Carpal Tunnel SyndromePhase 4NCT04767724
Extracorporeal Shock Wave Versus Local Corticosteroid Injection for Carpal Tunnel Syndrome
A Phase 4 study testing Extracorporeal shock wave in people with Carpal Tunnel Syndrome and Shock Wave, run by Chinese Medical Association at 1 site in China.
Trial summary
This RCT is to investigate the clinical effect of extracorporeal shock wave therapy (ESWT) compared to the local corticosteroid injection (LCI) in managing mild to moderate carpal tunnel syndrome (CTS). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Shock Wave
- What is being tested?
- Extracorporeal shock wave
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2018to 10 Apr 2020
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patients aged ≥18 years
- Should present a new episode of CTS with symptoms lasting for ≥ six weeks
- Symptoms include wrist pain, numbness, and paraesthesia on the hands
- Tested postive by the Phalen test and Tinel test
- Electrodiagnostically diagnosed with mild to moderate CTS
Who cannot join
- A lack of consent information
- A history of a CTS surgery or LCI in the carpal tunnel
- Asystemic disease that may interfere with the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Clinical Trial Comparing the Extracorporeal Shock Wave and Local Corticosteroid Injection for Carpal Tunnel Syndrome
This RCT is to investigate the clinical effect of extracorporeal shock wave therapy (ESWT) compared to the local corticosteroid injection (LCI) in managing mild to moderate carpal tunnel syndrome (CTS).
Read the detailed description
To investigate the effect of extracorporeal shock wave therapy (ESWT) compared to the local corticosteroid injection (LCI) in managing mild to moderate carpal tunnel syndrome (CTS). About 50-60 patients with mild to moderate CTS are supposed to be randomly allocated into either ESWT group or LCI group. The outcomes include the visual analog scale (VAS), the Boston Carpal Tunnel Questionnaire (BCTQ), and nerve conduction study at baseline and at 3 weeks, 9 weeks, 12 weeks, 6 months, and 12 months after the treatments.
- Conditions
- Carpal Tunnel Syndrome, Shock Wave
- Being tested
- Extracorporeal shock wave
- 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.
Extracorporeal shock waveDevice
Also called Local corticosteroid injection
Participants received 3 ESWT sessions once per week for 3 consecutive weeks or a single injection of one mL (40 mg) of betamethasone into the region surrounding the median nerve.
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal shock wave | Experimental | Participants received three ESWT sessions once per week for three consecutive weeks. The probe of the ESWT machine (FT-174; Swiss Dolor Class; Switzerland) was placed perpendicularly on the patient's palm over the median nerve on the carpal tunnel after application of the ultrasound gel as a coupling agent. Afterward, the ESWT was administered with 1000 shots, 1.5 bar of pressure, and a frequency of 6 Hz Receives: Device: Extracorporeal shock wave |
| Local corticosteroid injection | Active comparator | A single injection of one mL (40 mg) of betamethasone into the region surrounding the median nerve. Receives: Device: Extracorporeal shock wave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is frequently used as a tool to measure the degree of the pain felt by the participants. The score ranges from 0 to 10. The higher score means a higher degree of the pain.
Measured: At baseline (before the treatment)
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is frequently used as a tool to measure the degree of the pain felt by the participants. The score ranges from 0 to 10. The higher score means a higher degree of the pain.
Measured: At 6 months after the treatments
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is frequently used as a tool to measure the degree of the pain felt by the participants. The score ranges from 0 to 10. The higher score means a higher degree of the pain.
Measured: At 12 months after the treatments
Boston Carpal Tunnel Questionnaire (BCTQ)
Boston Carpal Tunnel Questionnaire (BCTQ) is the most widely used self-administered outcome scale in patients with carpal tunnel syndrome (CTS) for assessing patients' perceived symptom severity and functional status. The score ranges from 19 to 95. The higher score means a worse status of CTS.
Measured: At baseline (before the treatment)
Boston Carpal Tunnel Questionnaire (BCTQ)
Boston Carpal Tunnel Questionnaire (BCTQ) is the most widely used self-administered outcome scale in patients with carpal tunnel syndrome (CTS) for assessing patients' perceived symptom severity and functional status. The score ranges from 19 to 95. The higher score means a worse status of CTS.
Measured: At 6 months after the treatments
Boston Carpal Tunnel Questionnaire (BCTQ)
Boston Carpal Tunnel Questionnaire (BCTQ) is the most widely used self-administered outcome scale in patients with carpal tunnel syndrome (CTS) for assessing patients' perceived symptom severity and functional status. The score ranges from 19 to 95. The higher score means a worse status of CTS.
Measured: At 12 months after the treatments
The peak latency of the median sensory nerve action potential (SNAP)
The peak latency of the median sensory nerve action potential (SNAP) is used to assess the function status of the median sensory nerve. The value ranges from 0 ms. The less value means the quicker conduction of the action potential and the better function status of the nerve.
Measured: At baseline (before the treatment)
The peak latency of the median sensory nerve action potential (SNAP)
The peak latency of the median sensory nerve action potential (SNAP) is used to assess the function status of the median sensory nerve. The value ranges from 0 ms. The less value means the quicker conduction of the action potential and the better function status of the nerve.
Measured: At 6 months after the treatments
The peak latency of the median sensory nerve action potential (SNAP)
The peak latency of the median sensory nerve action potential (SNAP) is used to assess the function status of the median sensory nerve. The value ranges from 0 ms. The less value means the quicker conduction of the action potential and the better function status of the nerve.
Measured: At 12 months after the treatments
The amplitude of the median sensory nerve action potential
The amplitude of the median sensory nerve action potential is used to assess the function status of the median sensory nerve. The value ranges from 0 μV. The higher value means the better function status of the nerve.
Measured: At baseline (before the treatment)
The amplitude of the median sensory nerve action potential
The amplitude of the median sensory nerve action potential is used to assess the function status of the median sensory nerve. The value ranges from 0 μV. The higher value means the better function status of the nerve.
Measured: At 6 months after the treatments
The amplitude of the median sensory nerve action potential
The amplitude of the median sensory nerve action potential is used to assess the function status of the median sensory nerve. The value ranges from 0 μV. The higher value means the better function status of the nerve.
Measured: At 12 months after the treatments
The distal latency of the median compound motor action potential (CMAP)
The distal latency of the median compound motor action potential (CMAP) is used to assess the function status of the median compound motor nerve. The value ranges from 0 ms. The less value means the quicker conduction of the action potential and the better function status of the nerve.
Measured: At baseline (before the treatment)
The distal latency of the median compound motor action potential (CMAP)
The distal latency of the median compound motor action potential (CMAP) is used to assess the function status of the median compound motor nerve. The value ranges from 0 ms. The less value means the quicker conduction of the action potential and the better function status of the nerve.
Measured: At 6 months after the treatments
The distal latency of the median compound motor action potential (CMAP)
The distal latency of the median compound motor action potential (CMAP) is used to assess the function status of the median compound motor nerve. The value ranges from 0 ms. The less value means the quicker conduction of the action potential and the better function status of the nerve.
Measured: At 12 months after the treatments
The amplitude of the median compound motor action potential
The amplitude of the median compound motor action potential is used to assess the function status of the median compound motor nerve. The value ranges from 0 mV. The higher value means the better function status of the nerve.
Measured: At baseline (before the treatment)
The amplitude of the median compound motor action potential
The amplitude of the median compound motor action potential is used to assess the function status of the median compound motor nerve. The value ranges from 0 mV. The higher value means the better function status of the nerve.
Measured: At 6 months after the treatments
The amplitude of the median compound motor action potential
The amplitude of the median compound motor action potential is used to assess the function status of the median compound motor nerve. The value ranges from 0 mV. The higher value means the better function status of the nerve.
