Abstract | BACKGROUND: METHODS/DESIGN: One hundred and sixty people with painful radiographic knee osteoarthritis will be recruited via clinicians, local and social media advertising. Participants will be randomly allocated in a 1:1 ratio to receive either low dose amitriptyline (25 mg) or active placebo ( benztropine mesylate, 1 mg) for 3 months. The primary outcome is change from baseline in knee pain (WOMAC pain subscale) at 12 weeks. Secondary outcomes include change in function (total WOMAC) and the proportion of individuals achieving a substantial response (≥ 50% reduction in pain intensity, measured by Visual Analog Scale, VAS, from no pain to worst pain imaginable, 0-100 mm) and moderate response (≥ 30% reduction in pain intensity, measured by VAS) at 12 weeks. Intention to treat analyses will be performed. Subgroup analyses will be done. DISCUSSION: This study will provide high level evidence regarding the effectiveness of low dose amitriptyline compared to benztropine in reducing pain and improving function in knee OA. This trial has the potential to provide an effective new therapeutic approach for pain management in knee osteoarthritis, with the potential of ready translation into clinical practice, as it is repurposing an old drug, which is familiar to clinicians and with a well described safety record. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry prior to recruitment commencing ( ACTRN12615000301561 , March 31, 2015, amended 14 December 2018, February 2021). Additional amendment requested 18 July 2021.
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Authors | Anita E Wluka, Donna M Urquhart, Andrew J Teichtahl, Sultana Monira Hussain, Andrew Forbes, Carolyn Arnold, Yuanyuan Wang, Flavia M Cicuttini |
Journal | BMC musculoskeletal disorders
(BMC Musculoskelet Disord)
Vol. 22
Issue 1
Pg. 826
(Sep 27 2021)
ISSN: 1471-2474 [Electronic] England |
PMID | 34579675
(Publication Type: Clinical Trial Protocol, Journal Article)
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Copyright | © 2021. The Author(s). |
Chemical References |
- Amitriptyline
- Benztropine
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Topics |
- Amitriptyline
- Australia
- Benztropine
- Chronic Pain
(diagnosis, drug therapy)
- Double-Blind Method
- Humans
- Osteoarthritis, Knee
(diagnostic imaging, drug therapy)
- Randomized Controlled Trials as Topic
- Treatment Outcome
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