NCT00437762

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

February 28, 2013

Status Verified

February 1, 2013

Enrollment Period

5.2 years

First QC Date

February 19, 2007

Last Update Submit

February 27, 2013

Conditions

Tennis Elbow

Keywords

Lateral epicondylitis, tennis elbow, treatment

Outcome Measures

Primary Outcomes (1)

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

    at 3 month

Secondary Outcomes (5)

  • pain intensity

    to day 30, 90,180, 365

  • Number of painful days

    to day 30, 90,180, 365

  • Number of associated treatments.

    to day 30, 90,180, 365

  • Free pain grip strength

    to day 30, 90,180, 365

  • Rate of recidivism after initial relief

    to day 30, 90,180, 365

Study Arms (2)

1

EXPERIMENTAL

Botulinum Toxin A Injection

Drug: Botulinum Toxin A Injection

2

PLACEBO COMPARATOR

Placebo injection

Drug: Placebo injection

Interventions

Botulinum Toxin A InjectionDRUG

Botulinum Toxin A Injection

1
Placebo injectionDRUG

Placebo Injection

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité de médecine orthopédique- Hôpital Pellegrin RDC aile 2.

Bordeaux, 330076, France

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Mathieu DE SEZE, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2007

First Posted

February 21, 2007

Study Start

April 1, 2007

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

February 28, 2013

Record last verified: 2013-02

Locations

FR(1)