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Completed

NCT Number: NCT01860833

NSAID Treatment in Knee Osteoarthritis

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Orthopedic and Trauma Surgery

Catanzaro, 88100, Italy

About this study

not desired

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Ibuprofen

Drug

time of treatment 14 days

Other names: Brufen

Celecoxib

Drug

time of treatment 14 days

Other names: celebrex

Diclofenac

Drug

time of treatment 14 days

Other names: voltaren

Primary outcomes

  1. Western Ontario and McMaster universities (WOMAC) osteoarthritis index score

    Time frame: 0-14 days

    Womac was used to 77 measure the disease-specific health status of patients before and after the pharmacological treatment.

Secondary outcomes

  1. Naranjo probability scale

    Time frame: 14 days

    The Naranjo probability scale was used to evaluate the development of adverse drug reaction during this study

Sponsors and collaborators

Lead sponsor

University of Catanzaro

Other

Registry information

Official study title

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

Acronym: NSKO

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 23, 2013
Registry last updated
May 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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