Clinical trial NCT02885701: 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
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: postoperative dressing
postoperative splint
mini-open carpal tunnel release
Lead sponsor: OrthoIllinois
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
First posted: 2016-08-31
Enrollment: 249
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: QuickDASH
timeFrame: 10-14 days postoperatively
measure: Levine-Katz Symptom Severity Scale (SSS)
timeFrame: 10-14 days postoperatively
measure: Numerical Pain Rating Scale
timeFrame: 10-14 days postoperatively
measure: Grip Strength
timeFrame: 10-14 days postoperatively
measure: Wrist Flexion
timeFrame: 10-14 days postoperatively
measure: Lateral Pinch Strength
timeFrame: 10-14 days postoperatively
Secondary outcomes:
measure: Demographic Information
timeFrame: Preoperatively
measure: Complications
timeFrame: 10-14 days postoperatively
Other outcomes:
measure: QuickDASH
timeFrame: 6 weeks postoperatively
measure: QuickDASH
timeFrame: 3 months postoperatively
measure: QuickDASH
timeFrame: 6 months postoperatively
measure: QuickDASH
timeFrame: 12 months postoperatively
measure: Levine-Katz Functional Status Scale (FSS)
timeFrame: 10-14 days postoperatively
measure: Levine-Katz Functional Status Scale (FSS)
timeFrame: 6 weeks postoperatively
measure: Levine-Katz Functional Status Scale (FSS)
timeFrame: 3 months postoperatively
measure: Levine-Katz Functional Status Scale (FSS)
timeFrame: 6 months postoperatively
measure: Levine-Katz Functional Status Scale (FSS)
timeFrame: 12 months postoperatively
measure: Levine-Katz Symptom Severity Scale (SSS)
timeFrame: 6 weeks postoperatively
measure: Levine-Katz Symptom Severity Scale (SSS)
timeFrame: 3 months postoperatively
measure: Levine-Katz Symptom Severity Scale (SSS)
timeFrame: 6 months postoperatively
measure: Levine-Katz Symptom Severity Scale (SSS)
timeFrame: 12 months postoperatively
measure: Numerical Pain Rating Scale
timeFrame: 6 weeks postoperatively
measure: Numerical Pain Rating Scale
timeFrame: 3 months postoperatively
measure: Numerical Pain Rating Scale
timeFrame: 6 months postoperatively
measure: Numerical Pain Rating Scale
timeFrame: 12 months postoperatively
measure: Grip Strength
timeFrame: 6 weeks postoperatively
measure: Grip Strength
timeFrame: 3 months postoperatively
measure: Grip Strength
timeFrame: 6 months postoperatively
measure: Grip Strength
timeFrame: 12 months postoperatively
measure: Wrist Flexion
timeFrame: 6 weeks postoperatively
measure: Wrist Flexion
timeFrame: 3 months postoperatively
measure: Wrist Flexion
timeFrame: 6 months postoperatively
measure: Wrist Flexion
timeFrame: 12 months postoperatively
measure: Wrist Extension
timeFrame: 10-14 days postoperatively
measure: Wrist Extension
timeFrame: 6 weeks postoperatively
measure: Wrist Extension
timeFrame: 3 months postoperatively
measure: Wrist Extension
timeFrame: 6 months postoperatively
measure: Wrist Extension
timeFrame: 12 months postoperatively
measure: Lateral Pinch Strength
timeFrame: 6 weeks postoperatively
measure: Lateral Pinch Strength
timeFrame: 3 months postoperatively
measure: Lateral Pinch Strength
timeFrame: 6 months postoperatively
measure: Lateral Pinch Strength
timeFrame: 12 months postoperatively
measure: Complications
timeFrame: 6 weeks postoperatively
measure: Complications
timeFrame: 3 months postoperatively
measure: Complications
timeFrame: 6 months postoperatively
measure: Complications
timeFrame: 12 months postoperatively
Locations:
Study officials:
affiliation: OrthoIllinois
name: Brian J Bear, MD
role: STUDY_DIRECTOR
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