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AAHS#1: A Prospective Randomized Study Comparing the Effectiveness of One versus Two Injections for Symptomatic Stenosing Tenosynovitis (Trigger Finger)
Charles Leinberry, MD1, Emran Sheikh, MD2, John Peters, BS3, Will Sayde, MD4 and James Dowdell, BS3
1Rothman Institute, Thomas Jefferson University, Philadelphia, PA, 2Institute for Nerve, Hand and Reconstructive Surgery, Rutherford, NJ, 3Jefferson Medical College, Philadelphia, PA, 4Orthopaedic Surgery, Thomas Jefferson University Hospital, Philadelphia, PA
Stenosing tenosynovitis or trigger finger is a common clinical condition regularly treated with steroid injections in the office. Although various studies have reported success rates ranging from 72% to 91% with one versus two injections, we present a prospective, randomized IRB approved study designed to confirm these findings.
All patients presenting with symptoms of stenosing tenosynovitis who agreed to participate were included in this study. The patients were randomized into two groups. Group 1 received an injection of a 50 % mixture of Kenalog and local anesthetic. Group 2, an identical additional injection, 6 weeks later. Follow up occurred at 6 weeks, 3 months, 6 months and 1 year or longer. If the Group 1 patients were still symptomatic at 6 weeks (painful, clicking or locking) another injection was given. Treatment failure was considered if the patient required an additional injection or surgery.
One hundred and one patients were enrolled in the prospective trial. Fifty-six patients were randomized to the one-injection group and forty-five patients were randomized to the two-injection group (“intention to treat analysis” – ITT). After accounting for crossover between the groups, forty-two patients received one-injection versus fifty-nine patients receiving two injections (“actual” analysis).
Using a fisher's exact test, no difference between failure rates were noted between the one and two injection groups with respect to ITT or actual analysis at all follow up times. At one year a significantly higher surgery rate was noted for patients having undergone two i versus one injection. Time to surgery was also found to be earlier in the two-injection group (p<0.01 ITT, p<0.0004 actual). Using a multivariate logistic regression analysis, surgery was more likely in patients who had two injections (odds ratio 6.6, p<0.01 ITT; 28.4, p<0.001 actual), thumb involvement versus finger (odds ratio 5.5, p<0.03 ITT; 7.7, p<0.03 actual), or were diabetic (odds ratio 6.2, p<0.03 ITT; 10.4, p<0.03 actual). Gender, hand dominance, and tobacco smoking were not found to have significant predictive value although smoking did approach significance (odds ratio 4.1, p<0.13 ITT; 4.7, p<0.11 actual).
Undergoing a staged, two-injection corticosteroid treatment for trigger digits was not shown to be superior to a single-injection treatment. However, the chance of failure with surgery was higher after two injections. Diabetes and thumb involvement are also independent predictors of failure after injection and consequently, higher chance of needing surgery within a year.
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