Lateral EpicondylitisPhase 3NCT00257634
Randomized Trial of Iontophoresis Versus Injection of Corticosteroids for Lateral Epicondylitis
A Phase 3 study testing dexamethasone to injury site in people with Lateral Epicondylitis and Work Related Injury, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of this project is to compare different treatment options for lateral epicondylitis. Lateral epicondylitis is a pain condition involving extensor muscles fo the forearm originating from the lateral epicondyle. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lateral Epicondylitis, Work Related Injury
- What is being tested?
- dexamethasone to injury site
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Jan 2007
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tenderness at lateral epicondyle,
- No radiographic abnormality at the elbow,
- Mille's Sign positive- pain with elbow extension,
- Forearm pronation,
- Wrist flexion,
- Maudsley Test positive - pain with resisted passive
Who cannot join
- Pregnancy,
- History of fibromyalgia,
- Elbow surgery,
- Diagnosis of multilevel nerve compression,
- Symptoms of lateral epicondylitis for more than 2 year,
- Bilateral lateral epicondylitis,
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- Previous corticosteroid injection in the same elbow,
- Use of systemic steroid medication within the last 6 months,
- Evidence of active infection,
- History of allergic reaction to the study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexamethasone Delivery for Treatment of Lateral Epicondylitis (IRB #3260)
The purpose of this project is to compare different treatment options for lateral epicondylitis. Lateral epicondylitis is a pain condition involving extensor muscles fo the forearm originating from the lateral epicondyle. Controversy exists regarding the method of delivering pain relief so that conditioning and strengthening can be initiated and progress appropriately. Our hypothesis is that the steady even delivery via iontophoresis (compared to injection will provide better pain control and allow physical therapy to progress more effectively.
Read the detailed description
Therapy is standardized so treatment can begin before enrollment in the study. Patients who decide not to participate will get standard therapy. Therapy is based on the published Indiana Hand Center protocol. Phase 1 is rest, phase 2 is mobility and phase 3 is strengthening. Patients who agree to participate will be randomized to either the injection or iontopatch group after informed consent.
GROUP 1 (injection) Patients seen by physician. Based upon history and physical examination, injection wil be offered. Injection is 10 mg dexamethasone intramuscular. Therapy then is continued per standard protocol. Patient monitored for worsening of symptoms. If the patient worsens, the patient will be placed back into phase 1 and 2 for another 3 weeks then advanced again. Repeat injection will be at discretion of the treating physician. Patients with more than 2 injections wil be disqualified from the study and considered a treatment failure. Patients that injections wil be disqualified from the study and considered a treatment failure. Patients that completed phase 3 will be released from therapy with home management program instructions. Restrictions will be at the discretion of the physician. After 2 failures to progress to phase 3, the patient will be considered a failure of treatment. In the event of relapse after successful completion of therapy, the protocol will be repeated.
GROUP 2 (iontopatch) One volt patch with dexamethasone phosphate will be used.Patient will be treated with one patch every 2 days for a total of 3 patches. Application will be per the Birchpoint Medical Group Iontopatch 80 protocol. The patches will correlate with physical therapy phases 1 and 2. Phase 3 will not begin until the Iontopatch has been off for more than 24 hours. Therapy will progress based on the above protocol. If there is worsening of symptoms, the patient will be placed back to phase 1 and 2 for another 3 weeks and then advanced again. Iontopatches can be repeated if there has been a substantial worsening of symptoms. Patients are eligible for up to 6 patches for the duration of the study. Once the 6 patches have been used, therapy can continue per protocol but without iontopatch and/or injection. Patients that completed phase 3 will be released from therapy. After 2 failures to progress to phase 3, the patient will be considered a failure of treatment. Long term restrictions will be at the discretion of the physician.
Patients will complete a Forearm Pain Questionnaire at the time of enrollment, at completion of therapy and monthly after that for 3 months. This is a standardized published questionnaire specifically designed to identify and track lateral epicondylitis patients.
