#25 - TITLE: Splinting versus Early Mobilization following Carpal Tunnel Release: A Prospective Randomized Study AUTHORS: Andrew L. Terrono*, Paul G. Feldon**, Hervey L. Kimball***, Caroline R. Triepel****, Teresa A. Roach*****, Bryan H. Swaim*****, Anne H. Fossel******, Elena Losina*******, Jeffrey N. Katz******* *Hand Surgical Associates, New England Baptist Hospital, Boston, MA, USA **Hand Surgical Associates, New England Baptist Hospital, Boston, MA USA, & Caritas St. Elizabeth’s Medical Center, Boston, MA USA & Newton-Wellesley Hospital, Wellesley, MA USA ***Hand Surgical Associates, New England Baptist Hospital, Boston, MA, USA & Caritas St. Elizabeth’s Medical Center, Boston, MA, USA **** The Hand Center, Greenville, SC, USA ****Research Division, New England Baptist Hospital, Boston, MA, USA ******Division of Rheumatology, Immunology and Allergy, Brigham and Women’s Hospital, Boston, MA, USA. *******Orthopedic and Arthritis Center for Outcomes Research, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA USA. ******* Orthopedic and Arthritis Center for Outcomes Research, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA USA INTRODUCTION: Annually 270,0001 carpal tunnel releases are performed in the United States. However, there exists no consensus regarding splinting following carpal tunnel release. Some surgeons prefer not to splint their patients while other surgeons still choose to splint their patients from one to three weeks postoperatively. The current literature provides no consistent guidance on whether patients should be splinted following carpal tunnel release. Despite a lack of evidence showing that splinting is beneficial, splinting following carpal tunnel release remains in wide practice. OBJECTIVE: To evaluate differences in patients splinted for 3 weeks following carpal tunnel release as compared with those treated with early mobilization with regards to pain relief, functional status, return to activities of daily living and to work, scar tenderness, pillar pain, and strength. We hypothesized that: 1). Patients with early mobilization following carpal tunnel release will have significantly less early post-operative pain and pillar pain and will return to work at light and regular duty sooner than patients splinted for three weeks. 2). There will be no difference between early mobilization patients and splinted patients at 6 months with regard to symptom, function, work status or complication rate. In this abstract presentation, we will present the trial results with respect to improvement in symptom severity and functional status in the two randomized groups at six months postoperatively. METHODS: Subjects were selected from a pool of patients with idiopathic carpal tunnel syndrome undergoing carpal tunnel release at both Hand Surgical Associates in Boston, MA and Hand Surgery Center in Greenville, SC. The target sample size was 88. Once a patient was identified as having idiopathic carpal tunnel syndrome the patient was pre-screened. If the patient was eligible and agreed to participate, informed consent was obtained by the operating surgeon. The operating surgeon was blinded to the treatment arm until after the carpal tunnel release was performed. Subjects were seen at 2 week, 6 week, 3 month and 6-month post-operative dates. At these dates the subjects filled out a modified version of the Maine Carpal Tunnel Outcome Questionnaire, which has standardized scales measuring symptom severity and functional status (scores can range from 0-4, 4 = worse). . 1 Cullen, KA, Hall, MJ, Golosinskiy A. Ambulatory Surgery in the United States, 2006. Division of Health Care Statistics. 2009; 11:128. RESULTS: 219 patients were prescreened. 95 patients gave consent to participate for an enrollment rate of 43%. 82 patients completed the study. Nine patients have been lost to followup, while 3 patients withdrew their consent to participate and one patient was terminated from the study. Baseline features and key outcomes are shown in the table. The splinted group had somewhat more females, was younger and had less severe symptoms and functional limitations. Because there were minor baseline differences in age, sex, and baseline symptom severity and functional status, we adjusted for these variables in the analysis of six month outcomes. In these adjusted analyses, the improvement in symptom severity and functional status between the two groups was nearly identical with no statistically or clinically significant differences between groups. Table: Baseline features and six month outcomes in the randomized groups. Baseline Feature Splint Early mobilization % Female 67% 56% Age (mean, sd) 55.0 (14) 59.0 (12). Symptom severity (0-4, 4=worse) 1.8 (0.8) 2.1 (0.7) Functional status (0-4, 4=worse) 1.4 (0.8) 1.6 (0.9) Six Month Outcome Improvement in Symptom severity 1.4 (0.4) 1.5 (0.5) (adjusted mean, sd) Improvement in functional status 1.1 (0.4) 1.0 (0.5) (adjusted mean, sd) CONCLUSION: In this randomized controlled prospective study splinting and early mobilization were associated with similar improvements in symptom severity and functional status six months following limited incision open carpal tunnel release. Further analyses will examine group differences in return to work and activities and complications. CORRESPONDENCE CONTACT INFORMATION: Name: Andrew Teronno, MD E-mail: aterrono@caregroup.harvard.edu Phone: 1. 617. 754.5414 Institution: New England Baptist Hospital PARTICIPATION: Check your preference (double click the box): Poster Presentation