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NSAID Treatment in Knee Osteoarthritis

EFFECTS OF NSAIDs ON CLINICAL OUTCOMES, SYNOVIAL FLUID CYTOKINE CONCENTRATION AND SIGNAL TRANSDUCTION PATHWAYS IN KNEE OSTEOARTHRITIS

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01860833
Acronym
NSKO
Enrollment
90
Registered
2013-05-23
Start date
2010-04-30
Completion date
2011-08-31
Last updated
2013-05-23

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

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis

Brief summary

Central mechanisms may play a role in pain perception during osteoarthritis (OA).Local inflammation (which involves production of pro-inflammatory cytokines such as interleukin (IL) 4 TNF-alpha, IL-6 and IL-8) is considered to be a major source of pain. Certain therapies that specifically interfere with the expression or actions of pro-inflammatory cytokines have been explored. NSAIDs have analgesic, antipyretic and anti-inflammatory properties and are extensively prescribed for several musculoskeletal disorders. Indeed, the Osteoarthritis Research Society International (OARSI) recently recommended the use of NSAIDs for management of knee and hip OA in symptomatic patients. These drugs have been shown to influence cytokine metabolism in the synovial fluid of OA patients with satisfactory relief of painful osteoarthritic joints. The aim of the current study was to explore whether NSAID treatment inhibits TNF-alpha, IL-6, IL-8, and VEGF secretion in the synovial fluid of osteoarthritic joints. In particular, diclofenac, ibuprofen and celecoxib were studied. Under the hypothesis that relationships between proinflammatory cytokines and the clinical status of OA patients are possible, we also evaluated the association between the concentration of these molecules in the osteoarthritic knee synovial fluid and the pain and functional status of patients with OA. The effects of NSAIDS on signal transduction pathways in the synovial membrane were also investigated.

Detailed description

not desired

Interventions

DRUGIbuprofen

time of treatment 14 days

DRUGCelecoxib

time of treatment 14 days

DRUGDiclofenac

time of treatment 14 days

Sponsors

University of Catanzaro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

Patients eligible for the study were: * older than 50 years and * had primary knee OA diagnosed according to the clinical and radiological criteria of the American Rheumatism Association. Further inclusion criteria were: * clinical signs of joint inflammation (warmth, swelling or effusion) and * a disease severity grade 2 or 3 according to the Kellgren-Lawrence classification

Exclusion criteria

* allergy to NSAIDs, * progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease), * history of gastrointestinal ulcer or bleeding, * a hemoglobin concentration lower than 11.5 g/dL, * renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values), or * liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal range according to the central laboratory definition reference values).

Design outcomes

Primary

MeasureTime frameDescription
Western Ontario and McMaster universities (WOMAC) osteoarthritis index score0-14 daysWomac was used to 77 measure the disease-specific health status of patients before and after the pharmacological treatment.

Secondary

MeasureTime frameDescription
Naranjo probability scale14 daysThe Naranjo probability scale was used to evaluate the development of adverse drug reaction during this study

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026