Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03583151

Enrollment

100

Registered

2018-07-11

Start date

2018-05-10

Completion date

2019-12-31

Last updated

2018-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stenosing Tenosynovitis

Keywords

Corticosteroid

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.

Interventions

BIOLOGICALAmniotic 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.

BIOLOGICALSteroid injection

Solu-medrol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026