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

NCT05627349 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-08-30

No results posted yet for this study

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.

Conditions

  • Carpal Tunnel Syndrome

Interventions

DEVICE

wrist splinting

standard wrist splinting at night for 2 weeks

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 After the FNS treatment, the needle was withdrawn.

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Principal Investigators

  • Chih Ying Wu, MD · China Medical University, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-20
Primary Completion
2024-11-20
Completion
2025-06-20

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05627349 on ClinicalTrials.gov