Back to resultsSonographic Evaluation of Patients With Carpal Tunnel Syndrome Following Steroid Injection
Primary Purpose
Carpal Tunnel Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
steroid injection
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring carpal tunnel syndrome
Eligibility Criteria
Inclusion Criteria:
- clinical diagnosis of CTS
- The diagnosis of CTS was confirmed by electrophysiological tests.
Exclusion Criteria:
- neurologic disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome
- history of distal radius fracture
- pregnancy or lactation
- regular use of systemic NSAIDs or corticosteroids
- known allergy to corticosteroids and local anesthetics.
Sites / Locations
- Teipei Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
steroid injection
Arm Description
ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide
Outcomes
Primary Outcome Measures
Cross sectional area
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
flattening ratio
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.
Boston Carpal Tunnel Questionnaire (BQ)
The BQ was interviewed-administered to assess the severity of symptoms and functional status.
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
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.
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.
sensory nerve action potential amplitudes.
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.
Full Information
NCT ID
NCT03132051
First Posted
February 16, 2017
Last Updated
April 24, 2017
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT03132051
Brief Title
Sonographic Evaluation of Patients With Carpal Tunnel Syndrome Following Steroid Injection
Official Title
Sonographic Evaluation of Patients With Carpal Tunnel Syndrome Following Steroid Injection
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (Actual)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
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
5. Study Description
Brief Summary
The objective of this study was to assess sonographic changes of the median nerve after steroid injection for carpal tunnel syndrome.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
carpal tunnel syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients received steroid injection for carpel tunnel syndrome (CTS) and ultrasonographic evaluation before and after steroid injection
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
steroid injection
Arm Type
Experimental
Arm Description
ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide
Intervention Type
Drug
Intervention Name(s)
steroid injection
Other Intervention Name(s)
triamcinolone acetonide
Intervention Description
ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide
Primary Outcome Measure Information:
Title
Cross sectional area
Description
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)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
flattening ratio
Description
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.
Time Frame
2, 6, 12 weeks
Title
Boston Carpal Tunnel Questionnaire (BQ)
Description
The BQ was interviewed-administered to assess the severity of symptoms and functional status.
Time Frame
2, 6, 12 weeks
Title
Median nerve distal motor latency
Description
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
Time Frame
2, 6, 12 weeks
Title
sensory nerve conduction velocity
Description
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.
Time Frame
2, 6, 12 weeks
Title
compound muscle action potential amplitude (CMAP)
Description
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.
Time Frame
2, 6, 12 weeks
Title
sensory nerve action potential amplitudes.
Description
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.
Time Frame
2, 6, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of CTS
The diagnosis of CTS was confirmed by electrophysiological tests.
Exclusion Criteria:
neurologic disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome
history of distal radius fracture
pregnancy or lactation
regular use of systemic NSAIDs or corticosteroids
known allergy to corticosteroids and local anesthetics.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia chi Wang, MD
Phone
886-2-28757361
Email
jcwang0726@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia chi Wang
Organizational Affiliation
Taipei Veteran General hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Teipei Veterans General Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia chi Wang, MD
Phone
886-2-28757361
12. IPD Sharing Statement
Learn more about this trial
Sonographic Evaluation of Patients With Carpal Tunnel Syndrome Following Steroid Injection
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