Back to resultsCorticosteroid Injection in Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Triamcinolone Acetonide
lidocaine hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
Eligibility 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
Sites / Locations
- Taipei veteran general hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
low dose steroid
comparator
Arm Description
ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine)
ultrasound-guided steroid injection using 1ml of 40 mg (40mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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.
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).
Full Information
NCT ID
NCT03072290
First Posted
March 1, 2017
Last Updated
July 28, 2019
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT03072290
Brief Title
Corticosteroid Injection in Carpal Tunnel Syndrome
Official Title
Comparison of Different Dose of Steroid Injection in Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 18, 2017 (Actual)
Primary Completion Date
November 28, 2018 (Actual)
Study Completion Date
December 20, 2018 (Actual)
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low dose steroid
Arm Type
Experimental
Arm Description
ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine)
Arm Title
comparator
Arm Type
Active Comparator
Arm Description
ultrasound-guided steroid injection using 1ml of 40 mg (40mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine)
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Other Intervention Name(s)
triamcinolone acetonide 10mg/ml (shincort, YSP, Taiwan)
Intervention Description
ultrasound-guided injection using 1ml of 10 mg (10mg/ml) or 40 mg (40 mg/ml) triamcinolone acetonide (Shincort)
Intervention Type
Drug
Intervention Name(s)
lidocaine hydrochloride
Other Intervention Name(s)
lidocaine hydrochloride (Xylocaine)
Intervention Description
ultrasound-guided injection using 1 ml of 2% lidocaine hydrochloride (Xylocaine)
Primary Outcome Measure Information:
Title
Change from Baseline in the scores on the Boston Carpal Tunnel Questionnaire (BQ).
Description
The BQ was interviewed-administered to assess the severity of symptoms and functional status.
Time Frame
at 6, 12 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in 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
at 6, 12 weeks
Title
Change from Baseline in 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
at 6, 12 weeks
Title
Change from Baseline in 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
at 6, 12 weeks
Title
Change from Baseline in self-reported pain intensity
Description
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).
Time Frame
at 6, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Taipei veteran general hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
32682938
Citation
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.
Results Reference
derived
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Corticosteroid Injection in Carpal Tunnel Syndrome
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