Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger

Study Overview
=================
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.

Official Title
-----------------
Injection With Amniotic Fluid Versus Corticosteroid in Patients With Stenosing Tenosynovitis: a Randomized, Blinded Trial

Conditions
-----------------
Stenosing Tenosynovitis

Intervention / Treatment
-----------------
* Biological: Amniotic fluid injection
* Biological: Steroid injection


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Steroid injection<br>1 mL Solu-medrol mixed with 0.5mL marcaine and 0.5 mL of lidocaine | Biological: Steroid injection<br>* Solu-medrol<br>|
| Experimental: Amniotic fluid injection<br>1 mL amniotic fluid mixed with 0.5mL marcaine and 0.5 mL of lidocaine | Biological: Amniotic fluid injection<br>* Amniotic fluid contains various proteins that support cell proliferation, movement and differentiation. Amniotic fluid also includes collagen substrates, growth factors, amino acids, polyamines, lipids, carbohydrates, cytokines, extracellular matrix molecules like hyaluronic acid and fibronectin, cells and other chemical compounds that are needed for tissue protection and repair.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported pain level | Analog pain scale (0-10) | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Corticosteroid