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Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment (TBA)

Primary Purpose

Tennis Elbow

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Botulinum Toxin A Injection
Placebo injection
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow focused on measuring Lateral epicondylitis, tennis elbow, treatment

Eligibility Criteria

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

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

Sites / Locations

  • Unité de médecine orthopédique- Hôpital Pellegrin RDC aile 2.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Botulinum Toxin A Injection

Placebo injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

pain intensity
Number of painful days
Number of associated treatments.
Free pain grip strength
Rate of recidivism after initial relief

Full Information

First Posted
February 19, 2007
Last Updated
February 27, 2013
Sponsor
University Hospital, Bordeaux
Collaborators
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT00437762
Brief Title
Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment
Acronym
TBA
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Ipsen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow
Keywords
Lateral epicondylitis, tennis elbow, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Botulinum Toxin A Injection
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo injection
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin A Injection
Intervention Description
Botulinum Toxin A Injection
Intervention Type
Drug
Intervention Name(s)
Placebo injection
Intervention Description
Placebo Injection
Primary Outcome Measure Information:
Title
Principal criteria of assessment is pain intensity three months after injection.
Time Frame
at 3 month
Secondary Outcome Measure Information:
Title
pain intensity
Time Frame
to day 30, 90,180, 365
Title
Number of painful days
Time Frame
to day 30, 90,180, 365
Title
Number of associated treatments.
Time Frame
to day 30, 90,180, 365
Title
Free pain grip strength
Time Frame
to day 30, 90,180, 365
Title
Rate of recidivism after initial relief
Time Frame
to day 30, 90,180, 365

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu DE SEZE, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unité de médecine orthopédique- Hôpital Pellegrin RDC aile 2.
City
Bordeaux cedex
ZIP/Postal Code
330076
Country
France

12. IPD Sharing Statement

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Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment

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