Carpal Tunnel SyndromeNCT05627349
The Evaluation for Fu's Subcutaneous Needling (FSN) in Carpal Tunnel Syndrome.
A study testing wrist splinting and FSN in people with Carpal Tunnel Syndrome, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of Fu's Subcutaneous Needling (FSN) in carpal tunnel syndrome (CTS). The main questions it aims to answer are: Dose FSN improve the symptoms of CTS? Dose FSN decrease cross section area of median nerve in CTS patients? Dose FSN have the effect of… Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- wrist splinting and FSN
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Aug 2023to 20 Jun 2025
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged 20-85 years old.
- Meet the diagnosis of mild to moderate carpal tunnel syndrome.
- If the patient has carpal tunnel syndrome in both hands, choose the side with mild or moderate carpal tunnel syndrome.
- After being explained, join the trial voluntarily and sign the subject's consent form.
Who cannot join
- Caused by trauma or mass lesion.
- Thenar muscle atrophy.
- Electrophysiological examination revealed severe CTS.
- Chronic kidney disease, rheumatoid arthritis, abnormal thyroid function, diabetes.
- Psychiatric history or incapable of cooperating with the investigator.
- Pregnancy.
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- History of substance abuse or long-term steroid use.
- History of median nerve surgery.
- Those who do not sign the consent form.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hsinchu Hospital
Zhubei, Hsinchu County, 302
Chih-Ying Wu, MD, +886 4 2205 2121 ext. 5094, zingwu1029@gmail.com
Chih Ying Wu, MD
About this study
Official title: The Evaluation for Fu's Subcutaneous Needling in Carpal Tunnel Syndrome: a Randomized Controlled Trial.
The goal of this clinical trial is to evaluate the efficacy of Fu's Subcutaneous Needling (FSN) in carpal tunnel syndrome (CTS). The main questions it aims to answer are:
- Dose FSN improve the symptoms of CTS?
- Dose FSN decrease cross section area of median nerve in CTS patients?
- Dose FSN have the effect of electrophysiology exam in CTS patients? Participants will receive wrist splinting and FSN treatment respectively. Researchers will compare wrist splinting group with FSN group to see if FSN being effective for CTS.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- wrist splinting, FSN
- Keywords
- Fu's Subcutaneous Needling, 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.
wrist splintingDevice
standard wrist splinting at night for 2 weeks
FSNDevice
FSN is a single-use disposable needle(Trocar Acupuncture Needle, Nanjing FSN Medical Co. , Ltd, China.). The needle body is solid, and covered with a plastic tube. The needle penetrates the skin with insertion device. Under the guidance of ultrasound, the needle enter the loose subcutaneous layer obliquely without penetrating into the muscle. This is the difference from traditional acupuncture. The insertion point is midpoint of the anterior forearm. The needle tip is toward the carpal tunnel. After the needle is inserted, SM and RA are performed. The frequency of SM is 200 times in two minutes. The method of SM is to make a horizontal fan swaying with the base of the needle as the fulcrum. RA is performed while SM-slowly make a fist for 10 seconds and then relax for 5 seconds. Eight times of RA in two minutes. After the FNS treatment, the needle was withdrawn.
| Study group | Role | What they receive |
|---|---|---|
| wrist splinting group | Experimental | wrist splinting at night for 2 weeks Receives: Device: wrist splinting |
| FSN group | Experimental | The needle inserted at the midpoint of the anterior forearm of the affected side. Swaying movement (SM) frequency is 200 times in 2 minutes. Reperfusion approach (RA) was performed with slow repetitively grasping movement while SM. On the 1st, 2nd, and 4th days, three times of FSN treatment were arranged. Receives: Device: FSN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Boston Carpal Tunnel Questionnaire (BCTQ)
BCTQ
Measured: Change from baseline at one month after treatment.
Change of electrophysiology exam
Exam of motor latency
Measured: Change from baseline at one month after treatment.
