Corticosteroid injection in diabetic patients with trigger finger: A prospective, randomized, controlled double-blinded study

Transcription

1 Washington University School of Meicine igital Open Access Publications Corticosteroi injection in iabetic patients with trigger finger: A prospective, ranomize, controlleouble-bline stuy Keith M. Baumgarten The Orthopeic Institute avi Gerlach Washington University School of Meicine in St. Louis Martin I. Boyer Washington University School of Meicine in St. Louis Follow this an aitional works at: Part of the Meicine an Health Sciences Commons Recommene Citation Baumgarten, Keith M.; Gerlach, avi; an Boyer, Martin I.,,"Corticosteroi injection in iabetic patients with trigger finger: A prospective, ranomize, controlleouble-bline stuy." The Journal of Bone an Joint Surgery.89, (2007). This Open Access Publication is brought to you for free an open access by igital Commons@Becker. It has been accepte for inclusion in Open Access Publications by an authorize aministrator of igital Commons@Becker. For more information, please contact engeszer@wustl.eu.

2 2604 COPYRIGHT Ó 2007 BY THE JOURNAL OF BONE AN JOINT SURGERY, INCORPORATE Corticosteroi Injection in iabetic Patients with Trigger Finger A Prospective, Ranomize, Controlle ouble-bline Stuy By Keith M. Baumgarten, M, avi Gerlach, M, an Martin I. Boyer, M, FRCS Investigation performe at Washington University School of Meicine, St. Louis, Missouri Backgroun: It is generally accepte that the initial treatment for trigger finger is injection of corticosteroi into the flexor tenon sheath. In this stuy, the efficacy of corticosteroi injections for the treatment of trigger finger in patients with iabetes mellitus was evaluate in a prospective, ranomize, controlle, ouble-bline fashion an the efficacy in noniabetic patients was evaluate in a prospective, unbline fashion. Methos: Thirty iabetic patients (thirty-five igits) an twenty-nine noniabetic patients (twenty-nine igits) were enrolle. The noniabetic patients were given corticosteroi injections in an unbline manner. The cohort with iabetes was ranomize into a corticosteroi group (twenty igits) or a placebo group (fifteen igits). Both of these groups were ouble-bline. Aitional injections, surgical intervention, an recurrent symptoms of trigger finger were recore. Treatment success was efine as complete or nearly complete resolution of trigger finger symptoms such that surgical intervention was not require. Results: After one or two injections, twenty-five of the twenty-nine igits in the noniabetic group ha a successful outcome compare with twelve of the nineteen in the iabetic corticosteroi group (p = 0.03) an eight of the fifteen in the iabetic placebo group (p = 0.006). With the numbers stuie, no significant ifference was foun between the iabetic groups. Surgery was performe in three of the twenty-nine igits in the noniabetic group compare with seven of the nineteen in the iabetic corticosteroi group an six of the fifteen in the iabetic placebo group. There was a significant ifference in the prevalence of surgery between the noniabetic group an both the iabetic corticosteroi group an the iabetic placebo group (p = an p = 0.020, respectively). With the numbers stuie, no ifference was foun between the iabetic groups with regar to the persistence of symptoms. Nephropathy an neuropathy were significantly associate with the nee for surgery (p = an p = 0.03, respectively). Conclusions: Corticosteroi injections were significantly more effective in the igits of noniabetic patients than in those of iabetic patients. In patients with iabetes, corticosteroi injections i not ecrease the surgery rate or improve symptom relief compare with the placebo. The use of corticosteroi injections for the treatment of trigger finger may be less effective in patients with systemic manifestations of iabetes mellitus. Level of Evience: Therapeutic Level I. See Instructions to Authors for a complete escription of levels of evience. The prevalence of trigger finger in the general population has been reporte to be 3% 1. It is generally accepte that the initial treatment of choice for trigger finger is an injection of corticosteroi into the affecte flexor tenon sheath 2-6. This treatment has been shown to ecrease local pain, tenerness, an locking as well as to improve grip an function. Since the treatment was first escribe by Howar et al. in , consistent success rates of up to 80% have been reporte 4,5,8. These stuies have also emonstrate that a secon or thir injection may increase success rates to 97%. A isclosure: In support of their research for or preparation of this work, one or more of the authors receive, in any one year, outsie funing or grants in excess of $10,000 from the Orthopaeic Research an Eucation Founation (OREF). Neither they nor a member of their immeiate families receive payments or other benefits or a commitment or agreement to provie such benefits from a commercial entity. No commercial entity pai or irecte, or agree to pay or irect, any benefits to any research fun, founation, ivision, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immeiate families, are affiliate or associate. J Bone Joint Surg Am. 2007;89: oi: /jbjs.g.00230

3 2605 recent prospective stuy emonstrate that 64% of patients treate with a single corticosteroi injection ha relief of symptoms compare with 20% of patients treate with a placebo injection 6. This stuy i not inclue patients with iabetes mellitus; therefore, these finings o not emonstrate whether the clinical course of such patients is ifferent from that of noniabetic patients. Several stuies have emonstrate that the prevalence of trigger finger in patients with iabetes is significantly higher than that in the general population. In one comparative prospective stuy, 23% of patients with insulin-epenent iabetes mellitus an 16% of non-insulin-epenent iabetics were iagnose with a trigger finger compare with 2% of normoglycemic control patients (p < 0.01) 9. In another case-control stuy, the prevalence of trigger finger in iabetic patients was 17%, whereas only 3% of noniabetic patients ha a trigger finger (p < 0.05) 1. Observational stuies have suggeste that corticosteroi injection for the treatment of trigger finger is not as effective in iabetic patients as it is in the general population One retrospective review showe that iabetic patients respone less favorably to corticosteroi injection, with only 50% having relief after one, two, or three injections 10. A secon stuy emonstrate a clinical success rate of only 66% at one year after multiple injections 11. A thir retrospective case-control stuy showe that corticosteroi injection for trigger finger was significantly more effective in noniabetic patients than in iabetic patients (p < ), with rates of symptom resolution of 76% an 49%, respectively (p < ) 12. These stuies, supporte by empiric or retrospective ata, cause one to question the use of corticosteroi injections for the treatment of trigger finger in iabetic patients. The purpose of this ouble-bline, ranomize, placebo-controlle, prospective stuy was to evaluate whether (1) corticosteroi injection into the flexor tenon sheath is as effective in alleviating the symptoms of trigger finger in patients with iabetes mellitus as it is in noniabetic patients, (2) corticosteroi injection into the flexor tenon sheath is more effective than placebo injection for alleviating the symptoms of trigger finger in iabetic patients, an (3) the egree of glycemic control (as etermine by measurement of serum hemoglobin A 1c level at the time of the initial injection) affects the relief of symptoms of trigger finger with corticosteroi injection in iabetic patients. The two null hypotheses of this stuy were (1) a iagnosis of iabetes mellitus oes not change the effectiveness of corticosteroi injection for the treatment of trigger finger, an (2) corticosteroi injection(s) into the flexor tenon sheath have no significant effect on the resolution of trigger finger symptoms in patients with iabetes mellitus. Materials an Methos Inclusion an Exclusion Criteria The stuy subjects were selecte from a consecutive group of patients seen at the offices of four fellowship-traine han surgeons at one institution from March 2003 to July All patients who were oler than eighteen years of age an ha subjective symptoms of pain, catching, or triggering along the A1 pulley, consistent with sterile flexor tenosynovitis, were eligible. These symptoms were confirme with objective finings