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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Withdrawn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
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Outcomes
Full info

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:

  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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Measuring using questionnaires and therapy measurements.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 12, 2007
    Last Updated
    December 7, 2015
    Sponsor
    Vanderbilt University
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    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

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    Lateral Epicondylitis Iontophoresis Randomized Control Trial (LERCT)

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