Clinical Trial: Sonographic Evaluation of Patients With Carpal Tunnel Syndrome Following Steroid Injection

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Sonographic Evaluation of Patients With Carpal Tunnel Syndrome Following Steroid Injection

Brief Summary: The objective of this study was to assess sonographic changes of the median nerve after steroid injection for carpal tunnel syndrome.

Detailed Summary: Patients with CTS were recruited. The Boston Questionnaire (BQ) was administered and ultrasonographic and electrophysiological examinations were performed before and at two, six, and 12 weeks after steroid injection. Cross sectional area (CSA) was measured at 2 levels: at the tunnel inlet and in the mid-carpal tunnel. Flattening ratio (FR) was measured only in the mid-carpal tunnel. Correlation analyses between baseline ultrasonography, BQ, and electrophysiological measures were performed.
Sponsor: Taipei Veterans General Hospital, Taiwan

Current Primary Outcome: Cross sectional area [ Time Frame: 12 weeks ]

The CSA of the median nerve was measured at 2 levels: at the carpal tunnel inlet (CSA-I; immediately prior to the proximal margin of the flexor retinaculum) and in the mid-carpal tunnel (CSA-M; at the level of the pisiform bone and scaphoid tubercle)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • flattening ratio [ Time Frame: 2, 6, 12 weeks ]
    The flattening ratio was measured only at the mid-tunnel (FR-M). FR was calculated by dividing the horizontal diameter of the nerve by the vertical diameter.
  • Boston Carpal Tunnel Questionnaire (BQ) [ Time Frame: 2, 6, 12 weeks ]
    The BQ was interviewed-administered to assess the severity of symptoms and functional status.
  • Median nerve distal motor latency [ Time Frame: 2, 6, 12 weeks ]
    the CMAPs were obtained via surface electrodes placed on the abductor pollicis brevis muscle. The active recording electrode was placed on the muscle belly, and the reference electrode was placed on the tendon insertion. The median nerve was stimulated 8 cm proximal to the active recording electrode. Distal motor latencies were measured from the onset of stimulus artifact to the onset of the CMAP
  • sensory nerve conduction velocity [ Time Frame: 2, 6, 12 weeks ]
    SNAPs were obtained using an antidromic method and recorded by surface electrodes placed at the proximal and distal interphalangeal joints of the index finger for the median nerve and the same joints of the little finger for the ulnar nerve. The median nerves were stimulated at the wrist at a distance of 14 cm from the wrist to the active electrode. Distal sensory latencies were measured from the onset of the stimulus artifact to the onset of the SNAP. SNCV was calculated dividing the distance of 14 cm by the distal sensory latency.
  • compound muscle action potential amplitude (CMAP) [ Time Frame: 2, 6, 12 weeks ]
    the CMAPs were obtained via surface electrodes placed on the abductor pollicis brevis muscle. The active recording electrode was placed on the muscle belly, and the reference electrode was placed on the tendon insertion. The median nerve was stimulated 8 cm proximal to the active recording electrode. The amplitude of CMAP were measured from baseline to negative peak.
  • sensory nerve action potential amplitudes. [ Time Frame: 2, 6, 12 weeks ]
    SNAPs were obtained using an antidromic method and recorded by surface electrodes placed at the proximal and distal interphalangeal joints of the index finger for the median nerve and the same joints of the little finger for the ulnar nerve. The median nerves were stimulated at the wrist at a distance of 14 cm from the wrist to the active electrode. The amplitude of SNAP were measured from baseline to negative peak.


Original Secondary Outcome: Same as current

Information By: Taipei Veterans General Hospital, Taiwan

Dates:
Date Received: February 16, 2017
Date Started: April 2013
Date Completion: February 2018
Last Updated: April 24, 2017
Last Verified: February 2017