The effect of injectable and sustained-release pharmaceutical form of celecoxib in the treatment of knee osteoarthritis patients

Phase 3

Recruiting

Conditions: Knee osteoarthritis.
Osteoarthritis of knee

Registration Number: IRCT20221101056363N1

Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 84

Inclusion Criteria

Primary one-sided osteoarthritis of the knee that has been at least 6 months since it became symptomatic (painful) and aggravated by weight bearing and has not responded properly to conservative treatment.
Radiographic arthrosis stage 1, 2 and 3 of Kellgren Lawrence classification (KLS)
Signing the consent form and complete and voluntary willingness to participate in the study

Exclusion Criteria

Any history of trauma (fracture), surgery and tumor in the knee and lower limb of the same side
Clinically obvious alignment disorder
Any history of invasive procedure, injection or infection in the desired knee during the last 6 months
Any blood disorder
History or history of autoimmune disease or being treated with immunosuppressors and non-removable corticosteroids
Patients with secondary osteoarthritis
Proven liver and kidney disorders
Irrevocable consumption of oral or topical painkillers
Cognitive impairments and the inability to walk without a walker or the help of others
CVA and similar problemsInsulin-dependent diabetic patients
Patients with spine disorders and radicular pain to the lower limbs

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the parameters related to the immune system including the level of IL-10, TNF-a, IL-6, TGF-beta1). Timepoint: It will be performed at the beginning, second week and fourth weeks. Method of measurement: Commercial lab kits.;Liver tests including the serum level of ALT and AST. Timepoint: It will be performed at the beginning, second week and fourth weeks. Method of measurement: Commercial kits.;BUN and creatinine. Timepoint: It will be performed at the beginning, second week and fourth weeks. Method of measurement: Commercial kits.;Range of motion of the joint (goniometer and degree). Timepoint: It will be performed at the beginning, second week and fourth weeks. Method of measurement: goniometer and degree.;The sitting and standing test (number). Timepoint: It will be performed at the beginning, second week and fourth weeks. Method of measurement: Physical examination.

Secondary Outcome Measures