Evaluating the Role of Intra-articular Injections of Platelet Rich Plasma (PRP) in Patients With Rheumatoid Arthritis.

Not Applicable

• Conditions: RA - Rheumatoid Arthritis
• Interventions: Procedure: PRP intra articular injection; Procedure: NACL intra articular injection

• Registration Number: NCT04264494
• Lead Sponsor: Dalia Salah Saif

Brief Summary

To evaluate the therapeutic effect of 3 local doses of PRP intra-articular injection in patients with RA regarding the improvement of disease activity and quality of life versus placebo.

Detailed Description

100 patients with RA fulfilling the 2010 ACR-EULAR classification criteria for RA were recruited from the outpatient clinic of the Rheumatology and Rehabilitation department. All patients were subjected to clinical and laboratory assessment, visual analog score (VAS) scale and Health Assessment Questionnaire (HAQ). Fifty patients were injected intra-articularly with 3 doses of PRP and 50 patients who serve as a control injected with 3 doses of placebo at 4 weeks intervals for the tender joints and revaluated at 1, 3 months post the last injection regarding the same evaluating tools.

Study Timeline

• Study Start: 2018-02-26
• Status Verified: 2020-02
• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2020-02-08
• Study First Posted: 2020-02-11
• Last Update Submitted: 2020-02-14
• Last Update Posted: 2020-02-18
• Primary Completion: 2021-01-31
• Study Completion: 2021-02-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients diagnosed as RA regarding 2010 new criteria of RA, both sex,aged20-60 years old.

Exclusion Criteria

• Patients with Local abscess,
• systemic illness as (diabetes mellitus, malignancy),
• patients on opioids analgesics.
• pregnancy, blood disorders(coagulopathy, thrombocytopenia),

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRP group	PRP intra articular injection	Fifty RA patients were injected intra-articularly with 3 doses of PRP in their joints
placebo group	NACL intra articular injection	Fifty RA patients were injected intra-articularly with 3 doses of saline in their joints.

Primary Outcome Measures

Name	Time	Method
visual analogue scale (VAS).	Change from baseline to 6 months post injection.	the pain severity determined by the patients on scale of 0(no pain) to 10 (Agonizing pain)
Inflammatory mediators.	Change from baseline to 6 months post injection.	By means of ELISA (IL 1 beta and TNF alpha
Health assessment questionnaire disability index. (HAQ-DI)	Change from baseline to 6 months post injection.	Is a patient reported outcome which is usually self-administered by the patient and scales range from 0 (no difficulty) to 3 (unable to do)

Secondary Outcome Measures

Name	Time	Method
Disease Activity Score 28(DAS28)	At baseline,3 and 6 months post injection.	to asses disease activity by measuring the number of tender and swollen joints,patient global assessment and ESR. values range from 2.0 (remission) to 10.0 (higher disease activity).

Trial Locations

Locations (1)

Dalia Saif; 🇪🇬 Cairo, Egypt