Lateral Epicondylitis Iontophoresis Randomized Control Trial (LERCT)

December 7, 2015 updated by: Vanderbilt University
The intent of this double-blinded study is to investigate the short (2 months) and long-term (over 2 months) therapeutic capabilities of Iontophoresis.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The intent of this double-blinded study is to investigate the short (2 months) and long-term (over 2 months) therapeutic capabilities of Iontophoresis. We anticipate that patients treated with Iontophoresis will have improved scores on the VAS and DASH assessments, and will recover more quickly than those patients receiving the Sham treatment. A Sham treatment is a method used in medical trials to help researchers determine the effectiveness of a drug/treatment which in this case will be Iontophoretic Administration using Dexamethasone. Placebos are inactive substances (Saline) used in this study to compare results with an active substance (Dexamethasone). Furthermore, it is the hope of this research team that through careful analysis and comparison of these two treatment arms a clear conclusion is met regarding the efficacy of Iontophoresis as a powerful treatment paradigm for patients suffering from this disorder.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Patients who have clinical evidence of Lateral Epicondylitis

    - Tests: Palpation of Lateral Epicondylitis, Resisted Wrist Extension, Middle Finger Test, Manual Muscle Test

  • Patients who have symptoms (patient provided or documented information will be used to determine how long they have had symptoms) of Lateral Epicondylitis for at least a month, but no more than 3 months from most recent episode
  • X-rays must show no evidence of post-traumatic or degenerative arthritis. All patients who present to VOI Hand & Upper Extremity Center complaining of Lateral Epicondylitis Symptoms have radiographs taken.

Patient selection factors include:

  1. Ability and willingness to follow instructions
  2. Patients who are able and willing to return for follow-up evaluations
  3. Patients of all races and genders
  4. Patients who are able to follow care instructions

Exclusion Criteria

  • Patients less than 18 years old, or older than 75 years old
  • Patients who to their knowledge our pregnant
  • Patients unwillingly or unable to comply with a rehabilitation program, or who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol
  • Patients who qualify for inclusion in the study, but refuse consent to participate in the study
  • Patients who have had non-steroidal anti-inflammatory drugs or systemic corticosteroids/analgesics within three days prior
  • Patients who have local therapeutic modalities, such as: Iontophoresis, ultrasound, or heat within the last month

  • Patients who have had:

    • Injection of steroids within the last year or prior surgery
    • Recurrent injury or previous fracture of affected area
    • History of Rheumatoid or Degenerative Arthritis, Carpal Tunnel Syndrome, Rotator Cuff abnormalities, neurologic abnormalities, muscular or shoulder dysfunction, peripheral neuropathy, radial nerve entrapment, fracture or tumor to the upper extremity, neck or thoracic pain, or pacemaker use.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measuring using questionnaires and therapy measurements.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: Donald H Lee, M.D., Vanderbilt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

February 12, 2007

First Submitted That Met QC Criteria

February 12, 2007

First Posted (Estimate)

February 14, 2007

Study Record Updates

Last Update Posted (Estimate)

December 8, 2015

Last Update Submitted That Met QC Criteria

December 7, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 060984

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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