Comparative Study Between Platelet Rich Plasma and Steroid Injection in Trigger Finger Treatment

July 31, 2024 updated by: Olorunfemi Olayiwola, Obafemi Awolowo University Teaching Hospital

Comparative Study Between Intralesional Injection of Platelet Rich Plasma and Intralesional Steroid for the Treatment of Trigger Finger in Black Patients

The goal of this clinical trial is to learn if platelet rich plasma works to treat early stage trigger finger in adults. It will also learn about the safety platelet rich plasma. The main questions it aims to answer are:

Does platelet rich plasma lower the pain associated with trigger finger of participants? Does it improve the hand grip strength and Q DASH score of participants? Researchers will compare platelet rich plasma to Depo-Medrol steroid (a known standard of care for early stage trigger finger) to see if platelet rich plasma works to treat early trigger finger.

Participants will:

Take platelet rich plasma or a depo-medrol steroid intralesional injection at recruitment into the intervention Visit the clinic once every 4 weeks for checkups and parameter measurements. Investigator will will keep a record of participants progress in symptom remission

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who are 18year and above with mild or moderate trigger finger, who are willing to have intra-lesional administration of blood product.

No previous treatment for the affected finger.

Exclusion Criteria:

  • Previous steroid injection
  • Previous Surgery to that finger
  • Thrombocytopenic patients
  • Hand and finger contracture
  • Rheumatoid arthritis of the finger

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Patients here will have one milliliter of freshly prepared autologus platelet rich plasma injection for the treatment of their trigger finger.
Biological: Platelet rich plasma
Freshly prepared autologus platelet rich plasma
Active Comparator: Group B
Patients here will have one milliliter(20mg) injection of pfizer Depo-medrol(methylprednisolone acetate) injection for the treatment of their trigger finger.
Drug: Pfizer Depo-medrol
Methylprednisolone acetate 20mg/ml injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
symptom resolution post injection
Time Frame: 3 months
reduction of pain using VAS and absence snapping of finger
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand grip strength
Time Frame: 3 month
measured grip using hand dynamomter
3 month
Q- DASH score
Time Frame: 3month
11-item self reported disability questionnaire that consider upper extremity as one functional unit
3month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Obafemi Awolowo University Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 24, 2024

Primary Completion (Estimated)

December 23, 2024

Study Completion (Estimated)

June 23, 2025

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

July 31, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

August 1, 2024

Last Update Submitted That Met QC Criteria

July 31, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERC/2024/06/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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