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.

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.

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Device: wrist splinting; Device: FSN

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chih Ying Wu, MD; Phone Number: 5094 +886 4 2205 2121; Email: zingwu1029@gmail.com

Study Locations

• Taiwan
  • Hsinchu County
    • Zhubei, Hsinchu County, Taiwan, 302
      • Recruiting
      • China Medical University Hsinchu Hospital
      • Contact: Chih-Ying Wu, MD; Phone Number: 5094 +886 4 2205 2121; Email: zingwu1029@gmail.com
      • Principal Investigator: Chih Ying Wu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Study Chair: Chih Ying Wu, MD, China Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2023
• Primary Completion (Estimated): November 20, 2024
• Study Completion (Estimated): June 20, 2025

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 23, 2022
• First Posted (Actual): November 25, 2022

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Fu's Subcutaneous Needling, carpal tunnel syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: CMUH111-REC2-065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No