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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05627349
• Other study ID #: CMUH111-REC2-065
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2023
• Est. completion date: June 20, 2025

Study information

• Verified date: August 2023
• Source: China Medical University Hospital
• Contact: Chih Ying Wu, MD
• Phone: +886 4 2205 2121
• Email: zingwu1029[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 20, 2025
• Est. primary completion date: November 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Device:
• wrist splinting
standard wrist splinting at night for 2 weeks
• FSN
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.

Locations

Country	Name	City	State
Taiwan	China Medical University Hsinchu Hospital	Zhubei	Hsinchu County

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Boston Carpal Tunnel Questionnaire (BCTQ)	BCTQ	Change from baseline at one month after treatment.
Primary	Change of electrophysiology exam	Exam of motor latency	Change from baseline at one month after treatment.
Primary	Change of cross section area of median nerve in ultrasound	cross section area of median nerve	Change from baseline at one month after treatment