Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger

June 28, 2018 updated by: J&M Shuler

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Athens, Georgia, United States, 30606
        • Athens Orthopedic Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Steroid injection
1 mL Solu-medrol mixed with 0.5mL marcaine and 0.5 mL of lidocaine
Biological: Steroid injection
Solu-medrol
EXPERIMENTAL: Amniotic fluid injection
1 mL amniotic fluid mixed with 0.5mL marcaine and 0.5 mL of lidocaine
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

J&M Shuler

Collaborators

Vivex Biomedical

Investigators

  • Principal Investigator: Michael Shuler, MD, Athens Orthopedic Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 10, 2018

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

June 28, 2018

First Submitted That Met QC Criteria

June 28, 2018

First Posted (ACTUAL)

July 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 11, 2018

Last Update Submitted That Met QC Criteria

June 28, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Random TF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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