- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02885701
Splinting After Mini-Open Carpal Tunnel Release
A Prospective, Randomized Controlled Study of Splinting After Mini-Open Carpal Tunnel Release
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
We sought to determine if any significant difference in patient-reported or clinical outcomes existed among 3 different postoperative splinting regimens- no splint, removable splint, and plaster non-removable splint- following mini-open carpal tunnel release (CTR) surgery for symptomatic, isolated, nerve conduction study positive carpal tunnel syndrome (CTS).
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients were required to have failed conservative treatment for symptomatic, isolated, nerve conduction study positive CTS.
Exclusion Criteria:
- Exclusion criteria omitted patients who presented with acute onset CTS, concomitant peripheral neuropathy, metabolic disease, postoperative recurring CTS, or who required another operative procedure during carpal tunnel release.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Experimental: 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.
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
QuickDASH
Time Frame: 10-14 days postoperatively
|
The Quick Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure was designed in 1998 with the goal of providing a more accurate depiction of the everyday symptoms and handicaps exclusively experienced by a patient with an upper extremity musculoskeletal condition.
Designed as a patient-completed questionnaire, the DASH Outcome Measure can be administered multiple times throughout patient care to measure changes in function and symptoms over time
|
10-14 days postoperatively
|
Levine-Katz Symptom Severity Scale (SSS)
Time Frame: 10-14 days postoperatively
|
The Levine-Katz Symptom Severity Scale (SSS) assesses pain, weakness, and sensation with 11 questions the patient rates on a 5-point scale with 5 indicating the most difficult; the average score is reported.
|
10-14 days postoperatively
|
Numerical Pain Rating Scale
Time Frame: 10-14 days postoperatively
|
Patients are asked to describe their level of pain intensity over the last 24 hours.
The pain scale anchor points 0 and 10 correspond to no pain and worst imaginable pain, respectively.
The NPRS can be used multiple times throughout patient care, but has the greatest value in describing post-operative pain-related morbidity.
|
10-14 days postoperatively
|
Grip Strength
Time Frame: 10-14 days postoperatively
|
Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.
|
10-14 days postoperatively
|
Wrist Flexion
Time Frame: 10-14 days postoperatively
|
10-14 days postoperatively
|
|
Lateral Pinch Strength
Time Frame: 10-14 days postoperatively
|
Lateral pinch strength was taken with a Preston Pinch Gauge.
|
10-14 days postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographic Information
Time Frame: Preoperatively
|
Sex, age, BMI, Smoking Status, Hand Dominance, Workers' Compensation Status
|
Preoperatively
|
Complications
Time Frame: 10-14 days postoperatively
|
Complications were observed for and recorded throughout the study.
|
10-14 days postoperatively
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
QuickDASH
Time Frame: 6 weeks postoperatively
|
The Quick Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure was designed in 1998 with the goal of providing a more accurate depiction of the everyday symptoms and handicaps exclusively experienced by a patient with an upper extremity musculoskeletal condition.
Designed as a patient-completed questionnaire, the DASH Outcome Measure can be administered multiple times throughout patient care to measure changes in function and symptoms over time
|
6 weeks postoperatively
|
QuickDASH
Time Frame: 3 months postoperatively
|
The Quick Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure was designed in 1998 with the goal of providing a more accurate depiction of the everyday symptoms and handicaps exclusively experienced by a patient with an upper extremity musculoskeletal condition.
Designed as a patient-completed questionnaire, the DASH Outcome Measure can be administered multiple times throughout patient care to measure changes in function and symptoms over time
|
3 months postoperatively
|
QuickDASH
Time Frame: 6 months postoperatively
|
The Quick Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure was designed in 1998 with the goal of providing a more accurate depiction of the everyday symptoms and handicaps exclusively experienced by a patient with an upper extremity musculoskeletal condition.
Designed as a patient-completed questionnaire, the DASH Outcome Measure can be administered multiple times throughout patient care to measure changes in function and symptoms over time
|
6 months postoperatively
|
QuickDASH
Time Frame: 12 months postoperatively
|
The Quick Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure was designed in 1998 with the goal of providing a more accurate depiction of the everyday symptoms and handicaps exclusively experienced by a patient with an upper extremity musculoskeletal condition.
Designed as a patient-completed questionnaire, the DASH Outcome Measure can be administered multiple times throughout patient care to measure changes in function and symptoms over time
|
12 months postoperatively
|
Levine-Katz Functional Status Scale (FSS)
Time Frame: 10-14 days postoperatively
|
The Levine-Katz Functional Status Scale (FSS) has 8 questions self-rated on a 5-point scale on difficulty with 5 meaning so difficult patient is unable to perform the function.
|
10-14 days postoperatively
|
Levine-Katz Functional Status Scale (FSS)
Time Frame: 6 weeks postoperatively
|
The Levine-Katz Functional Status Scale (FSS) has 8 questions self-rated on a 5-point scale on difficulty with 5 meaning so difficult patient is unable to perform the function.
|
6 weeks postoperatively
|
Levine-Katz Functional Status Scale (FSS)
Time Frame: 3 months postoperatively
|
The Levine-Katz Functional Status Scale (FSS) has 8 questions self-rated on a 5-point scale on difficulty with 5 meaning so difficult patient is unable to perform the function.
|
3 months postoperatively
|
Levine-Katz Functional Status Scale (FSS)
Time Frame: 6 months postoperatively
|
The Levine-Katz Functional Status Scale (FSS) has 8 questions self-rated on a 5-point scale on difficulty with 5 meaning so difficult patient is unable to perform the function.
