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Tramadol versus Naproxen for Pain Relieving in Knee Osteoarthritis: a pragmatic randomized controlled trial

Phase 4
Completed
Conditions
Patients with knee osteoarthritis
Registration Number
TCTR20180216003
Lead Sponsor
Khon Kaen hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
40
Inclusion Criteria

Eligible patients were 20 years of age or older with a diagnosis of unilateral primary or secondary osteoarthritis of the knee defined by the American College of Rheumatology criteria.

Exclusion Criteria

Patients were excluded if they had used of analgesic e.g., acetaminophen, topical NSAIDs, and topical methyl salicylate or anti-inflamma drugs including NSAIDs and corticosteroids within one week before recruitment, diagnosed with rheumatoid arthritis, fibromyalgia, ankylosing spondylitis, active gout, pseudogout, or other inflammatory disorder, inflammatory or post-infectious arthritis, previous major knee trauma (knee fracture, knee subluxation/dislocation, neurovascular injury), previous arthroscopic treatment or total knee replacement, previous drug allergy or intolerance for opioid or NSAIDs, history of ASCVD (stroke, coronary heart disease) or high risk for ASCVD, history of drug or alcohol abuse, history of peptic ulcer disease, from patient or recorded in the patient card, hepatic or renal impairment (AST or ALT above normal range, GFR below 30 ml/min/1.73 m2), diagnosis of severe persistent asthma or COPD (uncontrolled symptom with exacerbate everyday), platelet <100,000 mm3, pregnancy or breast feeding (by LMP).

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
pain dimension of Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC) 2 weeks between&#45;group mean difference from baseline
Secondary Outcome Measures
NameTimeMethod
stiffness&#44; and physical&#45;function dimension of WOMAC scores as well as its total score&#44; serum liver e 2 weeks between&#45;group mean difference from baseline
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