Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger

Phase 3

• Conditions: Stenosing Tenosynovitis
• Interventions: Biological: Steroid injection; Biological: Amniotic fluid injection

• Registration Number: NCT03583151
• Lead Sponsor: J&M Shuler

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-10
• Status Verified: 2018-06
• Study First Submitted: 2018-06-28
• Study First Submitted QC: 2018-06-28
• Last Update Submitted: 2018-06-28
• Study First Posted: 2018-07-11
• Last Update Posted: 2018-07-11
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patient is at least 18 years of age
• Patient is diagnosed with stenosing tenosynovitis

Exclusion Criteria

• Patient is less than 18 years of age
• Pregnancy
• Enrolling clinician does not believe that the patient is mentally capable of understanding the research nature of the procedure due to mental handicap/disability or illiteracy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Steroid injection	Steroid injection	1 mL Solu-medrol mixed with 0.5mL marcaine and 0.5 mL of lidocaine
Amniotic fluid injection	Amniotic fluid injection	1 mL amniotic fluid mixed with 0.5mL marcaine and 0.5 mL of lidocaine

Primary Outcome Measures

Name	Time	Method
Patient reported pain level	12 months	Analog pain scale (0-10)

Secondary Outcome Measures

Name	Time	Method
Trigger frequency	12 months	Rate at which a patient's digit will lock or trigger
Disabilities of the Arm Shoulder and Hand score	12 months	Measure of disability in performing every day activities at work and around the house. Calculated value from DASH questionnaire.

Trial Locations

Locations (1)

Athens Orthopedic Clinic; 🇺🇸 Athens, Georgia, United States