Clinical trial NCT02747836: Ultrasound Analysis of Human Carpal Tunnel System
Official title: Ultrasound Analysis of Human Carpal Tunnel Synovium
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 120 volunteers without a history of carpal tunnel syndrome and 120 adult patients with carpal tunnel syndrome between the ages of 18 and 85 will be recruited. Patients and volunteers will be age and gender matched

Brief summary: This study evaluates the ability of ultrasound to measure the movement of tendons and nerves within the human carpal tunnel.

Detailed description: The overall goal of this project is to develop a novel ultrasonographic method to characterize the subsynovial connective tissue (SSCT) and detect differences between SSCT, median nerve and tendon motion for the evaluation and diagnosis of patients suspected of having carpal tunnel syndrome (CTS). CTS is usually diagnosed late in its evolution, by measuring electrophysiological changes in median nerve function. Once these changes have occurred, surgery is often the only effective treatment. At an earlier stage of evolution, non-surgical treatment might be more effective. Although ultrasonography and magnetic resonance imaging (MRI) have recently been used to measure changes in median nerve shape in CTS, such approaches also only capture late changes. Thus, a method for detection of CTS that could identify pathology before function or structure of the nerve is compromised could prevent significant morbidity and transition to a permanent neuropathy. One promising opportunity is presented in the subsynovial connective tissue (SSCT), which surrounds the tendons in the carpal tunnel. One of the most characteristic findings in surgically treated patients with CTS is a non-inflammatory fibrosis of the SSCT. Some investigators have suggested that the SSCT may be the cause of the nerve compression in CTS. In our previous work, the investigators have demonstrated differences in the mechanical properties, motion and thickness of the SSCT in patients with CTS compared to normals. More recently, an animal model has been described in which the structural changes in the SSCT have been shown to precede the changes in nerve function.

The investigators have demonstrated in cadaver studies that the normal SSCT can be imaged by ultrasound, and its motion, velocity, and thickness distinguished from that of the nearby tendon and nerve. Here the investigators propose to leverage this work, and study the ability of ultrasound to detect SSCT thickness and motion in individuals with and without CTS. Based on our preliminary research, the investigators formulate the following central hypothesis: An increase in SSCT thickness and changes in sliding velocities of the SSCT with respect to the corresponding tendon are indicative of CTS. In addition, this material property change at SSCT affects median nerve motions and transformations. This is because the SSCT becomes fibrotic in CTS, and the fibrosis alters the normal SSCT-median nerve-tendon functional relationship.

Eligibility criteria: Inclusion Criteria:

* Patients will be selected from among those undergoing diagnostic work up for CTS in the pre-treatment period. CTS diagnosis will be confirmed clinically and by nerve conduction study

Exclusion Criteria:

* The following disorders will be criteria for exclusion:

  * any history of cervical radiculopathy
  * rheumatoid arthritis
  * osteoarthritis
  * degenerative joint disease
  * flexor tendinitis
  * gout hemodialysis
  * sarcoidosis
  * peripheral nerve disease
  * amyloidosis
  * traumatic injuries to the ipsilateral arm

Primary outcomes:
measure: Study the ability of ultrasound to detect differences in SSCT thickness in individuals with and without CTS.
timeFrame: at the time of study enrollment. patients are enrolled only for the purpose of obtaining a single imaging study.
Secondary outcomes:
measure: study the ability to detect differences in median nerve and tendon motion in the transverse plane of individuals with and without carpal tunnel syndrome
timeFrame: at time of enrollment. patients are enrolled only for the purpose of obtaining a single imaging study.
measure: Study the ability of ultrasound to detect differences in SSCT motion in individuals with and without CTS.
timeFrame: at the time of study enrollment. patients are enrolled only for the purpose of obtaining a single imaging study.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References: