NCT02421419

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

April 7, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 20, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2017

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 23, 2018

Completed
Last Updated

September 28, 2018

Status Verified

September 1, 2018

Enrollment Period

1.7 years

First QC Date

April 7, 2015

Results QC Date

July 10, 2017

Last Update Submit

September 26, 2018

Conditions

Trigger Finger Disorder

Keywords

flexor tendon entrapmentsnapping fingertrigger digitstrigger thumb

Outcome Measures

Primary Outcomes (1)

  • VAS

    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 Outcomes (3)

  • Presence of Triggering

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

  • Degree of Triggering

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

  • Number of Participants With Adverse Effects

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

Study Arms (3)

Corticosteroid alone (CS) Group

ACTIVE COMPARATOR

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

Drug: Dexamethasone Sodium Phosphate

Corticosteroid/Lidocaine (CSL) Group

ACTIVE COMPARATOR

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

Drug: Dexamethasone Sodium PhosphateDrug: Xylocaine

Corticosteroid/Saline (CSS) Group

ACTIVE COMPARATOR

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

Drug: Dexamethasone Sodium PhosphateDrug: Sodium Chloride

Interventions

Dexamethasone Sodium PhosphateDRUG

adreno-cortical steroid anti-inflammatory drug

Also known as: Decadron phosphate
Corticosteroid alone (CS) GroupCorticosteroid/Lidocaine (CSL) GroupCorticosteroid/Saline (CSS) Group
XylocaineDRUG

a local anesthetic agent

Also known as: Lidocaine HCL
Corticosteroid/Lidocaine (CSL) Group
Sodium ChlorideDRUG

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

Also known as: Saline
Corticosteroid/Saline (CSS) Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (7)

  • 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.

    PMID: 11476534BACKGROUND

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

    PMID: 269967BACKGROUND

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

    PMID: 8973080BACKGROUND

  • 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.

    PMID: 2754207BACKGROUND

  • 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.

    PMID: 1640148BACKGROUND

  • 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.

    PMID: 7594291BACKGROUND

  • 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.

    PMID: 14599834BACKGROUND

MeSH Terms

Conditions

Trigger Finger Disorder

Interventions

dexamethasone 21-phosphateLidocaineSodium Chloride

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Limitations and Caveats

Study closed prematurely on 1/25/2017 with 26 patients enrolled and 1 withdrawal.

Results Point of Contact

Title
Kenneth Taylor, M.D.
Organization
Penn State Milton S. Hershey Medical Center
ktaylor2@pennstatehealth.psu.edu
(717) 531-5638

Study Officials

  • Kenneth Taylor, MD

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Orthopaedics

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 20, 2015

Study Start

June 1, 2015

Primary Completion

January 25, 2017

Study Completion

January 25, 2017

Last Updated

September 28, 2018

Results First Posted

January 23, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)