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

NCT ID: NCT02421419

Last Updated: 2018-09-28

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-01-25

Brief Summary

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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

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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.

Conditions

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Trigger Finger Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Corticosteroid alone (CS) Group

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

Group Type ACTIVE_COMPARATOR

Dexamethasone Sodium Phosphate

Intervention Type DRUG

adreno-cortical steroid anti-inflammatory drug

Corticosteroid/Lidocaine (CSL) Group

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

Group Type ACTIVE_COMPARATOR

Dexamethasone Sodium Phosphate

Intervention Type DRUG

adreno-cortical steroid anti-inflammatory drug

Xylocaine

Intervention Type DRUG

a local anesthetic agent

Corticosteroid/Saline (CSS) Group

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

Group Type ACTIVE_COMPARATOR

Dexamethasone Sodium Phosphate

Intervention Type DRUG

adreno-cortical steroid anti-inflammatory drug

Sodium Chloride

Intervention Type DRUG

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

Interventions

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Dexamethasone Sodium Phosphate

adreno-cortical steroid anti-inflammatory drug

Intervention Type DRUG

Xylocaine

a local anesthetic agent

Intervention Type DRUG

Sodium Chloride

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

Intervention Type DRUG

Other Intervention Names

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Decadron phosphate Lidocaine HCL Saline

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kenneth Taylor, M.D.

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Taylor, M.D.

Associate Professor, Orthopaedics

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kenneth Taylor, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

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Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 11476534 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 269967 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8973080 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2754207 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1640148 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7594291 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14599834 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB - 001858

Identifier Type: -

Identifier Source: org_study_id

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