Improvement in Function, Reduction in Pain, Reduction of Inflammation
Conditions
Keywords
methotrexate,, osteoarthritis,, pain,, function,, synovitis
Brief summary
Osteoarthritis (OA) is a common disabling condition, for which no effective therapy currently exists. Synovitis has been demonstrated in hand OA imaging. Synovial inflammation due to the release of cytokines is an important cause of pain. Methotrexate (MTX) helps to decrease synovitis in many inflammatory joint diseases, particularly rheumatoid arthritis. The aim of the present study is to assess the efficacy of MTX in decreasing pain and inflammation in symptomatic hand OA. Methods: One hundred and twenty patients with American College of Rheumatology (ACR) clinical and radiographic criteria of primary knee OA with hand pain, \[\>4 on the 24-hour average pain severity scale (0-10) using mean of daily ratings from week preceding randomization\] for \> 14 days/month during 3 consecutive months preceding enrollment will be included in this randomized double-blind placebo-controlled trial. Patients meeting the eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral MTX (n=60) or placebo (n=60) together with their usual therapy provided the dosages were kept constant for 28 weeks. Pain will be assessed using the Visual Analogue pain Scale, (VAS, 0-100 mm). Functional assessment will be performed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Activities of daily living (ADL) scores. Alterations in dosage of analgesic/NSAID drugs used will be recorded. Safety and tolerability will also be assessed. Synovitis will be detected by ultrasound imaging.
Interventions
active oral methotrexate drug
placebo comparator oral drug
Sponsors
University of Alexandria
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* primary knee osteoarthritis * persistent pain * synovitis
Exclusion criteria
* rheumatoid arthritis * gout and pseudogout * traumatic arthritis * other secondary arthritis * renal disease * liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain reduction | 28 weeks | The primary outcome will be pain reduction at 28 weeks compared to baseline using a Visual Analogue Pain Scale (VAS) 0-100 mm. Data will be collected at baseline and monthly up to 28 weeks to determine any change in results from those obtained at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| physical function improvement Functional assessment | 28 weeks | Improvements in physical functioning McMaster Universities Osteoarthritis Index (WOMAC) subscores for pain, stiffness and function , the patient global assessment of the severity of knee OA measured on a 0-100 mm VAS. The physician-reported disease activity VAS was also recorded. Data will be collected at baseline and monthly up to 28 weeks to determine any change in results from those obtained at baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| safety and tolerability | 28 weeks | Safety and tolerability to treatment will be assessed at each visit. Safety will be assessed by identifying adverse events using open-ended questions and a checklist including common oral methotrexate side effects, physical examination and by laboratory assessment including complete blood picture and liver enzymes. Adverse events will be collected at each visit and up to 28 weeks. |
Countries
Egypt
Outcome results
None listed