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Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger

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

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

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.




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.



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

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


Locations
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United States, Georgia
Athens Orthopedic Clinic
Athens, Georgia, United States, 30606
Sponsors and Collaborators
J&M Shuler
Vivex Biomedical
Investigators
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Principal Investigator: Michael Shuler, MD Athens Orthopedic Clinic

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Responsible Party: J&M Shuler
ClinicalTrials.gov Identifier: NCT03583151     History of Changes
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

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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:
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Tenosynovitis
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases