Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger

Stenosing Tenosynovitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03583151
• Other study ID #: Random TF
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: May 10, 2018
• Est. completion date: December 2019

Study information

• Verified date: June 2018
• Source: J&M Shuler
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stenosing Tenosynovitis
• Tendon Entrapment
• Tenosynovitis

Intervention

Biological:
• Amniotic fluid injection
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.
• Steroid injection
Solu-medrol

Locations

Country	Name	City	State
United States	Athens Orthopedic Clinic	Athens	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
J&M Shuler	Vivex Biomedical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient reported pain level	Analog pain scale (0-10)	12 months
Secondary	Trigger frequency	Rate at which a patient's digit will lock or trigger	12 months
Secondary	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