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

Primary Purpose

Carpal Tunnel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
wrist splinting
FSN
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Fu's Subcutaneous Needling, carpal tunnel syndrome

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • China Medical University Hsinchu HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

wrist splinting group

FSN group

Arm Description

wrist splinting at night for 2 weeks

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.

Outcomes

Primary Outcome Measures

Change of Boston Carpal Tunnel Questionnaire (BCTQ)
BCTQ
Change of electrophysiology exam
Exam of motor latency
Change of cross section area of median nerve in ultrasound
cross section area of median nerve

Secondary Outcome Measures

Full Information

First Posted
November 15, 2022
Last Updated
August 28, 2023
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05627349
Brief Title
The Evaluation for Fu's Subcutaneous Needling (FSN) in Carpal Tunnel Syndrome.
Official Title
The Evaluation for Fu's Subcutaneous Needling in Carpal Tunnel Syndrome: a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2023 (Actual)
Primary Completion Date
November 20, 2024 (Anticipated)
Study Completion Date
June 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Fu's Subcutaneous Needling, carpal tunnel syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
wrist splinting group
Arm Type
Experimental
Arm Description
wrist splinting at night for 2 weeks
Arm Title
FSN group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
wrist splinting
Intervention Description
standard wrist splinting at night for 2 weeks
Intervention Type
Device
Intervention Name(s)
FSN
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Boston Carpal Tunnel Questionnaire (BCTQ)
Description
BCTQ
Time Frame
Change from baseline at one month after treatment.
Title
Change of electrophysiology exam
Description
Exam of motor latency
Time Frame
Change from baseline at one month after treatment.
Title
Change of cross section area of median nerve in ultrasound
Description
cross section area of median nerve
Time Frame
Change from baseline at one month after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chih Ying Wu, MD
Phone
+886 4 2205 2121
Ext
5094
Email
zingwu1029@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chih Ying Wu, MD
Organizational Affiliation
China Medical University, China
Official's Role
Study Chair
Facility Information:
Facility Name
China Medical University Hsinchu Hospital
City
Zhubei
State/Province
Hsinchu County
ZIP/Postal Code
302
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chih-Ying Wu, MD
Phone
+886 4 2205 2121
Ext
5094
Email
zingwu1029@gmail.com
First Name & Middle Initial & Last Name & Degree
Chih Ying Wu, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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