Clinical trial NCT02421419: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Trigger Finger Disorder
Keywords: flexor tendon entrapment
snapping finger
trigger digits
trigger thumb
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2015-04-20
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: VAS
timeFrame: 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:
measure: Presence of Triggering
timeFrame: Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, and 6 weeks post-injection
measure: Degree of Triggering
timeFrame: Patients are assessed pre-injection objectively by investigator and at 6 weeks post-injection subjectively via Patient Survey
measure: Number of Participants With Adverse Effects
timeFrame: Patients are assessed 1 minute post-injection, 10 minutes post-injection, and at 6 week post-injection.
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Kenneth Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Strom L. Trigger finger in diabetes. J Med Soc N J. 1977 Nov;74(11):951-4. No abstract available.
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.
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.
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.
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.
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.