Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger

• ClinicalTrials.gov Identifier: NCT03583151
• Recruitment Status: Enrolling by invitation
• First Posted: July 11, 2018
• Last Update Posted: July 11, 2018
• Sponsor: J&M Shuler
• Collaborator: Vivex Biomedical
• Information provided by (Responsible Party): J&M Shuler

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.

Condition or disease	Intervention/treatment	Phase
Stenosing Tenosynovitis	Biological: Amniotic fluid injection; Biological: Steroid injection	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Injection With Amniotic Fluid Versus Corticosteroid in Patients With Stenosing Tenosynovitis: a Randomized, Blinded Trial
• Actual Study Start Date: May 10, 2018
• Estimated Primary Completion Date: December 2018
• Estimated Study Completion Date: December 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Patient reported pain level [ Time Frame: 12 months ]
   Analog pain scale (0-10)

Secondary Outcome Measures :

1. Trigger frequency [ Time Frame: 12 months ]
   Rate at which a patient's digit will lock or trigger
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Georgia

Athens Orthopedic Clinic

Athens, Georgia, United States, 30606

Sponsors and Collaborators

J&M Shuler

Vivex Biomedical

Investigators

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

More Information

• Responsible Party: J&M Shuler
• ClinicalTrials.gov Identifier: NCT03583151 History of Changes
• Other Study ID Numbers: Random TF
• First Posted: July 11, 2018
• Last Update Posted: July 11, 2018
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by J&M Shuler:

Corticosteroid

Additional relevant MeSH terms:

Tenosynovitis; Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases