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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Nortriptyline in knee osteoarthritis (NortIKA Study): study protocol for a randomised controlled trial

Authors: Ben Hudson, Jonathan A. Williman, Lisa K. Stamp, John S. Alchin, Gary J. Hooper, Dee Mangin, Bronwyn F. Thompson, Les Toop

Published in: Trials | Issue 1/2015

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Abstract

Background

Osteoarthritis (OA) is a common cause of pain and disability. Currently available analgesics are often insufficiently effective or have unacceptable adverse effects. Tricyclic antidepressants may offer a useful centrally-acting analgesic. Nortriptyline is a readily-available, cheap and comparatively well-tolerated tricyclic antidepressant.

Methods/Design

We will conduct a parallel group, two-arm, participant and investigator-blinded, randomised controlled superiority trial comparing nortriptyline with placebo. Two hundred participants with primary knee OA will be enrolled. Participants will take study medication for 14 weeks. The primary outcome is difference between treatment arms in mean pain score measured on the Western Ontario and McMaster Universities (WOMAC) pain scale at 14 weeks.

Discussion

This protocol describes the first randomised controlled trial of a tricyclic antidepressant in the treatment of OA. The results of the study may have significant implications for the management of this common and painful condition.

Trial registration

The trial was registered with the Australian New Zealand Clinical Trials Registry on 27 June 2014. The trial registration number is: ACTRN12614000683​639.
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Metadata
Title
Nortriptyline in knee osteoarthritis (NortIKA Study): study protocol for a randomised controlled trial
Authors
Ben Hudson
Jonathan A. Williman
Lisa K. Stamp
John S. Alchin
Gary J. Hooper
Dee Mangin
Bronwyn F. Thompson
Les Toop
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0961-1

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