Comparison of the effect of intra-articular injection of autologous and hyaluronic acid interleukin-1 (IL-1Ra) antagonist in controlling the pain of knee osteoarthritis in patients with knee osteoarthritis

Phase 2

• Conditions: Knee Osteoarthritis.; Osteoarthritis of knee

• Registration Number: IRCT20131124015515N6
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 23 April 2019

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Signed written informed consent to participate in the study
Patients 40 years of age and above
Patients suffering from knee osteoarthritis for more than 3 months
Radiological findings confirming knee osteoarthritis based on the American College of Rheumatology (ACR)

Exclusion Criteria

Patients' refusal to participate in clinical research
Patients with a history of knee surgery
Patients with deformity and lower limb contraction,
Patients with neuromascular disease of the lower extremity,
Patients with acute lumbosacral pathology
Patients undergone injection of steroid medications in the last two months
Patients with a history of inflammatory rheumatoid arthritis
Patients with infection
Nursing mothers
BMI > 35
patients with knee surgery
Patient with knee deviations (verrucous or valgus more than 5 degrees) confirmed by three joint views
Patients with knee radicular pain
Patients with anticoagulant therapy
Patients with post-traumatic arthritis
Patient with history of Intra-articular injection or ozone therapy for the past 12 months
Patients with allergy to any of the medications will be prescribed in this study
Patients with systemic or psychiatric disease
Patients with severe osteoarthritis of grade III
Patients with intra-articular injection of hyaluronic acid in the past 12 months
Patients with hepatitis
Patients with HIV
Patients with Cytomegalovirus
Patient with Syphlis
Patient with Osteomyelitis
Alcohol or substance abuse
Patient with diabetes
Pregnancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain level. Timepoint: Before treatment, one month, three months and six months after the last injection. Method of measurement: En visual analog scale (VAS) (0 None; 1-3 Mild; 4-7 Moderate; 8-10 Severe).;WOMAC Knee Score (Western Ontario & McMaster Universities Osteoarthritis Index ). Timepoint: Before treatment and three months after the last injection. Method of measurement: WOMAC Knee Score (Western Ontario & McMaster Universities Osteoarthritis Index ) Questionnaire.;Knee injury and Osteoarthritis Outcome Score (KOOS). Timepoint: Before the intervention and 3 months after the last injection. Method of measurement: Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire.

Secondary Outcome Measures

Name	Time	Method
Procedure side effects. Timepoint: 1, 3, 6 months after the injection procedure. Method of measurement: Documentation of the name of complication based on the findings of Pain Fellowship observation.