Nortriptyline in knee osteoarthritis (NortIKA Study): study protocol for a randomised controlled trial
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...
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Published in | Current controlled trials in cardiovascular medicine Vol. 16; no. 1; p. 448 |
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Main Authors | , , , , , , , |
Format | Journal Article |
Language | English |
Published |
England
BioMed Central Ltd
09.10.2015
BioMed Central |
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Abstract | 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.
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.
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.
The trial was registered with the Australian New Zealand Clinical Trials Registry on 27 June 2014. The trial registration number is: ACTRN12614000683639 . |
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AbstractList | 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. 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. 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. 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. 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. 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. The trial was registered with the Australian New Zealand Clinical Trials Registry on 27 June 2014. The trial registration number is: ACTRN12614000683639 . BackgroundOsteoarthritis (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/DesignWe 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.DiscussionThis 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 registrationThe trial was registered with the Australian New Zealand Clinical Trials Registry on 27 June 2014. The trial registration number is: ACTRN12614000683639. 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: ACTRN12614000683639. Keywords: Osteoarthritis, Analgesia, Nortriptyline, Tricyclic antidepressant, Randomised controlled trial |
ArticleNumber | 448 |
Audience | Academic |
Author | Thompson, Bronwyn F Mangin, Dee Hudson, Ben Williman, Jonathan A Hooper, Gary J Stamp, Lisa K Alchin, John S Toop, Les |
Author_xml | – sequence: 1 givenname: Ben surname: Hudson fullname: Hudson, Ben email: ben.hudson@otago.ac.nz organization: Department of General Practice, University of Otago, Christchurch, PO Box 4345, Christchurch, 8140, New Zealand. ben.hudson@otago.ac.nz – sequence: 2 givenname: Jonathan A surname: Williman fullname: Williman, Jonathan A email: jonathan.williman@otago.ac.nz organization: Biostatistics and Computational Biology Unit, University of Otago, Christchurch, PO Box 4345, Christchurch, 8140, New Zealand. jonathan.williman@otago.ac.nz – sequence: 3 givenname: Lisa K surname: Stamp fullname: Stamp, Lisa K email: Lisa.stamp@cdhb.health.nz, Lisa.stamp@cdhb.health.nz organization: Canterbury District Health Board, Christchurch, New Zealand. Lisa.stamp@cdhb.health.nz – sequence: 4 givenname: John S surname: Alchin fullname: Alchin, John S email: John.alchin@cdhb.health.nz organization: Pain Management Centre, Canterbury District Health Board, Christchurch, New Zealand. John.alchin@cdhb.health.nz – sequence: 5 givenname: Gary J surname: Hooper fullname: Hooper, Gary J email: gary.hooper@otago.ac.nz, gary.hooper@otago.ac.nz organization: Canterbury District Health Board, Christchurch, New Zealand. gary.hooper@otago.ac.nz – sequence: 6 givenname: Dee surname: Mangin fullname: Mangin, Dee email: dee.mangin@otago.ac.nz organization: Department of General Practice, University of Otago, Christchurch, PO Box 4345, Christchurch, 8140, New Zealand. dee.mangin@otago.ac.nz – sequence: 7 givenname: Bronwyn F surname: Thompson fullname: Thompson, Bronwyn F email: bronwyn.thompson@otago.ac.nz organization: Department of Orthopaedic Surgery and Musculoskeletal Medicine, University of Otago, Christchurch, PO Box 4345, Christchurch, 8140, New Zealand. bronwyn.thompson@otago.ac.nz – sequence: 8 givenname: Les surname: Toop fullname: Toop, Les email: les.toop@otago.ac.nz organization: Department of General Practice, University of Otago, Christchurch, PO Box 4345, Christchurch, 8140, New Zealand. les.toop@otago.ac.nz |
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CitedBy_id | crossref_primary_10_3399_BJGP_2020_0797 crossref_primary_10_1002_14651858_CD012157_pub2 crossref_primary_10_1080_07853890_2022_2132531 crossref_primary_10_1093_rheumatology_keaa544 |
Cites_doi | 10.1002/art.1780290816 10.1016/S0895-4356(98)00138-3 10.1111/j.1533-2500.2010.00401.x 10.1093/rheumatology/ker283 10.1590/S1516-31802009000600015 10.1016/j.joca.2004.02.001 10.1192/bjp.bp.108.061960 10.1002/art.24000 10.1186/1471-2474-8-59 10.1185/03007995.2011.633502 10.1212/WNL.51.4.1166 10.1002/art.24837 10.1186/1744-8069-4-47 10.1136/ard.2003.017236 10.1111/j.1526-4637.2009.00637.x 10.1002/14651858.CD004257.pub2 10.1016/j.jpainsymman.2003.11.006 10.1002/art.22460 10.1136/bmj.320.7240.987 10.1002/art.11401 10.1016/S0140-6736(13)60900-9 10.7326/0003-4819-141-10-200411160-00009 10.1093/ageing/afs072 10.1001/jama.2008.944 10.1136/bmj.b1805 10.1016/S1063-4584(05)80101-3 10.1136/bmj.332.7542.639 10.1002/1529-0131(200110)45:5<453::AID-ART365>3.0.CO;2-W |
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Snippet | Osteoarthritis (OA) is a common cause of pain and disability. Currently available analgesics are often insufficiently effective or have unacceptable adverse... Background Osteoarthritis (OA) is a common cause of pain and disability. Currently available analgesics are often insufficiently effective or have unacceptable... BackgroundOsteoarthritis (OA) is a common cause of pain and disability. Currently available analgesics are often insufficiently effective or have unacceptable... |
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SubjectTerms | Analgesics Analgesics - adverse effects Analgesics - therapeutic use Antidepressants Arthralgia - diagnosis Arthralgia - drug therapy Care and treatment Cartilage Clinical Protocols Clinical trials Constipation Development and progression Double-Blind Method Female Fractures Humans Knee Male Middle Aged Narcotics New Zealand Nortriptyline Nortriptyline - adverse effects Nortriptyline - therapeutic use Orthopedics Osteoarthritis Osteoarthritis, Knee - diagnosis Osteoarthritis, Knee - drug therapy Pain Pain Measurement Patient outcomes Patients Primary care Research Design Rheumatism Rheumatoid arthritis Risk factors Severity of Illness Index Study Protocol Time Factors Treatment Outcome |
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Title | Nortriptyline in knee osteoarthritis (NortIKA Study): study protocol for a randomised controlled trial |
URI | https://www.ncbi.nlm.nih.gov/pubmed/26453560 https://www.proquest.com/docview/2795270066/abstract/ https://pubmed.ncbi.nlm.nih.gov/PMC4600280 |
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