Carpal Tunnel SyndromeNCT02708693
Efficacy of Combined Ultrasound Guided Steroid Injection and Splinting in Patients With Carpal Tunnel Syndrome
A study testing Triamcinolone Acetonide, thermoplastic wrist splint and lidocaine hydrochloride in people with Carpal Tunnel Syndrome, run by Taipei Veterans General Hospital, Taiwan.
Trial summary
To compare the effectiveness of ultrasound guided-steroid injection plus splinting to that of steroid injection alone using clinical and electrophysiological parameters in patients with carpal tunnel syndrome 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, thermoplastic wrist splint and lidocaine hydrochloride
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Jun 2014
- 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 or carpal tunnel surgery
- history of distal radius fracture
- pregnancy or lactation
- regular use of systemic NSAIDs or corticosteroids
- known allergy to corticosteroids and local anesthetics.
About this study
To compare the effectiveness of ultrasound guided-steroid injection plus splinting to that of steroid injection alone using clinical and electrophysiological parameters in patients with carpal tunnel syndrome
Read the detailed description
This is a prospective, single-blinded randomized controlled study. Patient with CTS were randomly assigned to group receiving ultrasound guided steroid injection and group receiving ultrasound guided corticosteroid injection and splinting. The steroid injection was using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine). The inclusion criteria included an age of more than 18 years and typical signs of CTS according to American Academy of Neurology criteria lasting for at least 3 months. The diagnosis of CTS was confirmed by electrophysiological tests.The exclusion criteria included the following: 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 or carpal tunnel surgery; history of distal radius fracture; pregnancy or lactation; regular use of systemic NSAIDs or corticosteroids; and known allergy to corticosteroids and local anesthetics.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Triamcinolone Acetonide, thermoplastic wrist splint, 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) triamcinolone acetonide (Shincort)
thermoplastic wrist splintDevice
thermoplastic wrist splint with wrist placed in a neutral position
lidocaine hydrochlorideDrug
Also called lidocaine hydrochloride (Xylocaine)
ultrasound-guided injection using 1 ml of 2% lidocaine hydrochloride (Xylocaine)
| Study group | Role | What they receive |
|---|---|---|
| experimental: steroid injection and splinting | Experimental | ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine) and a customized volar thermoplastic wrist splint Receives: Drug: Triamcinolone Acetonide; Device: thermoplastic wrist splint; Drug: lidocaine hydrochloride |
| steroid injection | Active comparator | 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 |
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 2, 6, 12 weeks
Secondary outcomes (7)
Change from Baseline in Median nerve distal motor latency
or the motor studies, 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 2, 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 2, 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 2, 6, 12 weeks
Change from Baseline in 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: at 2, 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 2, 6, 12 weeks
change from Baseline in Cross sectional area
The CSA of the median nerve was measured using ultrasound 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). The CSA within the surrounding hyperechoic rim was measured. The CSA was measured using a continuous boundary trace of the nerve and was directly calculated using the area measurement software included with the ultrasonography device
Measured: at 2, 6, 12 weeks
change from Baseline in flattening ratio
The flattening ratio was measured only at the mid-tunnel (FR-M) using ultrasound. FR was calculated by dividing the horizontal diameter of the nerve by the vertical diameter.
Measured: at 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 posted15 Mar 2016 (estimated)
- Study startApr 2013
- Primary completionApr 2014
- Study completionJun 2014
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
- 52 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
- NCT02708693
- Sponsor's protocol ID
- 2012-05-021A
- Status last verified
- Apr 2013
- First submitted
- 5 Jan 2016
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Combined Ultrasound Guided Steroid Injection and Splinting in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT02708693
- Acronym / sponsor ID
- 2012-05-021A
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 15 Mar 2016 (estimated)
- 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 ultrasound guided-steroid injection plus splinting to that of steroid injection alone using clinical and electrophysiological parameters in patients with carpal tunnel syndrome
Detailed description
This is a prospective, single-blinded randomized controlled study. Patient with CTS were randomly assigned to group receiving ultrasound guided steroid injection and group receiving ultrasound guided corticosteroid injection and splinting. The steroid injection was using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine). The inclusion criteria included an age of more than 18 years and typical signs of CTS according to American Academy of Neurology criteria lasting for at least 3 months. The diagnosis of CTS was confirmed by electrophysiological tests.The exclusion criteria included the following: 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 or carpal tunnel surgery; history of distal radius fracture; pregnancy or lactation; regular use of systemic NSAIDs or corticosteroids; and known allergy to corticosteroids and local anesthetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental: steroid injection and splinting | Experimental | Drug: Triamcinolone Acetonide, Device: thermoplastic wrist splint, 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) and a customized volar thermoplastic wrist splint |
| steroid injection | Active comparator | 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) |
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 (7 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 or 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) triamcinolone acetonide (Shincort) | Drug | experimental: steroid injection and splinting, steroid injection |
| thermoplastic wrist splintthermoplastic wrist splint with wrist placed in a neutral position | Device | experimental: steroid injection and splinting |
| lidocaine hydrochlorideAlso: lidocaine hydrochloride (Xylocaine)ultrasound-guided injection using 1 ml of 2% lidocaine hydrochloride (Xylocaine) | Drug | experimental: steroid injection and splinting, steroid injection |
Primary outcome
Change from Baseline in the scores on the Boston Carpal Tunnel Questionnaire (BQ).
Time frame: at 2, 6, 12 weeks
The BQ was interviewed-administered to assess the severity of symptoms and functional status.
7 secondary outcomes
Change from Baseline in Median nerve distal motor latency
Time frame: at 2, 6, 12 weeks
Change from Baseline in sensory nerve conduction velocity
Time frame: at 2, 6, 12 weeks
Change from Baseline in compound muscle action potential amplitude (CMAP)
Time frame: at 2, 6, 12 weeks
Change from Baseline in sensory nerve action potential amplitudes.
Time frame: at 2, 6, 12 weeks
Change from Baseline in self-reported pain intensity
Time frame: at 2, 6, 12 weeks
change from Baseline in Cross sectional area
Time frame: at 2, 6, 12 weeks
change from Baseline in flattening ratio
Time frame: at 2, 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 15 Mar 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone Acetonide, thermoplastic wrist splint and lidocaine hydrochloride in people with Carpal Tunnel Syndrome, run by Taipei Veterans General Hospital, 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 7 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 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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 2, 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 15 Mar 2016.