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

Primary Purpose

RA - Rheumatoid Arthritis

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

PRP intra articular injection

NACL intra articular injection

About this trial

This is an interventional treatment trial for RA - Rheumatoid Arthritis

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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),

Sites / Locations

Dalia Saif

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PRP group

placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

visual analogue scale (VAS).

the pain severity determined by the patients on scale of 0(no pain) to 10 (Agonizing pain)

Inflammatory mediators.

By means of ELISA (IL 1 beta and TNF alpha

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)

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT04264494

First Posted

February 3, 2020

Last Updated

February 14, 2020

Sponsor

Dalia Salah Saif

1. Study Identification

Unique Protocol Identification Number

NCT04264494

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

February 26, 2018 (Actual)

Primary Completion Date

January 31, 2021 (Anticipated)

Study Completion Date

February 26, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dalia Salah Saif

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

RA - Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PRP group

Arm Type

Experimental

Arm Description

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

Arm Title

placebo group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

PRP intra articular injection

Other Intervention Name(s)

PRP Injection.

Intervention Description

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

Intervention Name(s)

NACL intra articular injection

Other Intervention Name(s)

Placebo injection(NACL)

Intervention Description

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.

Primary Outcome Measure Information:

Title

visual analogue scale (VAS).

Description

the pain severity determined by the patients on scale of 0(no pain) to 10 (Agonizing pain)

Time Frame

Change from baseline to 6 months post injection.

Title

Inflammatory mediators.

Description

By means of ELISA (IL 1 beta and TNF alpha

Time Frame

Change from baseline to 6 months post injection.

Title

Health assessment questionnaire disability index. (HAQ-DI)

Description

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)

Time Frame

Change from baseline to 6 months post injection.

Secondary Outcome Measure Information:

Title

Disease Activity Score 28(DAS28)

Description

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).

Time Frame

At baseline,3 and 6 months post injection.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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),

Facility Information:

Facility Name

Dalia Saif

City

Cairo

ZIP/Postal Code

11311

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

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

Learn more about this trial

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

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