Splinting After Mini-Open Carpal Tunnel Release
- Conditions
- Carpal Tunnel Syndrome
- Registration Number
- NCT02885701
- Lead Sponsor
- Anthony L. Logli
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 249
- Patients were required to have failed conservative treatment for symptomatic, isolated, nerve conduction study positive CTS.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Levine-Katz Symptom Severity Scale (SSS) 10-14 days postoperatively 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.
QuickDASH 10-14 days postoperatively 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
Lateral Pinch Strength 10-14 days postoperatively Lateral pinch strength was taken with a Preston Pinch Gauge.
Grip Strength 10-14 days postoperatively Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.
Numerical Pain Rating Scale 10-14 days postoperatively 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.
Wrist Flexion 10-14 days postoperatively
- Secondary Outcome Measures
Name Time Method Complications 10-14 days postoperatively Complications were observed for and recorded throughout the study.
Demographic Information Preoperatively Sex, age, BMI, Smoking Status, Hand Dominance, Workers' Compensation Status