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

Trigger Finger Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02421419
• Other study ID #: IRB - 001858
• Status: Terminated
• Phase: Phase 4
• Start date: June 2015
• Est. completion date: January 25, 2017

Study information

• Verified date: September 2018
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: January 25, 2017
• Est. primary completion date: January 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Trigger Finger Disorder

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Kenneth Taylor, M.D.

Country where clinical trial is conducted

United States, 

References & Publications (7)

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

Murphy D, Failla JM, Koniuch MP. Steroid versus placebo injection for trigger finger. J Hand Surg Am. 1995 Jul;20(4):628-31. Erratum in: J Hand Surg [Am] 1995 Nov;20(6):1075. — View Citation

Saldana MJ. Trigger digits: diagnosis and treatment. J Am Acad Orthop Surg. 2001 Jul-Aug;9(4):246-52. Review. — View Citation

Strom L. Trigger finger in diabetes. J Med Soc N J. 1977 Nov;74(11):951-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, and 6 weeks post-injection
Secondary	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.	Patients are assessed pre-injection objectively by investigator and at 6 weeks post-injection subjectively via Patient Survey
Secondary	Number of Participants With Adverse Effects	Incidence of adverse effects	Patients are assessed 1 minute post-injection, 10 minutes post-injection, and at 6 week post-injection.