Clinical Trial: Splinting After Mini-Open Carpal Tunnel Release

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective, Randomized Controlled Study of Splinting After 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 Summary:

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


Sponsor: Anthony L. Logli

Current Primary Outcome:

  • QuickDASH [ Time Frame: 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
  • Levine-Katz Symptom Severity Scale (SSS) [ Time Frame: 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.
  • Numerical Pain Rating Scale [ Time Frame: 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.
  • Grip Strength [ Time Frame: 10-14 days postoperatively ]
    Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.
  • Wrist Flexion [ Time Frame: 10-14 days postoperatively ]
  • Lateral Pinch Strength [ Time Frame: 10-14 days

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Demographic Information [ Time Frame: Preoperatively ]
      Sex, age, BMI, Smoking Status, Hand Dominance, Workers' Compensation Status
    • Complications [ Time Frame: 10-14 days postoperatively ]
      Complications were observed for and recorded throughout the study.


    Original Secondary Outcome: Same as current

    Information By: OrthoIllinois

    Dates:
    Date Received: August 22, 2016
    Date Started: December 2010
    Date Completion:
    Last Updated: August 25, 2016
    Last Verified: August 2016