|
6 months postoperatively
|
Levine-Katz Functional Status Scale (FSS)
Time Frame: 12 months postoperatively
|
The Levine-Katz Functional Status Scale (FSS) has 8 questions self-rated on a 5-point scale on difficulty with 5 meaning so difficult patient is unable to perform the function.
|
12 months postoperatively
|
Levine-Katz Symptom Severity Scale (SSS)
Time Frame: 6 weeks postoperatively
|
The Levine-Katz Symptom Severity Scale (SSS) assesses pain, weakness, and sensation with 11 questions the patient rates on a 5-point scale with 5 indicating the most difficult; the average score is reported.
|
6 weeks postoperatively
|
Levine-Katz Symptom Severity Scale (SSS)
Time Frame: 3 months postoperatively
|
The Levine-Katz Symptom Severity Scale (SSS) assesses pain, weakness, and sensation with 11 questions the patient rates on a 5-point scale with 5 indicating the most difficult; the average score is reported.
|
3 months postoperatively
|
Levine-Katz Symptom Severity Scale (SSS)
Time Frame: 6 months postoperatively
|
The Levine-Katz Symptom Severity Scale (SSS) assesses pain, weakness, and sensation with 11 questions the patient rates on a 5-point scale with 5 indicating the most difficult; the average score is reported.
|
6 months postoperatively
|
Levine-Katz Symptom Severity Scale (SSS)
Time Frame: 12 months postoperatively
|
The Levine-Katz Symptom Severity Scale (SSS) assesses pain, weakness, and sensation with 11 questions the patient rates on a 5-point scale with 5 indicating the most difficult; the average score is reported.
|
12 months postoperatively
|
Numerical Pain Rating Scale
Time Frame: 6 weeks postoperatively
|
Patients are asked to describe their level of pain intensity over the last 24 hours.
The pain scale anchor points 0 and 10 correspond to no pain and worst imaginable pain, respectively.
The NPRS can be used multiple times throughout patient care, but has the greatest value in describing post-operative pain-related morbidity.
|
6 weeks postoperatively
|
Numerical Pain Rating Scale
Time Frame: 3 months postoperatively
|
Patients are asked to describe their level of pain intensity over the last 24 hours.
The pain scale anchor points 0 and 10 correspond to no pain and worst imaginable pain, respectively.
The NPRS can be used multiple times throughout patient care, but has the greatest value in describing post-operative pain-related morbidity.
|
3 months postoperatively
|
Numerical Pain Rating Scale
Time Frame: 6 months postoperatively
|
Patients are asked to describe their level of pain intensity over the last 24 hours.
The pain scale anchor points 0 and 10 correspond to no pain and worst imaginable pain, respectively.
The NPRS can be used multiple times throughout patient care, but has the greatest value in describing post-operative pain-related morbidity.
|
6 months postoperatively
|
Numerical Pain Rating Scale
Time Frame: 12 months postoperatively
|
Patients are asked to describe their level of pain intensity over the last 24 hours.
The pain scale anchor points 0 and 10 correspond to no pain and worst imaginable pain, respectively.
The NPRS can be used multiple times throughout patient care, but has the greatest value in describing post-operative pain-related morbidity.
|
12 months postoperatively
|
Grip Strength
Time Frame: 6 weeks postoperatively
|
Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.
|
6 weeks postoperatively
|
Grip Strength
Time Frame: 3 months postoperatively
|
Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.
|
3 months postoperatively
|
Grip Strength
Time Frame: 6 months postoperatively
|
Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.
|
6 months postoperatively
|
Grip Strength
Time Frame: 12 months postoperatively
|
Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.
|
12 months postoperatively
|
Wrist Flexion
Time Frame: 6 weeks postoperatively
|
6 weeks postoperatively
|
|
Wrist Flexion
Time Frame: 3 months postoperatively
|
3 months postoperatively
|
|
Wrist Flexion
Time Frame: 6 months postoperatively
|
6 months postoperatively
|
|
Wrist Flexion
Time Frame: 12 months postoperatively
|
12 months postoperatively
|
|
Wrist Extension
Time Frame: 10-14 days postoperatively
|
10-14 days postoperatively
|
|
Wrist Extension
Time Frame: 6 weeks postoperatively
|
6 weeks postoperatively
|
|
Wrist Extension
Time Frame: 3 months postoperatively
|
3 months postoperatively
|
|
Wrist Extension
Time Frame: 6 months postoperatively
|
6 months postoperatively
|
|
Wrist Extension
Time Frame: 12 months postoperatively
|
12 months postoperatively
|
|
Lateral Pinch Strength
Time Frame: 6 weeks postoperatively
|
Lateral pinch strength was taken with a Preston Pinch Gauge.
|
6 weeks postoperatively
|
Lateral Pinch Strength
Time Frame: 3 months postoperatively
|
Lateral pinch strength was taken with a Preston Pinch Gauge.
|
3 months postoperatively
|
Lateral Pinch Strength
Time Frame: 6 months postoperatively
|
Lateral pinch strength was taken with a Preston Pinch Gauge.
|
6 months postoperatively
|
Lateral Pinch Strength
Time Frame: 12 months postoperatively
|
Lateral pinch strength was taken with a Preston Pinch Gauge.
|
12 months postoperatively
|
Complications
Time Frame: 6 weeks postoperatively
|
Complications were observed for and recorded throughout the study.
|
6 weeks postoperatively
|
Complications
Time Frame: 3 months postoperatively
|
Complications were observed for and recorded throughout the study.
|
3 months postoperatively
|
Complications
Time Frame: 6 months postoperatively
|
Complications were observed for and recorded throughout the study.
|
6 months postoperatively
|
Complications
Time Frame: 12 months postoperatively
|
Complications were observed for and recorded throughout the study.
|
12 months postoperatively
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Brian J Bear, MD, OrthoIllinois
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FWA00009558
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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