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

NCT ID: NCT04264494

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-26
• Study Completion Date: 2021-02-26

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.

Conditions

RA - Rheumatoid Arthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRP group

Fifty RA patients were injected intra-articularly with 3 doses of PRP in their joints

Group Type: EXPERIMENTAL

PRP intra articular injection

Intervention Type: PROCEDURE

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.

placebo group

Fifty RA patients were injected intra-articularly with 3 doses of saline in their joints.

Group Type: PLACEBO_COMPARATOR

NACL intra articular injection

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Other Intervention Names

PRP Injection.; Placebo injection(NACL)

Eligibility Criteria

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),

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dalia Salah Saif

OTHER

Sponsor Role: lead

Responsible Party

Dalia Salah Saif

principle investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Dalia Saif

Cairo, , Egypt

Countries

Egypt

Other Identifiers

1475

Identifier Type: -

Identifier Source: org_study_id