Doxycycline for Lateral Epicondylalgia - RCT - Tabular View

Tracking Information

First Received Date ^ICMJE

February 27, 2008

Last Updated Date

February 27, 2008

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Pain (VAS) [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Doxycycline for Lateral Epicondylalgia - RCT

Official Title ^ICMJE

Brief 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.

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Lateral Epicondylalgia (Tennis Elbow)

Intervention ^ICMJE

Drug: Placebo
Drug: Doxycycline

Study Arms / Comparison Groups

Experimental: 100 mg twice daily

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Alfredas Smailys, MD, PhD

+370 37 327201

smailys@takas.lt

Location Countries ^ICMJE

Lithuania

Administrative Information

NCT ID ^ICMJE

NCT00631501

Responsible Party

Per Aspenberg, Dept of Orthopaedics, University Hospital Linkoeping

Study ID Numbers ^ICMJE

BE-2-47

Study Sponsor ^ICMJE

Kaunas University of Medicine

Collaborators ^ICMJE

University Hospital, Linkoeping

Investigators ^ICMJE

Information Provided By

Kaunas University of Medicine

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP