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

Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting: A Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01886157
Enrollment
100
Registered
2013-06-25
Start date
2013-05-31
Completion date
2016-05-31
Last updated
2015-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stenosing Tenosynovitis, Trigger Finger

Keywords

trigger finger, orthotic intervention

Brief summary

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

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.

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.

Sponsors

The Philadelphia & South Jersey Hand Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Stage of finger triggering1, 2, 4-6, and 12 monthsTrigger 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)

Secondary

MeasureTime frameDescription
Failed treatment: surgical intervention required1,2, 4-6, 12monthsFailed treatment OR Successful treatment
Patient rated functional outcome1, 2, 4-6, 12monthsQuick Disabilities of the Arm, Shoulder and Hand questionnaire Patient Specific Functional Scale
Pain1, 2, 4-6, 12 monthsVisual Analog Scale

Other

MeasureTime frameDescription
Compliance with splint and hand exercises1, 2 monthsFor patients who are assigned to injection and splint group, home exercise and splint compliance will be assessed by patients maintaining a case log.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026