Trigger finger, or stenosing tenosynovitis, Corticosteroid Injections in the Treatment of Trigger Finger: A Level I and II Systematic Review

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1 Corticosteroid Injections in the Treatment of Trigger Finger: A Level I and II Systematic Review Sheryl B. Fleisch, BS Kurt P. Spindler, MD Donald H. Lee, MD Ms. Fleisch is Medical Student, Vanderbilt University School of Medicine, Nashville, TN. Dr. Spindler is Professor and Vice Chairman, Department of Orthopaedics/Sports Medicine, Vanderbilt Orthopaedic Institute, Nashville. Dr. Lee is Professor, Department of Orthopaedics, Vanderbilt Orthopaedic Institute. None of the following authors has received anything of value from or owns stock in a commercial company or institution related directly or indirectly to the subject of this article: Ms. Fleisch, Dr. Spindler, and Dr. Lee. Reprint requests: Dr. Lee, Vanderbilt Orthopaedic Institute, Medical Center East, South Tower, Suite 3200, st Avenue, Nashville, TN J Am Acad Orthop Surg 2007;15: Copyright 2007 by the American Academy of Orthopaedic Surgeons. Abstract Trigger finger is a tendinitis (stenosing tenosynovitis) with multiple management approaches. We conducted an evidencebased medicine systematic review of level I and II prospective randomized controlled trials to determine the effectiveness of injection in managing trigger finger. MEDLINE, Cochrane database, and secondary references were reviewed to locate all English-language prospective randomized controlled trials evaluating trigger finger treatment. Four studies using injectable s were identified, based on the following inclusion criteria: all were prospective randomized controlled trials of adults with >85% follow-up. This review indicates that the incidence of trigger finger is greatest in women (75%), with an average patient age range of 52 to 62 years. Combined analysis of these four studies shows that injections are effective in 57% of patients. Trigger finger, or stenosing tenosynovitis, is a condition in which the flexor tendon is prohibited from gliding through the tendon sheath because of thickening of the synovial sheath over the tendon. 1 As a result, digital movement is impaired, and the affected digit locks in either flexion (the most common position) or extension, causing pain and swelling. Trigger digit pathology can be associated with occupations involving lifting or gripping, but it also is associated with disease states, such as rheumatoid arthritis and diabetes mellitus. 2 Trigger finger has a reported incidence of 28 cases per 100,000 subjects annually, or a risk of 2.6% over a lifetime. 3 A survey of 516 patients treated between 1975 and 1994 indicated that 61% of trigger fingers occurred in women. 4 Multiple approaches are available for managing trigger finger. Splinting, s (either single or multiple injections), percutaneous surgery, and open surgery are all established means of treatment. The many published articles that address methods of managing trigger finger are predominantly retrospective and are confounded by significant bias. A survey of the available literature without regard to evidence-based medicine (EBM) showed that splinting was effective in relieving trigger finger in 55% to 66% of patients. 5,6 A single injection of relieved symptoms in 47% to 87% of patients with trigger finger No data are available on recurrence of trigger finger symptoms with splinting. However, the recurrence of trigger finger with injec- 166 Journal of the American Academy of Orthopaedic Surgeons

2 Sheryl B. Fleisch, BS, et al tion can be 27% in just 1 year, 12 suggesting that injection, although useful, may not provide long-term relief. According to Newport et al, 13 each additional injection resulted in decreased efficacy. Despite the lack of an EBM review on the efficacy of injection in the management of trigger finger, injection has been widely accepted as firstline treatment. 8,9,14-16 When splinting and/or injections fail, surgery is recommended. 14,15 Non- EBM literature indicates that surgical procedures (open and percutaneous) have a success rate of 89% to 100% Thus, there is a need to determine whether EBM supports the use of injection as first-line treatment of trigger finger. A systematic EBM review of level I and II studies is required to determine the most appropriate management for trigger finger, noting that multiple management options, coupled with variable success rates, especially for injections, have been proposed. We sought prospective randomized controlled trials (RCTs) that would meet the EBM criteria. 20 By relying on the highest levels of evidence, bias is reduced, and clinicians can feel more confident about executing change in their clinical practice. Our goal in this study was twofold. First, we wanted to determine whether sufficient EBM data exist to adequately determine whether injections are effective in managing trigger finger. Second, we wanted to analyze the EBM data that do exist to determine whether EBM supports injection of in the treatment of patients with trigger finger. This EBM systematic review identified and analyzed four level I and II RCTs. 8-10,21 These studies were culled from an extensive review of the medical literature on the treatment available for trigger finger. Methods Only prospective RCTs (level I and II) were reviewed because this type of study provides the highest level of reliable evidence. 20 MEDLINE and Cochrane database searches, coupled with a secondary search of the references of selected articles, were performed to identify all Englishlanguage clinical papers assessing treatment options for trigger finger from January 1966 through January Key words used in the literature search were trigger finger, stenosing tenosynovitis, tenosynovitis, stenosing tendovaginitis, and tendon entrapment. Of 56 total trigger finger studies identified, only four met specific criteria for RCTs using injectable s. Fifty of the remaining articles were excluded because they were not RCTs (many were retrospective reviews of data). Two studies were excluded that met all of the inclusion criteria because they compared efficacy of surgical procedures rather than injection efficacy. Other criteria required for inclusion in this review were that the study must be prospective, must have at least 85% follow-up, and must include only adults, the latter because disease pathology and treatment is reportedly different in children. 13,22 Because of the paucity of RCTs on trigger finger, studies stated as using randomized techniques were included despite a lack of precise definition of the exact randomization methods used. Further, because of their small sample size (<50 patients), two included studies 8,9 are level II, as defined by the Journal of Bone and Joint Surgery (American edition) criteria. 23 The four RCTs included in this systematic analysis were reviewed using a worksheet developed by an orthopaedics, biostatistics, and health services research center at a university-based medical center. 24 Use of this worksheet allowed for efficient organization of articles reviewed, including hypotheses, results, and potential sources of bias. Results were analyzed for specific treatment, age, sex, inclusion and exclusion criteria, percentage of digits at follow-up, digit being studied, method of randomization, time to follow-up, outcomes of each study, and statistical significance. Data from each study were organized and presented in tabular form. Reproducibility between studies was assessed to identify similar comparative information between the RCTs. The treatment methods included in each study, along with the sex and mean age of participants, are summarized in Table 1. The details of inclusion and exclusion criteria, as well as methods of randomization and follow-up, are summarized in Table 2. The success rate of injections in the treatment of trigger finger is analyzed and compared in Table 3. Results Demographics Mean reported patient age range was 52 to 62 years (Table 1). Interestingly, more women were enrolled than men, with women accounting for 75% of this EBM study population. The preponderance of women in these RCTs validates previous, lesser controlled studies 4 that suggested that most trigger finger patients are women. Duration of follow-up after injection was highly variable among these studies, ranging from 1 month to 27 months. Prior symptoms also were variable: Lambert et al 8 enrolled only individuals who had trigger finger lasting longer than 3 months. The other three studies 9,10,21 did not specify the number of months an individual must have had trigger finger to be included in the study. Patients with comorbidities such as diabetes and rheumatoid disease were omitted from most studies, 8,9,21 although Maneerit et al 10 allowed inclusion of diabetic patients (Table 2). Volume 15, Number 3, March

