Long Term Effectiveness of Trigger Finger Injections With Triamcinolone vs. Dexamethasone
Condition: Trigger Finger Disorder
MeSH terms: Trigger Finger Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Trigger finger (stenosing tenosynovitis) is a very common condition and in office treatment
      with corticosteroid injection is widely accepted to be first line treatment. Previous studies
      have reported resolution of triggering after injection at rates ranging from 50% to 93%. Many
      factors contribute to this variability, including duration of symptoms, presence of diabetes,
      etc. This study will be a single center, prospective, randomized control trial. Patients will
      be collected into two different cohorts. The main cohort will be of patients with primary,
      idiopathic trigger finger. A second cohort of patients with diabetes will also be collected
      for secondary study questions. Study procedures will include clinical examination of the
      patient, injection of trigger fingers with mix of local anesthetic and one of two steroids,
      possible repeat trigger finger injections, and if patients are so indicated, surgical
      treatment of the trigger finger. Surgical treatment is considered clinical care of these
      patients who have continued or recurrent symptoms and the surgical treatment would not be
      considered part of this study. During the study, patients will also fill out surveys about
      their symptoms. The study drugs used will be 1% lidocaine without epinephrine mixed with
      either triamcinolone or dexamethasone. These medications are FDA approved for injection
      treatment of "acute non-specific tenosynovitis." This indication includes trigger finger
      which is also known as acute stenosing tenosynovitis. The package inserts listing the
      indications for use of these medications are included in the attachments portion of the IRB
      application.
    

Detailed description: 
      Upon coming to a clinical visit, patients who are complaining of trigger finger will be asked
      if they would like to participate in a study. After finishing the consent process, patients
      who elect to participate will be randomized to one of the two steroid groups. All patients
      will complete an initial enrollment survey as well as a DASH score (Disabilities of the Arm,
      Shoulder, and Hand), and the Michigan Hand Questionnaire (MHQ). Each patient will be examined
      by one of the attending physicians or one of the experienced physician's assistants and their
      Quinnell grade of trigger finger will be documented. Injection will performed in a
      standardized fashion in clinic. Multiple trigger fingers in any one patient will be treated
      but patients will be randomized, not individual fingers. The most radial finger treated will
      be the one followed for outcome measures. Patients will have the option to be treated with a
      different medication if they require further injections. However, all patients and data will
      be analyzed in an intention to treat manner. Follow-up visits will be arranged at 6 weeks, 6
      months, 1 year, and 2 years. At each follow-up visit, patients will again fill out the DASH
      score, MHQ, and a study-specific survey to evaluate outcome. In anticipation of the
      difficulty of obtaining a high follow-up rate at the 1 year and 2 year marks, the
      study-specific survey and the DASH and the MHQ may be administered to the patients over the
      phone or be sent an electronic version of the surveys. Additionally, these patients will also
      receive a written copy of the surveys via mail to complete and return. All patients will be
      followed for a total of 2 years after their latest injection. Most of these procedures are
      standard of care, the only research visits are the 1 and 2 year follow-up visits. Some
      patients with recurrent or continued symptoms may be indicated for surgical treatment of
      their trigger finger. Surgical treatment is considered clinical care of these patients who
      have continued or recurrent symptoms and the surgical treatment would not be considered part
      of this study.

      Data collected from the patient's medical record will include demographic information such as
      age, sex, birthdate. The investigators will also review whether the patient is currently
      taking any medications for the treatment of diabetes mellitus.
    

Intervention name(s): Triamcinolone; Dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble). This will be mixed with 1% lidocaine without epinephrine; dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble). Again, this will be mixed with 1% lidocaine without epinephrine
Other intervention name(s): Kenalog; Decadron
Intervention MeSH terms: Dexamethasone; Triamcinolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: trigger finger