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

Primary Purpose

Trigger Finger Disorder

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Dexamethasone Sodium Phosphate

Xylocaine

Sodium Chloride

About this trial

This is an interventional treatment trial for Trigger Finger Disorder focused on measuring flexor tendon entrapment, snapping finger, trigger digits, trigger thumb

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Corticosteroid alone (CS) Group

Corticosteroid/Lidocaine (CSL) Group

Corticosteroid/Saline (CSS) Group

Arm Description

1 cc dexamethasone sodium phosphate (4mg/ml) injectable

1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable

1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)

Outcomes

Primary Outcome Measures

VAS

Visual Analogue Pain Scale (VAS) - measurement of pain on scale of 0 (least) to 10 (worst).

Secondary Outcome Measures

Presence of Triggering

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.

Degree of Triggering

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.

Number of Participants With Adverse Effects

Incidence of adverse effects

Full Information

NCT ID

NCT02421419

First Posted

April 7, 2015

Last Updated

September 26, 2018

Sponsor

Kenneth Taylor, M.D.

1. Study Identification

Unique Protocol Identification Number

NCT02421419

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Terminated

Why Stopped

Study closed; recruitment problems

Study Start Date

June 2015 (undefined)

Primary Completion Date

January 25, 2017 (Actual)

Study Completion Date

January 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Kenneth Taylor, M.D.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trigger Finger Disorder

Keywords

flexor tendon entrapment, snapping finger, trigger digits, trigger thumb

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Corticosteroid alone (CS) Group

Arm Type

Active Comparator

Arm Description

1 cc dexamethasone sodium phosphate (4mg/ml) injectable

Arm Title

Corticosteroid/Lidocaine (CSL) Group

Arm Type

Active Comparator

Arm Description

1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable

Arm Title

Corticosteroid/Saline (CSS) Group

Arm Type

Active Comparator

Arm Description

1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)

Intervention Type

Drug

Intervention Name(s)

Dexamethasone Sodium Phosphate

Other Intervention Name(s)

Decadron phosphate

Intervention Description

adreno-cortical steroid anti-inflammatory drug

Intervention Type

Drug

Intervention Name(s)

Xylocaine

Other Intervention Name(s)

Lidocaine HCL

Intervention Description

a local anesthetic agent

Intervention Type

Drug

Intervention Name(s)

Sodium Chloride

Other Intervention Name(s)

Saline

Intervention Description

Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment

Primary Outcome Measure Information:

Title

VAS

Description

Visual Analogue Pain Scale (VAS) - measurement of pain on scale of 0 (least) to 10 (worst).

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

Secondary Outcome Measure Information:

Title

Presence of Triggering

Description

Time Frame

Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, and 6 weeks post-injection

Title

Degree of Triggering

Description

Time Frame

Patients are assessed pre-injection objectively by investigator and at 6 weeks post-injection subjectively via Patient Survey

Title

Number of Participants With Adverse Effects

Description

Incidence of adverse effects

Time Frame

Patients are assessed 1 minute post-injection, 10 minutes post-injection, and at 6 week post-injection.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kenneth Taylor, MD

Organizational Affiliation

Milton S. Hershey Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Penn State Milton S. Hershey Medical Center

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

11476534

Citation

Saldana MJ. Trigger digits: diagnosis and treatment. J Am Acad Orthop Surg. 2001 Jul-Aug;9(4):246-52. doi: 10.5435/00124635-200107000-00004.

Results Reference

background

PubMed Identifier

269967

Citation

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

Results Reference

background

PubMed Identifier

8973080

Citation

Kasdan ML, Leis VM, Lewis K, Kasdan AS. Trigger finger: not always work related. J Ky Med Assoc. 1996 Nov;94(11):498-9.

Results Reference

background

PubMed Identifier

2754207

Citation

Marks MR, Gunther SF. Efficacy of cortisone injection in treatment of trigger fingers and thumbs. J Hand Surg Am. 1989 Jul;14(4):722-7. doi: 10.1016/0363-5023(89)90199-8.

Results Reference

background

PubMed Identifier

1640148

Citation

Lambert MA, Morton RJ, Sloan JP. Controlled study of the use of local steroid injection in the treatment of trigger finger and thumb. J Hand Surg Br. 1992 Feb;17(1):69-70. doi: 10.1016/0266-7681(92)90014-s.

Results Reference

background

PubMed Identifier

7594291

Citation

Murphy D, Failla JM, Koniuch MP. Steroid versus placebo injection for trigger finger. J Hand Surg Am. 1995 Jul;20(4):628-31. doi: 10.1016/S0363-5023(05)80280-1. Erratum In: J Hand Surg [Am] 1995 Nov;20(6):1075.

Results Reference

background

PubMed Identifier

14599834

Citation

Maneerit J, Sriworakun C, Budhraja N, Nagavajara P. Trigger thumb: results of a prospective randomised study of percutaneous release with steroid injection versus steroid injection alone. J Hand Surg Br. 2003 Dec;28(6):586-9. doi: 10.1016/s0266-7681(03)00172-4.

Results Reference

background

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

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