Comparison of Ultrasound-guided Corticosteroid Injection Versus Corticosteroid Injection and Hydrodissection for Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Comparison of Ultrasound-guided Corticosteroid Injection Versus Corticosteroid Injection and Hydrodissection for Carpal Tunnel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04346030
• Other study ID #: 2016-01-011C
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2020
• Est. completion date: July 2021

Study information

• Verified date: April 2020
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to investigate the effect of ultrasound guided steroid injection versus ultrasound guided steroid hydrodissection to treat patients with CTS.

Description:

This study was a prospective, randomized clinical trial. Patients with CTS were randomly treated with sonographically guided corticosteroid injection (group A); sonographically guided hydrodissection and corticosteroid injection (group B).

Boston Carpal tunnel questionnaire, nerve conduction studies and VAS pain score were performed on initial visit and after 6 weeks and 12 weeks .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

presence of thenar atrophy any accompanying orthopedic or neurologic disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome prior steroid injection into the affected carpal tunnel within 6 months or ever received carpal tunnel surgery history of distal radius fracture pregnancy or lactation regular use of systemic NSAIDs ,corticosteroids or diuretics known allergy to corticosteroids and local anesthetics. impaired cognitive function

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Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Drug:
• Triamcinolone Acetonide
ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS
• lidocaine hydrochloride
ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS
• normal saline
ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS

Locations

Country	Name	City	State
Taiwan	Taipei veteran 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	change from baseline in the scores on Boston Carpal tunnel Questionnaire (BQ)	The BQ was interviewed-administered to assess the severity of symptoms and functional status	0, 6, 12 weeks.
Secondary	change from baseline in self reported pain intensity	patient were asked to indicate the intensity of their average level of pain for the wrist-hand region, using an 11-point scale, ranging from 0 to 10 (worst pain imaginable)	0, 6, 12 weeks
Secondary	change from baseline in 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	0, 6, 12 weeks
Secondary	Change from Baseline in 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.	0, 6, 12 weeks