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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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RA - Rheumatoid Arthritis

Intervention / Treatment
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* Procedure: PRP intra articular injection
* Procedure: NACL intra articular injection


Participation Criteria
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Eligibility Criteria
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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),

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP group<br>Fifty RA patients were injected intra-articularly with 3 doses of PRP in their joints | Procedure: PRP intra articular injection<br>* 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.<br>* Other names: PRP Injection.;|
| Placebo Comparator: placebo group<br>Fifty RA patients were injected intra-articularly with 3 doses of saline in their joints. | Procedure: NACL intra articular injection<br>* 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.<br>* Other names: Placebo injection(NACL);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| Inflammatory mediators. | By means of ELISA (IL 1 beta and TNF alpha | Change from baseline to 6 months post injection. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |