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

NCT05627349 | Unknown

• 1 other identifier: CMUH111-REC2-065
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

Fu's Subcutaneous Needling, carpal tunnel syndrome

Outcome Measures

Primary Outcomes (3)

• Change of Boston Carpal Tunnel Questionnaire (BCTQ)

  BCTQ

  Change from baseline at one month after treatment.

• Change of electrophysiology exam

  Exam of motor latency

  Change from baseline at one month after treatment.

• Change of cross section area of median nerve in ultrasound

  cross section area of median nerve

  Change from baseline at one month after treatment

Study Arms (2)

wrist splinting group

EXPERIMENTAL

wrist splinting at night for 2 weeks

Device: wrist splinting

FSN group

EXPERIMENTAL

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

Interventions

wrist splinting DEVICE

standard wrist splinting at night for 2 weeks

wrist splinting group

FSN DEVICE

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.

FSN group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hsinchu Hospital

Zhubei, Hsinchu County, 302, Taiwan

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Chih Ying Wu, MD

  China Medical University, China

  STUDY CHAIR

Central Study Contacts

Chih Ying Wu, MD

CONTACT

+886 4 2205 2121; zingwu1029@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 25, 2022
• Study Start: August 20, 2023
• Primary Completion: November 20, 2024
• Study Completion: June 20, 2025
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)