Carpal Tunnel SyndromeNCT04346030
Comparison of Ultrasound-guided Corticosteroid Injection Versus Corticosteroid Injection and Hydrodissection for Carpal Tunnel Syndrome
A study testing Triamcinolone Acetonide, lidocaine hydrochloride and normal saline 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 is to investigate the effect of ultrasound guided steroid injection versus ultrasound guided steroid hydrodissection to treat patients with CTS. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Triamcinolone Acetonide, lidocaine hydrochloride and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Apr 2020to Jul 2021
- 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 20 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
- presence of thenar atrophy 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.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei veteran general hospital
Taipei
Jia chi Wang, +886-28757361, jcwang0726@gmail.com
About this study
The objective of this study is to investigate the effect of ultrasound guided steroid injection versus ultrasound guided steroid hydrodissection to treat patients with CTS.
Read the detailed description
This study was a prospective, randomized clinical trial. Patients with CTS were randomly treated with sonographically guided corticosteroid injection (group A); sonographically guided hydrodissection and corticosteroid injection (group B).
Boston Carpal tunnel questionnaire, nerve conduction studies and VAS pain score were performed on initial visit and after 6 weeks and 12 weeks .
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Triamcinolone Acetonide, lidocaine hydrochloride, normal saline
- 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
ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS
lidocaine hydrochlorideDrug
ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS
normal salineDrug
ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS
| Study group | Role | What they receive |
|---|---|---|
| steroid and hydrodissection | Experimental | ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS Receives: Drug: Triamcinolone Acetonide; Drug: lidocaine hydrochloride; Drug: normal saline |
| steroid only | Active comparator | ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml 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 Boston Carpal tunnel Questionnaire (BQ)
The BQ was interviewed-administered to assess the severity of symptoms and functional status
Measured: 0, 6, 12 weeks.
Secondary outcomes (3)
change from baseline in self reported pain intensity
patient were asked to indicate the intensity of their average level of pain for the wrist-hand region, using an 11-point scale, ranging from 0 to 10 (worst pain imaginable)
Measured: 0, 6, 12 weeks
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: 0, 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: 0, 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 posted15 Apr 2020
- Study start17 Apr 2020
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346030
- Sponsor's protocol ID
- 2016-01-011C
- Status last verified
- Apr 2020
- First submitted
- 9 Apr 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-guided Corticosteroid Injection Versus Corticosteroid Injection and Hydrodissection for Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT04346030
- Acronym / sponsor ID
- 2016-01-011C
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 15 Apr 2020 (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 is to investigate the effect of ultrasound guided steroid injection versus ultrasound guided steroid hydrodissection to treat patients with CTS.
Detailed description
This study was a prospective, randomized clinical trial. Patients with CTS were randomly treated with sonographically guided corticosteroid injection (group A); sonographically guided hydrodissection and corticosteroid injection (group B).
Boston Carpal tunnel questionnaire, nerve conduction studies and VAS pain score were performed on initial visit and after 6 weeks and 12 weeks .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| steroid and hydrodissection | Experimental | Drug: Triamcinolone Acetonide, Drug: lidocaine hydrochloride, Drug: normal salineultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS |
| steroid only | Active comparator | Drug: Triamcinolone Acetonide, Drug: lidocaine hydrochlorideultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of CTS The diagnosis of CTS was confirmed by electrophysiological tests.
Key exclusion criteria (2 listed)
- presence of thenar atrophy 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
- -
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 Acetonideultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS | Drug | steroid and hydrodissection, steroid only |
| lidocaine hydrochlorideultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS | Drug | steroid and hydrodissection, steroid only |
| normal salineultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS | Drug | steroid and hydrodissection |
Primary outcome
change from baseline in the scores on Boston Carpal tunnel Questionnaire (BQ)
Time frame: 0, 6, 12 weeks.
The BQ was interviewed-administered to assess the severity of symptoms and functional status
3 secondary outcomes
change from baseline in self reported pain intensity
Time frame: 0, 6, 12 weeks
change from baseline in median nerve distal motor latency
Time frame: 0, 6, 12 weeks
Change from Baseline in sensory nerve conduction velocity
Time frame: 0, 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 21 Apr 2020.
- Individual participant dataSharing planned: No
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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.
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, lidocaine hydrochloride and normal saline 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 1 inclusion and 2 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 21 Apr 2020. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in the scores on Boston Carpal tunnel Questionnaire (BQ) (time frame: 0, 6, 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 21 Apr 2020.