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Doxycycline for Lateral Epicondylalgia - RCT

Primary Purpose

Lateral Epicondylalgia (Tennis Elbow)

Status
Unknown status
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Placebo
Doxycycline
Sponsored by
Kaunas University of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylalgia (Tennis Elbow) focused on measuring tendinopathy, tennis elbow, lateral epicondylitis, lateral epicondylalgia, MMP-inhibitor

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept of Orthopaedics, Kaunas Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

2

Doxycycline

Arm Description

100 mg twice daily

Outcomes

Primary Outcome Measures

Pain (VAS)

Secondary Outcome Measures

Full Information

First Posted
February 27, 2008
Last Updated
February 27, 2008
Sponsor
Kaunas University of Medicine
Collaborators
University Hospital, Linkoeping
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1. Study Identification

Unique Protocol Identification Number
NCT00631501
Brief Title
Doxycycline for Lateral Epicondylalgia - RCT
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Kaunas University of Medicine
Collaborators
University Hospital, Linkoeping

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylalgia (Tennis Elbow)
Keywords
tendinopathy, tennis elbow, lateral epicondylitis, lateral epicondylalgia, MMP-inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Title
Doxycycline
Arm Type
Experimental
Arm Description
100 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Primary Outcome Measure Information:
Title
Pain (VAS)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alfredas Smailys, MD, PhD
Phone
+370 37 327201
Email
smailys@takas.lt
Facility Information:
Facility Name
Dept of Orthopaedics, Kaunas Medical University
City
Kaunas
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfredas Smailys
Email
smailys@takas.lt

12. IPD Sharing Statement

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Doxycycline for Lateral Epicondylalgia - RCT

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