None listed
Conditions
Brief summary
Knee osteoarthritis is one of the most common forms of arthritis. Pain, the main symptom, is poorly controlled by current treatment strategies. Pain is thought initially to originate from structural changes in an affected joint. However, after a while, in some people, changes occur in the nervous system that perpetuate the pain. These changes are referred to as pain sensitisation. They are not addressed by current treatments. Amitriptyline is commonly used to treat pain related to pain sensitisation, such as in shingles or diabetic neuropathy. This study is a randomised controlled trial of the use of amitriptyline, in addition to usual care, to manage pain in people with painful knee osteoarthritis. People with knee osteoarthritis will be randomised to receiving low dose amitriptyline or a placebo with many of the same side effects of the active drug, benztropine. They will be followed for 12 weeks to determine the effect of amitriptyline on pain, function and other symptoms of knee osteoarthritis.
Interventions
Low-dose amitriptyline; 25mg; to be taken by mouth, in capsule form, alternate days for 2 weeks, then daily administration; 3 month duration
Bottles will be returned at the end of the study to assess compliance.
Sponsors
Monash University
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
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1) Males and females with symptomatic knee OA for at least 3 months, defined by the ACR clinical and radiographic criteria (ie pain and radiographic OA) (Altman, R., et al., Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. . Arthritis Rheum, 1986. 29(8): p. 1039-49.) 2) Pain score of at least 30 mm on a 100 mm visual analogue scale (VAS); 3) Age > 40 years, and < 75 years old
Exclusion criteria
1) Inability to give informed consent; 2) Intra articular therapy over the past 3 months; Planning knee injection or surgical intervention in the next 4 months 3) Patients with rheumatoid arthritis, other inflammatory arthritis, or significant knee injury; 4) Patients with major depressive disorder for whom anti-depressant therapy is indicated 5) Patients taking medications that are contra-indicated when taking amitriptyline (monoamine oxidase inhibitors, other antidepressants, opioids, drugs that inhibit CYP3A4, etc) 6) Co-morbidity that may limit participation (e.g. any planned joint replacement in the next 4 months, medical conditions e.g. malignancy in the past 5 years other than non-melanoma skin cancer) or relocation; 7) Fibromyalgia, as this is evidence of an alternative underlying explanatory condition 8) Patients with contraindications to amitriptyline therapy eg acute angle glaucoma, prostatism,etc
Outcome results
None listed