mortazavi, M.D. Tehran University of Medical Sciences
  More Information

No publications provided by Tehran University of Medical Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00497913     History of Changes
Other Study ID Numbers: 85-02-53-4207
Study First Received: July 6, 2007
Last Updated: April 22, 2008
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
Tennis Elbow
Botulinum Toxin

Additional relevant MeSH terms:
Tennis Elbow
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013