3 Corticosteroid Injections in the Treatment of Trigger Finger Table 1 Prospective Randomized Controlled Trials by Type and Demographic Sex Study Journal Year Country Treatment Male Female Total No. of Digits Mean Age in Years (Range) Murphy et al 9 Surgery (Am) 1995 United States Corticosteroid (NR) Placebo (NR) Lambert et al 8 Surgery (Br) 1992 England Corticosteroid (22-56) Placebo (30-76) Maneerit et al 10 * Surgery (Br) 2003 Thailand Percutaneous release with Corticosteroid alone (31-68) (31-76) Taras et al 21 Surgery (Am) 1998 United States Intrasheath Subcutaneous (NR) (NR) Total * 127 patients initially included, with sex determination indicated only for the 125 patients at follow-up 95 patients with involvement of 107 digits NR = not reported Study Design Study design was analyzed for each trial, including percentage of follow-up, percentage of thumbs versus fingers, method of randomization, and blinding methods (Table 2). Patient population ranged from 24 to 127 patients across the four RCTs. Murphy et al 9 and Lambert et al 8 had the smallest patient populations, with 24 and 41 patients, respectively. Although both studies were RCTs, their small patient populations may have induced a type II error (low power) into the outcome. 20 All studies 8-10,21 had >95% follow-up, which minimizes exclusion bias or systemic differences between groups because of inadequate follow-up. 25 Maneerit et al 10 included trigger finger patients with involvement solely in thumbs. The remaining three studies 8,9,21 included patients with predominant finger, rather than thumb, involvement. Fingers accounted for 67% to 77% of the patient population in these studies. Because the thumb and the finger have intrinsically different anatomic properties, the vast difference in the number of thumbs and fingers studied in each report may potentially contribute to exclusion bias and may affect the results. 26 Corticosteroid Injection Only two studies 8,9 specifically analyzed the effect of injection versus placebo. Maneerit et al 10 compared the success rate of injection with that of percutaneous surgical release in combination with injection. Taras et al 21 compared the efficacy of placing a injection into the subcutaneous tissue versus directly into the tendon sheath. The combined results of the four RCTs 8-10,21 indicate that surgical percutaneous release with injection relieved 91% of triggering, injection alone relieved 57% of triggering, and placebo relieved 17% of symptoms (Table 3). Despite intrinsic differences between each RCT, three of these studies 8-10 reported statistically significant data (P < 0.05). The Taras et al 21 study did not achieve statistical significance (β < 0.08) because of the low power of the study. Despite differences in the type of 168 Journal of the American Academy of Orthopaedic Surgeons

4 Sheryl B. Fleisch, BS, et al Table 2 Study Design Study No. of Treatment Groups Intervention Inclusion Criteria Exclusion Criteria No. of Digits at Follow-up (%) Thumb vs Fingers Average Method of Follow-up Randomization (mos) Murphy 2 Corticosteroid et al 9 vs placebo NR Lambert 2 Corticosteroid >3 mos et al 8 vs placebo TF/thumb Maneerit et al 10 2 Percutaneous release with Trigger thumb, grade 2-4, diabetes vs alone Taras NR et al 21 vs subcutaneous injection RA, IDDM, previous tendon laceration or TF injection RA, IDDM, eczema, concurrent infection, injection in the past 3 mos Trauma, carpal tunnel syndrome TF>6mos, IDDM/ NIDDM, systemic connective tissue disease 24/24 (100) 39/41 (95) 125/127 (98) 107/107 (100) 33% Fingers, 67% 29% Fingers, 71% 100% 23% Fingers, 77% Sealed envelopes 4 NR 1 NR 23 Medical record number: odd file number received subcutaneous injection, even file number received intrasheath injection 27 IDDM = insulin-dependent diabetes mellitus, NIDDM = non insulin-dependent diabetes mellitus, NR = not reported, RA = rheumatoid arthritis, TF = trigger finger used, our meta-analysis of these four studies showed that injection was useful in relieving trigger finger in 57% of patients. Complications from all of the aforementioned interventions were minimal. Discussion Evidence-based Evaluation of Bias Selection bias occurs when patients are selected for a particular intervention group based on different variables that could affect the outcome of the study. 20 Two studies 9,21 used randomization techniques that could be prone to selection bias: 20 medical record number 21 and, if improperly performed, sealed envelopes. 9 The remaining two studies 8,10 did not mention method of randomization. Despite potential selection bias in the four RCTs, all were included in this systematic review because of the scarcity of level I and II studies available for analysis. Besides selection and exclusion bias, detection bias occurs when examiners are not blinded to the intervention. Only two studies 8,9 were double-blind, such that the intervention and examination were performed by different clinicians and the examiner did not know which intervention was performed on which individual. The remaining two studies 10,21 did not report whether their studies were blinded. The number of thumbs and fingers included in each study and the different types and doses of also could contribute to bias. Outcome Measures The outcome measures used in the four EBM studies 8-10,21 were highly variable, thus providing no consistent evaluation technique for trigger finger. A more uniform scale is needed to measure resolution of trigger finger symptoms based on pain and mobility before and after interven- Volume 15, Number 3, March

5 Corticosteroid Injections in the Treatment of Trigger Finger Table 3 Results of Corticosteroid Versus Placebo Success (No. of Patients) Study Pain Type of Corticosteroid Corticosteroid Placebo Percutaneous Release With Corticosteroid Difference P value* Murphy et al 9 Lambert et al 8 Maneerit et al 10 Subjectively graded by patient before and after injection Patients kept a diary of pain experienced Visual analog pain scale 1 ml betamethasone sodium phosphate + 3mL1% lidocaine 0.5 ml methylprednisolone acetate ml 1% lidocaine 1 ml triamcinolone acetonide ml 1% lidocaine hydrochloride Taras et al 21 NR 1 ml betamethasone sodium phosphate ml 1.0% lidocaine 64% (9/14) 20% (2/10) 60% (12/20) 47% (28/60) Total 57% (115/201) 15% (3/20) NA 91% (59/65) NA 44% <0.02 NA 44% < % % NA NA NA NS, NR (66/107) 17% (5/30) 91% (59/65) * Determined by chi-square test Number of successful injections/total number of patients injected Corticosteroid injections were administered in either the intrasheath or subcutaneous compartment, with no significant difference between the two. NA = not applicable, NR = not reported, NS = not significant (lack of significance was attributed to low power [β < 0.8]) tion. Three of the four studies used variable subjective nonstandard rating scales; 8,9,21 Maneerit et al 10 used a trigger grading scale that was not explicitly explained. Three tools may improve outcome measures for the treatment of trigger finger: (1) a classification system for diagnosing trigger finger severity, 2,27 (2) a visual analog pain scale for measuring pain intensity, and (3) a goniometer for measuring total active motion as a quantification of digit mobility. Standard systems for evaluating trigger finger would permit a more confident assessment of the efficacy of a procedure, thus enabling better comparison of clinical outcomes in future RCTs. Summary This EBM review indicates that trigger finger is most prevalent in women aged 52 to 62 years, which supports previous non-ebm data. 4 Furthermore, although injection is widely used in the treatment of trigger finger, there is a paucity of well-controlled EBM studies evaluating its effectiveness. Only two of the studies in this systematic review specifically compared injection with placebo. 8,9 Maneerit et al 10 compared injection with percutaneous release in combination with injection, while Taras et al 21 compared subcutaneous injection with intrasheath injection. EBM analysis of these four RCTs demonstrates that injection provided relief in 57% of patients. These results contrast with those of non-ebm studies, which indicated that injection may be useful in up to 87% of patients Nevertheless, these recent EBM data are consistent with older non-ebm studies that recommended intervention as a first-line treatment option for trigger finger. Corticosteroid injections continue to be recommended because the procedure is relatively simple and because more than half of patients experience relief after injection, thus obviating the need for 170 Journal of the American Academy of Orthopaedic Surgeons

