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

RA - Rheumatoid Arthritis Clinical Trial

Official title:

Evaluating the Role of Intra-articular Injections of Platelet-rich Plasma (PRP) in Patients With Rheumatoid Arthritis and Its Impact on Disease Activity and Quality of Life.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04264494
• Other study ID #: 1475
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: February 26, 2021

Study information

• Verified date: February 2020
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: February 26, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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),

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• RA - Rheumatoid Arthritis

Intervention

Procedure:
• PRP intra articular injection
Fifty RA patients were injected intra-articularly with 3 doses of PRP at 4 weeks intervals for the joints with only tenderness (arthralgia without swelling or effusion) and revaluated at 3 and 6 months post the last injection regarding the same evaluating tools.
• NACL intra articular injection
and 50 patients who serve as a control and injected intra-articularly with 3 doses of placebo (NaCl saline) at 4 weeks intervals for the joints with only tenderness (arthralgia without swelling or effusion) and revaluated at 3 and 6months post last injection regarding the same evaluating tools.

Locations

Country	Name	City	State
Egypt	Dalia Saif	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Dalia Salah Saif

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue scale (VAS).	the pain severity determined by the patients on scale of 0(no pain) to 10 (Agonizing pain)	Change from baseline to 6 months post injection.
Primary	Inflammatory mediators.	By means of ELISA (IL 1 beta and TNF alpha	Change from baseline to 6 months post injection.
Primary	Health assessment questionnaire disability index. (HAQ-DI)	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)	Change from baseline to 6 months post injection.
Secondary	Disease Activity Score 28(DAS28)	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).	At baseline,3 and 6 months post injection.