Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
249 participants
INTERVENTIONAL
2010-12-31
2015-01-31
Brief Summary
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Detailed Description
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A total of 249 patients received a mini-open CTR and were subsequently randomized into 1 of the 3 splinting regimens to be removed at the first postoperative visit 10-14 days later. Patient-reported outcomes included QuickDASH surveys, Levine-Katz Symptom Severity Scale (SSS) and Functional Status Scale (FSS) and Pain at Rest and in Action using a Numerical Pain Rating Scale (NPRS). Clinical outcomes included wrist range of motion (ROM), grip and lateral pinch strengths. All outcomes were evaluated bilaterally at 10-14 days, 6 weeks, 3 months, 6 months and 12 months after surgery. Demographic information was obtained preoperatively and complications were observed for and recorded throughout the study
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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No splint
No Splint
The no splint group received a soft dressing consisting of an occlusive petroleum gauze strip (Xeroform, Mansfield, MA) over the wound, one folded 4x4 gauze, and a single wrap of roll gauze around the hand, and the wrist was placed and secured by a Coban wrap (3M, St. Paul, MN). The dressing permitted wrist and finger motion. Patients were further instructed to remove the dressing at five days and place an adhesive bandage (Band-Aid, Johnson \& Johnson, New Brunswick, NJ) over the incision.
Removable Splint
Removable Splint
The removable splint group received a V-strap Wrist support (Medical Specialties, Inc., Charlotte, NC) placed over the identical soft dressing that was placed on the no splint group. The cock-up wrist splint was designed to keep the wrist fixed in a 20 degree extended wrist position. Patients were instructed to wear the splint for comfort as needed during day and night. While the patient was wearing the cock-up splint, only finger motion was permitted. Wrist motion was permitted when the cock-up splint was removed.
Non-removable Splint
Non-removable Splint
The plaster non-removable splint group received an occlusive petroleum gauze strip placed over the wound, followed by a 4X4 gauze, and a Webril cotton roll wrap (Covidien, Inc., Covidien, Ireland). A 4- inch, 15-layer thick plaster splint was placed across the volar wrist and molded to keep the wrist in approximately 20 degrees of extension allowing full digital range of motion (ROM). The splint was to be kept dry and not removed by the patient.
Interventions
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No Splint
The no splint group received a soft dressing consisting of an occlusive petroleum gauze strip (Xeroform, Mansfield, MA) over the wound, one folded 4x4 gauze, and a single wrap of roll gauze around the hand, and the wrist was placed and secured by a Coban wrap (3M, St. Paul, MN). The dressing permitted wrist and finger motion. Patients were further instructed to remove the dressing at five days and place an adhesive bandage (Band-Aid, Johnson \& Johnson, New Brunswick, NJ) over the incision.
Removable Splint
The removable splint group received a V-strap Wrist support (Medical Specialties, Inc., Charlotte, NC) placed over the identical soft dressing that was placed on the no splint group. The cock-up wrist splint was designed to keep the wrist fixed in a 20 degree extended wrist position. Patients were instructed to wear the splint for comfort as needed during day and night. While the patient was wearing the cock-up splint, only finger motion was permitted. Wrist motion was permitted when the cock-up splint was removed.
Non-removable Splint
The plaster non-removable splint group received an occlusive petroleum gauze strip placed over the wound, followed by a 4X4 gauze, and a Webril cotton roll wrap (Covidien, Inc., Covidien, Ireland). A 4- inch, 15-layer thick plaster splint was placed across the volar wrist and molded to keep the wrist in approximately 20 degrees of extension allowing full digital range of motion (ROM). The splint was to be kept dry and not removed by the patient.
Eligibility Criteria
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Inclusion Criteria
ALL
Yes
Sponsors
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University of Illinois at Chicago
OTHER
Anthony L. Logli
OTHER
Responsible Party
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Anthony L. Logli
Student Doctor
Principal Investigators
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Brian J Bear, MD
Role: STUDY_DIRECTOR
OrthoIllinois
References
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Patterson JD, Simmons BP. Outcomes assessment in carpal tunnel syndrome. Hand Clin. 2002 May;18(2):359-63, viii. doi: 10.1016/s0749-0712(01)00002-6.
Jessurun W, Hillen B, Huffstadt AJ. Carpal tunnel release; postoperative care. Handchir Mikrochir Plast Chir. 1988 Jan;20(1):39-40.