such as tenerness over the A1 pulley, a palpable noule at the A1 pulley or between the A1 an A2 pulleys, pain along the flexor tenon with resiste flexion or with passive stretch in extension, an reproucible locking, triggering, or catching. Both patients with an those without iabetes mellitus were eligible for inclusion in this stuy. To be inclue in the iabetes cohort, the patient ha to have a iagnosis of either insulin-epenent or non-insulin-epenent iabetes an be uner the care of an internist or enocrinologist prior to his or her initial presentation to us for inclusion. Exclusion criteria for this stuy were (1) previous treatment of the trigger finger with surgical release of the A1 pulley or with corticosteroi injection; (2) an inflammatory or potentially pathologic etiology, such as rheumatoi arthritis, of the trigger finger(s); the patient s unwillingness to consier operative management of the trigger finger (as surgery was one of the en points of this stuy); an (4) an inability to tolerate injections into the flexor sheath or venipuncture for etermination of hemoglobin A 1c levels or previous averse reactions to corticosterois or local anesthetics. All patients who met the criteria were offere enrollment, an fifty-nine (twenty-nine noniabetic an thirty iabetic) patients agree to participate. There were twenty-one men an thirty-eight women. After the stuy rationale was explaine by the treating han surgeon an an informe consent form approve by the human stuies committee at our institution was signe, a stanarize initial stuy interview an examination were performe. ata that were recore for all patients inclue age, haneness, occupation, presence of iabetes, type of iabetes, uration of iabetes, amount an type of insulin use per ay, other systemic iabetic manifestations (retinopathy, neuropathy, or nephropathy), carpal tunnel synrome, upuytren isease, affecte han(s), affecte igit(s), an symptoms. All patients, incluing those without a iagnosis of iabetes, ha bloorawn to etermine the hemoglobin A 1c level at the initiation of the stuy. Ranomization iabetic patients were ranomize into either the corticosteroi or the placebo group by a bline, prestuy rawing of cars labele as either corticosteroi or placebo. All injections were prepare by the stuy coorinator an aministere, by a fellowship-traine han surgeon, in opaque syringes that hi the appearance of the injectate from both the surgeon an the patient. Both investigators (K.M.B. an.g.) responsible for ata analysis were bline to the treatment metho as well. All patients in the noniabetic control arm of the stuy were treate with corticosteroi injection in a nonbline fashion. Injections Patients assigne to the corticosteroi arm were injecte with a mixture of 1.0 ml (6 mg) of betamethasone soium

4 2606 phosphate/acetate solution (Celestone Soluspan) an 0.5 ml (5 mg) of 1% liocaine. Placebo injections consiste of 0.5 ml (5 mg) of 1% liocaine an 1 ml of sterile saline solution. Patients with partial relief or recurrence of symptoms were treate with a secon an/or thir injection with at least three months between injections. These aitional injections all consiste of corticosteroi, even in the placebo group. We thought that it was unethical to continue with placebo treatment if patients ha major, persistent symptoms that require a secon injection. However, the surgeon remaine bline to the contents of the original injection. Follow-up Patients were interviewe an reexamine at six weeks, three months, an one year, or at more frequent intervals if they were having increase or persistent symptoms. Follow-up inclue evaluation of the subjective symptoms an physical finings consistent with trigger finger (objective triggering, tenerness at the A1 pulley, an presence of a painful noule) as well as any complications relate to the treatment. Failure of Treatment If symptoms recurre following a thir injection of corticosteroi or if the patient obtaine no relief from any of the three injections, the patient was offere surgical release of the A1 pulley. Treatment failure was efine as persistence of local pain, tenerness, an locking of the flexor tenon that the patient believe warrante surgical intervention. Treatment success was efine as either complete or nearly complete resolution