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Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger

Phase 3
Waitlist Available
Led By Michael Shuler, MD
Research Sponsored by J&M Shuler
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

The proposed study aims to investigate whether amniotic fluid injections are a better alternative to corticosteroid injections as a conservative treatment for stenosing tenosynovitis. Based on results from our most recent pilot study exploring patient outcomes after receiving an amnion injection, we were able to observe symptom resolution in more than half of the study population. Adverse events were extremely rare and not related to study participation. Given the numerous occurrences of successful symptom resolution, the next step is to compare patient outcomes to those of patients who receive the standard steroid injection. This study will compare outcome measurements of patients who receive amnion injections to those who receive steroid injections.

Eligible Conditions
  • Trigger Finger

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient reported pain level
Secondary study objectives
Disabilities of the Arm Shoulder and Hand score
Trigger frequency

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Amniotic fluid injectionExperimental Treatment1 Intervention
1 mL amniotic fluid mixed with 0.5mL marcaine and 0.5 mL of lidocaine
Group II: Steroid injectionActive Control1 Intervention
1 mL Solu-medrol mixed with 0.5mL marcaine and 0.5 mL of lidocaine

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Who is running the clinical trial?

J&M ShulerLead Sponsor
7 Previous Clinical Trials
716 Total Patients Enrolled
Vivex BiomedicalUNKNOWN
1 Previous Clinical Trials
24 Total Patients Enrolled
Michael Shuler, MDPrincipal InvestigatorAthens Orthopedic Clinic
3 Previous Clinical Trials
160 Total Patients Enrolled
~13 spots leftby Jan 2026
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