Emran Sheikh1, John D Peters2, Will Sayde3, Mitchell Maltenfort4, Charles Leinberry5. 1. 201 Route 17 North 11th Floor, Rutherford, NJ 07070 USA. 2. Jefferson Medical College, 103 Fairway Dr, Clarks Summit, PA 18411 USA. 3. Department of Orthopedics, Thomas Jefferson University Hospital, 1015 Walnut St. Curtis Building, Rm 801, Philadelphia, PA 19107 USA. 4. Statistics, Rothman Institute, 925 Chestnut Street, Philadelphia, PA 19107 USA. 5. Orthopaedics, Rothman Institute, 925 Chestnut Street, Philadelphia, PA 19107 USA.
Abstract
BACKGROUND:Stenosing tenosynovitis or trigger finger is a common clinical condition regularly treated with steroid injections. Varied success is reported at early time points following injection. We present a prospective, randomized IRB-approved study to confirm these findings at a long-term follow-up. METHODS:Adult patients presenting with symptoms of stenosing tenosynovitis who agreed to participate were randomized into two groups. Group 1 received an initial injection of triamcinolone and local anesthetic mixture. Group 2 received the same initial injection and an additional staged injection at 6 weeks. The patients were then followed beyond 2 years. If Group 1 patients were still symptomatic at 6 weeks, another injection was given. An additional injection or surgery was defined as treatment failure. DASH scores were obtained at baseline, 3, 6, and 12 months. RESULTS:Ninety-seven patients (101 trigger digits) were enrolled in the prospective trial. Fifty-six digits were randomized to the one-injection group versus 45 digits randomized to the two-injection group ("intention to treat analysis"-ITT). After accounting for crossover between the groups, 42 patients received one-injection versus fifty-nine patients receiving two injections ("actual" analysis). Overall failure was the same between the two groups. However, a higher surgery rate was noted for patients having undergone two injections versus one injection [47 % versus 27 % (p < 0.013), ITT]. Diabetes was associated with a higher surgery rate at 1 year within the group of overall failures [56 % versus 37 % (p = 0.0505), ITT]. High baseline DASH score (>40) was associated with a median time of 10 months for failure and 6 months for surgery as per a Kaplan-Meier survival analysis (p < 0.005 and p < 0.001, respectively, ITT). CONCLUSIONS: As overall failure of steroid injection for trigger finger is not improved with staged, two-injection treatment, we recommend a single injection initial treatment for trigger finger with a second injection given in cases of recurrence or failure. Diabetes was a risk factor for needing surgery if failure occurred within 1 year. The baseline DASH score is helpful in predicting which patients have a higher chance of failing as well as needing surgery. Level of evidence Prospective, randomized trial, level I.
RCT Entities:
BACKGROUND:Stenosing tenosynovitis or trigger finger is a common clinical condition regularly treated with steroid injections. Varied success is reported at early time points following injection. We present a prospective, randomized IRB-approved study to confirm these findings at a long-term follow-up. METHODS: Adult patients presenting with symptoms of stenosing tenosynovitis who agreed to participate were randomized into two groups. Group 1 received an initial injection of triamcinolone and local anesthetic mixture. Group 2 received the same initial injection and an additional staged injection at 6 weeks. The patients were then followed beyond 2 years. If Group 1 patients were still symptomatic at 6 weeks, another injection was given. An additional injection or surgery was defined as treatment failure. DASH scores were obtained at baseline, 3, 6, and 12 months. RESULTS: Ninety-seven patients (101 trigger digits) were enrolled in the prospective trial. Fifty-six digits were randomized to the one-injection group versus 45 digits randomized to the two-injection group ("intention to treat analysis"-ITT). After accounting for crossover between the groups, 42 patients received one-injection versus fifty-nine patients receiving two injections ("actual" analysis). Overall failure was the same between the two groups. However, a higher surgery rate was noted for patients having undergone two injections versus one injection [47 % versus 27 % (p < 0.013), ITT]. Diabetes was associated with a higher surgery rate at 1 year within the group of overall failures [56 % versus 37 % (p = 0.0505), ITT]. High baseline DASH score (>40) was associated with a median time of 10 months for failure and 6 months for surgery as per a Kaplan-Meier survival analysis (p < 0.005 and p < 0.001, respectively, ITT). CONCLUSIONS: As overall failure of steroid injection for trigger finger is not improved with staged, two-injection treatment, we recommend a single injection initial treatment for trigger finger with a second injection given in cases of recurrence or failure. Diabetes was a risk factor for needing surgery if failure occurred within 1 year. The baseline DASH score is helpful in predicting which patients have a higher chance of failing as well as needing surgery. Level of evidence Prospective, randomized trial, level I.
Authors: Cyriac Peters-Veluthamaningal; Daniëlle A W M van der Windt; Jan C Winters; Betty Meyboom-de Jong Journal: Cochrane Database Syst Rev Date: 2009-01-21