Carpal Tunnel SyndromePhase 2/3NCT02870673
Assessment of the Effectiveness of Ultrasound-guided Acupuncture in the Management of Carpal Tunnel Syndrome
A Phase 2/3 study testing SHINCORT, XYLOCAINE and electroacupuncture in people with Carpal Tunnel Syndrome, run by Taipei Medical University Hospital.
Trial summary
In clinical practice, carpal tunnel syndrome (CTS) is the common disease of peripheral neuropathy and usually happened to female, mid-age population, overweight persons, and those who overused their hands for work or production. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- SHINCORT, XYLOCAINE and electroacupuncture
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Sep 2017
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants are must above 20 years old,
- All participants are willing to join and can be cooperated with all the interviews and examinations.
- The symptoms are compatible with carpal tunnel syndrome, including numbness, pain, paresthesia, tingling, burning sensation over a least 2 fingers and hand motor limitation which are dominated by median nerve.These symptoms have to sustain for more than 3 months and be diagnosed by electromyography, physical examination and physicians.
- Those who underwent local injection including glucose, steroid or anaphylaxis will be recruited if the treatments finished more than a year.
Who cannot join
- symptoms due to radiculopathy (When the patient also complains of symptoms radiating to the elbow or neck movement pain, the orthopedic doctor will make the definite diagnosis. )
- Those who underwent decompression surgery.
- CTS due to traumatic injury (confirmed by image)
- Those who underwent local injection within a year.
- CTS due to rheumatoid arthritis
- CTS due to cancer
Show all 9Show fewer
- CTS due to peripheral artery occlusive disease
- Those who have past history of psychosis.
- Pregnancy(every woman will be confirmed by urine pregnancy test)
Trial locations and contacts
No sites are listed yet.
About this study
In clinical practice, carpal tunnel syndrome (CTS) is the common disease of peripheral neuropathy and usually happened to female, mid-age population, overweight persons, and those who overused their hands for work or production. Some research claimed this might be correlated to anatomical characteristics such as the longer anteroposterior diameter or smaller cross section area of the wrist. Preliminary symptoms often start with sensory domain (pain, tingling, paresthesia and especially night awakening due to symptoms mentioned above) and then progress to motor domain (thenar muscle atrophy and clumsiness) if left untreated.
Depending on the severity, patient's willingness and convenience, there are many options for CTS. For those whose symptoms are mild to moderate, conservative therapies are usually the first choice, including physiotherapies, local injection and night splints. Local steroid is proven to be effective to relieve the symptoms of CTS shortly up to 3 months. However, the effects will decline gradually and repetitive injections is suggestive. The patients with severe symptoms which comprise thenar muscle atrophy will be advised to receive decompression surgery.the surgery can alleviate the illness with high success rate up to 70%. Unfortunately, there are still patients who will relapse or undergo side effects, for example, finger weakness.
Read more
In recent years, acupuncture researches focused on CTS intervention have been outgrowing and promising. Whereas, there are still lack of evidence which stands for the therapeutic effects comparing with local steroid injection. This limits the built-up of suspect mechanism of acupuncture intervention for CTS.
This is a preliminary, randomized and single-blinded study which started since 2016 and last for a year. The investigators utilize ultrasound to guide the depth of needle penetration which prevents unnecessarily tissues injury such as artery or dry needle injury. This procedure also guarantees the needles lie directly on the upper surface of the median nerve. One group will receive electrical stimulation and another won't. The investigators use electromyography, cross-section area of median nerve, visual analog scale, Boston Carpal Tunnel Syndrome Questionnaire, six-item scale, The disabilities of the arm, shoulder and hand score and Jamar grip dynamometer as outcome measurements. The results gathered from two experimental groups will be compared with the data from the control group whose participants only receiving local steroid injection once in the first week. The participants are all above 18 years old and complain of illness for a least 3 months without any surgery or local injection for a least 1 year. The investigators set up strict exclusive criteria and sample size estimation is 70.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- SHINCORT, XYLOCAINE, sham electroacupuncture, electroacupuncture
- Keywords
- acupuncture, electrical stimulation, 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.
