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Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger

J

J&M Shuler

Status and phase

Unknown
Phase 3

Conditions

Stenosing Tenosynovitis

Treatments

Biological: Amniotic fluid injection
Biological: Steroid injection

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT03583151
Random TF

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

Steroid injection
Active Comparator group
Description:
1 mL Solu-medrol mixed with 0.5mL marcaine and 0.5 mL of lidocaine
Treatment:
Biological: Steroid injection
Amniotic fluid injection
Experimental group
Description:
1 mL amniotic fluid mixed with 0.5mL marcaine and 0.5 mL of lidocaine
Treatment:
Biological: Amniotic fluid injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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