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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP group | Experimental | Fifty RA patients were injected intra-articularly with 3 doses of PRP in their joints |
|
| placebo group | Placebo Comparator | Fifty RA patients were injected intra-articularly with 3 doses of saline in their joints. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP intra articular injection | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dalia Saif | Cairo | 11311 | Egypt |
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
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| NACL intra articular injection | 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. |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |