A Study to Compare Ultrasound Guided – Incisionless Thread Carpal Tunnel Release Versus Standard Mini-Open Carpal Tunnel Release for the Treatment of Carpal Tunnel Syndrome

Overview

About this study

The purpose of this study is to establish the safety and effectiveness of the ultra-minimally invasive thread carpal tunnel release technique versus the mini-open carpal tunnel release (standard of care).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • A diagnosis of carpal tunnel syndrome (CTS) with symptoms including pain, paresthesia’s, and weakness of the hand in the median nerve distribution for minimum of 3 months.
  • Age 18-70 years old.
  • Persistence of symptoms after 6 weeks of conservative treatment such as splinting, activity modification, and/or injection therapy.
  • Electromyographic evidence of mild, moderate, moderately severe, or severe median nerve neuropathy at the wrist.
  • Ability to complete all follow up appointments.

Exclusion Criteria:

  • Previous CTS surgical release on affected side.
  • Diabetes mellitus.
  • Hypothyroidism.
  • Hand arthritis (rheumatologic or osteoarthritis).
  • Pregnancy.
  • Electromyographic evidence of any condition other than CTS affecting the hand.
  • Workman’s compensation.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Alexander Shin, M.D.

Closed for enrollment

More information

Publications

  • Previous studies have indicated that the thread carpal tunnel release (TCTR) is a safe and effective technique. Through a study on 11 cadaveric wrists, the TCTR procedure was modified and the needle control accuracy was improved to 0.15 to 0.2 mm, which is precise enough to preserve superficial palmar aponeurosis (SupPA), Berrettini branch, and common digital nerves. The aim of the present study was to verify the modified TCTR clinically. Read More on PubMed
  • The thread carpal tunnel release (TCTR) technique has been improved and offers more precise control in dissecting thread placement. The purpose of this cadaveric study was to test the procedure operationally and verify the modified TCTR anatomically. Read More on PubMed
  • This study aims to develop an alternate technique for improving the surgical procedure of carpal tunnel release. Read More on PubMed
  • With advancement in biomechanical and biological research on idiopathic carpal tunnel syndrome, the insight on the pathophysiology of carpal tunnel syndrome has gained much clinical relevance. Open carpal tunnel release is still a gold standard procedure for carpal tunnel syndrome, which has evolved into mini-open procedure with development of new devices. Endoscopic carpal tunnel release has become popular in recent practice of hand surgery with an advantage of early recovery of hand function with minimal morbidity. However, endoscopic carpal tunnel release has its own limitation such as long learning curve with obvious surgical risk reported in the literature. In this review article, various treatment protocols for idiopathic carpal tunnel syndrome are presented with special highlight on endoscopic carpal tunnel release, which is gaining popularity in current practice. Read More on PubMed
  • To investigate the changes, trends, and implications of carpal tunnel release (CTR) surgery within an ambulatory setting over the past decade in the United States. Read More on PubMed
  • To review literature systematically concerning effectiveness of nonsurgical interventions for treating carpal tunnel syndrome (CTS). Read More on PubMed
  • To present an evidence-based overview of the effectiveness of surgical and postsurgical interventions to treat carpal tunnel syndrome (CTS). Read More on PubMed
  • This prospective study evaluates if the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is an adequately responsive outcome measure in carpal tunnel syndrome by comparing it with the disease-specific Boston questionnaire (BQ). To measure responsiveness (sensitivity to clinical change), 57 patients with a clinical diagnosis of carpal tunnel syndrome completed the DASH and BQ preoperatively and again 3 months after open carpal tunnel decompression. A second group of 31 patients completed the questionnaires in the outpatient clinic and again 2 weeks later to assess test-retest reliability. The time to complete all questionnaires was recorded. Responsiveness of the DASH is comparable with the BQ with standardized response means of 0.66, 1.07 and 0.62 for the DASH, BQ-symptoms and BQ-function, respectively. Test-retest data show both questionnaires are reliable. Mean times to complete questionnaires were 6.8minutes (DASH) and 5.6minutes (BQ). This study concludes that the DASH questionnaire is a reliable, responsive and practical outcome instrument in carpal tunnel syndrome. Read More on PubMed
  • The purpose of this cross-sectional study was to evaluate the prevalence and intensity of nerve compression symptoms and to estimate the prevalence of carpal tunnel syndrome (CTS) in the general population. A survey that included the Katz hand diagram, the Carpal Tunnel Instrument (CTI), and the Short Form-36 questionnaire was sent to 1,559 people. A short telephone survey was conducted to a random sample of 110 nonresponders to determine if they were systematically different from the responders. Of the responders 35.1% had a symptom severity (CTI subscale) score of > or =1.5. Of the responders and the nonresponders 23.2% and 14.5%, respectively, reported waking at least once per night with numbness; 37.3% of the responders and 33.6% of the nonresponders experienced pain in the hand at least once per day. As determined by the Katz hand diagrams, 58 (16.3%) of the responders had classic or probable distributions of symptoms (likely to have CTS) and 298 (83.7%) had possible and unlikely distributions. After correcting for nonresponders our lowest possible estimate of CTS prevalence in the general US population is 3.72%, indicating a larger pool of symptomatic people than previously reported. Read More on PubMed
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CLS-20506988

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