Splinting After Mini-Open Carpal Tunnel Release
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
No Splint
Removable Splint
Non-removable Splint
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring postoperative dressing, postoperative splint, mini-open carpal tunnel release
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
No splint
Removable Splint
Non-removable Splint
Arm Description
Outcomes
Primary Outcome Measures
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
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.
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.
Grip Strength
Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.
Wrist Flexion
Lateral Pinch Strength
Lateral pinch strength was taken with a Preston Pinch Gauge.
Secondary Outcome Measures
Demographic Information
Sex, age, BMI, Smoking Status, Hand Dominance, Workers' Compensation Status
Complications
Complications were observed for and recorded throughout the study.
Full Information
NCT ID
NCT02885701
First Posted
August 22, 2016
Last Updated
August 25, 2016
Sponsor
Anthony L. Logli
Collaborators
University of Illinois at Chicago
1. Study Identification
Unique Protocol Identification Number
NCT02885701
Brief Title
Splinting After Mini-Open Carpal Tunnel Release
Official Title
A Prospective, Randomized Controlled Study of Splinting After Mini-Open Carpal Tunnel Release
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anthony L. Logli
Collaborators
University of Illinois at Chicago
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
postoperative dressing, postoperative splint, mini-open carpal tunnel release
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
249 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No splint
Arm Type
Experimental
Arm Title
Removable Splint
Arm Type
Experimental
Arm Title
Non-removable Splint
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
No Splint
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Removable Splint
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Non-removable Splint
Intervention Description
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.
Primary Outcome Measure Information:
Title
QuickDASH
Description
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
Time Frame
10-14 days postoperatively
Title
Levine-Katz Symptom Severity Scale (SSS)
Description
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.
Time Frame
10-14 days postoperatively
Title
Numerical Pain Rating Scale
Description
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.
Time Frame
10-14 days postoperatively
Title
Grip Strength
Description
Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.
Time Frame
10-14 days postoperatively
Title
Wrist Flexion
Time Frame
10-14 days postoperatively
Title
Lateral Pinch Strength
Description
Lateral pinch strength was taken with a Preston Pinch Gauge.
Time Frame
10-14 days postoperatively
Secondary Outcome Measure Information:
Title
Demographic Information
Description
Sex, age, BMI, Smoking Status, Hand Dominance, Workers' Compensation Status
Time Frame
Preoperatively
Title
Complications
Description
Complications were observed for and recorded throughout the study.
Time Frame
10-14 days postoperatively
Other Pre-specified Outcome Measures:
Title
QuickDASH
Description
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
Time Frame
6 weeks postoperatively
Title
QuickDASH
Description
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
Time Frame
3 months postoperatively
Title
QuickDASH
Description
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
Time Frame
6 months postoperatively
Title
QuickDASH
Description
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
Time Frame
12 months postoperatively
Title
Levine-Katz Functional Status Scale (FSS)
Description
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.
Time Frame
10-14 days postoperatively
Title
Levine-Katz Functional Status Scale (FSS)
Description
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.
Time Frame
6 weeks postoperatively
Title
Levine-Katz Functional Status Scale (FSS)
Description
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.
Time Frame
3 months postoperatively
Title
Levine-Katz Functional Status Scale (FSS)
Description
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.
Time Frame
6 months postoperatively
Title
Levine-Katz Functional Status Scale (FSS)
Description
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.
Time Frame
12 months postoperatively
Title
Levine-Katz Symptom Severity Scale (SSS)
Description
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.
Time Frame
6 weeks postoperatively
Title
Levine-Katz Symptom Severity Scale (SSS)
Description
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.
Time Frame
3 months postoperatively
Title
Levine-Katz Symptom Severity Scale (SSS)
Description
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.
Time Frame
6 months postoperatively
Title
Levine-Katz Symptom Severity Scale (SSS)
Description
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.
Time Frame
12 months postoperatively
Title
Numerical Pain Rating Scale
Description
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.
Time Frame
6 weeks postoperatively
Title
Numerical Pain Rating Scale
Description
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.
Time Frame
3 months postoperatively
Title
Numerical Pain Rating Scale
Description
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.
Time Frame
6 months postoperatively
Title
Numerical Pain Rating Scale
Description
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.
Time Frame
12 months postoperatively
Title
Grip Strength
Description
Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.
Time Frame
6 weeks postoperatively
Title
Grip Strength
Description
Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.
Time Frame
3 months postoperatively
Title
Grip Strength
Description
Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.
Time Frame
6 months postoperatively
Title
Grip Strength
Description
Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.
Time Frame
12 months postoperatively
Title
Wrist Flexion
Time Frame
6 weeks postoperatively
Title
Wrist Flexion
Time Frame
3 months postoperatively
Title
Wrist Flexion
Time Frame
6 months postoperatively
Title
Wrist Flexion
Time Frame
12 months postoperatively
Title
Wrist Extension
Time Frame
10-14 days postoperatively
Title
Wrist Extension
Time Frame
6 weeks postoperatively
Title
Wrist Extension
Time Frame
3 months postoperatively
Title
Wrist Extension
Time Frame
6 months postoperatively
Title
Wrist Extension
Time Frame
12 months postoperatively
Title
Lateral Pinch Strength
Description
Lateral pinch strength was taken with a Preston Pinch Gauge.
Time Frame
6 weeks postoperatively
Title
Lateral Pinch Strength
Description
Lateral pinch strength was taken with a Preston Pinch Gauge.
Time Frame
3 months postoperatively
Title
Lateral Pinch Strength
Description
Lateral pinch strength was taken with a Preston Pinch Gauge.
Time Frame
6 months postoperatively
Title
Lateral Pinch Strength
Description
Lateral pinch strength was taken with a Preston Pinch Gauge.
Time Frame
12 months postoperatively
Title
Complications
Description
Complications were observed for and recorded throughout the study.
Time Frame
6 weeks postoperatively
Title
Complications
Description
Complications were observed for and recorded throughout the study.
Time Frame
3 months postoperatively
Title
Complications
Description
Complications were observed for and recorded throughout the study.
Time Frame
6 months postoperatively
Title
Complications
Description
Complications were observed for and recorded throughout the study.
Time Frame
12 months postoperatively
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian J Bear, MD
Organizational Affiliation
OrthoIllinois
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Splinting After Mini-Open Carpal Tunnel Release
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