None listed
Conditions
Brief summary
Osteoarthritis (OA) is a very common and painful condition. Medicines currently available for treating OA pain are not ideal: they are either inadequately effective or cause unpleasant or dangerous side effects. Recent research has shown how the brain processes pain in OA and this has opened up the possibility of using different types of medicines for OA pain. Nortriptyline (an antidepressant) has been used to treat persistent pain in other conditions, and other antidepressants may reduce pain in knee OA. It is not known whether nortriptyline is useful in this condition. We plan to test this effect by randomly allocating participants to treatment with nortriptyline or placebo and to measure changes in their pain before and after a period on the medication. We hope that this will tell us whether nortriptyline will be helpful. If it is, then we believe that many people may benefit from taking this medicine.
Interventions
Nortriptyline as 25mg capsules. Dose adjusted during 8 week dose-finding period according to participant response from starting dose of 25mg daily to maximum potential dose of 100mg daily. During the dose-finding period each participant will be contacted fortnightly by the research nurse to make dose adjustments. This period will then be followed by a 6 week steady dosing period. Participants will be asked to complete medication diaries to assess adherence.
Sponsors
Dr Ben Hudson
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Primary knee OA defined according to American College of Rheumatology (ACR) classification criteria (knee pain plus 3 of: age >50 years, stiffness <30 mins, crepitus, bony tenderness, bony enlargement, no palpable warmth). 2. Pain severity of >=20 points on the Western Ontario and McMaster Universities (WOMAC) numerical rating scale (range 0 to 50 points) at the study knee.
Exclusion criteria
01. Prior joint replacement surgery on the study knee 02. Intra-articular steroid injection within the previous 3 months 03. Secondary OA (OA due to inflammatory arthritis [eg gout, rheumatoid arthritis, juvenile arthritis], septic arthritis or trauma) 04. Known hypersensitivity to nortriptyline or history of adverse reaction to any tricyclic antidepressant 05. Current use of nortriptyline or other antidepressants, or amiodarone 06. Within 6 months of myocardial infarction 07. Heart block 08. Postural hypotension 09. Pregnancy 10. Hyperthyroidism or phaeochromocytoma under current investigation or treatment 11. History of epilepsy or other seizure 12. History of bipolar disorder or manic episode 13. History of increased intra-ocular pressure or history of angle-closure glaucoma 14. Chronic constipation 15. Urinary retention
Outcome results
None listed