NCT00257634

Brief Summary

The purpose of this project is to compare different treatment options for lateral epicondylitis. Lateral epicondylitis is a pain condition involving extensor muscles fo the forearm originating from the lateral epicondyle. Controversy exists regarding the method of delivering pain relief so that conditioning and strengthening can be initiated and progress appropriately. Our hypothesis is that the steady even delivery via iontophoresis (compared to injection will provide better pain control and allow physical therapy to progress more effectively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2004

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

Study Start

First participant enrolled

December 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

April 27, 2007

Status Verified

April 1, 2007

First QC Date

November 21, 2005

Last Update Submit

April 26, 2007

Conditions

Lateral EpicondylitisWork Related Injury

Keywords

lateral epicondylitisiontophoresisdexamethasone

Outcome Measures

Primary Outcomes (3)

  • outcome measurement instrument

  • grip strength

  • return to work

Secondary Outcomes (1)

  • cost

Interventions

dexamethasone to injury siteDRUG

Eligibility Criteria

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

You may qualify if:

  • Tenderness at lateral epicondyle,
  • No radiographic abnormality at the elbow,
  • Mille's Sign positive- pain with elbow extension,
  • Forearm pronation,
  • Wrist flexion,
  • Maudsley Test positive - pain with resisted passive

You may not qualify if:

  • Pregnancy,
  • History of fibromyalgia,
  • Elbow surgery,
  • Diagnosis of multilevel nerve compression,
  • Symptoms of lateral epicondylitis for more than 2 year,
  • Bilateral lateral epicondylitis,
  • Previous corticosteroid injection in the same elbow,
  • Use of systemic steroid medication within the last 6 months,
  • Evidence of active infection,
  • History of allergic reaction to the study medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Officials

  • aamir siddiqui, MD

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 21, 2005

First Posted

November 23, 2005

Study Start

December 1, 2004

Study Completion

January 1, 2007

Last Updated

April 27, 2007

Record last verified: 2007-04

Locations

US(1)