- Conditions
- Lateral Epicondylitis, Work Related Injury
- Being tested
- dexamethasone to injury site
- Keywords
- lateral epicondylitis, iontophoresis, dexamethasone
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasone to injury siteDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
outcome measurement instrument
grip strength
return to work
Secondary outcomes (1)
cost
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2005 (estimated)
- Study startDec 2004
- Study completionJan 2007
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.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Birch Point Medical
- Investigators
- aamir siddiqui, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257634
- Sponsor's protocol ID
- HFHS-3260
- Status last verified
- Apr 2007
- First submitted
- 21 Nov 2005
- Last updated
- 27 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Delivery for Treatment of Lateral Epicondylitis (IRB #3260)
- ClinicalTrials.gov ID
- NCT00257634
- Acronym / sponsor ID
- HFHS-3260
- Conditions
- Lateral Epicondylitis, Work Related Injury
- Keywords
- lateral epicondylitis, iontophoresis, dexamethasone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Birch Point Medical
- Study start
- Dec 2004
- Study completion
- Jan 2007 (actual)
- First posted
- 23 Nov 2005 (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 purpose of this project is to compare different treatment options for lateral epicondylitis. Lateral epicondylitis is a pain condition involving extensor muscles fo the forearm originating from the lateral epicondyle. Controversy exists regarding the method of delivering pain relief so that conditioning and strengthening can be initiated and progress appropriately. Our hypothesis is that the steady even delivery via iontophoresis (compared to injection will provide better pain control and allow physical therapy to progress more effectively.
Detailed description
Therapy is standardized so treatment can begin before enrollment in the study. Patients who decide not to participate will get standard therapy. Therapy is based on the published Indiana Hand Center protocol. Phase 1 is rest, phase 2 is mobility and phase 3 is strengthening. Patients who agree to participate will be randomized to either the injection or iontopatch group after informed consent.
GROUP 1 (injection) Patients seen by physician. Based upon history and physical examination, injection wil be offered. Injection is 10 mg dexamethasone intramuscular. Therapy then is continued per standard protocol. Patient monitored for worsening of symptoms. If the patient worsens, the patient will be placed back into phase 1 and 2 for another 3 weeks then advanced again. Repeat injection will be at discretion of the treating physician. Patients with more than 2 injections wil be disqualified from the study and considered a treatment failure. Patients that injections wil be disqualified from the study and considered a treatment failure. Patients that completed phase 3 will be released from therapy with home management program instructions. Restrictions will be at the discretion of the physician. After 2 failures to progress to phase 3, the patient will be considered a failure of treatment. In the event of relapse after successful completion of therapy, the protocol will be repeated.
GROUP 2 (iontopatch) One volt patch with dexamethasone phosphate will be used.Patient will be treated with one patch every 2 days for a total of 3 patches. Application will be per the Birchpoint Medical Group Iontopatch 80 protocol. The patches will correlate with physical therapy phases 1 and 2. Phase 3 will not begin until the Iontopatch has been off for more than 24 hours. Therapy will progress based on the above protocol. If there is worsening of symptoms, the patient will be placed back to phase 1 and 2 for another 3 weeks and then advanced again. Iontopatches can be repeated if there has been a substantial worsening of symptoms. Patients are eligible for up to 6 patches for the duration of the study. Once the 6 patches have been used, therapy can continue per protocol but without iontopatch and/or injection. Patients that completed phase 3 will be released from therapy. After 2 failures to progress to phase 3, the patient will be considered a failure of treatment. Long term restrictions will be at the discretion of the physician.
Patients will complete a Forearm Pain Questionnaire at the time of enrollment, at completion of therapy and monthly after that for 3 months. This is a standardized published questionnaire specifically designed to identify and track lateral epicondylitis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Tenderness at lateral epicondyle,
- No radiographic abnormality at the elbow,
- Mille's Sign positive- pain with elbow extension,
- Forearm pronation,
- Wrist flexion,
Key exclusion criteria (10 listed)
- Pregnancy,
- History of fibromyalgia,
- Elbow surgery,
- Diagnosis of multilevel nerve compression,
- Symptoms of lateral epicondylitis for more than 2 year,
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 |
|---|---|---|
| dexamethasone to injury site | Drug | – |
Primary outcome
outcome measurement instrument
grip strength
return to work
1 secondary outcome
cost
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2007.
Related trials for Lateral Epicondylitis
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A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
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Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
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Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
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Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
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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.
aamir siddiqui, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dexamethasone to injury site in people with Lateral Epicondylitis and Work Related Injury, run by Henry Ford Health System at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 27 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
outcome measurement instrument. The study lists 3 primary outcomes in all. 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 27 Apr 2007.