NCT00497913

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2007

Shorter than P25 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

July 6, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2007

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

April 23, 2008

Status Verified

April 1, 2008

Enrollment Period

7 months

First QC Date

July 6, 2007

Last Update Submit

April 22, 2008

Conditions

Tennis Elbow

Keywords

Tennis ElbowBotulinum Toxin

Outcome Measures

Primary Outcomes (1)

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

    4 months

Secondary Outcomes (5)

  • Patients subjective feeling of improvement.

    4 months

  • Tenderness on lateral epicondyle

    4 months

  • Pain sensation on resisted wrist extension, and passive wrist flexion

    4 months

  • Pain-free grip strength, and pinch strength

    4 months

  • Maximal grip strength, and pinch strength

    4 months

Study Arms (2)

A

ACTIVE COMPARATOR
Drug: Botulinum Toxin A

B

PLACEBO COMPARATOR
Drug: NaCl 0.9%

Interventions

NaCl 0.9%DRUG
B
Botulinum Toxin ADRUG
Also known as: Dysport
A

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imam Khomeini Hospital

Tehran, Tehran Province, 1419173341, Iran

Location

Related Publications (1)

  • 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.

    PMID: 20421357DERIVED

MeSH Terms

Conditions

Tennis Elbow

Interventions

Sodium ChlorideBotulinum Toxins, Type AabobotulinumtoxinA

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsBotulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Seyed Mohammad J Mortazavi, M.D.

    Tehran University of Medical Sciences

    STUDY DIRECTOR

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, 2007

First Posted

July 9, 2007

Study Start

August 1, 2007

Primary Completion

March 1, 2008

Study Completion

April 1, 2008

Last Updated

April 23, 2008

Record last verified: 2008-04

Locations

IR(1)