Pain With Trigger Finger Injection: A Comparison of Steroid Alone Versus Steroid/Lidocaine Mixture
NCT ID: NCT02421419
Last Updated: 2018-09-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
26 participants
INTERVENTIONAL
2015-06-30
2017-01-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Corticosteroid alone (CS) Group
1 cc dexamethasone sodium phosphate (4mg/ml) injectable
Dexamethasone Sodium Phosphate
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
Dexamethasone Sodium Phosphate
adreno-cortical steroid anti-inflammatory drug
Xylocaine
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)
Dexamethasone Sodium Phosphate
adreno-cortical steroid anti-inflammatory drug
Sodium Chloride
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
Xylocaine
a local anesthetic agent
Sodium Chloride
Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
No
Sponsors
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Kenneth Taylor, M.D.
OTHER
Responsible Party
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Kenneth Taylor, M.D.
Associate Professor, Orthopaedics
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
Countries
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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.
Strom L. Trigger finger in diabetes. J Med Soc N J. 1977 Nov;74(11):951-4. No abstract available.
Kasdan ML, Leis VM, Lewis K, Kasdan AS. Trigger finger: not always work related. J Ky Med Assoc. 1996 Nov;94(11):498-9.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB - 001858
Identifier Type: -
Identifier Source: org_study_id
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