Change of cross section area of median nerve in ultrasound
cross section area of median nerve
Measured: Change from baseline at one month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start20 Aug 2023
- Primary completion20 Nov 2024 (estimated)
- Study completion20 Jun 2025 (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 China Medical University HospitalThe 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
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chih Ying Wu, MD, Study chair, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627349
- Sponsor's protocol ID
- CMUH111-REC2-065
- Status last verified
- Aug 2023
- First submitted
- 15 Nov 2022
- Last updated
- 30 Aug 2023
- 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 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation for Fu's Subcutaneous Needling in Carpal Tunnel Syndrome: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05627349
- Acronym / sponsor ID
- CMUH111-REC2-065
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Fu's Subcutaneous Needling, carpal tunnel syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- 20 Nov 2024 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 25 Nov 2022 (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 goal of this clinical trial is to evaluate the efficacy of Fu's Subcutaneous Needling (FSN) in carpal tunnel syndrome (CTS). The main questions it aims to answer are:
- Dose FSN improve the symptoms of CTS?
- Dose FSN decrease cross section area of median nerve in CTS patients?
- Dose FSN have the effect of electrophysiology exam in CTS patients? Participants will receive wrist splinting and FSN treatment respectively. Researchers will compare wrist splinting group with FSN group to see if FSN being effective for CTS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wrist splinting group | Experimental | Device: wrist splintingwrist splinting at night for 2 weeks |
| FSN group | Experimental | Device: FSNThe needle inserted at the midpoint of the anterior forearm of the affected side. Swaying movement (SM) frequency is 200 times in 2 minutes. Reperfusion approach (RA) was performed with slow repetitively grasping movement while SM. On the 1st, 2nd, and 4th days, three times of FSN treatment were arranged. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged 20-85 years old.
- Meet the diagnosis of mild to moderate carpal tunnel syndrome.
- If the patient has carpal tunnel syndrome in both hands, choose the side with mild or moderate carpal tunnel syndrome.
- After being explained, join the trial voluntarily and sign the subject's consent form.
Key exclusion criteria (9 listed)
- Caused by trauma or mass lesion.
- Thenar muscle atrophy.
- Electrophysiological examination revealed severe CTS.
- Chronic kidney disease, rheumatoid arthritis, abnormal thyroid function, diabetes.
- Psychiatric history or incapable of cooperating with the investigator.
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 |
|---|---|---|
| wrist splintingstandard wrist splinting at night for 2 weeks | Device | wrist splinting group |
| FSNFSN is a single-use disposable needle(Trocar Acupuncture Needle, Nanjing FSN Medical Co. , Ltd, China.). The needle body is solid, and covered with a plastic tube. The needle penetrates the skin with insertion device. Under the guidance of ultrasound, the needle enter the loose subcutaneous layer obliquely without penetrating into the muscle. This is the difference from traditional acupuncture. The insertion point is midpoint of the anterior forearm. The needle tip is toward the carpal tunnel. After the needle is inserted, SM and RA are performed. The frequency of SM is 200 times in two minutes. The method of SM is to make a horizontal fan swaying with the base of the needle as the fulcrum. RA is performed while SM-slowly make a fist for 10 seconds and then relax for 5 seconds. Eight times of RA in two minutes. After the FNS treatment, the needle was withdrawn. | Device | FSN group |
Primary outcome
Change of Boston Carpal Tunnel Questionnaire (BCTQ)
Time frame: Change from baseline at one month after treatment.
BCTQ
Change of electrophysiology exam
Time frame: Change from baseline at one month after treatment.
Exam of motor latency
Change of cross section area of median nerve in ultrasound
Time frame: Change from baseline at one month after treatment
cross section area of median nerve
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- 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.
Chih Ying Wu, MD study chair
China Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wrist splinting and FSN in people with Carpal Tunnel Syndrome, run by China Medical University Hospital 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 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 30 Aug 2023. 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?
Contact Chih Ying Wu, MD (+886 4 2205 2121 ext. 5094, zingwu1029@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Boston Carpal Tunnel Questionnaire (BCTQ) (time frame: Change from baseline at one month after treatment.). The study lists 3 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 30 Aug 2023.