Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger
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ClinicalTrials.gov Identifier: NCT03583151 |
Recruitment Status : Unknown
Verified June 2018 by J&M Shuler.
Recruitment status was: Enrolling by invitation
First Posted : July 11, 2018
Last Update Posted : July 11, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stenosing Tenosynovitis | Biological: Amniotic fluid injection Biological: Steroid injection | Phase 3 |
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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Steroid injection
1 mL Solu-medrol mixed with 0.5mL marcaine and 0.5 mL of lidocaine
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Biological: Steroid injection
Solu-medrol |
Experimental: Amniotic fluid injection
1 mL amniotic fluid mixed with 0.5mL marcaine and 0.5 mL of lidocaine
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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. |
- Patient reported pain level [ Time Frame: 12 months ]Analog pain scale (0-10)
- Trigger frequency [ Time Frame: 12 months ]Rate at which a patient's digit will lock or trigger
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583151
United States, Georgia | |
Athens Orthopedic Clinic | |
Athens, Georgia, United States, 30606 |
Principal Investigator: | Michael Shuler, MD | Athens Orthopedic Clinic |
Responsible Party: | J&M Shuler |
ClinicalTrials.gov Identifier: | NCT03583151 |
Other Study ID Numbers: |
Random TF |
First Posted: | July 11, 2018 Key Record Dates |
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 |
Corticosteroid |
Tenosynovitis Tendon Entrapment Tendinopathy Muscular Diseases Musculoskeletal Diseases |