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

Sponsor

China Medical University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05627349

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome	Device: wrist splinting Device: FSN	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 20, 2022

Anticipated Primary Completion Date :

Nov 20, 2024

Anticipated Study Completion Date :

Jun 20, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: wrist splinting group wrist splinting at night for 2 weeks	Device: wrist splinting standard wrist splinting at night for 2 weeks
Experimental: FSN group 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.	Device: 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.

Arm

Intervention/Treatment

Experimental: wrist splinting group

wrist splinting at night for 2 weeks

Device: wrist splinting

standard wrist splinting at night for 2 weeks

Experimental: FSN group

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.

Device: 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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.
History of substance abuse or long-term steroid use.
History of median nerve surgery.
Those who do not sign the consent form.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

China Medical University Hospital

Investigators

Study Chair: Chih Ying Wu, MD, China Medical University, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

China Medical University Hospital

ClinicalTrials.gov Identifier:

NCT05627349

Other Study ID Numbers:

CMUH111-REC2-065

First Posted:

Nov 25, 2022

Last Update Posted:

Nov 25, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by China Medical University Hospital

Fu's Subcutaneous Needling, carpal tunnel syndrome

Additional relevant MeSH terms:

Carpal Tunnel Syndrome

Syndrome

Study Results

No Results Posted as of Nov 25, 2022