Pain With Trigger Finger Injection: A Comparison of Steroid Alone Versus Steroid/Lidocaine Mixture

September 26, 2018 updated by: Kenneth Taylor, M.D.
This research is being done to compare pain relief and efficacy of trigger finger injection using a combination of lidocaine/corticosteroid versus corticosteroid injection alone versus corticosteroid/saline combination.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized study comparing pain relief and efficacy of trigger finger injection using a combination of lidocaine/corticosteroid versus corticosteroid injection alone versus corticosteroid/saline combination.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-90
  • Male or female (non-pregnant)
  • Clinically diagnosed trigger digit
  • Subject is able to provide voluntary, written informed consent
  • Subject, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits.

Exclusion Criteria:

  • Age <18 or >90
  • Pregnant or lactating women
  • Non-English speaking individuals
  • Medication contradictions to lidocaine, corticosteroids and/or saline
  • Prior injection or surgery on the affected finger
  • Diagnosis of reflex symptomatic dystrophy (RSD) or complex regional pain syndrome (CRPS)
  • Open wound

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Corticosteroid alone (CS) Group
1 cc dexamethasone sodium phosphate (4mg/ml) injectable
Drug: Dexamethasone Sodium Phosphate
adreno-cortical steroid anti-inflammatory drug
Other Names:
  • Decadron phosphate
Active Comparator: Corticosteroid/Lidocaine (CSL) Group
1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable
Drug: Dexamethasone Sodium Phosphate
adreno-cortical steroid anti-inflammatory drug
Other Names:
  • Decadron phosphate
Drug: Xylocaine
a local anesthetic agent
Other Names:
  • Lidocaine HCL
Active Comparator: Corticosteroid/Saline (CSS) Group
1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)
Drug: Dexamethasone Sodium Phosphate
adreno-cortical steroid anti-inflammatory drug
Other Names:
  • Decadron phosphate
Drug: Sodium Chloride
Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS
Time Frame: Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, at 6 weeks post-injection and also asked to recollect their pain at time of injection when seen at 6 weeks post-injection
Visual Analogue Pain Scale (VAS) - measurement of pain on scale of 0 (least) to 10 (worst).
Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, at 6 weeks post-injection and also asked to recollect their pain at time of injection when seen at 6 weeks post-injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Triggering
Time Frame: Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, and 6 weeks post-injection
Patients are asked how often their finger triggers - not at all, rarely, occasionally, or frequently at time intervals indicated in the outcome measure time frame. Count of participants for each of these answers was collected.
Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, and 6 weeks post-injection
Degree of Triggering
Time Frame: Patients are assessed pre-injection objectively by investigator and at 6 weeks post-injection subjectively via Patient Survey
A Green classification number (0-4) is given to each subject pre-injection and at 6 weeks post-injection based on their degree of triggering. 0 = No triggering, no pain; 1 = Pre-triggering; pain, history of catching, but not demonstrable on physical examination; tenderness over the A1 pulley; 2 = Active; demonstrable catching, but the patient can actively extend the digit; 3= Passive; demonstrable catching requiring passive extension or inability to actively flex; and 4 = Contracture; demonstrable catching with a fixed flexion contracture of the PIP joint.
Patients are assessed pre-injection objectively by investigator and at 6 weeks post-injection subjectively via Patient Survey
Number of Participants With Adverse Effects
Time Frame: Patients are assessed 1 minute post-injection, 10 minutes post-injection, and at 6 week post-injection.
Incidence of adverse effects
Patients are assessed 1 minute post-injection, 10 minutes post-injection, and at 6 week post-injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kenneth Taylor, M.D.

Investigators

  • Principal Investigator: Kenneth Taylor, MD, Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

January 25, 2017

Study Completion (Actual)

January 25, 2017

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 17, 2015

First Posted (Estimate)

April 20, 2015

Study Record Updates

Last Update Posted (Actual)

September 28, 2018

Last Update Submitted That Met QC Criteria

September 26, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB - 001858

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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