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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by The Philadelphia & South Jersey Hand Center
Sponsor:
Information provided by (Responsible Party):
Stephanie Sweet, The Philadelphia & South Jersey Hand Center
ClinicalTrials.gov Identifier:
NCT01886157
First received: June 21, 2013
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention
Trigger Finger
Stenosing Tenosynovitis
Procedure: Corticosteroid injection + Trigger Splint+ Education and Home exercises
Procedure: Corticosteroid injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by The Philadelphia & South Jersey Hand Center:

Primary Outcome Measures:
  • Stage of finger triggering [ Time Frame: 1, 2, 4-6, and 12 months ] [ Designated as safety issue: No ]

    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)


Secondary Outcome Measures:
  • Failed treatment: surgical intervention required [ Time Frame: 1,2, 4-6, 12months ] [ Designated as safety issue: No ]
    Failed treatment OR Successful treatment

  • Patient rated functional outcome [ Time Frame: 1, 2, 4-6, 12months ] [ Designated as safety issue: No ]
    Quick Disabilities of the Arm, Shoulder and Hand questionnaire Patient Specific Functional Scale

  • Pain [ Time Frame: 1, 2, 4-6, 12 months ] [ Designated as safety issue: No ]
    Visual Analog Scale


Other Outcome Measures:
  • Compliance with splint and hand exercises [ Time Frame: 1, 2 months ] [ Designated as safety issue: No ]
    For patients who are assigned to injection and splint group, home exercise and splint compliance will be assessed by patients maintaining a case log.


Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Corticosteroid injection
Standard corticosteroid injection.
Procedure: Corticosteroid injection
Standard trigger finger corticosteroid injection.
Experimental: Corticosteroid Injection and Trigger Splint
Corticosteroid Injection + Trigger Splint + Education + Home Exercises
Procedure: Corticosteroid 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01886157

Contacts
Contact: Sue Blackmore, CHT Sue Blackmore <sblackmore@HANDCENTERS.com>

Locations
United States, Pennsylvania
The Philadelphia and South Jersey Hand Center Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Sue Blackmore, CHT       sblackmore@HANDCENTERS.com   
Contact: Sidney M Jacoby, MD       smjacoby@handcenters.com   
Principal Investigator: Stephanie Sweet, MD         
Sub-Investigator: Sidney M Jacoby, MD         
Sub-Investigator: Sue Blackmore, CHT         
Sub-Investigator: Abdo Bachoura, MD         
Sponsors and Collaborators
The Philadelphia & South Jersey Hand Center
Investigators
Principal Investigator: Stephanie Sweet, MD The Philadelphia and South Jersey Hand Center
Study Director: Sue Blackmore, CHT The Philadelphia and South Jersey Hand Center
  More Information

Publications:
Responsible Party: Stephanie Sweet, Clinical Assistant Professor, The Philadelphia & South Jersey Hand Center
ClinicalTrials.gov Identifier: NCT01886157     History of Changes
Other Study ID Numbers: 11C.554
Study First Received: June 21, 2013
Last Updated: June 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Philadelphia & South Jersey Hand Center:
trigger finger
orthotic intervention

Additional relevant MeSH terms:
Tendon Entrapment
Tenosynovitis
Trigger Finger Disorder
Muscular Diseases
Musculoskeletal Diseases
Tendinopathy

ClinicalTrials.gov processed this record on November 25, 2014