Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Corticosteroid Injection in Carpal Tunnel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03072290
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Drug: Triamcinolone Acetonide Drug: lidocaine hydrochloride Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Different Dose of Steroid Injection in Carpal Tunnel Syndrome
Actual Study Start Date : February 18, 2017
Actual Primary Completion Date : November 28, 2018
Actual Study Completion Date : December 20, 2018


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: Triamcinolone Acetonide
ultrasound-guided injection using 1ml of 10 mg (10mg/ml) or 40 mg (40 mg/ml) triamcinolone acetonide (Shincort)
Other Name: triamcinolone acetonide 10mg/ml (shincort, YSP, Taiwan)

Drug: lidocaine hydrochloride
ultrasound-guided injection using 1 ml of 2% lidocaine hydrochloride (Xylocaine)
Other Name: lidocaine hydrochloride (Xylocaine)

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: Triamcinolone Acetonide
ultrasound-guided injection using 1ml of 10 mg (10mg/ml) or 40 mg (40 mg/ml) triamcinolone acetonide (Shincort)
Other Name: triamcinolone acetonide 10mg/ml (shincort, YSP, Taiwan)

Drug: lidocaine hydrochloride
ultrasound-guided injection using 1 ml of 2% lidocaine hydrochloride (Xylocaine)
Other Name: lidocaine hydrochloride (Xylocaine)




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


Secondary Outcome Measures :
  1. Change from Baseline in Median nerve distal motor latency [ Time Frame: 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

  2. Change from Baseline in sensory nerve conduction velocity [ Time Frame: 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.

  3. Change from Baseline in compound muscle action potential amplitude (CMAP) [ Time Frame: 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.

  4. Change from Baseline in self-reported pain intensity [ Time Frame: 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072290


Locations
Layout table for location information
Taiwan
Taipei veteran general hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan

Layout table for additonal information
Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03072290     History of Changes
Other Study ID Numbers: 2016-07-006A
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuromuscular Diseases
Lidocaine
Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents