Splinting After Mini-Open Carpal Tunnel Release

NCT02885701 | Completed

• 1 other identifier: FWA00009558
• Study Type: interventional
• Target: 249
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Carpal Tunnel Syndrome

Keywords

postoperative dressing; postoperative splint; mini-open carpal tunnel release

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• Grip Strength

  Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.

  10-14 days postoperatively

• Wrist Flexion

  10-14 days postoperatively

• Lateral Pinch Strength

  Lateral pinch strength was taken with a Preston Pinch Gauge.

  10-14 days postoperatively

Secondary Outcomes (2)

• Demographic Information

  Preoperatively

• Complications

  10-14 days postoperatively

Other Outcomes (38)

• QuickDASH

  6 weeks postoperatively

• QuickDASH

  3 months postoperatively

• QuickDASH

  6 months postoperatively

Study Arms (3)

No splint

EXPERIMENTAL

Other: No Splint

Removable Splint

EXPERIMENTAL

Other: Removable Splint

Non-removable Splint

EXPERIMENTAL

Other: Non-removable Splint

Interventions

No Splint OTHER

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.

No splint

Removable Splint OTHER

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.

Removable Splint

Non-removable Splint OTHER

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.

Non-removable Splint

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients were required to have failed conservative treatment for symptomatic, isolated, nerve conduction study positive CTS.

Sponsors & Collaborators

• Anthony L. Logli: lead
• University of Illinois at Chicago: collaborator

Related Publications (18)

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  PMID: 12371039 BACKGROUND

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  PMID: 7797977 BACKGROUND

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  PMID: 11062571 BACKGROUND

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  PMID: 7574280 BACKGROUND

• 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.

  PMID: 10429608 BACKGROUND

• 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.

  PMID: 17119800 BACKGROUND

• 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.

  PMID: 22133704 BACKGROUND

• 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.

  PMID: 20599039 BACKGROUND

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  PMID: 21063494 BACKGROUND

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  PMID: 12385074 BACKGROUND

• 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.

  PMID: 23740605 BACKGROUND

• 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.

  PMID: 6715829 BACKGROUND

• 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.

  PMID: 3584886 BACKGROUND

• 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.

  PMID: 23021173 BACKGROUND

• 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.

  PMID: 24294152 BACKGROUND

• 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.

  PMID: 25747738 BACKGROUND

• 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.

  PMID: 24058309 RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Brian J Bear, MD

  OrthoIllinois

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Student Doctor

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 31, 2016
• Study Start: December 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: August 31, 2016

Record last verified: 2016-08