Lateral EpicondylitisNCT00435318
Lateral Epicondylitis Iontophoresis Randomized Control Trial (LERCT)
A study testing Iontophoresis in people with Lateral Epicondylitis, run by Vanderbilt University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Iontophoresis
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Feb 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
About this study
The intent of this double-blinded study is to investigate the short (2 months) and long-term (over 2 months) therapeutic capabilities of Iontophoresis.
Read the 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.
- Conditions
- Lateral Epicondylitis
- Being tested
- Iontophoresis
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IontophoresisProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring using questionnaires and therapy measurements.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionFeb 2007
- Study completionFeb 2007
Why it stopped: Study approval deferred by the IRB.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Investigators
- Donald H Lee, M.D., Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435318
- Sponsor's protocol ID
- 060984
- Status last verified
- Dec 2015
- First submitted
- 12 Feb 2007
- Last updated
- 8 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Epicondylitis Iontophoresis Randomized Control Trial (LERCT)
- ClinicalTrials.gov ID
- NCT00435318
- Acronym / sponsor ID
- 060984
- Conditions
- Lateral Epicondylitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study approval deferred by the IRB.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 14 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who have clinical evidence of Lateral Epicondylitis
- 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.
- Ability and willingness to follow instructions
- Patients who are able and willing to return for follow-up evaluations
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iontophoresis | Procedure or surgery | – |
Primary outcome
Measuring using questionnaires and therapy measurements.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald H Lee, M.D. principal investigator
Vanderbilt University
Questions about this trial
What is this clinical trial studying?
A study testing Iontophoresis in people with Lateral Epicondylitis, run by Vanderbilt University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring using questionnaires and therapy measurements.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2015.