of local pain, tenerness, an locking of the flexor tenon that obviate the nee for surgical release or another injection into the A1 pulley. The ecision to pursue surgery instea of continuing the injections was subjectively etermine by the patient an the han surgeon on the basis of the egree anuration of symptom relief an the recurrence of symptoms. Power Analysis A prestuy statistical analysis was performe to etermine the number of igits require in each trial group to achieve an alpha value of 0.05 (egree of significance) an a power of 0.8 (a beta value of 0.2). If the proportion of iabetic cases treate with corticosterois that eventually unergo surgery is approximately 0.5, as reporte by Griggs et al. 10, an the proportion of untreate cases that eventually unergo surgery is 1.0, as reporte by Murphy et al. 6, a minimum sample size of approximately seventeen igits in each group (iabetic corticosteroi, iabetic placebo, an noniabetic), for a total sample size of fifty-one igits, is require to achieve the state power per group. These cohort sizes are base on an assumeifference in population means of 0.5, a within-group stanar eviation of 0.5, an approximately equal numbers of stuy participants in each group. The stuy was powere sufficiently to emonstrate (1) at least a 50% ifference between the results of corticosteroi injection an those of placebo injection among iabetic igits an (2) at least a 50% ifference between iabetic igits an noniabetic igits with regar to symptom resolution resulting from corticosteroi injection. ata Analysis An intention-to-treat analysis was performe. Accoring to the principles of this analysis, igits in the placebo group that receive aitional injections that inclue corticosteroi were analyze within the placebo group. Analysis of variance was use to compare continuous ata, an the chi-square test was use to compare iscrete ata. Survival analysis was performe with use of proportional hazars regression techniques. All analyses were two-taile, an a = 0.05 was use to etermine significance. Results emographic Characteristics Fifty-nine patients were initially enrolle in the stuy. Twenty-nine patients (twenty-nine igits) i not have iabetes mellitus an thus serve as the control subjects. Thirty patients ha a prior iagnosis of iabetes mellitus; fourteen of them (fifteen igits) were ranomize into the placebo group an seventeen (twenty igits), into the corticosteroi group. One patient with involvement of two igits was ranomize into both groups, with one igit assigne to the iabetic placebo group an one assigne to the iabetic corticosteroi group. Three igits crosse over from the iabetic placebo group to the iabetic corticosteroi group. One receive one corticosteroi injection, one receive two corticosteroi injections, an one receive one corticosteroi injection an then unerwent a subsequent surgical release of the A1 pulley. These three igits were kept in the iabetic placebo group for the intention-to-treat ata analysis 13. One patient (one igit) in the iabetic corticosteroi group was lost to follow-up after six weeks; this patient was not inclue in the stuy analysis. There were no significant ifferences between the noniabetic aniabetic patients with regar to age, gener, haneness, affecte han, or affecteigits (p > 0.05). These two groups iiffer significantly with regar to the mean hemoglobin A 1c level (0.059 compare with 0.073; p = ) an the prevalence of nephropathy, retinopathy, neuropathy, an other pathologic conitions involving the han (such as carpal tunnel synrome, upuytren isease, an joint contractures) (p < 0.05). There were no significant ifferences between the iabetic placebo aniabetic corticosteroi groups with regar to age, gener, haneness, affecte han, affecte igits, or hemoglobin A 1c level or the prevalence of insulinepenent iabetes, other haniseases, neuropathy, nephropathy, or retinopathy (Table I). A final follow-up evaluation was performe for fiftyeight patients between thirteen an forty-one months. The mean uration of follow-up (an stanareviation) was 28 ± 7 months for the noniabetic group, 23 ± 9 months for the iabetic corticosteroi group, an 26 ± 10 months for the iabetic placebo group (p > 0.05). Fifty-eight (98%) of the original fifty-nine returne for final follow-up.

