Lateral EpicondylitisPhase 4NCT00554476
Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis
A Phase 4 study testing Triamcinolone Acetonide- Indomethacin-Cryotherapy-Casting in people with Lateral Epicondylitis, run by Azad University of Medical Sciences at 1 site in Iran.
Trial summary
To compare the effectiveness of two combined therapeutic methods including corticosteroid injections with elbow cast versus ice massage and non-steroidal anti inflammatory drugs (NSAIDs). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Triamcinolone Acetonide- Indomethacin-Cryotherapy-Casting
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- Jan 2003to Apr 2006
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pain at the lateral side of the elbow
- pain at the lateral epicondyle during resisted dorsiflexion of the wrist with the elbow in full extension, or resisted extension of middle finger at the metacarpophalangeal joint
- pain to be continued for longer than 6 weeks or even with recurrent pain during similar period
Who cannot join
- previous history of receiving any treatment for lateral epicondylitis within 6 months prior to intervention
- patients who were unable to return for follow up
- patients with nerve entrapment
- pregnancy
- breast-feeding
- presence of systemic neuromuscular disorders such as myasthenia gravis
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- upper limb fractures
- other arm/forearm pathology such as radial nerve compression
- known thrombocytopenia
- coagulopathy or bleeding diathesis
- history of diffuse pain syndrome
- history of inflammatory arthropathy
- intolerance/allergy to corticosteroids or NSAIDs or any contraindication for these
- untreated depression
- history of narcotic use for pain management greater than 1 month or history of narcotic abuse problem
Trial locations and contacts
1 site in 1 country.
Iran1 site
Azad University of Medical Sciences, Boo-Ali Hospital
Tehran, Tehran Province, 13456/7889
About this study
Official title: Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis: A Randomized Clinical Trial
To compare the effectiveness of two combined therapeutic methods including corticosteroid injections with elbow cast versus ice massage and non-steroidal anti inflammatory drugs (NSAIDs).
Read the detailed description
Design: Randomized clinical trial. Setting: Boo-Ali and Baqyiatallah Hospital in Tehran. Patients: 50 randomly selected patients, in two groups of 25 subjects. Interventions: Corticosteroid injections with elbow cast versus icing and NSAIDs.
Outcome measures: Patients were evaluated for outcomes, complications and patients' satisfaction at 2nd, 4th, and 12th week after beginning of treatment. We measured the pain severity by Visual Analogue Scale (VAS).
- Conditions
- Lateral Epicondylitis
- Being tested
- Triamcinolone Acetonide- Indomethacin-Cryotherapy-Casting
- Keywords
- Lateral Epicondylitis, Treatment, Corticosteroid, Elbow Cast, Icing, NSAIDs
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone Acetonide- Indomethacin-Cryotherapy-CastingDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale (VAS)
Secondary outcomes (1)
Patient's satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startJan 2003
- Study completionApr 2006
Why it stopped: Because the sample volume was completed during three years.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Azad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Jaleh Hassanloo, MD, Principal investigator, Department of Orthopedics, Boo-Ali Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554476
- Sponsor's protocol ID
- RCT-246910-06
- Status last verified
- Nov 2007
- First submitted
- 5 Nov 2007
- Last updated
- 7 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00554476
- Acronym / sponsor ID
- RCT-246910-06
- Conditions
- Lateral Epicondylitis
- Keywords
- Lateral Epicondylitis, Treatment, Corticosteroid, Elbow Cast, Icing, NSAIDs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because the sample volume was completed during three years.
- Enrolment
- 50 participants
- Lead sponsor
- Azad University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2003
- Study completion
- Apr 2006
- First posted
- 7 Nov 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.
To compare the effectiveness of two combined therapeutic methods including corticosteroid injections with elbow cast versus ice massage and non-steroidal anti inflammatory drugs (NSAIDs).
Detailed description
Design: Randomized clinical trial. Setting: Boo-Ali and Baqyiatallah Hospital in Tehran. Patients: 50 randomly selected patients, in two groups of 25 subjects. Interventions: Corticosteroid injections with elbow cast versus icing and NSAIDs.
Outcome measures: Patients were evaluated for outcomes, complications and patients' satisfaction at 2nd, 4th, and 12th week after beginning of treatment. We measured the pain severity by Visual Analogue Scale (VAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- pain at the lateral side of the elbow
- pain at the lateral epicondyle during resisted dorsiflexion of the wrist with the elbow in full extension, or resisted extension of middle finger at the metacarpophalangeal joint
- pain to be continued for longer than 6 weeks or even with recurrent pain during similar period
Key exclusion criteria (15 listed)
- previous history of receiving any treatment for lateral epicondylitis within 6 months prior to intervention
- patients who were unable to return for follow up
- patients with nerve entrapment
- pregnancy
- breast-feeding
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 |
|---|---|---|
| Triamcinolone Acetonide- Indomethacin-Cryotherapy-Casting | Drug | – |
Primary outcome
visual analogue scale (VAS)
1 secondary outcome
Patient's satisfaction
Results and safety
The study was stopped early (reason given: Because the sample volume was completed during three years.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2007.
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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.
Jaleh Hassanloo, MD principal investigator
Department of Orthopedics, Boo-Ali Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triamcinolone Acetonide- Indomethacin-Cryotherapy-Casting in people with Lateral Epicondylitis, run by Azad University of Medical Sciences at 1 site in Iran.
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 3 inclusion and 15 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: stopped early, as of the sponsor's last update on 7 Nov 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 Iran. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Because the sample volume was completed during three years.). Results are not available in the source record.
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?
visual analogue scale (VAS). 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 7 Nov 2007.