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

Sponsor

Dalia Salah Saif (Other)

Overall Status

Unknown status

CT.gov ID

NCT04264494

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
RA - Rheumatoid Arthritis	Procedure: PRP intra articular injection Procedure: NACL intra articular injection	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Feb 26, 2018

Anticipated Primary Completion Date :

Jan 31, 2021

Anticipated Study Completion Date :

Feb 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PRP group Fifty RA patients were injected intra-articularly with 3 doses of PRP in their joints	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. Other Names: PRP Injection.
Placebo Comparator: placebo group Fifty RA patients were injected intra-articularly with 3 doses of saline in their joints.	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. Other Names: Placebo injection(NACL)

Arm

Intervention/Treatment

Experimental: PRP group

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

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.

Other Names:

PRP Injection.

Placebo Comparator: placebo group

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

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.

Other Names:

Placebo injection(NACL)

Outcome Measures

Primary Outcome Measures

visual analogue scale (VAS). [Change from baseline to 6 months post injection.]
the pain severity determined by the patients on scale of 0(no pain) to 10 (Agonizing pain)
Inflammatory mediators. [Change from baseline to 6 months post injection.]
By means of ELISA (IL 1 beta and TNF alpha
Health assessment questionnaire disability index. (HAQ-DI) [Change from baseline to 6 months post injection.]
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) [At baseline,3 and 6 months post injection.]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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),

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dalia Saif	Cairo		Egypt	11311

Sponsors and Collaborators

Dalia Salah Saif

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dalia Salah Saif, principle investigator, Menoufia University

ClinicalTrials.gov Identifier:

NCT04264494

Other Study ID Numbers:

1475

First Posted:

Feb 11, 2020

Last Update Posted:

Feb 18, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Study Results

No Results Posted as of Feb 18, 2020