Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger
Primary Purpose
Stenosing Tenosynovitis
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Amniotic fluid injection
Steroid injection
Sponsored by
About this trial
This is an interventional treatment trial for Stenosing Tenosynovitis focused on measuring Corticosteroid
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.
Sites / Locations
- Athens Orthopedic Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Steroid injection
Amniotic fluid injection
Arm Description
1 mL Solu-medrol mixed with 0.5mL marcaine and 0.5 mL of lidocaine
1 mL amniotic fluid mixed with 0.5mL marcaine and 0.5 mL of lidocaine
Outcomes
Primary Outcome Measures
Patient reported pain level
Analog pain scale (0-10)
Secondary Outcome Measures
Trigger frequency
Rate at which a patient's digit will lock or trigger
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.
Full Information
NCT ID
NCT03583151
First Posted
June 28, 2018
Last Updated
June 28, 2018
Sponsor
J&M Shuler
Collaborators
Vivex Biomedical
1. Study Identification
Unique Protocol Identification Number
NCT03583151
Brief Title
Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger
Official Title
Injection With Amniotic Fluid Versus Corticosteroid in Patients With Stenosing Tenosynovitis: a Randomized, Blinded Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2018 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
J&M Shuler
Collaborators
Vivex Biomedical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stenosing Tenosynovitis
Keywords
Corticosteroid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Steroid injection
Arm Type
Active Comparator
Arm Description
1 mL Solu-medrol mixed with 0.5mL marcaine and 0.5 mL of lidocaine
Arm Title
Amniotic fluid injection
Arm Type
Experimental
Arm Description
1 mL amniotic fluid mixed with 0.5mL marcaine and 0.5 mL of lidocaine
Intervention Type
Biological
Intervention Name(s)
Amniotic fluid injection
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Steroid injection
Intervention Description
Solu-medrol
Primary Outcome Measure Information:
Title
Patient reported pain level
Description
Analog pain scale (0-10)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Trigger frequency
Description
Rate at which a patient's digit will lock or trigger
Time Frame
12 months
Title
Disabilities of the Arm Shoulder and Hand score
Description
Measure of disability in performing every day activities at work and around the house. Calculated value from DASH questionnaire.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Shuler, MD
Organizational Affiliation
Athens Orthopedic Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Athens Orthopedic Clinic
City
Athens
State/Province
Georgia
ZIP/Postal Code
30606
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger
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