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

Primary Purpose

Tennis Elbow

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
NaCl 0.9%
Botulinum Toxin A
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow focused on measuring Tennis Elbow, Botulinum Toxin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Imam Khomeini Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patients subjective feeling of improvement.
Tenderness on lateral epicondyle
Pain sensation on resisted wrist extension, and passive wrist flexion
Pain-free grip strength, and pinch strength
Maximal grip strength, and pinch strength

Full Information

First Posted
July 6, 2007
Last Updated
April 22, 2008
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00497913
Brief Title
Dysport® Injection in the Treatment of Chronic Lateral Epicondylitis
Acronym
DCLE
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow
Keywords
Tennis Elbow, Botulinum Toxin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
NaCl 0.9%
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin A
Other Intervention Name(s)
Dysport
Primary Outcome Measure Information:
Title
Pain score on VAS at maximal grip, at maximal pinch, and during previous month at rest
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Patients subjective feeling of improvement.
Time Frame
4 months
Title
Tenderness on lateral epicondyle
Time Frame
4 months
Title
Pain sensation on resisted wrist extension, and passive wrist flexion
Time Frame
4 months
Title
Pain-free grip strength, and pinch strength
Time Frame
4 months
Title
Maximal grip strength, and pinch strength
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyed Mohammad J Mortazavi, M.D.
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Imam Khomeini Hospital
City
Tehran
ZIP/Postal Code
1419173341
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
20421357
Citation
Espandar R, Heidari P, Rasouli MR, Saadat S, Farzan M, Rostami M, Yazdanian S, Mortazavi SM. Use of anatomic measurement to guide injection of botulinum toxin for the management of chronic lateral epicondylitis: a randomized controlled trial. CMAJ. 2010 May 18;182(8):768-73. doi: 10.1503/cmaj.090906. Epub 2010 Apr 26.
Results Reference
derived

Learn more about this trial

Dysport® Injection in the Treatment of Chronic Lateral Epicondylitis

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