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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180216003
Enrollment
40
Registered
2018-02-16
Start date
2017-10-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with knee osteoarthritis

Interventions

oral Tramadol KCL 50mg,oral Naproxen 250mg
Active Comparator Drug,Active Comparator Drug
Tramadol,Naproxen

Sponsors

Khon Kaen hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Patients were excluded if they had used of analgesic e.g.&#44; acetaminophen&#44; topical NSAIDs&#44; and topical methyl salicylate or anti&#45;inflamma drugs including NSAIDs and corticosteroids within one week before recruitment&#44; diagnosed with rheumatoid arthritis&#44; fibromyalgia&#44; ankylosing spondylitis&#44; active gout&#44; pseudogout&#44; or other inflammatory disorder&#44; inflammatory or post&#45;infectious arthritis&#44; previous major knee trauma (knee fracture&#44; knee subluxation/dislocation&#44; neurovascular injury)&#44; previous arthroscopic treatment or total knee replacement&#44; previous drug allergy or intolerance for opioid or NSAIDs&#44; history of ASCVD (stroke&#44; coronary heart disease) or high risk for ASCVD&#44; history of drug or alcohol abuse&#44; history of peptic ulcer disease&#44; from patient or recorded in the patient card&#44; hepatic or renal impairment (AST or ALT above normal range&#44; GFR below 30 ml/min/1.73 m2)&#44; diagnosis of severe persistent asthma or COPD (uncontrolled symptom with exacerbate everyday)&#44; platelet <100&#44;000 mm3&#44; pregnancy or breast feeding (by LMP).

Design outcomes

Primary

MeasureTime frame
pain dimension of Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC) 2 weeks between&#45;group mean difference from baseline

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactTeerasak Ouncharoen

Khon Kaen Hospital

teerasak_oun@fammedkkh.com+66813932099

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026