Splinting After Mini-Open Carpal Tunnel Release

Carpal Tunnel Syndrome Clinical Trial

Official title:

A Prospective, Randomized Controlled Study of Splinting After Mini-Open Carpal Tunnel Release

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02885701
• Other study ID #: FWA00009558
• Status: Completed
• Phase: N/A
• First received: August 22, 2016
• Last updated: August 25, 2016
• Start date: December 2010
• Est. completion date: January 2015

Study information

• Verified date: August 2016
• Source: OrthoIllinois
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if any difference exists among 3 different postoperative splinting regimens- no splint, removable splint, and plaster non-removable splint- following mini-open carpal tunnel release (CTR) surgery.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Anthony L. Logli	University of Illinois at Chicago

References & Publications (18)

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. — View Citation

Bury TF, Akelman E, Weiss AP. Prospective, randomized trial of splinting after carpal tunnel release. Ann Plast Surg. 1995 Jul;35(1):19-22. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Jessurun W, Hillen B, Huffstadt AJ. Carpal tunnel release; postoperative care. Handchir Mikrochir Plast Chir. 1988 Jan;20(1):39-40. — View Citation

Keilani MY, Crevenna R, Fialka-Moser V. [Postoperative rehabilitation of patients with carpal tunnel syndrome]. Wien Med Wochenschr. 2002;152(17-18):479-80. Review. German. — View Citation

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. — View Citation

Martins RS, Siqueira MG, Simplício H. Wrist immobilization after carpal tunnel release: a prospective study. Arq Neuropsiquiatr. 2006 Sep;64(3A):596-9. — View Citation

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. — View Citation

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. — View Citation

Patterson JD, Simmons BP. Outcomes assessment in carpal tunnel syndrome. Hand Clin. 2002 May;18(2):359-63, viii. Review. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2016;2:CD004158. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	QuickDASH	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	No
Other	QuickDASH	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	No
Other	QuickDASH	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	No
Other	QuickDASH	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	No
Other	Levine-Katz Functional Status Scale (FSS)	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	No
Other	Levine-Katz Functional Status Scale (FSS)	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	No
Other	Levine-Katz Functional Status Scale (FSS)	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	No
Other	Levine-Katz Functional Status Scale (FSS)	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	No
Other	Levine-Katz Functional Status Scale (FSS)	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	No
Other	Levine-Katz Symptom Severity Scale (SSS)	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	No
Other	Levine-Katz Symptom Severity Scale (SSS)	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	No
Other	Levine-Katz Symptom Severity Scale (SSS)	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	No
Other	Levine-Katz Symptom Severity Scale (SSS)	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	No
Other	Numerical Pain Rating Scale	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	No
Other	Numerical Pain Rating Scale	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	No
Other	Numerical Pain Rating Scale	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	No
Other	Numerical Pain Rating Scale	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	No
Other	Grip Strength	Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.	6 weeks postoperatively	No
Other	Grip Strength	Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.	3 months postoperatively	No
Other	Grip Strength	Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.	6 months postoperatively	No
Other	Grip Strength	Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.	12 months postoperatively	No
Other	Wrist Flexion		6 weeks postoperatively	No
Other	Wrist Flexion		3 months postoperatively	No
Other	Wrist Flexion		6 months postoperatively	No
Other	Wrist Flexion		12 months postoperatively	No
Other	Wrist Extension		10-14 days postoperatively	No
Other	Wrist Extension		6 weeks postoperatively	No
Other	Wrist Extension		3 months postoperatively	No
Other	Wrist Extension		6 months postoperatively	No
Other	Wrist Extension		12 months postoperatively	No
Other	Lateral Pinch Strength	Lateral pinch strength was taken with a Preston Pinch Gauge.	6 weeks postoperatively	No
Other	Lateral Pinch Strength	Lateral pinch strength was taken with a Preston Pinch Gauge.	3 months postoperatively	No
Other	Lateral Pinch Strength	Lateral pinch strength was taken with a Preston Pinch Gauge.	6 months postoperatively	No
Other	Lateral Pinch Strength	Lateral pinch strength was taken with a Preston Pinch Gauge.	12 months postoperatively	No
Other	Complications	Complications were observed for and recorded throughout the study.	6 weeks postoperatively	No
Other	Complications	Complications were observed for and recorded throughout the study.	3 months postoperatively	No
Other	Complications	Complications were observed for and recorded throughout the study.	6 months postoperatively	No
Other	Complications	Complications were observed for and recorded throughout the study.	12 months postoperatively	No
Primary	QuickDASH	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	No
Primary	Levine-Katz Symptom Severity Scale (SSS)	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	No
Primary	Numerical Pain Rating Scale	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	No
Primary	Grip Strength	Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.	10-14 days postoperatively	No
Primary	Wrist Flexion		10-14 days postoperatively	No
Primary	Lateral Pinch Strength	Lateral pinch strength was taken with a Preston Pinch Gauge.	10-14 days postoperatively	No
Secondary	Demographic Information	Sex, age, BMI, Smoking Status, Hand Dominance, Workers' Compensation Status	Preoperatively	No
Secondary	Complications	Complications were observed for and recorded throughout the study.	10-14 days postoperatively	No