Corticosteroid Injection in Carpal Tunnel Syndrome

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Drug: Triamcinolone Acetonide; Drug: lidocaine hydrochloride

• Registration Number: NCT03072290
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Study Start: 2017-02-18
• Study First Submitted: 2017-03-01
• Study First Submitted QC: 2017-03-01
• Study First Posted: 2017-03-07
• Primary Completion: 2018-11-28
• Study Completion: 2018-12-20
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-28
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low dose steroid	Triamcinolone Acetonide	ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine)
low dose steroid	lidocaine hydrochloride	ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine)
comparator	lidocaine hydrochloride	ultrasound-guided steroid injection using 1ml of 40 mg (40mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine)
comparator	Triamcinolone Acetonide	ultrasound-guided steroid injection using 1ml of 40 mg (40mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine)

Primary Outcome Measures

Name	Time	Method
Change from Baseline in the scores on the Boston Carpal Tunnel Questionnaire (BQ).	at 6, 12 weeks	The BQ was interviewed-administered to assess the severity of symptoms and functional status.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Median nerve distal motor latency	at 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
Change from Baseline in sensory nerve conduction velocity	at 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.
Change from Baseline in compound muscle action potential amplitude (CMAP)	at 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.
Change from Baseline in self-reported pain intensity	at 6, 12 weeks	Patients 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).

Trial Locations

Locations (1)

Taipei veteran general hospital; 🇨🇳 Taipei, Taiwan