Lateral Epicondylitis Iontophoresis Randomized Control Trial (LERCT)
Primary Purpose
Lateral Epicondylitis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Iontophoresis
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Epicondylitis
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.
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
No
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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