5 2607 TABLE I emographic Characteristics Noniabetic Group iabetic Corticosteroi Group* iabetic Placebo Group No. of patients No. of igits Male Female Age 63.1 ± ± ± 9.12 Right-hanominant# Left-hanominant# Right han affecte# Left han affecte# Involveigit# Thumb Inex finger Long finger Ring finger Small finger Hemoglobin A 1c level ** ± ± ± Other hanisease ** Carpal tunnel synrome upuytren isease History of trigger finger in other igits Carpometacarpal osteoarthritis Non-insulin-epenent iabetes mellitus#** Insulin-epenent iabetes mellitus# Nephropathy#** Retinopathy#** Neuropathy#** *One patient (one igit) was lost to follow-up an is not inclue. One male patient (two igits) was ranomize to both the iabetic placebo group an the iabetic corticosteroi group. The values are given as the number of patients. The values are given as the mean an stanareviation. #The values are given as the number of igits. **There was a significant ifference between the noniabetic an iabetic groups (p < 0.05). (There was no significant ifference in any characteristic between the iabetic corticosteroi group an the iabetic placebo group.) Success of Injection Treatment Twenty-two (76%) of the twenty-nine igits in the noniabetic group respone to a single corticosteroi injection. Six igits require a secon injection. After one or two injections, twentyfive (86%) of the twenty-nine igits ha relief of symptoms, obviating the nee for surgical intervention. Eleven of the nineteen igits in the iabetic corticosteroi group respone to a single corticosteroi injection. One igit require a secon injection. After one or two injections, twelve of the nineteen igits ha relief of symptoms, obviating the nee for surgical intervention. Seven of the fifteen igits in the iabetic placebo group respone to a single placebo injection. Three patients (three igits) requeste unblining after the initial placebo injection an subsequently receive a corticosteroi injection (Table II). After one or two injections, eight of the fifteen igits in the iabetic placebo group ha relief of symptoms so that they i not require surgical intervention. One patient (one igit) in the iabetic placebo group receive a secon corticosteroi injection (three injections in total). After one, two, or three injections, nine of the fifteen igits in the iabetic placebo group ha relief of symptoms that obviate the nee for surgery (Fig. 1). The outcomes of the injections in the iabetic corticosteroi group an the iabetic placebo group were similar after both the first (p = 0.52) an secon injections (p = 0.56). There was no significant ifference in the results after the first injection between the noniabetic group an either the iabetic corticosteroi group (p = 0.30) or the iabetic placebo group (p = 0.09). However, there were significant ifferences

6 2608 in the results after the secon injection between the noniabetic group an the iabetic corticosteroi group (p = 0.03) an the iabetic placebo group (p = 0.006). Surgery was performe in three (10%) of the twenty-nine igits in the noniabetic group. (An aitional patient [one igit] requeste surgery, but it ha not been performe by the time of final follow-up.) Seven of the nineteen igits in the iabetic corticosteroi group an six of the fifteen igits in the iabetic placebo group require surgical management (p = an p = 0.020, respectively, for the comparisons with the noniabetic group). With the numbers stuie, there was no significant ifference in the frequency of surgery between the two iabetic groups (p = 0.76). Although many patients were consiere to have ha successful treatment because they avoie surgery, not all of them remaine symptom-free at the time of final follow-up. Twenty of the twenty-six igits that were not treate with surgery in the noniabetic group were asymptomatic at the time of final follow-up compare with ten of the twelve igits without surgery in the iabetic corticosteroi group (p = 0.65) an seven of the nine igits without surgery in the iabetic placebo group (p = 0.96). With the numbers available, there was no significant ifference between the iabetic groups (p = 0.75). In the intention-to-treat analysis, igits that ha ha surgical intervention at the time of final follow-up were con- TABLE II Injections an Surgical Treatment Noniabetic Group iabetic Corticosteroi Group iabetic Placebo Group No. of patients No. of igits No. of crossovers 0/0 0/0 3/3 (patients/igits) No. of igits requiring a 2n injection (corticosteroi) No. of igits requiring a 3r injection (corticosteroi) No. of patients/igits treate with surgery No. of crossovers requiring surgery /3 5/7 6/ siere to have been symptomatic. Twenty of the twenty-nine igits in the noniabetic group were asymptomatic at the time of final follow-up compare with ten of the nineteen igits in the iabetic corticosteroi group (p = 0.25) an seven Fig. 1 Success of nonoperative treatment. *There was a significant ifference between the noniabetic group an the iabetic corticosteroi group (p = 0.03) an the iabetic placebo group (p = 0.006).

7 2609 Fig. 2 Persistence of trigger finger symptoms at the time of final follow-up. *There was a significant ifference in the prevalence of a palpable, painful noule between the noniabetic group an the iabetic corticosteroi group (p = 0.05). #Subjective triggering at the time of follow-up was significantly more prevalent in the iabetic placebo group than in the noniabetic group (p = 0.05). of the fifteen in the iabetic placebo group (p = 0.15). Again, there was no significant ifference between the two iabetic groups (p = 0.73). At the time of final follow-up, there was no ifference between the two iabetic groups with regar to the persistence of trigger finger symptoms, incluing subjective triggering (p = 0.72), objective triggering (p = 0.97), tenerness at the A1 pulley (p = 0.73), an a palpable, painful noule (p = 0.97). There was a significant ifference in the prevalence of a palpable, painful noule between the noniabetic group an the iabetic corticosteroi group (p = 0.05). Subjective triggering at the time of follow-up was more prevalent in the iabetic placebo group than in the noniabetic group (p = 0.05) (Fig. 2). Effect of Hemoglobin A 1c The serum hemoglobin A 1c levels were etermine at the time of the patients initial office visit an consent to enter into the stuy. The mean hemoglobin A 1c level was significantly higher in the iabetic groups (0.073) than in the noniabetic group (0.059) (normal = to 0.060) (p = ). There was no ifference in the initial hemoglobin A 1c levels between the two iabetic groups ( compare with ; p = 0.95). The only significant interaction foun between treatment success an hemoglobin A 1c levels was in the iabetic placebo group. iabetic patients who respone to the placebo injection ha a lower mean hemoglobin A 1c level than those who i not respon to the initial injection an ha a repeat injection (of corticosteroi) or surgical intervention (0.068 compare with 0.076; p = 0.03). Type of iabetes an iabetic Comorbiities There was no significant ifference in the prevalence of surgery (p = 0.55) or the response to the first corticosteroi injection (p = 0.51) between the patients with insulin-epenent iabetes mellitus an those with non-insulin-epenent iabetes mellitus. Patients with iabetic neuropathy (p = 0.03) an those with iabetic nephropathy (p = 0.008) were more likely to unergo surgical intervention. Patients with iabetic nephropathy were less likely to obtain symptom relief after the first injection an thus more likely to require either another injection or surgical intervention (p = 0.04). However, no significant association was foun between treatment outcome an the presence of iabetic retinopathy. Although this stuy emonstrate a significant relationship between nephropathy an neuropathy anecrease efficacy of corticosteroi injection for the treatment of trigger finger, these evaluations shoul be consiere as suggestive because of the small sample sizes.

8 2610 Complications There were no averse events or complications associate with the corticosteroi injections aministereuring this stuy. iscussion We performe a prospective, ranomize stuy to evaluate the efficacy of corticosteroi injection into the flexor tenon sheath for the treatment of trigger finger in both iabetic an noniabetic patients. Our finings confirm that corticosteroi injections are, in general, more effective in noniabetic patients than in iabetic patients, as has been previously shown Specifically, noniabetic patients were significantly more likely to avoi surgery than were iabetics treate with corticosteroi injection aniabetics treate with a placebo (surgical rates, three of twenty-nine compare with seven of nineteen an six of fifteen, respectively). Prospective stuies in the enocrinology literature have implie that if iabetic patients manage their isease aggressively an maintain nearly normal hemoglobin A 1c levels, they will exhibit fewer symptoms of retinopathy, neuropathy, an nephropathy compare with iabetics who have higher hemoglobin A 1c levels 14. We ha hypothesize that poorly controlle iabetes mellitus might be a barrier to effective nonoperative management of trigger finger, since iabetic patients experience trigger finger more often than oes the general population an high bloo glucose levels porten more iabetic-relate complications an comorbiities. This stuy iemonstrate that iabetic patients who respone to the placebo injection ha a significantly lower mean hemoglobin A 1c level than i patients in the iabetic placebo group who ha persistence of symptoms requiring either surgery or a secon injection (crossover to corticosteroi treatment). This fining suggests that patients with lower hemoglobin A 1c levels are more likely to have spontaneous resolution or amelioration of trigger finger symptoms than are patients with poorly controlleiabetes mellitus. Further investigation may eluciate a threshol of glycemic control in iabetic patients, above which nonoperative management of trigger finger may be significantly less effective. We also hypothesize that patients with systemic manifestations of iabetes mellitus woul not respon as well to the corticosteroi injection as woul patients without nephropathy, neuropathy, or retinopathy. Patients with iabetic nephropathy ha a higher prevalence of surgical intervention (p = 0.008) an fewer successful responses to the first corticosteroi injection (p = 0.04). In aition, patients with iabetic neuropathy ha a significantly higher prevalence of surgical intervention (p = 0.03). This suggests that the efficacy of intrasheath corticosteroi injection may be ecrease in patients with systemic manifestations of iabetes. This may be ue to either a longer uration of the iabetes or less stringent glycemic control. Several potential limitations regaring the interpretation of these ata shoul be note. Taras et al. reporte that 17% of corticosteroi injections faile to enter the tenon sheath, with the injectate remaining subcutaneous 15. espite confirmation of a flui wave along the flexor tenon with the injection in all of our subjects, we i not obtain efinitive proof of accurate, intra-sheath injection. However, it has been shown that resolution of trigger finger symptoms following subcutaneous injection is similar to that following injection into the flexor sheath 15. Thus, while it is not impossible that inaccurate injection playe a role in the poor outcomes, it is unlikely. A secon potential limitation of the stuy lies in the statistical analysis of the three patients who ha involvement of multiple igits. None of the noniabetic patients ha involvement of multiple igits, but three patients with iabetes i. One ha involvement of four igits, all of which were treate with a steroi injection; another ha involvement of two igits, both of which receive a placebo injection; an a thir ha involvement of two igits, one of which was treate with a steroi injection an the other of which ha a placebo injection. Because so few patients ha involvement of multiple igits, statistical analysis of this subgroup was not performe, an these igits were by necessity analyze as separate entities. The results of this stuy shoul be interprete in light of the fact that three patients crosse over from the iabetic placebo group to the corticosteroi treatment group. For the purpose of ata analysis, these three crossovers remaine in the iabetic placebo group accoring to the intention-totreat principles 13, in orer to protect the integrity of the initial ranomization process. Two of these patients i not require surgery after corticosteroi treatment, an one i. It is important to note, however, that there was no significant ifference between the