NCT00119704

Brief Summary

The purpose of this study is to determine whether Botulinum A toxin is effective in the treatment of tennis elbow (lateral epicondylitis).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2002

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

September 1, 2002

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2005

Completed
Last Updated

May 9, 2006

Status Verified

June 1, 2005

First QC Date

July 6, 2005

Last Update Submit

May 8, 2006

Conditions

Epicondylitis, Lateral Humeral

Outcome Measures

Primary Outcomes (1)

  • 100 mm visual analog scale (VAS)

Secondary Outcomes (1)

  • Grip strength measured with a Jamar Hydraulic Hand Dynamometer with the elbow fully extended and the hand in middle position.

Interventions

Botulinum toxin A injection or normal salineDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18 years and up
  • Pain at the lateral side of the elbow
  • Pain at the lateral epicondyle during resisted dorsiflexion of the wrist with the elbow in full extension
  • Pain for longer than 3 months

You may not qualify if:

  • Previous operations (including previous steroid injections for the disorder)
  • Nerve entrapment
  • Pregnancy and while breast-feeding
  • Presence of systemic neuromuscular disorders such as myasthenia gravis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Location

North District Hospital

Sheung Shui, New Territories, Hong Kong

Location

Related Publications (1)

  • Wong SM, Hui AC, Tong PY, Poon DW, Yu E, Wong LK. Treatment of lateral epicondylitis with botulinum toxin: a randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2005 Dec 6;143(11):793-7. doi: 10.7326/0003-4819-143-11-200512060-00007.

    PMID: 16330790RESULT

MeSH Terms

Conditions

Tennis Elbow

Interventions

Botulinum Toxins, Type ASaline Solution

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 FactorsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Andrew CF Hui, MRCP

    Department of Medicine & Therapeutics, Facutly of Medicine, The Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2005

First Posted

July 14, 2005

Study Start

September 1, 2002

Study Completion

March 1, 2005

Last Updated

May 9, 2006

Record last verified: 2005-06

Locations

HK(2)