Lateral Epicondylalgia (Tennis Elbow)NCT00631501
Doxycycline for Lateral Epicondylalgia - RCT
A study testing Doxycycline in people with Lateral Epicondylalgia (Tennis Elbow), run by Kaunas University of Medicine at 1 site in Lithuania.
Trial summary
Matrix metalloproteinases are involved in the pathogenesis of tendinopathy. Doxycycline, a widely available pharmaceutical agent mostly used for its antibiotic properties, also functions as an inhibitor of MMPs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylalgia (Tennis Elbow)
- What is being tested?
- Doxycycline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteLithuania
- Study dates
- Start not givento not given
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65
- Pain at the lateral side of the elbow ≥8 weeks
- Local tenderness on palpation of the lateral epicondyle
- Pain on resisted extension of the wrist
Who cannot join
- Rheumatic disorder
- History of fibromyalgia or generalised pain
- Elbow surgery (on the painful side)
- Active infection
- Glucocorticoid treatment during the duration of symtoms of epicondylalgia
- NSAID use within 1 w before presentation and during the study
- Pregnancy
- Taking drug that might interact with doxycycline
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Dept of Orthopaedics, Kaunas Medical University
Kaunas, Kaunas County
Alfredas Smailys, smailys@takas.lt
About this study
Matrix metalloproteinases are involved in the pathogenesis of tendinopathy. Doxycycline, a widely available pharmaceutical agent mostly used for its antibiotic properties, also functions as an inhibitor of MMPs.
This study aims to investigate the effect of doxycycline treatment on lateral epicondylalgia (tennis elbow). During three weeks, patients receive doxycycline tablets 100 mg twice daily, or placebo. Main outcome variable is pain (VAS) at three weeks.
Serum and/or plasma levels of matrix metalloproteinases and tissue inhibitors of metalloproteinases are measured.
- Conditions
- Lateral Epicondylalgia (Tennis Elbow)
- Being tested
- Placebo, Doxycycline
- Keywords
- tendinopathy, tennis elbow, lateral epicondylitis, lateral epicondylalgia, MMP-inhibitor
- Medical subject headings
- Tennis Elbow, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
DoxycyclineDrug
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
| Doxycycline | Experimental | 100 mg twice daily Receives: Drug: Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (VAS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Epicondylalgia (Tennis Elbow)Studies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaunas University of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631501
- Sponsor's protocol ID
- BE-2-47
- Status last verified
- Feb 2008
- First submitted
- 27 Feb 2008
- Last updated
- 7 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doxycycline for Lateral Epicondylalgia - RCT
- ClinicalTrials.gov ID
- NCT00631501
- Acronym / sponsor ID
- BE-2-47
- Conditions
- Lateral Epicondylalgia (Tennis Elbow)
- Keywords
- tendinopathy, tennis elbow, lateral epicondylitis, lateral epicondylalgia, MMP-inhibitor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Kaunas University of MedicineUniversity, hospital or other
- Collaborators
- University Hospital, Linkoeping
- First posted
- 7 Mar 2008 (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.
Matrix metalloproteinases are involved in the pathogenesis of tendinopathy. Doxycycline, a widely available pharmaceutical agent mostly used for its antibiotic properties, also functions as an inhibitor of MMPs.
This study aims to investigate the effect of doxycycline treatment on lateral epicondylalgia (tennis elbow). During three weeks, patients receive doxycycline tablets 100 mg twice daily, or placebo. Main outcome variable is pain (VAS) at three weeks.
Serum and/or plasma levels of matrix metalloproteinases and tissue inhibitors of metalloproteinases are measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: Placebo |
| Doxycycline | Experimental | Drug: Doxycycline100 mg twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65
- Pain at the lateral side of the elbow ≥8 weeks
- Local tenderness on palpation of the lateral epicondyle
- Pain on resisted extension of the wrist
Key exclusion criteria (8 listed)
- Rheumatic disorder
- History of fibromyalgia or generalised pain
- Elbow surgery (on the painful side)
- Active infection
- Glucocorticoid treatment during the duration of symtoms of epicondylalgia
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 |
|---|---|---|
| Placebo | Drug | 2 |
| Doxycycline | Drug | Doxycycline |
Primary outcome
Pain (VAS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2008.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doxycycline in people with Lateral Epicondylalgia (Tennis Elbow), run by Kaunas University of Medicine at 1 site in Lithuania.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Mar 2008. 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 Lithuania. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alfredas Smailys, MD, PhD (+370 37 327201, smailys@takas.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (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 Mar 2008.