Carpal Tunnel SyndromeNCT03072290
Corticosteroid Injection in Carpal Tunnel Syndrome
A study testing Triamcinolone Acetonide and lidocaine hydrochloride in people with Carpal Tunnel Syndrome, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Triamcinolone Acetonide and lidocaine hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Feb 2017to 20 Dec 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 years and older
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Different Dose of Steroid Injection in Carpal Tunnel Syndrome
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
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Triamcinolone Acetonide, lidocaine hydrochloride
- 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.
Triamcinolone AcetonideDrug
Also called triamcinolone acetonide 10mg/ml (shincort, YSP, Taiwan)
ultrasound-guided injection using 1ml of 10 mg (10mg/ml) or 40 mg (40 mg/ml) triamcinolone acetonide (Shincort)
lidocaine hydrochlorideDrug
Also called lidocaine hydrochloride (Xylocaine)
ultrasound-guided injection using 1 ml of 2% lidocaine hydrochloride (Xylocaine)
| Study group | Role | What they receive |
|---|---|---|
| low dose steroid | Experimental | ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine) Receives: Drug: Triamcinolone Acetonide; Drug: lidocaine hydrochloride |
| comparator | Active comparator | ultrasound-guided steroid injection using 1ml of 40 mg (40mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine) Receives: Drug: Triamcinolone Acetonide; Drug: lidocaine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 6, 12 weeks
Secondary outcomes (4)
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
Measured: at 6, 12 weeks
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.
Measured: at 6, 12 weeks
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.
Measured: at 6, 12 weeks
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).
Measured: at 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 posted7 Mar 2017
- Study start18 Feb 2017
- Primary completion28 Nov 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072290
- Sponsor's protocol ID
- 2016-07-006A
- Status last verified
- Jul 2019
- First submitted
- 1 Mar 2017
- Last updated
- 30 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32682938
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Dose of Steroid Injection in Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT03072290
- Acronym / sponsor ID
- 2016-07-006A
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 18 Feb 2017 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 7 Mar 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low dose steroid | Experimental | Drug: Triamcinolone Acetonide, Drug: lidocaine hydrochlorideultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine) |
| comparator | Active comparator | Drug: Triamcinolone Acetonide, Drug: lidocaine hydrochlorideultrasound-guided steroid injection using 1ml of 40 mg (40mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine) |
Who may qualify
- Ages
- 18 years and older
- 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 (8 listed)
- 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
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 |
|---|---|---|
| Triamcinolone AcetonideAlso: triamcinolone acetonide 10mg/ml (shincort, YSP, Taiwan)ultrasound-guided injection using 1ml of 10 mg (10mg/ml) or 40 mg (40 mg/ml) triamcinolone acetonide (Shincort) | Drug | comparator, low dose steroid |
| lidocaine hydrochlorideAlso: lidocaine hydrochloride (Xylocaine)ultrasound-guided injection using 1 ml of 2% lidocaine hydrochloride (Xylocaine) | Drug | comparator, low dose steroid |
Primary outcome
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.
4 secondary outcomes
Change from Baseline in Median nerve distal motor latency
Time frame: at 6, 12 weeks
Change from Baseline in sensory nerve conduction velocity
Time frame: at 6, 12 weeks
Change from Baseline in compound muscle action potential amplitude (CMAP)
Time frame: at 6, 12 weeks
Change from Baseline in self-reported pain intensity
Time frame: at 6, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Derived from this study: PubMed 32682938Hsu 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone Acetonide and lidocaine hydrochloride 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 8 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: finished, as of the sponsor's last update on 30 Jul 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the scores on the Boston Carpal Tunnel Questionnaire (BQ). (time frame: at 6, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03072290, which also lists 1 linked publication.
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 30 Jul 2019.