Health TrialsbyHealthPanel

Conservative Treatment of Trigger Finger

ConditionsHand InjuriesTrigger Finger
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorCedars-Sinai Medical Center

About this trial

This study is to analyze the effectiveness of a nighttime extension orthosis after receiving a cortisone injection for the treatment of trigger finger to improve pain and restore functional outcomes. The investigators hypothesize that the extension orthosis will improve pain and functional outcomes compared to those without a digital night extension orthosis in those with trigger finger at 12 weeks from the injection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals 18 years old or older are included

Patients with trigger finger, aka stenosing flexor tenosynovitis

Status post receiving cortisone injection of the affected digit(s)

Disqualifiers

Any records flagged with break the glass or research opt out

Patients with rheumatoid arthritis

Patients with a history of traumatic injury to the hand

Cognitive or behavioral problems which would preclude informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oval-8 ® Orthosis

    Device

    The experimental group will consist of receiving a PIP joint on the day they receive their cortisone injection. The Oval-8 ® will be issued to the subject by an Occupational Therapist to ensure correct fit and comfort as well as given written instructions for night use. The orthosis will be worn at night for 6-week duration. Participants will have 1 follow up phone call or email at the 6-week mark and then 1 follow up phone call or email at the 12 week mark by a member of the research team from the time they received their cortisone injection where the time for resolution of trigger finger symptoms, VAS (Visual Analogue Scale), subjective questionnaire and QuickDASH scores will all be recorded in their medical research file.

  • Cortisone injection only

    Other intervention

    The control group will receive a cortisone injection and be instructed to move their fingers normally

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: Experimental Group with Cortisone Injection of affected digit(s) and nighttime orthosisExperimental treatment 1 intervention
Group B: Control Group-No OrthosisActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Resolution of Trigger Finger Symptoms

Questionnaire used to determine resolution of Trigger Finger Symptoms

Time frame
6 Weeks
2

Resolution of Trigger Finger Symptoms

Questionnaire used to determine resolution of Trigger Finger Symptoms

Time frame
12 Weeks

Secondary outcomes

1

Change in Pain

Visual Analogue Scale for Pain (0 pain free to 10 severe pain)

Time frame
6 weeks
2

Change in Pain

Visual Analogue Scale for Pain (0 pain free to 10 severe pain)

Time frame
12 weeks
3

Change in Perception of Function

QuickDash scores (0% no functional limitations to 100% disabled)

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cedars-Sinai Medical Center

Lead sponsor

Source ClinicalTrials.gov
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