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
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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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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.
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.
- Change of Boston Carpal Tunnel Questionnaire (BCTQ) [ Time Frame: Change from baseline at one month after treatment. ]BCTQ
- Change of electrophysiology exam [ Time Frame: Change from baseline at one month after treatment. ]Exam of motor latency
- 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|
- 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.
- 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.
- History of substance abuse or long-term steroid use.
- History of median nerve surgery.
- Those who do not sign the consent form.
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
|Contact: Chih Ying Wu, MD||+886 4 2205 2121 ext email@example.com|
|China Medical University Hsinchu Hospital|
|Zhubei, Hsinchu County, Taiwan, 302|
|Contact: Chih-Ying Wu, MD +886 4 2205 2121 ext 5094 firstname.lastname@example.org|
|Principal Investigator: Chih Ying Wu, MD|
|Study Chair:||Chih Ying Wu, MD||China Medical University, China|
|Responsible Party:||China Medical University Hospital|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Fu's Subcutaneous Needling, carpal tunnel syndrome
Carpal Tunnel Syndrome
Peripheral Nervous System Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries