Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sonographic Evaluation of Patients With Carpal Tunnel Syndrome Following Steroid Injection

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: NCT03132051
Recruitment Status : Unknown
Verified February 2017 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was:  Recruiting
First Posted : April 27, 2017
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Brief Summary:
The objective of this study was to assess sonographic changes of the median nerve after steroid injection for carpal tunnel syndrome.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Drug: steroid injection Not Applicable

Detailed Description:
Patients with CTS were recruited. The Boston Questionnaire (BQ) was administered and ultrasonographic and electrophysiological examinations were performed before and at two, six, and 12 weeks after steroid injection. Cross sectional area (CSA) was measured at 2 levels: at the tunnel inlet and in the mid-carpal tunnel. Flattening ratio (FR) was measured only in the mid-carpal tunnel. Correlation analyses between baseline ultrasonography, BQ, and electrophysiological measures were performed.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All patients received steroid injection for carpel tunnel syndrome (CTS) and ultrasonographic evaluation before and after steroid injection
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sonographic Evaluation of Patients With Carpal Tunnel Syndrome Following Steroid Injection
Actual Study Start Date : April 2013
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018


Arm Intervention/treatment
Experimental: steroid injection
ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide
Drug: steroid injection
ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide
Other Name: triamcinolone acetonide




Primary Outcome Measures :
  1. Cross sectional area [ Time Frame: 12 weeks ]
    The CSA of the median nerve was measured at 2 levels: at the carpal tunnel inlet (CSA-I; immediately prior to the proximal margin of the flexor retinaculum) and in the mid-carpal tunnel (CSA-M; at the level of the pisiform bone and scaphoid tubercle)


Secondary Outcome Measures :
  1. flattening ratio [ Time Frame: 2, 6, 12 weeks ]
    The flattening ratio was measured only at the mid-tunnel (FR-M). FR was calculated by dividing the horizontal diameter of the nerve by the vertical diameter.

  2. Boston Carpal Tunnel Questionnaire (BQ) [ Time Frame: 2, 6, 12 weeks ]
    The BQ was interviewed-administered to assess the severity of symptoms and functional status.

  3. Median nerve distal motor latency [ Time Frame: 2, 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

  4. sensory nerve conduction velocity [ Time Frame: 2, 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.

  5. compound muscle action potential amplitude (CMAP) [ Time Frame: 2, 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.

  6. sensory nerve action potential amplitudes. [ Time Frame: 2, 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. The amplitude of SNAP were measured from baseline to negative peak.



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 to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. clinical diagnosis of CTS
  2. The diagnosis of CTS was confirmed by electrophysiological tests.

Exclusion Criteria:

  1. neurologic disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome
  2. history of distal radius fracture
  3. pregnancy or lactation
  4. regular use of systemic NSAIDs or corticosteroids
  5. known allergy to corticosteroids and local anesthetics.

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): NCT03132051


Contacts
Layout table for location contacts
Contact: Jia chi Wang, MD 886-2-28757361 jcwang0726@gmail.com

Locations
Layout table for location information
Taiwan
Teipei Veterans General Hospital Recruiting
Taipei, Taiwan
Contact: Jia chi Wang, MD    886-2-28757361      
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Layout table for investigator information
Principal Investigator: Jia chi Wang Taipei Veteran General hospital

Layout table for additonal information
Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03132051     History of Changes
Other Study ID Numbers: 2016-07-006A; 2012-05-021A
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: February 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Taipei Veterans General Hospital, Taiwan:
carpal tunnel syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
Nerve Compression Syndromes
Anti-Inflammatory Agents
Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action