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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

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 referring to pain clinics of Shohada Tajrish, Taleghani and Akhtar hospitals in 1397

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20131124015515N6
Enrollment
60
Registered
2019-04-13
Start date
2019-01-15
Completion date
Unknown
Last updated
2019-04-23

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

Conditions

Knee Osteoarthritis. Osteoarthritis of knee

Interventions

Intervention 1: Intervention group: Intra-articular injection of IL-1RA group: In order to prepare IL-1RA, 50 ml of venous blood is taken from the patient using the Orthokine syringe (manufacturer co

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Masoud Hashemi MD.

Shahid Beheshti University of Medical Sciences

dr.hashemi@sbmu.ac.ir+98 21 2261 2252

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026