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The Evaluation for Fu's Subcutaneous Needling (FSN) in Carpal Tunnel Syndrome.

The Evaluation for Fu's Subcutaneous Needling in Carpal Tunnel Syndrome: a Randomized Controlled Trial.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05627349
Enrollment
60
Registered
2022-11-25
Start date
2023-08-20
Completion date
2025-06-20
Last updated
2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

Keywords

Fu's Subcutaneous Needling, carpal tunnel syndrome

Brief 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 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.

Interventions

standard wrist splinting at night for 2 weeks

DEVICEFSN

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 After the FNS treatment, the needle was withdrawn.

Sponsors

China Medical University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

1. Male or female aged 20-85 years old. 2. Meet the diagnosis of mild to moderate carpal tunnel syndrome. 3. If the patient has carpal tunnel syndrome in both hands, choose the side with mild or moderate carpal tunnel syndrome. 4. After being explained, join the trial voluntarily and sign the subject's consent form.

Exclusion criteria

1. Caused by trauma or mass lesion. 2. Thenar muscle atrophy. 3. Electrophysiological examination revealed severe CTS. 4. Chronic kidney disease, rheumatoid arthritis, abnormal thyroid function, diabetes. 5. Psychiatric history or incapable of cooperating with the investigator. 6. Pregnancy. 7. History of substance abuse or long-term steroid use. 8. History of median nerve surgery. 9. Those who do not sign the consent form.

Design outcomes

Primary

MeasureTime frameDescription
Change of electrophysiology examChange from baseline at one month after treatment.Exam of motor latency
Change of cross section area of median nerve in ultrasoundChange from baseline at one month after treatmentcross section area of median nerve
Change of Boston Carpal Tunnel Questionnaire (BCTQ)Change from baseline at one month after treatment.BCTQ

Countries

Taiwan

Contacts

Primary ContactChih Ying Wu, MD
zingwu1029@gmail.com+886 4 2205 2121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026