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Lateral Epicondylitis Iontophoresis Randomized Control Trial (LERCT)

Primary Purpose

Lateral Epicondylitis

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Iontophoresis

About this trial

This is an interventional treatment trial for Lateral Epicondylitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

Outcomes

Primary Outcome Measures

Measuring using questionnaires and therapy measurements.

Secondary Outcome Measures

Full Information

NCT ID

NCT00435318

First Posted

February 12, 2007

Last Updated

December 7, 2015

Sponsor

Vanderbilt University

1. Study Identification

Unique Protocol Identification Number

NCT00435318

Brief Title

Lateral Epicondylitis Iontophoresis Randomized Control Trial (LERCT)

Official Title

Lateral Epicondylitis Iontophoresis Randomized Control Trial (LERCT)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Study approval deferred by the IRB.

Study Start Date

February 2007 (undefined)

Primary Completion Date

February 2007 (Actual)

Study Completion Date

February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Vanderbilt University

4. Oversight

5. Study Description

Brief Summary

The intent of this double-blinded study is to investigate the short (2 months) and long-term (over 2 months) therapeutic capabilities of Iontophoresis.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lateral Epicondylitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Iontophoresis

Primary Outcome Measure Information:

Title

Measuring using questionnaires and therapy measurements.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: Ability and willingness to follow instructions Patients who are able and willing to return for follow-up evaluations Patients of all races and genders 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donald H Lee, M.D.

Organizational Affiliation

Vanderbilt University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Lateral Epicondylitis Iontophoresis Randomized Control Trial (LERCT)

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