Doxycycline for Lateral Epicondylalgia - RCT

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2008 by Kaunas University of Medicine. Recruitment status was Recruiting

First Received on February 27, 2008. No Changes Posted

Sponsor:	Kaunas University of Medicine
Collaborator:	University Hospital, Linkoeping
Information provided by:	Kaunas University of Medicine
ClinicalTrials.gov Identifier:	NCT00631501

Purpose

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.

Condition	Intervention
Lateral Epicondylalgia (Tennis Elbow)	Drug: Placebo Drug: Doxycycline

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Elbow Injuries and Disorders Tendinitis

Drug Information available for: Doxycycline Doxycycline hyclate Doxycycline calcium

U.S. FDA Resources

Further study details as provided by Kaunas University of Medicine:

Primary Outcome Measures:

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

Estimated Enrollment:

Arms	Assigned Interventions
Placebo Comparator: 2	Drug: Placebo
Experimental: Doxycycline 100 mg twice daily	Drug: Doxycycline

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631501

Contacts

Contact: Alfredas Smailys, MD, PhD

+370 37 327201

smailys@takas.lt

Locations

Lithuania
Dept of Orthopaedics, Kaunas Medical University	Recruiting
Kaunas, Lithuania
Contact: Alfredas Smailys smailys@takas.lt

Sponsors and Collaborators

Kaunas University of Medicine

University Hospital, Linkoeping

More Information

No publications provided

Responsible Party:	Per Aspenberg, Dept of Orthopaedics, University Hospital Linkoeping
ClinicalTrials.gov Identifier:	NCT00631501 History of Changes
Other Study ID Numbers:	BE-2-47
Study First Received:	February 27, 2008
Last Updated:	February 27, 2008
Health Authority:	Lithuania: Kaunas University of Medicine

Keywords provided by Kaunas University of Medicine:

tendinopathy
tennis elbow
lateral epicondylitis
lateral epicondylalgia
MMP-inhibitor

Additional relevant MeSH terms:

Tennis Elbow
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on February 09, 2012