Clinical Trials Directory

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UnknownNCT05627349

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

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
China Medical University Hospital · Academic / Other
Sex
All
Age
20 Years – 85 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DEVICEwrist splintingstandard wrist splinting at night for 2 weeks
DEVICEFSNFSN 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 After the FNS treatment, the needle was withdrawn.

Timeline

Start date
2023-08-20
Primary completion
2024-11-20
Completion
2025-06-20
First posted
2022-11-25
Last updated
2023-08-30

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT05627349. Inclusion in this directory is not an endorsement.