SHINCORTDrug
Also called triamcinolone Acetonide
triamcinolone Acetonide (10mg/ml) 0.5 ml
XYLOCAINEDrug
Also called XYLOCAINE IV INJECTION
xylocaine(20mg/ml) 0.5 ml
sham electroacupunctureDevice
1.5 inches 32 gauze stainless steel needles Transcutaneous electrical nerve stimulation machine (MODEL-05B(6))
electroacupunctureDevice
1.5 inches 32 gauze stainless steel needles Transcutaneous electrical nerve stimulation machine (MODEL-05B(6))
| Study group | Role | What they receive |
|---|---|---|
| Injection of Shincort 0.5 ml and Xylocaine 0.5ml mixture | Active comparator | In the first week of recruitment, this group will receive the local injection around the distal wrist crease with mixture of Shincort Inj(10mg/ml) 0.5 ml and xylocaine(20mg/ml) 0.5 ml only one time.
The ultrasound-guided procedure is performed by the orthopedic physician. Receives: Drug: SHINCORT; Drug: XYLOCAINE |
| sham electroacupuncture | Experimental | In this group, the participants receive acupuncture treatment and only 2 minutes electrical stimulation.
Each needle insertion depth and position are confirmed by the ultrasound. The procedure makes sure that needle pin is directly placed on the median nerve and prevent nerve penetration. Then the electrical stimulator is connected to the needles as cathode and anode and is turned on to the intensity which can induce thenar muscle contraction or reach the upper limit of the participant. After 2 minutes, the stimulator will turn off spontaneously and the participant will not be informed.
The whole course will cost 20 minutes after needles are pulled out. Every participant is asked to receive 1 treatment per week in the consecutive 3 months(total 12 times). Receives: Device: sham electroacupuncture |
| electroacupuncture | Experimental | In this group, the participants receive acupuncture treatment and 20 minutes electrical stimulation.
Each needle insertion depth and position are confirmed by the ultrasound. The procedure makes sure that needle pin is directly placed on the median nerve and prevent nerve penetration. Then the electrical stimulator is connected to the needles as cathode and anode and is turned on to the intensity which can induce thenar muscle contraction or reach the upper limit of the participant.
The whole course will cost 20 minutes after needles are pulled out. Every participant is asked to receive 1 treatment per week in the consecutive 3 months(total 12 times). Receives: Device: electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain assessed on visual analog scale
Measured: 24 weeks
Boston Carpal Tunnel Syndrome Questionaire
Measured: 24 weeks
The 6-item CTS symptoms scale
Measured: 24 weeks
cross sectional area(CSA) of the median nerve
CSA of the median nerve below the distal wrist crease which is measured by the ultrasound(transverse view )
Measured: 24 weeks
hand grip power
Jamar Hand grip Dynamometer as the measuring tool
Measured: 24 weeks
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
Measured: 24 weeks
compound muscle action potential(CMAP)
The CMAP is a summated voltage response from the individual muscle fibre action potentials and measured in millivolts (mV).
Measured: 24 weeks
Wrist-palm sensory nerve conduction velocity(Wrist-palm SNCV)
Wrist-palm SNCV (m/s) = distance between stimulation site 1 and site 2 (mm)/[latency wrist- latency palm(ms)].
Measured: 24 weeks
motor nerve conduction velocity(MNCV)
MNCV (m/s) = distance between stimulation site 1 and site 2 (mm)/[latency site 2 - latency site 1 (ms)].
Measured: 24 weeks
sensory nerve action potential(SNAP)
The sensory nerve action potential (SNAP) is obtained by electrically stimulating sensory fibres and recording the nerve action potential at a point further along that nerve.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017 (estimated)
- Study completionSep 2017 (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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, You-Jen Tang, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870673
- Sponsor's protocol ID
- N201605074
- Status last verified
- Aug 2016
- First submitted
- 8 Aug 2016
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of Ultrasound-guided Acupuncture in the Management of Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT02870673
- Acronym / sponsor ID
- N201605074
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- acupuncture, electrical stimulation, carpal tunnel syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 17 Aug 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.
In clinical practice, carpal tunnel syndrome (CTS) is the common disease of peripheral neuropathy and usually happened to female, mid-age population, overweight persons, and those who overused their hands for work or production. Some research claimed this might be correlated to anatomical characteristics such as the longer anteroposterior diameter or smaller cross section area of the wrist. Preliminary symptoms often start with sensory domain (pain, tingling, paresthesia and especially night awakening due to symptoms mentioned above) and then progress to motor domain (thenar muscle atrophy and clumsiness) if left untreated.
Depending on the severity, patient's willingness and convenience, there are many options for CTS. For those whose symptoms are mild to moderate, conservative therapies are usually the first choice, including physiotherapies, local injection and night splints. Local steroid is proven to be effective to relieve the symptoms of CTS shortly up to 3 months. However, the effects will decline gradually and repetitive injections is suggestive. The patients with severe symptoms which comprise thenar muscle atrophy will be advised to receive decompression surgery.the surgery can alleviate the illness with high success rate up to 70%. Unfortunately, there are still patients who will relapse or undergo side effects, for example, finger weakness.
In recent years, acupuncture researches focused on CTS intervention have been outgrowing and promising. Whereas, there are still lack of evidence which stands for the therapeutic effects comparing with local steroid injection. This limits the built-up of suspect mechanism of acupuncture intervention for CTS.
This is a preliminary, randomized and single-blinded study which started since 2016 and last for a year. The investigators utilize ultrasound to guide the depth of needle penetration which prevents unnecessarily tissues injury such as artery or dry needle injury. This procedure also guarantees the needles lie directly on the upper surface of the median nerve. One group will receive electrical stimulation and another won't. The investigators use electromyography, cross-section area of median nerve, visual analog scale, Boston Carpal Tunnel Syndrome Questionnaire, six-item scale, The disabilities of the arm, shoulder and hand score and Jamar grip dynamometer as outcome measurements. The results gathered from two experimental groups will be compared with the data from the control group whose participants only receiving local steroid injection once in the first week. The participants are all above 18 years old and complain of illness for a least 3 months without any surgery or local injection for a least 1 year. The investigators set up strict exclusive criteria and sample size estimation is 70.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Injection of Shincort 0.5 ml and Xylocaine 0.5ml mixture | Active comparator | Drug: SHINCORT, Drug: XYLOCAINEIn the first week of recruitment, this group will receive the local injection around the distal wrist crease with mixture of Shincort Inj(10mg/ml) 0.5 ml and xylocaine(20mg/ml) 0.5 ml only one time. The ultrasound-guided procedure is performed by the orthopedic physician. |
| sham electroacupuncture | Experimental | Device: sham electroacupunctureIn this group, the participants receive acupuncture treatment and only 2 minutes electrical stimulation. Each needle insertion depth and position are confirmed by the ultrasound. The procedure makes sure that needle pin is directly placed on the median nerve and prevent nerve penetration. Then the electrical stimulator is connected to the needles as cathode and anode and is turned on to the intensity which can induce thenar muscle contraction or reach the upper limit of the participant. After 2 minutes, the stimulator will turn off spontaneously and the participant will not be informed. The whole course will cost 20 minutes after needles are pulled out. Every participant is asked to receive 1 treatment per week in the consecutive 3 months(total 12 times). |
| electroacupuncture | Experimental | Device: electroacupunctureIn this group, the participants receive acupuncture treatment and 20 minutes electrical stimulation. Each needle insertion depth and position are confirmed by the ultrasound. The procedure makes sure that needle pin is directly placed on the median nerve and prevent nerve penetration. Then the electrical stimulator is connected to the needles as cathode and anode and is turned on to the intensity which can induce thenar muscle contraction or reach the upper limit of the participant. The whole course will cost 20 minutes after needles are pulled out. Every participant is asked to receive 1 treatment per week in the consecutive 3 months(total 12 times). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All participants are must above 20 years old,
- All participants are willing to join and can be cooperated with all the interviews and examinations.
