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

China Medical University

Status: Enrolling

Conditions: Carpal Tunnel Syndrome

Treatments: Device: FSN; Device: wrist splinting

Study type: Interventional

Funder types: Other

Identifiers

NCT05627349

CMUH111-REC2-065

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

wrist splinting group

Experimental group

Description:

wrist splinting at night for 2 weeks

Treatment:

Device: wrist splinting

FSN group

Experimental group

Description:

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.

Treatment:

Device: FSN