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

Not Applicable

Recruiting

• Conditions: Carpal Tunnel Syndrome
• Interventions: Device: wrist splinting; Device: FSN

• Registration Number: NCT05627349
• Lead Sponsor: China Medical University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-11-23
• Study First Posted: 2022-11-25
• Status Verified: 2023-08
• Study Start: 2023-08-20
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30
• Primary Completion: 2024-11-20
• Study Completion: 2025-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
wrist splinting group	wrist splinting	wrist splinting at night for 2 weeks
FSN group	FSN	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.

Primary Outcome Measures

Name	Time	Method
Change of Boston Carpal Tunnel Questionnaire (BCTQ)	Change from baseline at one month after treatment.	BCTQ
Change of electrophysiology exam	Change from baseline at one month after treatment.	Exam of motor latency
Change of cross section area of median nerve in ultrasound	Change from baseline at one month after treatment	cross section area of median nerve

Trial Locations

Locations (1)

China Medical University Hsinchu Hospital; 🇨🇳 Zhubei, Hsinchu County, Taiwan