Comparative Study of Olive Oil With Piroxicam Gel in Osteoarthritis of the Knee

this is a randomized double blinded trial which is conducted to measure the efficacy of topical virgin olive oil on osteoarthritis of knee that will be done in contrast to standard piroxicam gel.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Drug: Piroxicam; Dietary supplement: Olive Oil

Detailed Description

application of herbal product has old history in therapy of human diseases. olive oil is one of the important diet in Iran which its efficacy in reducing of rheumatic pains was pointed out by Avicenna in 10th century. Nevertheless, its efficacy is not confirmed by scientific study.

in this double blinded study, 200 patients with diagnosed osteoarthritis of knee will be recruited that will randomly be assigned in piroxicam or olive oil group. the piroxicam gel or olive oil will be repackaged in anonymous tubes, which only recognizable via codes. the patients or visiting clinicians will be unaware of content of tubes. the final assessor will be blind to groups and interventions.

the efficacy of therapies will be evaluated by means of WOMAC and PGs standard questionnaires.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Ardabil, Iran, Islamic Republic of, 56197
    • ArdabiUMS Clinic of Rheumatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• men and non-pregnant women, age 40-85 years with primary OA of at least one knee, and a flare of pain after withdrawal of prior therapy with either an oral NSAID or acetaminophen (used at least 3 days per week during the previous month).

Exclusion Criteria:

• secondary arthritis related to systemic inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis, post-infectious arthritis and metabolic arthritis, traumatic arthritis or surgical joint replacement); corticosteroid use:

  • oral corticosteroid within the previous 14 days, or
  • intramuscular corticosteroid within 30 days, or
  • intraarticular corticosteroid into the study knee within 90 days,
  • intra-articular corticosteroid into any other joint within 30 days, or
  • topical corticosteroid at the site of application within 14 days;
• ongoing use of prohibited medication including NSAID, other oral analgesic, muscle relaxant, or low-dose antidepressant for any chronic pain management; - ongoing use of glucosamine or chondroitin (unless used continuously for 90 days prior to study entry);
• sensitivity to diclofenac, acetylsalicylic acid (ASA) or any other NSAID, acetaminophen, dimethyl sulphoxide, propylene glycol, glycerine or ethanol; clinically-active renal, hepatic or peptic ulcer disease;
• history of alcohol or drug abuse;
• lactation;
• concomitant skin disease at the application site;
• current application for disability benefits on the basis of knee osteoarthritis; fibromyalgia; other painful or disabling condition affecting the knee;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: P (Pircoxicam Group); in this arm 100 patients with osteoarthritis of knee will receive piroxicam gel in blinded 60 grams tubes,they will be instructed to use 1 gram of piroxicam gel (with inserted dispensing device) three times in a day on the affected knee.	Drug: Piroxicam; In this interventional arm gel of piroxicam (manufactured by Iran najo co,Iran), repackaged in a 60 g anonymous tubes will be administered to the patients.; Other Names: Piroxicam topical gel
Experimental: O (olive oil group); in this arm 100 patients with osteoarthritis of knee will receive virgin olive oil in blinded 60 grams tubes,they will be instructed to use 1 gram of olive oil (with inserted dispensing device) three times in a day on the affected knee.	Dietary supplement: Olive Oil; virgin olive oil prepared directly from olive fruit from "olive gardens of north of iran, Gilan province" will packaged in a 60 g anonymous tubes.; Other Names: Topical virigin olive oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA).	the outcome is assessed at week 1
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA).	the outcome is assessed at week 2
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA).	the outcome is assessed at week 3
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA).	the outcome is assessed at week 4

Secondary Outcome Measures

Outcome Measure	Time Frame
the secondary measure will be changes in stiffness	the outcome is assessed at week 1
the secondary measure will be changes in stiffness	the outcome is assessed at week 2
the secondary measure will be changes in stiffness	the outcome is assessed at week 3
the secondary measure will be changes in stiffness	the outcome is assessed at week 4

Collaborators and Investigators

• Sponsor: Ardabil University of Medical Sciences
• Investigators: Principal Investigator: Shahab Bohlooli, PhD, Pharmacology Dept, Faculty of Medicine, ArdabilUMS; Principal Investigator: Marina Jastan, MD, Rheomatology clinic, Faculty of Medicine, ArdabilUMS

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: April 29, 2008
• First Submitted That Met QC Criteria: April 29, 2008
• First Posted (Estimate): May 1, 2008

Study Record Updates

• Last Update Posted (Estimate): April 29, 2010
• Last Update Submitted That Met QC Criteria: April 28, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: osteoarthritis; Knee; Topical; piroxicam; virgin olive oil
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Piroxicam
• Other Study ID Numbers: 1/86010