Measured: At 12 months after the treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start10 Apr 2018
- Primary completion2 Aug 2019
- Study completion10 Apr 2020
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jin Li, MD, Study chair, Ningbo Medical Center Lihuili Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767724
- Sponsor's protocol ID
- LH2017-012
- Status last verified
- Feb 2021
- First submitted
- 10 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Details of interventions, data of the results
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Clinical Trial Comparing the Extracorporeal Shock Wave and Local Corticosteroid Injection for Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT04767724
- Acronym / sponsor ID
- LH2017-012
- Conditions
- Carpal Tunnel Syndrome, Shock Wave
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 23 Feb 2021 (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.
This RCT is to investigate the clinical effect of extracorporeal shock wave therapy (ESWT) compared to the local corticosteroid injection (LCI) in managing mild to moderate carpal tunnel syndrome (CTS).
Detailed description
To investigate the effect of extracorporeal shock wave therapy (ESWT) compared to the local corticosteroid injection (LCI) in managing mild to moderate carpal tunnel syndrome (CTS). About 50-60 patients with mild to moderate CTS are supposed to be randomly allocated into either ESWT group or LCI group. The outcomes include the visual analog scale (VAS), the Boston Carpal Tunnel Questionnaire (BCTQ), and nerve conduction study at baseline and at 3 weeks, 9 weeks, 12 weeks, 6 months, and 12 months after the treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal shock wave | Experimental | Device: Extracorporeal shock waveParticipants received three ESWT sessions once per week for three consecutive weeks. The probe of the ESWT machine (FT-174; Swiss Dolor Class; Switzerland) was placed perpendicularly on the patient's palm over the median nerve on the carpal tunnel after application of the ultrasound gel as a coupling agent. Afterward, the ESWT was administered with 1000 shots, 1.5 bar of pressure, and a frequency of 6 Hz |
| Local corticosteroid injection | Active comparator | Device: Extracorporeal shock waveA single injection of one mL (40 mg) of betamethasone into the region surrounding the median nerve. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The patients aged ≥18 years
- Should present a new episode of CTS with symptoms lasting for ≥ six weeks
- Symptoms include wrist pain, numbness, and paraesthesia on the hands
- Tested postive by the Phalen test and Tinel test
- Electrodiagnostically diagnosed with mild to moderate CTS
Key exclusion criteria (3 listed)
- A lack of consent information
- A history of a CTS surgery or LCI in the carpal tunnel
- Asystemic disease that may interfere with the study
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 |
|---|---|---|
| Extracorporeal shock waveAlso: Local corticosteroid injectionParticipants received 3 ESWT sessions once per week for 3 consecutive weeks or a single injection of one mL (40 mg) of betamethasone into the region surrounding the median nerve. | Device | Extracorporeal shock wave, Local corticosteroid injection |
Primary outcome
Visual Analog Scale (VAS)
Time frame: At baseline (before the treatment)
The Visual Analog Scale (VAS) is frequently used as a tool to measure the degree of the pain felt by the participants. The score ranges from 0 to 10. The higher score means a higher degree of the pain.
Visual Analog Scale (VAS)
Time frame: At 6 months after the treatments
The Visual Analog Scale (VAS) is frequently used as a tool to measure the degree of the pain felt by the participants. The score ranges from 0 to 10. The higher score means a higher degree of the pain.
Visual Analog Scale (VAS)
Time frame: At 12 months after the treatments
The Visual Analog Scale (VAS) is frequently used as a tool to measure the degree of the pain felt by the participants. The score ranges from 0 to 10. The higher score means a higher degree of the pain.
Boston Carpal Tunnel Questionnaire (BCTQ)
Time frame: At baseline (before the treatment)
Boston Carpal Tunnel Questionnaire (BCTQ) is the most widely used self-administered outcome scale in patients with carpal tunnel syndrome (CTS) for assessing patients' perceived symptom severity and functional status. The score ranges from 19 to 95. The higher score means a worse status of CTS.
Boston Carpal Tunnel Questionnaire (BCTQ)
Time frame: At 6 months after the treatments
Boston Carpal Tunnel Questionnaire (BCTQ) is the most widely used self-administered outcome scale in patients with carpal tunnel syndrome (CTS) for assessing patients' perceived symptom severity and functional status. The score ranges from 19 to 95. The higher score means a worse status of CTS.