- The symptoms are compatible with carpal tunnel syndrome, including numbness, pain, paresthesia, tingling, burning sensation over a least 2 fingers and hand motor limitation which are dominated by median nerve.These symptoms have to sustain for more than 3 months and be diagnosed by electromyography, physical examination and physicians.
- Those who underwent local injection including glucose, steroid or anaphylaxis will be recruited if the treatments finished more than a year.
Key exclusion criteria (9 listed)
- symptoms due to radiculopathy (When the patient also complains of symptoms radiating to the elbow or neck movement pain, the orthopedic doctor will make the definite diagnosis. )
- Those who underwent decompression surgery.
- CTS due to traumatic injury (confirmed by image)
- Those who underwent local injection within a year.
- CTS due to rheumatoid arthritis
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 |
|---|---|---|
| SHINCORTAlso: triamcinolone Acetonidetriamcinolone Acetonide (10mg/ml) 0.5 ml | Drug | Injection of Shincort 0.5 ml and Xylocaine 0.5ml mixture |
| XYLOCAINEAlso: XYLOCAINE IV INJECTIONxylocaine(20mg/ml) 0.5 ml | Drug | Injection of Shincort 0.5 ml and Xylocaine 0.5ml mixture |
| sham electroacupuncture1.5 inches 32 gauze stainless steel needles Transcutaneous electrical nerve stimulation machine (MODEL-05B(6)) | Device | sham electroacupuncture |
| electroacupuncture1.5 inches 32 gauze stainless steel needles Transcutaneous electrical nerve stimulation machine (MODEL-05B(6)) | Device | electroacupuncture |
Primary outcome
pain assessed on visual analog scale
Time frame: 24 weeks
Boston Carpal Tunnel Syndrome Questionaire
Time frame: 24 weeks
The 6-item CTS symptoms scale
Time frame: 24 weeks
cross sectional area(CSA) of the median nerve
Time frame: 24 weeks
CSA of the median nerve below the distal wrist crease which is measured by the ultrasound(transverse view )
hand grip power
Time frame: 24 weeks
Jamar Hand grip Dynamometer as the measuring tool
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time frame: 24 weeks
compound muscle action potential(CMAP)
Time frame: 24 weeks
The CMAP is a summated voltage response from the individual muscle fibre action potentials and measured in millivolts (mV).
Wrist-palm sensory nerve conduction velocity(Wrist-palm SNCV)
Time frame: 24 weeks
Wrist-palm SNCV (m/s) = distance between stimulation site 1 and site 2 (mm)/[latency wrist- latency palm(ms)].
motor nerve conduction velocity(MNCV)
Time frame: 24 weeks
MNCV (m/s) = distance between stimulation site 1 and site 2 (mm)/[latency site 2 - latency site 1 (ms)].
sensory nerve action potential(SNAP)
Time frame: 24 weeks
The sensory nerve action potential (SNAP) is obtained by electrically stimulating sensory fibres and recording the nerve action potential at a point further along that nerve.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Individual participant dataSharing planned: No
Related trials for Carpal Tunnel Syndrome
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Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
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Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SHINCORT, XYLOCAINE and electroacupuncture in people with Carpal Tunnel Syndrome, run by Taipei Medical University Hospital.
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 4 inclusion and 9 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 19 Aug 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 You-Jen Tang, MD (+886932182791, 9502060@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain assessed on visual analog scale (time frame: 24 weeks). The study lists 10 primary outcomes in all. 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 19 Aug 2016.