Cook AC, Szabo RM, Birkholz SW, King EF. Early mobilization following carpal tunnel release. A prospective randomized study. J Hand Surg Br. 1995 Apr;20(2):228-30. doi: 10.1016/s0266-7681(05)80057-9.
Bhatia R, Field J, Grote J, Huma H. Does splintage help pain after carpal tunnel release? J Hand Surg Br. 2000 Apr;25(2):150. doi: 10.1054/jhsb.2000.0365.
Bury TF, Akelman E, Weiss AP. Prospective, randomized trial of splinting after carpal tunnel release. Ann Plast Surg. 1995 Jul;35(1):19-22. doi: 10.1097/00000637-199507000-00004.
Finsen V, Andersen K, Russwurm H. No advantage from splinting the wrist after open carpal tunnel release. A randomized study of 82 wrists. Acta Orthop Scand. 1999 Jun;70(3):288-92. doi: 10.3109/17453679908997810.
Martins RS, Siqueira MG, Simplicio H. Wrist immobilization after carpal tunnel release: a prospective study. Arq Neuropsiquiatr. 2006 Sep;64(3A):596-9. doi: 10.1590/s0004-282x2006000400013.
Ritting AW, Leger R, O'Malley MP, Mogielnicki H, Tucker R, Rodner CM. Duration of postoperative dressing after mini-open carpal tunnel release: a prospective, randomized trial. J Hand Surg Am. 2012 Jan;37(1):3-8. doi: 10.1016/j.jhsa.2011.10.011. Epub 2011 Nov 30.
Huisstede BM, Randsdorp MS, Coert JH, Glerum S, van Middelkoop M, Koes BW. Carpal tunnel syndrome. Part II: effectiveness of surgical treatments--a systematic review. Arch Phys Med Rehabil. 2010 Jul;91(7):1005-24. doi: 10.1016/j.apmr.2010.03.023.
Isaac SM, Okoro T, Danial I, Wildin C. Does wrist immobilization following open carpal tunnel release improve functional outcome? A literature review. Curr Rev Musculoskelet Med. 2010 Jul 11;3(1-4):11-7. doi: 10.1007/s12178-010-9060-9.
Keilani MY, Crevenna R, Fialka-Moser V. [Postoperative rehabilitation of patients with carpal tunnel syndrome]. Wien Med Wochenschr. 2002;152(17-18):479-80. doi: 10.1046/j.1563-258x.2002.01137.x. German.
Peters S, Page MJ, Coppieters MW, Ross M, Johnston V. Rehabilitation following carpal tunnel release. Cochrane Database Syst Rev. 2013 Jun 5;(6):CD004158. doi: 10.1002/14651858.CD004158.pub2.
Mathiowetz V, Weber K, Volland G, Kashman N. Reliability and validity of grip and pinch strength evaluations. J Hand Surg Am. 1984 Mar;9(2):222-6. doi: 10.1016/s0363-5023(84)80146-x.
Duncan KH, Lewis RC Jr, Foreman KA, Nordyke MD. Treatment of carpal tunnel syndrome by members of the American Society for Surgery of the Hand: results of a questionnaire. J Hand Surg Am. 1987 May;12(3):384-91. doi: 10.1016/s0363-5023(87)80011-4.
Leinberry CF, Rivlin M, Maltenfort M, Beredjiklian P, Matzon JL, Ilyas AM, Hutchinson DT. Treatment of carpal tunnel syndrome by members of the American Society for Surgery of the Hand: a 25-year perspective. J Hand Surg Am. 2012 Oct;37(10):1997-2003.e3. doi: 10.1016/j.jhsa.2012.07.016.
Shin EK, Bachoura A, Jacoby SM, Chen NC, Osterman AL. Treatment of carpal tunnel syndrome by members of the American Association for Hand Surgery. Hand (N Y). 2012 Dec;7(4):351-6. doi: 10.1007/s11552-012-9455-8.
Munns JJ, Awan HM. Trends in carpal tunnel surgery: an online survey of members of the American Society for Surgery of the Hand. J Hand Surg Am. 2015 Apr;40(4):767-71.e2. doi: 10.1016/j.jhsa.2014.12.046. Epub 2015 Mar 4.
Dziura JD, Post LA, Zhao Q, Fu Z, Peduzzi P. Strategies for dealing with missing data in clinical trials: from design to analysis. Yale J Biol Med. 2013 Sep 20;86(3):343-58. eCollection 2013 Sep.
Other Identifiers
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FWA00009558
Identifier Type: -
Identifier Source: org_study_id