Sonographic Evaluation of Patients With Carpal Tunnel Syndrome Following Steroid Injection

Carpal Tunnel Syndrome Clinical Trial

Official title:

Sonographic Evaluation of Patients With Carpal Tunnel Syndrome Following Steroid Injection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03132051
• Other study ID #: 2016-07-006A; 2012-05-021A
• Status: Recruiting
• Phase: N/A
• First received: February 16, 2017
• Last updated: April 24, 2017
• Start date: April 2013
• Est. completion date: February 2018

Study information

• Verified date: February 2017
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Jia chi Wang, MD
• Phone: 886-2-28757361
• Email: jcwang0726[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. clinical diagnosis of CTS

2. The diagnosis of CTS was confirmed by electrophysiological tests.

Exclusion Criteria:

1. neurologic disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome

2. history of distal radius fracture

3. pregnancy or lactation

4. regular use of systemic NSAIDs or corticosteroids

5. known allergy to corticosteroids and local anesthetics.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Drug:
• steroid injection
ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide

Locations

Country	Name	City	State
Taiwan	Teipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cross sectional area	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)	12 weeks
Secondary	flattening ratio	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.	2, 6, 12 weeks
Secondary	Boston Carpal Tunnel Questionnaire (BQ)	The BQ was interviewed-administered to assess the severity of symptoms and functional status.	2, 6, 12 weeks
Secondary	Median nerve distal motor latency	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	2, 6, 12 weeks
Secondary	sensory nerve conduction velocity	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.	2, 6, 12 weeks
Secondary	compound muscle action potential amplitude (CMAP)	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.	2, 6, 12 weeks
Secondary	sensory nerve action potential amplitudes.	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.	2, 6, 12 weeks