Safety and effectiveness of fluoroscopy-guided acupotomy for carpal tunnel syndrome

Safety and effectiveness of fluoroscopy-guided acupotomy for carpal tunnel syndrome; a randomized, patient-assessor blind, parallel clinical trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003067

Enrollment

Registered

2018-08-06

Start date

2018-03-28

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(acupotomy) : Apply acupotomy to PC7. Pull out the needle after stimulation. Treatment group: Use fluoroscopy-guided acupotomy. Control group: Apply acupotomy without using fluoroscopy. Shoot X

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Male and female aged 20 to 69 ? Having numbness, tingling, nyctalgia symptom in the hand area with VAS over 5 ? Positive in Tinel’s sign or Phalen’s sign ? Cross-section area of medial nerve over 10mm2 measured by ultrasonography

Exclusion criteria

Exclusion criteria: ? Patients who had surgery for treating carpal tunnel syndrome. ? Patients who has physical abnormality in carpal tunnel such as tumor or malunion. ? Patients who are taking medicine related to mental disorder, immune disease, or diabetes. ? Patients who are taking adrenocortical hormone or nonsteroidal inflammatory analgesic to treat carpal tunnel syndrome. In case of taking inflammatory analgesic, the patient has to stop taking the medicine 1 week prior to enroll in the study. ? Patients who has skin allergy or skin infection. ? Patients who are insulin-treated diabetic patient, has cardiovascular disease or wearing a pacemaker, or has kindney disease. ? Pregnant women, lactating women, who are positive in pregnancy test before random allocation, and who do not agree to use medically appropriate contraceptives (e.g., oral medication, hormone implants, intrauterine devices, condoms, or spermicides) ? Patients deemed by a clinical research investigator to be inappropriate for participation in the clinical trial

Design outcomes

Primary

Measure	Time frame
Allevation of pain measured by Visual Analogue Scale(VAS)	—

Secondary

Measure	Time frame
Improvement of Nerve conduction velocity(NCV) test;Improvement of Tinel test;Improvement of Phalen’s test;EuroQol-5D(EQ-5D);Cross-section area of medial nerve measured by ultrasonography;Boston Carpal Tunnel Syndrome Questionnaire(BCTQ) score;Vital sign;Electrocardiography;Blood test, general chemical test, urine test;Grip strength test	—

Countries

Korea, Republic of

Contacts

Public ContactJae Kyoun Kim

Wonkwang University, Gwangju Medical Center

jaekyoun.kim@gmail.com+82-62-670-6406

Outcome results