ClinicalTrials.gg
Status unknownNCT01886157Updated Mar 18, 2015

Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting

An interventional study of Corticosteroid injection + Trigger Splint+ Education and Home exercises and Corticosteroid injection in Trigger Finger and Stenosing Tenosynovitis, sponsored by The Philadelphia & South Jersey Hand Center. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-18.

Sponsored by The Philadelphia & South Jersey Hand Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2015), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 35 studies in Trigger Finger Disorder with a site in United States — 6 open to participants now, 6 under way, none of them phase 3. Trigger Finger Disorder · United States.

Planned enrollment
14th of 30
100 · median 88
Started
2013
the only one that year
No phase
18 of 35
3 open now
Registered
4th of 35
by date

Among the 35 studies in Trigger Finger Disorder with a site in United States, this one is the 14th largest by planned enrollment of the 30 interventional ones, is the only one that started in 2013, is one of 18 with no phase, and was the 4th registered.

By phase

35 studies; the count open now beside each. This study's row is marked.

No phasethis study18 · 3 open
Phase 48 · 2 open
Observational5 · 0 open
Phase 22 · 1 open
Phase 11 · 0 open
Phase 31 · 0 open

By the year they started

First in 2009; this study’s year is marked. 1 started in 2013.

Size and results

Median enrollment 88 across the 30 interventional studies, 86 across the 5 observational. Of the 23 that completed or were terminated, 9 (39%) have results posted.

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02

Study summary

Hypothesis: Treatment of trigger finger by corticosteroid injection and splinting is superior to corticosteroid treatment alone.

Read the detailed description

Stenosing tenosynovitis, or more commonly "trigger finger" is a disease that can severely impact a patient's quality of life. Its incidence is said to be 28 persons per 100,000 annually. The disease is manifested in one or more fingers by finger locking in flexion or extension, leading to pain, discomfort and at times, loss of function. Patients frequently report having to snap their fingers back in position to alleviate symptoms. The pathophysiology relates to thickening of the flexor tendon sheath, which can impair tendon gliding within it.

Although multiple treatment strategies are available, it is not entirely clear which treatment offers the best outcome, especially when the finger has not reached end stage locking. In general, corticosteroid injection into the tendon sheath is offered as the first line of treatment. Splinting alone has also been described as a reliable method treatment. However, Patel and Bassini indicated that steroid injection results in fewer recurrences than splinting alone. Surgery is typically reserved for recurrent triggering, cases refractory to injection, or digits locked in flexion. The effects of steroid injection followed by splinting however have not been reported in a comprehensive fashion. It may be that this form of treatment could result in a synergistic effect, which can offer a treatment modality superior to either injection or splinting alone. The purpose of this research study is to determine whether steroid injection followed by splinting is superior to injection alone.

03

Conditions studied

  • Trigger Finger
  • Stenosing Tenosynovitis

Keywords

  • trigger finger
  • orthotic intervention
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Trigger finger in one or more trigger fingers, in stages 2 to 5 (inclusive)
  • Adult patient aged over 18 years.
  • No prior treatment (splinting, injection or surgery) to the involved finger OR at least 1 year since last treatment of the involved finger.

Exclusion criteria

Exclusion Criteria:

  • Exclude Trigger thumbs because they appear to be respond very favorably or unfavorably to treatment3
  • Exclude locked digits because surgery is indicated in these cases
  • Pregnant patients
  • Prisoners
  • Patients with impaired decision-making capacity
  • Patients that do not speak English and cannot fill in English language questionnaires.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Corticosteroid injection

    Standard corticosteroid injection.

    Procedure: Corticosteroid injection

  • Experimental
    Corticosteroid Injection and Trigger Splint

    Corticosteroid Injection + Trigger Splint + Education + Home Exercises

    Procedure: Corticosteroid injection + Trigger Splint+ Education and Home exercises

Interventions

  • ProcedureCorticosteroid injection + Trigger Splint+ Education and Home exercises

    Standard corticosteroid injection. Hand based, single digit trigger splint will be applied. Education and instructions about home exercises.

  • ProcedureCorticosteroid injection

    Standard trigger finger corticosteroid injection.

06

What researchers measure

Primary outcomes

  1. Stage of finger triggering

    Trigger Finger Stage: 1. Normal 2. Painful palpable nodule 3. Triggering = Clicking = Catching 4. Locking of finger in flexion or extension unlocked by active finger movement 5. Locking of finger in flexion or extension unlocked by passive finger movement 6. Locked finger in flexion or extension (Each stage may be painless or painful)

    Time frame: 1, 2, 4-6, and 12 months

Secondary outcomes

  1. Failed treatment: surgical intervention required

    Failed treatment OR Successful treatment

    Time frame: 1,2, 4-6, 12months

  2. Patient rated functional outcome

    Quick Disabilities of the Arm, Shoulder and Hand questionnaire Patient Specific Functional Scale

    Time frame: 1, 2, 4-6, 12months

  3. Pain

    Visual Analog Scale

    Time frame: 1, 2, 4-6, 12 months

Other outcomes

  1. Compliance with splint and hand exercises

    For patients who are assigned to injection and splint group, home exercise and splint compliance will be assessed by patients maintaining a case log.

    Time frame: 1, 2 months

07

Study locations

1 site
  • The Philadelphia and South Jersey Hand Center
    Philadelphia, Pennsylvania 19107, United States
08

References and documents

Publications

  • Ring D, Lozano-Calderon S, Shin R, Bastian P, Mudgal C, Jupiter J. A prospective randomized controlled trial of injection of dexamethasone versus triamcinolone for idiopathic trigger finger. J Hand Surg Am. 2008 Apr;33(4):516-22; discussion 523-4. doi: 10.1016/j.jhsa.2008.01.001. PubMed 18406955 ↗
  • Strom L. Trigger finger in diabetes. J Med Soc N J. 1977 Nov;74(11):951-4. No abstract available. PubMed 269967 ↗
  • Colbourn J, Heath N, Manary S, Pacifico D. Effectiveness of splinting for the treatment of trigger finger. J Hand Ther. 2008 Oct-Dec;21(4):336-43. doi: 10.1197/j.jht.2008.05.001. Epub 2008 Aug 22. PubMed 19006759 ↗
  • Patel MR, Bassini L. Trigger fingers and thumb: when to splint, inject, or operate. J Hand Surg Am. 1992 Jan;17(1):110-3. doi: 10.1016/0363-5023(92)90124-8. PubMed 1538090 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2013, a primary completion of Dec 2015 and a completion of May 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 21, 2013
First posted
Jun 25, 2013
Start
May 2013
Primary completionEst.
Dec 2015
CompletionEst.
May 2016
Last update
Mar 18, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01886157
Lead sponsor
The Philadelphia & South Jersey Hand Center
Responsible party
Sidney M. Jacoby (Associate Professor, The Philadelphia & South Jersey Hand Center) — Principal investigator
First posted
Jun 25, 2013
Start date
May 2013
Primary completion
Dec 2015 (estimated)
Completion
May 2016 (estimated)
Last update
Mar 18, 2015

Study contacts

Sidney Jacoby, MD
study director · The Philadelphia and South Jersey Hand Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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