Clinical trial to evaluate the efficacy and safety of Mae-sun therapy on patients with carpal tunnel syndrome

A 4-week, randomized, single blind, investigator-initiated medical device clinical trial to evaluate the efficacy and safety of Mae-sun therapy on patients with Carpal Tunnel Syndrome

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0003312

Enrollment

Registered

2018-11-02

Start date

2019-05-31

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

Medical Device : 1. Number of treatments: total 4 times (Treatment once a week) 2. Acupuncture usage: 2~5 per 1 treatment 3. Acupuncture treatment method 1) Experimental group - Mae-sun acupuncture

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults over twenty (male and female), more than 40 points in 100mm VAS(visual analogue scale). 2. Those who show positive sign on Tinel's sign, phalen's test, carpal tunnel pressure test. 3. Those who free from language and speech and concentration. 4. Agreed with written informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. A past surgeon on a hand or wrist diagnosed with carpal tunnel syndrome 2. Carpal tunnel syndrome came as a result of trauma 3. A person who similar diseases and symptom to those of carpal tunnel syndrome and on history . 4. Fracture of wrist recently or in the past. 5. A person diagnosed as cubital tynnel syndrome in the result of EMG (electromyogram). 6. If there are anatomical variations without established ultrasonic measurement methods (ex., bifid median nerves, aberrant persistent median artery etc.). 7. Martin-Gruber or median nerve and ulnar nerves ar combined. 8. A carpal tunnel syndrome patient who received treatment for local steroids within the last six months. 9. Those who were considered as unsuitable for participation by the researcher .

Design outcomes

Primary

Measure	Time frame
Change of 100mm VAS(visual analog scale)	—

Secondary

Measure	Time frame
Change of 100mm VAS(visual analog scale);Ratio of subjects whose 100mm VAS(visual analog sclae) has decreased by more than 50 percent from the baseline for each visit;Ratio of subjects whose 100mm VAS(visual analog sclae) has decreased by more than 30 percent from the baseline for each visit;Boston carpal tunnel syndrome Questionnaire (BCTQ);SF(Short-Foam)-36 health survey;Patient Global Impression of Change (PGIC)	—

Measure

Time frame

Change of 100mm VAS(visual analog scale);Ratio of subjects whose 100mm VAS(visual analog sclae) has decreased by more than 50 percent from the baseline for each visit;Ratio of subjects whose 100mm VAS(visual analog sclae) has decreased by more than 30 percent from the baseline for each visit;Boston carpal tunnel syndrome Questionnaire (BCTQ);SF(Short-Foam)-36 health survey;Patient Global Impression of Change (PGIC)

—

Countries

Korea, Republic of

Contacts

Public ContactYoung Kwon

Wonkwang University, Gwangju Medical Center

exeterin@naver.com+82-62-670-6451

Outcome results