NCT01886157

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

2.6 years

First QC Date

June 21, 2013

Last Update Submit

March 17, 2015

Conditions

Trigger FingerStenosing Tenosynovitis

Keywords

trigger fingerorthotic intervention

Outcome Measures

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)

    1, 2, 4-6, and 12 months

Secondary Outcomes (3)

  • Failed treatment: surgical intervention required

    1,2, 4-6, 12months

  • Patient rated functional outcome

    1, 2, 4-6, 12months

  • Pain

    1, 2, 4-6, 12 months

Other Outcomes (1)

  • Compliance with splint and hand exercises

    1, 2 months

Study Arms (2)

Corticosteroid injection

ACTIVE COMPARATOR

Standard corticosteroid injection.

Procedure: Corticosteroid injection

Corticosteroid Injection and Trigger Splint

EXPERIMENTAL

Corticosteroid Injection + Trigger Splint + Education + Home Exercises

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

Interventions

Corticosteroid injection + Trigger Splint+ Education and Home exercisesPROCEDURE

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

Corticosteroid Injection and Trigger Splint
Corticosteroid injectionPROCEDURE

Standard trigger finger corticosteroid injection.

Corticosteroid injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Philadelphia and South Jersey Hand Center

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (4)

  • 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.

    PMID: 18406955BACKGROUND

  • Strom L. Trigger finger in diabetes. J Med Soc N J. 1977 Nov;74(11):951-4. No abstract available.

    PMID: 269967RESULT

  • 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.

    PMID: 19006759RESULT

  • 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.

    PMID: 1538090RESULT

MeSH Terms

Conditions

Trigger Finger DisorderTendon Entrapment

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

TendinopathyMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Sidney Jacoby, MD

    The Philadelphia and South Jersey Hand Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 21, 2013

First Posted

June 25, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2015

Study Completion

May 1, 2016

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations

US(1)