Boston Carpal Tunnel Questionnaire (BCTQ)
Time frame: At 12 months after the treatments
Boston Carpal Tunnel Questionnaire (BCTQ) is the most widely used self-administered outcome scale in patients with carpal tunnel syndrome (CTS) for assessing patients' perceived symptom severity and functional status. The score ranges from 19 to 95. The higher score means a worse status of CTS.
The peak latency of the median sensory nerve action potential (SNAP)
Time frame: At baseline (before the treatment)
The peak latency of the median sensory nerve action potential (SNAP) is used to assess the function status of the median sensory nerve. The value ranges from 0 ms. The less value means the quicker conduction of the action potential and the better function status of the nerve.
The peak latency of the median sensory nerve action potential (SNAP)
Time frame: At 6 months after the treatments
The peak latency of the median sensory nerve action potential (SNAP) is used to assess the function status of the median sensory nerve. The value ranges from 0 ms. The less value means the quicker conduction of the action potential and the better function status of the nerve.
The peak latency of the median sensory nerve action potential (SNAP)
Time frame: At 12 months after the treatments
The peak latency of the median sensory nerve action potential (SNAP) is used to assess the function status of the median sensory nerve. The value ranges from 0 ms. The less value means the quicker conduction of the action potential and the better function status of the nerve.
The amplitude of the median sensory nerve action potential
Time frame: At baseline (before the treatment)
The amplitude of the median sensory nerve action potential is used to assess the function status of the median sensory nerve. The value ranges from 0 μV. The higher value means the better function status of the nerve.
The amplitude of the median sensory nerve action potential
Time frame: At 6 months after the treatments
The amplitude of the median sensory nerve action potential is used to assess the function status of the median sensory nerve. The value ranges from 0 μV. The higher value means the better function status of the nerve.
The amplitude of the median sensory nerve action potential
Time frame: At 12 months after the treatments
The amplitude of the median sensory nerve action potential is used to assess the function status of the median sensory nerve. The value ranges from 0 μV. The higher value means the better function status of the nerve.
The distal latency of the median compound motor action potential (CMAP)
Time frame: At baseline (before the treatment)
The distal latency of the median compound motor action potential (CMAP) is used to assess the function status of the median compound motor nerve. The value ranges from 0 ms. The less value means the quicker conduction of the action potential and the better function status of the nerve.
The distal latency of the median compound motor action potential (CMAP)
Time frame: At 6 months after the treatments
The distal latency of the median compound motor action potential (CMAP) is used to assess the function status of the median compound motor nerve. The value ranges from 0 ms. The less value means the quicker conduction of the action potential and the better function status of the nerve.
The distal latency of the median compound motor action potential (CMAP)
Time frame: At 12 months after the treatments
The distal latency of the median compound motor action potential (CMAP) is used to assess the function status of the median compound motor nerve. The value ranges from 0 ms. The less value means the quicker conduction of the action potential and the better function status of the nerve.
The amplitude of the median compound motor action potential
Time frame: At baseline (before the treatment)
The amplitude of the median compound motor action potential is used to assess the function status of the median compound motor nerve. The value ranges from 0 mV. The higher value means the better function status of the nerve.
The amplitude of the median compound motor action potential
Time frame: At 6 months after the treatments
The amplitude of the median compound motor action potential is used to assess the function status of the median compound motor nerve. The value ranges from 0 mV. The higher value means the better function status of the nerve.
The amplitude of the median compound motor action potential
Time frame: At 12 months after the treatments
The amplitude of the median compound motor action potential is used to assess the function status of the median compound motor nerve. The value ranges from 0 mV. The higher value means the better function status of the nerve.
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 26 Feb 2021.
- Individual participant dataSharing planned: Yes. Details of interventions, data of the results
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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.
Jin Li, MD study chair
Ningbo Medical Center Lihuili Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Extracorporeal shock wave in people with Carpal Tunnel Syndrome and Shock Wave, run by Chinese Medical Association at 1 site in China.
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 5 inclusion and 3 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 26 Feb 2021. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Visual Analog Scale (VAS) (time frame: At baseline (before the treatment)). The study lists 18 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 26 Feb 2021.