iabetic corticosteroi group an the iabetic placebo group with regar to the success of the injection treatment before or after the crossovers occurre. The lack of a proscribe objective criterion for surgical intervention shoul be note. Clinical ecision-making regaring the transition from nonoperative treatment to operative treatment of trigger finger is by necessity subjective an base on a iscussion of risks an benefits between the patient an surgeon. Although the lack of a specific criterion for surgery is a limitation of a scientific stuy, it reprouces the clinical ecision-making process in the treatment of trigger finger. A final limitation of the stuy is that patients for whom one injection faile were not require to have a secon or thir injection prior to consiering surgical intervention. Although aitional injections were offere an may have inee obviate the nee for surgery, we i not believe that it was ethical to withhol surgery if the patient i not want to unergo repeat injection. Although no complications of corticosteroi injection were foun in this stuy, a previous stuy showe transient hyperglycemia after corticosteroi injection into the flexor tenon sheath for the treatment of trigger finger 16.Postinjection bloo glucose levels were not examine in our stuy. In conclusion, given the absence of sie effects in our patients, we recommen corticosteroi injection as a soun, low-risk primary treatment option for trigger finger in iabetic patients irrespective of their glycemic control. However, it

9 2611 shoul be emphasize that the efficacy of corticosteroi injection in iabetic patients is significantly ecrease compare with that in noniabetic patients. In aition, this stuy suggests that patients with systemic iabetic manifestations may have a poorer response to corticosteroi injections for the treatment of trigger finger. n NOTE: The authors thank Richar H. Gelberman, M, Paul R. Manske, M, an Charles A. Golfarb, M, for their assistance with patient recruitment for this stuy, an Paul Thompson, Ph, Washington University epartment of Biostatistics, for his assistance with the statistical analysis. Keith M. Baumgarten, M Sports Meicine an Shouler Surgery Section, The Orthopeic Institute, 810 East 23r Street, Sioux Falls, S aress: Kbaumga@yahoo.com avi Gerlach, M Martin I. Boyer, M, FRCS epartment of Orthopaeic Surgery, Washington University School of Meicine, 660 South Eucli Avenue, Campus Box 8233, St. Louis, MO References 1. Strom L. Trigger finger in iabetes. J Me Soc N J. 1977;74: Freiberg A, Mulhollan RS, Levine R. Nonoperative treatment of trigger fingers an thumbs. J Han Surg [Am]. 1989;14: Marks MR, Gunther SF. Efficacy of cortisone injection in treatment of trigger fingers an thumbs. J Han Surg [Am]. 1989;14: Newport ML, Lane LB, Stuchin SA. Treatment of trigger finger by steroi injection. J Han Surg [Am]. 1990;15: Anerson B, Kaye S. Treatment of flexor tenosynovitis of the han ( trigger finger ) with corticosterois. A prospective stuy of the response to local injection. Arch Intern Me. 1991;151: Murphy, Failla JM, Koniuch MP. Steroi versus placebo injection for trigger finger. J Han Surg [Am]. 1995;20: Howar L Jr, Pratt R, Bunnell S. The use of compoun F (hyrocortone) in operative an non-operative conitions of the han. J Bone Joint Surg Am. 1953;35: Rhoaes CE, Gelberman RH, Manjarris JF. Stenosing tenosynovitis of the fingers an thumb. Results of a prospective trial of steroi injection an splinting. Clin Orthop Relat Res. 1984;190: Chammas M, Bousquet P, Renar E, Poirier JL, Jaffiol C, Allieu Y. upuytren s isease, carpal tunnel synrome, trigger finger, aniabetes mellitus. J Han Surg [Am]. 1995;20: Griggs SM, Weiss AP, Lane LB, Schwenker C, Akelman E, Sachar K. Treatment of trigger finger in patients with iabetes mellitus. J Han Surg [Am]. 1995;20: Sibbitt WL Jr, Eaton RP. Corticosteroi responsive tenosynovitis is a common pathway for limite joint mobility in the iabetic han. J Rheumatol. 1997;24: Stahl S, Kanter Y, Karnielli E. Outcome of trigger finger treatment in iabetes. J iabetes Complications. 1997;11: Bubbar VK, Kreer HJ. The intention-to-treat principle: a primer for the orthopaeic surgeon. J Bone Joint Surg Am. 2006;88: The effect of intensive treatment of iabetes on the evelopment an progression of long-term complications in insulin-epenent iabetes mellitus. The iabetes Control an Complications Trial Research Group. N Engl J Me. 1993;329: Taras JS, Raphael JS, Pan WT, Movagharnia F, Sotereanos G. Corticosteroi injections for trigger igits: is intrasheath injection necessary? J Han Surg [Am]. 1998;23: Wang AA, Hutchinson T. The effect of corticosteroi injection for trigger finger on bloo glucose level in iabetic patients. J Han Surg [Am]. 2006;31: