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Corticosteroid Injection in Carpal Tunnel Syndrome

Comparison of Different Dose of Steroid Injection in Carpal Tunnel Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03072290
Enrollment
56
Registered
2017-03-07
Start date
2017-02-18
Completion date
2018-12-20
Last updated
2019-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

Brief summary

To compare the effectiveness of different dose of ultrasound guided steroid injection in patient with carpal tunnel syndrome, by using clinical and electrophysiological parameters in evlauation

Detailed description

This is a prospective, single-blinded randomized controlled study to determine the efficacy of low dose corticosteroid in patient with CTS. Patient with CTS were randomly assigned to group receiving ultrasound guided steroid injection with different dosage of triamcinolone acetonide (Shincort) mixed, 1ml 10mg (10mg/ml) or 1ml 40mg (40mg/ml) with 1 ml of 2% lidocaine hydrochloride. The follow up at 6 and 12 weeks includes Boston Carpal Tunnel Questionnaire, nerve conductive study and VAS pain score.

Interventions

DRUGTriamcinolone Acetonide

ultrasound-guided injection using 1ml of 10 mg (10mg/ml) or 40 mg (40 mg/ml) triamcinolone acetonide (Shincort)

DRUGlidocaine hydrochloride

ultrasound-guided injection using 1 ml of 2% lidocaine hydrochloride (Xylocaine)

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* presence of thenar atrophy * existence of disorders such as hypothyroidism, diabetes mellitus, chronic renal failure, or rheumatoid arthritis; 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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in the scores on the Boston Carpal Tunnel Questionnaire (BQ).at 6, 12 weeksThe BQ was interviewed-administered to assess the severity of symptoms and functional status.

Secondary

MeasureTime frameDescription
Change from Baseline in Median nerve distal motor latencyat 6, 12 weeksthe 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
Change from Baseline in sensory nerve conduction velocityat 6, 12 weeksSNAPs 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.
Change from Baseline in compound muscle action potential amplitude (CMAP)at 6, 12 weeksthe 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.
Change from Baseline in self-reported pain intensityat 6, 12 weeksPatients were asked to indicate the intensity of their average level of pain for the wrist-hand region within the past 1 week, using an 11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable).

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026