6 Sheryl B. Fleisch, BS, et al surgical intervention. Despite providing the best evidence available, the RCTs analyzed in this review used questionable methods of randomization, two studies exhibited a lack of examiner blinding, 10,21 and two studies had limited duration of follow-up (<2 years). 8,9 Future RCTs are needed that incorporate both pharmacologic and surgical interventions. We also strongly recommend the establishment and use of a more universal rating scale (classification system, visual analog scale, mobility assessment test) so that efficacy of trigger finger management can be better evaluated using EBM principles. Acknowledgment The authors thank Cameron T. Atkinson for technical assistance, Lynn S. Cain for editorial assistance, and each of the authors of the four excellent studies reviewed. This work was funded entirely by the Vanderbilt Sports Medicine Research Fund. Additional Resource CME Course: Managing Complicated Hand and Wrist Problems. Course Directors: Mark E. Baratz, MD, and Mark S. Cohen, MD. May 11-12, 2007, Rosemont, IL: mastcaldb/cmedetails.cfm?recor dnum=2106 References Evidence-based Medicine: Level I/II randomized prospective trials are references 8-10 and 21. Reference 2 is expert opinion. Citation numbers printed in bold type indicated references published within the past 5 years. 1. Saldana MJ: Trigger digits: Diagnosis and treatment. J Am Acad Orthop Surg 2001;9: Wolfe SW: Tenosynovitis, in Green DP, Hotchkiss RN, Pederson WC, Wolfe SW (eds): Green s Operative Hand Surgery, ed 5. Philadelphia, PA: Churchill Livingstone, 2005, Strom L: Trigger finger in diabetes. J Med Soc N J 1977;74: Kasdan ML, Leis VM, Lewis K, Kasdan AS: Trigger finger: Not always work related. J Ky Med Assoc 1996;94: Patel MR, Bassini L: Trigger fingers and thumb: When to splint, inject, or operate. J Hand Surg [Am] 1992;17: Patel MR, Moradia VJ: Percutaneous release of trigger digit with and without cortisone injection. J Hand Surg [Am] 1997;22: Marks MR, Gunther SF: Efficacy of cortisone injection in treatment of trigger fingers and thumbs. J Hand Surg [Am] 1989;14: 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;17: Murphy D, Failla JM, Koniuch MP: Steroid versus placebo injection for trigger finger. J Hand Surg [Am] 1995;20: 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;28: Freiberg A, Mulholland RS, Levine R: Nonoperative treatment of trigger fingers and thumbs. J Hand Surg [Am] 1989;14: Anderson B, Kaye S: Treatment of flexor tenosynovitis of the hand ( trigger finger ) with s: A prospective study of the response to local injection. Arch Intern Med 1991;151: Newport ML, Lane LB, Stuchin SA: Treatment of trigger finger by steroid injection. J Hand Surg [Am] 1990;15: Nimigan AS, Ross DC, Gan BS: Steroid injections in the management of trigger fingers. Am J Phys Med Rehabil 2006;85: Akhtar S, Bradley MJ, Quinton DN, Burke FD: Management and referral for trigger finger/thumb. BMJ 2005; 331: Benson LS, Ptaszek AJ: Injection versus surgery in the treatment of trigger finger. J Hand Surg [Am] 1997;22: Gilberts EC, Beekman WH, Stevens HJ, Wereldsma JC: Prospective randomized trial of open versus percutaneous surgery for trigger digits. J Hand Surg [Am] 2001;26: Lorthioir J Jr: Surgical treatment of trigger-finger by a subcutaneous method. J Bone Joint Surg Am 1958; 40: Lyu SR: Closed division of the flexor tendon sheath for trigger finger. J Bone Joint Surg Br 1992;74: Mayer D: Essential Evidence-Based Medicine. Cambridge, England: Cambridge University Press, Taras JS, Raphael JS, Pan WT, Movagharnia F, Sotereanos DG: Corticosteroid injections for trigger digits: Is intrasheath injection necessary? J Hand Surg [Am] 1998;23: Fahey JJ, Bollinger JA: Trigger-finger in adults and children. J Bone Joint Surg Am 1954;36: Wright JG, Swiontkowski MF, Heckman JD: Introducing levels of evidence to the journal. J Bone Joint Surg Am 2003;85: Spindler KP, Kuhn JE, Dunn W, Matthews CE, Harrell FE Jr, Dittus RS: Reading and reviewing the orthopaedic literature: A systematic, evidence-based medicine approach. JAmAcadOrthopSurg2005;13: Greenhalgh T: How to Read a Paper: The Basics of Evidence Based Medicine. London, England: British Medical Journal Publishing Group, Moriya K, Uchiyama T, Kawaji Y: Comparison of the surgical outcomes for trigger finger and trigger thumb: Preliminary results. Hand Surg 2005; 10: Eastwood DM, Gupta KJ, Johnson DP: Percutaneous release of the trigger finger: An office procedure. J Hand Surg [Am] 1992;17: Volume 15, Number 3, March