Carpal Tunnel SyndromeNCT03132051
Sonographic Evaluation of Patients With Carpal Tunnel Syndrome Following Steroid Injection
A study testing steroid injection in people with Carpal Tunnel Syndrome, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
The objective of this study was to assess sonographic changes of the median nerve after steroid injection for carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- steroid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2013to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of CTS
- The diagnosis of CTS was confirmed by electrophysiological tests.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Teipei Veterans General Hospital
Taipei
Jia chi Wang, MD, 886-2-28757361
About this study
The objective of this study was to assess sonographic changes of the median nerve after steroid injection for carpal tunnel syndrome.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- steroid injection
- Keywords
- carpal tunnel syndrome
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
steroid injectionDrug
Also called triamcinolone acetonide
ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide
| Study group | Role | What they receive |
|---|---|---|
| steroid injection | Experimental | ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide Receives: Drug: steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Secondary outcomes (6)
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.
Measured: 2, 6, 12 weeks
Boston Carpal Tunnel Questionnaire (BQ)
The BQ was interviewed-administered to assess the severity of symptoms and functional status.
Measured: 2, 6, 12 weeks
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
Measured: 2, 6, 12 weeks
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.
Measured: 2, 6, 12 weeks
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.
Measured: 2, 6, 12 weeks
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.
Measured: 2, 6, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study startApr 2013
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients received steroid injection for carpel tunnel syndrome (CTS) and ultrasonographic evaluation before and after steroid injection
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jia chi Wang, Principal investigator, Taipei Veteran General hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132051
- Sponsor's protocol ID
- 2016-07-006A; 2012-05-021A
- Status last verified
- Feb 2017
- First submitted
- 16 Feb 2017
- Last updated
- 27 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Evaluation of Patients With Carpal Tunnel Syndrome Following Steroid Injection
- ClinicalTrials.gov ID
- NCT03132051
- Acronym / sponsor ID
- 2016-07-006A; 2012-05-021A
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Apr 2013 (actual)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients received steroid injection for carpel tunnel syndrome (CTS) and ultrasonographic evaluation before and after steroid injection
| Arm | Type | Receives |
|---|---|---|
| steroid injection | Experimental | Drug: steroid injectionultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of CTS
- The diagnosis of CTS was confirmed by electrophysiological tests.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| steroid injectionAlso: triamcinolone acetonideultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide | Drug | steroid injection |
Primary outcome
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)
6 secondary outcomes
flattening ratio
Time frame: 2, 6, 12 weeks
Boston Carpal Tunnel Questionnaire (BQ)
Time frame: 2, 6, 12 weeks
Median nerve distal motor latency
Time frame: 2, 6, 12 weeks
sensory nerve conduction velocity
Time frame: 2, 6, 12 weeks
compound muscle action potential amplitude (CMAP)
Time frame: 2, 6, 12 weeks
sensory nerve action potential amplitudes.
Time frame: 2, 6, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia chi Wang principal investigator
Taipei Veteran General hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing steroid injection in people with Carpal Tunnel Syndrome, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia chi Wang, MD (886-2-28757361, jcwang0726@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross sectional area (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.