Sonographic Evaluation of Patients With Carpal Tunnel Syndrome Following Steroid Injection

Not Applicable

• Conditions: Carpal Tunnel Syndrome
• Interventions: Drug: steroid injection

• Registration Number: NCT03132051
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2013-04
• Status Verified: 2017-02
• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-04-24
• Last Update Submitted: 2017-04-24
• Study First Posted: 2017-04-27
• Last Update Posted: 2017-04-27
• Primary Completion: 2018-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
steroid injection	steroid injection	ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide

Primary Outcome Measures

Name	Time	Method
Cross sectional area	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)

Secondary Outcome Measures

Name	Time	Method
flattening ratio	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)	2, 6, 12 weeks	The BQ was interviewed-administered to assess the severity of symptoms and functional status.
Median nerve distal motor latency	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	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)	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.	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.

Trial Locations

Locations (1)

Teipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan