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

NCT06532318 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: ERC/2024/06/12
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Trigger Finger Disorder

Outcome Measures

Primary Outcomes (1)

• symptom resolution post injection

  reduction of pain using VAS and absence snapping of finger

  3 months

Secondary Outcomes (2)

• Hand grip strength

  3 month

• Q- DASH score

  3month

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

ACTIVE COMPARATOR

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

Interventions

Platelet rich plasma BIOLOGICAL

Freshly prepared autologus platelet rich plasma

Group A

Pfizer Depo-medrol DRUG

Methylprednisolone acetate 20mg/ml injection

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Obafemi Awolowo University Teaching Hospital: lead

MeSH Terms

Conditions

Trigger Finger Disorder

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: All participants will have the same assessment and have blood drawn for CBC. Opaque tape masking of the syringes will be done so that care giver and patients are not aware of interventional drug given.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: orthopaedic surgeon

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: July 24, 2024
• Primary Completion: December 23, 2024
• Study Completion: June 23, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07