Corticosteroid Injection in Carpal Tunnel Syndrome

Comparison of Different Dose of Steroid Injection in Carpal Tunnel Syndrome

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

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Drug: lidocaine hydrochloride; Drug: Triamcinolone Acetonide

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei Veteran General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: low dose steroid; ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine)	Drug: lidocaine hydrochloride; ultrasound-guided injection using 1 ml of 2% lidocaine hydrochloride (Xylocaine); Other Names: lidocaine hydrochloride (Xylocaine); Drug: Triamcinolone Acetonide; ultrasound-guided injection using 1ml of 10 mg (10mg/ml) or 40 mg (40 mg/ml) triamcinolone acetonide (Shincort); Other Names: triamcinolone acetonide 10mg/ml (shincort, YSP, Taiwan)
Active Comparator: comparator; ultrasound-guided steroid injection using 1ml of 40 mg (40mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine)	Drug: lidocaine hydrochloride; ultrasound-guided injection using 1 ml of 2% lidocaine hydrochloride (Xylocaine); Other Names: lidocaine hydrochloride (Xylocaine); Drug: Triamcinolone Acetonide; ultrasound-guided injection using 1ml of 10 mg (10mg/ml) or 40 mg (40 mg/ml) triamcinolone acetonide (Shincort); Other Names: triamcinolone acetonide 10mg/ml (shincort, YSP, Taiwan)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at 6, 12 weeks
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.	at 6, 12 weeks
Change from Baseline in 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.	at 6, 12 weeks
Change from Baseline in self-reported pain intensity	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).	at 6, 12 weeks

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Publications and helpful links

General Publications

• Hsu PC, Liao KK, Lin KP, Chiu JW, Wu PY, Chou CL, Wang NY, Wang JC. Comparison of Corticosteroid Injection Dosages in Mild to Moderate Idiopathic Carpal Tunnel Syndrome: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Nov;101(11):1857-1864. doi: 10.1016/j.apmr.2020.06.018. Epub 2020 Jul 16.

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2017
• Primary Completion (Actual): November 28, 2018
• Study Completion (Actual): December 20, 2018

Study Registration Dates

• First Submitted: March 1, 2017
• First Submitted That Met QC Criteria: March 1, 2017
• First Posted (Actual): March 7, 2017

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 28, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: 2016-07-006A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No