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

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ClinicalTrials.gov Identifier: NCT05627349
Recruitment Status : Not yet recruiting
First Posted : November 25, 2022
Last Update Posted : February 8, 2023
Information provided by (Responsible Party):
China Medical University Hospital

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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Device: wrist splinting Device: FSN Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Evaluation for Fu's Subcutaneous Needling in Carpal Tunnel Syndrome: a Randomized Controlled Trial.
Estimated Study Start Date : February 20, 2023
Estimated Primary Completion Date : November 20, 2024
Estimated Study Completion Date : June 20, 2025

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.

Primary Outcome Measures :
  1. Change of Boston Carpal Tunnel Questionnaire (BCTQ) [ Time Frame: Change from baseline at one month after treatment. ]

  2. Change of electrophysiology exam [ Time Frame: Change from baseline at one month after treatment. ]
    Exam of motor latency

  3. Change of cross section area of median nerve in ultrasound [ Time Frame: Change from baseline at one month after treatment ]
    cross section area of median nerve

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05627349

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Contact: Chih Ying Wu, MD +886 4 2205 2121 ext 5094 zingwu1029@gmail.com

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China Medical University Hsinchu Hospital
Zhubei, Hsinchu County, Taiwan, 302
Contact: Chih-Ying Wu, MD    +886 4 2205 2121 ext 5094    zingwu1029@gmail.com   
Principal Investigator: Chih Ying Wu, MD         
Sponsors and Collaborators
China Medical University Hospital
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Study Chair: Chih Ying Wu, MD China Medical University, China
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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT05627349    
Other Study ID Numbers: CMUH111-REC2-065
First Posted: November 25, 2022    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by China Medical University Hospital:
Fu's Subcutaneous Needling, carpal tunnel syndrome
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Pathologic Processes
Median Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries