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Splinting After Mini-Open Carpal Tunnel Release

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02885701
Enrollment
249
Registered
2016-08-31
Start date
2010-12-31
Completion date
2015-01-31
Last updated
2016-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

Keywords

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

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

Interventions

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.

OTHERRemovable 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.

OTHERNon-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.

Sponsors

University of Illinois at Chicago
CollaboratorOTHER
Anthony L. Logli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
Lateral Pinch Strength10-14 days postoperativelyLateral pinch strength was taken with a Preston Pinch Gauge.
Grip Strength10-14 days postoperativelyGrip strength was taken with a Jamar Dynamometer in the 2nd hand position.
Wrist Flexion10-14 days postoperatively
Levine-Katz Symptom Severity Scale (SSS)10-14 days postoperativelyThe 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.
QuickDASH10-14 days postoperativelyThe 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
Numerical Pain Rating Scale10-14 days postoperativelyPatients 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.

Secondary

MeasureTime frameDescription
Complications10-14 days postoperativelyComplications were observed for and recorded throughout the study.
Demographic InformationPreoperativelySex, age, BMI, Smoking Status, Hand Dominance, Workers' Compensation Status

Other

MeasureTime frameDescription
QuickDASH6 weeks postoperativelyThe 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
Complications6 weeks postoperativelyComplications were observed for and recorded throughout the study.
Levine-Katz Functional Status Scale (FSS)10-14 days postoperativelyThe 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.
Levine-Katz Symptom Severity Scale (SSS)6 weeks postoperativelyThe 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 Scale6 weeks postoperativelyPatients 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 Strength6 weeks postoperativelyGrip strength was taken with a Jamar Dynamometer in the 2nd hand position.
Wrist Flexion6 weeks postoperatively
Wrist Extension10-14 days postoperatively
Lateral Pinch Strength6 weeks postoperativelyLateral pinch strength was taken with a Preston Pinch Gauge.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026