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This research is planned to build a basis about the effect of acupuncture on serum metabolic parameters in pre-menopausal obese women with economic evaluation.
It is consisted with two sub research.
First, clinical research to assess the effect of acupuncture for obesity on serum metabolic parameters will be processed with randomized, patient-assessor blinding, and sham-acupuncture controlled study design. 120 subjects would be collected and divided into two groups(experimental and placebo, 60 subjects each). Experimental group will undergo with real acupuncture treatment(manual acupuncture + electroacupuncture) twice a week, for 6 weeks. The effect on serum metabolic parameters will be assessed at 0 and 6 weeks.
Second is qualitative research to make a basis through the evaluation of economic efficacy and patients' satisfaction with acupuncture treatment for obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real acupuncture | Experimental | manual acupuncture + electroacupuncture, twice a week, for 6 weeks |
|
| Sham acupuncture | Sham Comparator | sham acupuncture + placebo acupuncture without electrical stimulation, twice a week, for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real acupuncture | Device | manual acupuncture (bilateral LI4, LI11, SP6, ST25, ST28, ST36) + electroacupuncture (middle CV6, CV12), twice a week, for 6 weeks common approaches for the treatment of obesity used by doctors of Korean medicine in Korea today |
| Measure | Description | Time Frame |
|---|---|---|
| change in serum metabolic profile | before treatment at week1 (baseline) and after treatment at week6 (endpoint) |
| Measure | Description | Time Frame |
|---|---|---|
| change in body weight | using bioelectrical impedance analysis (BIA) | baseline, 1, 2, 3, 4, 5, and 6 weeks |
| change in body fat mass | using bioelectrical impedance analysis (BIA) |
| Measure | Description | Time Frame |
|---|---|---|
| change in Measure Yourself Medical Outcome Profile (MYMOP) | outcome measure for the evaluation of patients' satisfaction and economic efficacy in secondary sub-study | baseline, 1, 2, 3, 4, 5, and 6 weeks |
| change in EuroQol-5 Dimension (EQ-5D) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mi-Yeon Song, Ph.D. | Department of Rehabilitation Medicine of Korean Medicine, Kyung Hee University Gangdong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Korean Medicine Hospital at Gangdong | Seoul | 134-727 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32299241 | Derived | Kim KW, Shin WC, Choi MS, Cho JH, Park HJ, Yoo HH, Song MY. Effects of acupuncture on anthropometric and serum metabolic parameters in premenopausal overweight and obese women: a randomized, patient- and assessor-blind, sham-controlled clinical trial. Acupunct Med. 2021 Feb;39(1):30-40. doi: 10.1177/0964528420912259. Epub 2020 Apr 17. | |
| 26238111 |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Sham acupuncture | Device | sham acupuncture (bilateral LI4, LI11, SP6, ST25, ST28, ST36) + placebo acupuncture without electrical stimulation (middle CV6, CV12), twice a week, for 6 weeks sham acupuncture (0.25mm diameter x 40mm length, stainless steel, Acuprime, UK) as control for manual acupuncture (0.25mm diameter x 40mm length, stainless steel, Dongbangacupuncture Inc., Korea) placebo acupuncture without electrical stimulation as control for electroacupuncture (0.25mm diameter x 90mm length, stainless steel, Dongbangacupuncture Inc., Korea) |
|
| baseline, 1, 2, 3, 4, 5, and 6 weeks |
| change in muscle mass | using bioelectrical impedance analysis (BIA) | baseline, 1, 2, 3, 4, 5, and 6 weeks |
| change in waist circumference | baseline, 1, 2, 3, 4, 5, and 6 weeks |
| change in hip circumference | baseline, 1, 2, 3, 4, 5, and 6 weeks |
| change in Beck Depression Index (BDI) | baseline and 6 weeks |
| change in Social Readjustment Rating Scale (SRRS) | baseline and 6 weeks |
| change in Stress Response Inventory (SRI) | baseline and 6 weeks |
| change in International Physical Activity Questionnaire (IPAQ) | baseline and 6 weeks |
| change in Fatigue Severity Scale (FSS) | baseline, 1, 2, 3, 4, 5, and 6 weeks |
| heart rate variability (HRV) | just before treatment at visit1(baseline), 10 minutes after treatment at visit1, just before treatment at visit12 (6 weeks), 10 minutes after treatment at visit12(end point) |
| number of participants with adverse events |
| up to the end of study |
outcome measure for the evaluation of patients' satisfaction and economic efficacy in secondary sub-study
| baseline and 6 weeks |
| Kim KW, Yoo HH, Cho JH, Yang YC, Kim JI, Kim SY, Park JY, Park HJ, Song MY. Effects of acupuncture on serum metabolic parameters in premenopausal obese women: study protocol for a randomized controlled trial. Trials. 2015 Aug 4;16:327. doi: 10.1186/s13063-015-0867-y. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |