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The purpose of this study is to integrate Traditional Chinese Medicine (TCM) theory and therapeutic methods with modern low-level laser stimulation on corresponding acupoints, applying this combined approach to the field of weight management in menopausal women. The trial aims to investigate whether lifestyle modifications in accordance with WHO guidelines (dietary control and exercise), combined with adjunctive low-level laser acupuncture, can enhance weight reduction and improve body composition more effectively than standard lifestyle interventions alone.
*Study Objective: Investigate the effects of multi-acupoint low-level laser therapy on body composition in obese menopausal women, combining traditional Chinese medicine theory with laser stimulation of specific acupoints, alongside lifestyle interventions including diet and exercise according to WHO guidelines.
*Participants: Total: 40 women, aged 45-55 years BMI > 24 kg/m² or waist-to-hip ratio > 0.88 Recruited from the outpatient clinic Randomly assigned to either the laser acupuncture group or control group
*Intervention: Experimental group: 12 sessions of laser acupuncture over 6 weeks Each session: 30 minutes, targeting 10 acupoints related to weight management Both groups: standardized diet and exercise guidance per WHO recommendations
*Primary Endpoints: Body composition changes:Body fat mass, Body fat percentage, Skeletal muscle mass, Total body weight, Limb muscle mass, Waist-to-hip ratio
Conducted at baseline, mid-treatment, and post-treatment Safety and tolerability monitored throughout the study
*Statistical Analysis: Software: SPSS Methods: Independent t-tests, paired t-tests, Chi-square tests, correlation, regression analyses Significance: p < 0.05
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser Acupuncture Group | Experimental | Participants receive multi-acupoint low-level laser therapy combined with diet and exercise guidance. Treatment is delivered twice weekly for 6 weeks (12 sessions total), targeting 10 specific acupoints related to weight management. Body composition and menopausal symptom assessments will be conducted at baseline, mid-treatment, and post-treatment. |
|
| Control Group | Sham Comparator | Participants receive sham laser treatment combined with diet and exercise guidance. The sham procedure mimics the appearance and treatment process of active laser therapy but does not emit therapeutic laser energy. Participants will receive treatment twice weekly for 6 weeks (12 sessions total). Body composition and menopausal symptom assessments will be conducted at baseline, mid-treatment, and post-treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-acupoint low-level laser therapy | Device | Low-level laser therapy, 780 nm wavelength, 30 minutes per session, 12 sessions over 6 weeks, targeting 10 acupoints: bilateral Shenshu (BL23), Sanyinjiao (SP6), Tianshu (ST25), Shuifen (CV9), Guanyuan (CV4), and Dàdài (GB26). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body fat mass | Body fat mass (kg) measured using bioelectrical impedance analysis (InBody body composition analyzer). Measurements will be performed by trained research staff. | Baseline, Week 3, Week 4, and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Body weight (kg) measured using the InBody body composition analyzer. | Baseline, Week 3, Week 4, and Week 6 |
| Change in menopausal symptoms (Menopause Rating Scale score) |
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Inclusion Criteria:
Exclusion Criteria:
Sex: Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Wei Chang | Contact | 886-02-24313131#2677 | yenlin@cgmh.org.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital, Keelung Medical Center | Recruiting | Keelung | Taiwan | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 衛生福利部國民健康署. 婦女更年期保健手冊 - 更年期不適症狀評估量表. (Taipei: 國民健康署). Year. | ||
| Result | Gong Y-Y, Guo B-Z, et al. 更年期證型與自律神經相關性研究. 中醫藥雜誌. 2012;23(1). DOI: 10.6940/JCM.201206_23(1).01. | ||
| Result | Comparing the Efficacy of a Dual-Frequency LLLT Device With a Sham Device as a Therapy for Adipose Tissue Loss. ClinicalTrials.gov Identifier: NCT03811093. | ||
| 31473867 | Result | Croghan IT, Hurt RT, Schroeder DR, Fokken SC, Jensen MD, Clark MM, Ebbert JO. Low-level laser therapy for weight reduction: a randomized pilot study. Lasers Med Sci. 2020 Apr;35(3):663-675. doi: 10.1007/s10103-019-02867-5. Epub 2019 Aug 31. | |
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Not applicable - this is a small, non-commercial pilot study
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Random 1:1 allocation: Experimental vs. Control Experimental group: Laser acupuncture + diet/exercise Control group: Sham laser + diet/exercise Assessments at baseline, mid-treatment, post-treatmen
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Both participants and investigators administering the treatment will be blinded to group assignment.
The control group will receive a sham laser treatment that mimics the appearance and procedure of the active laser therapy but does not emit therapeutic laser energy.
Outcome assessors will also be blinded to group allocation to reduce assessment bias.
| Sham Laser irradiation | Device | Sham laser treatment that mimics the appearance and procedure of active low-level laser therapy but does not emit therapeutic laser energy. Sessions are conducted twice weekly for 6 weeks (12 sessions total). |
|
| Diet and exercise guidance | Behavioral | WHO guideline-based diet and exercise counseling; weekly 5-10 minute sessions including waist, hip, and body composition monitoring. |
|
Menopausal symptoms assessed using the validated Traditional Chinese version of the Menopause Rating Scale (MRS). The MRS consists of 11 items scored from 0-4, total score range 0-44, with higher scores indicating more severe symptoms.
| Baseline and Week 6 |
| Change in satiety level (Visual Analog Scale) | Satiety level assessed using a 100-mm visual analog scale (VAS), where 0 indicates "not satisfied at all" and 100 indicates "extremely satisfied." Participants will rate their average satiety over the past 7 days. | Baseline and Week 6 |
| Menopausal constitution classification score | Menopausal constitution assessed using the 37-item Questionnaire of Menopausal Constitution. Scores are calculated according to published scoring criteria, with transformed scores ranging from 0-100 for six constitution types. | Baseline |
| Change in skeletal muscle mass | Skeletal muscle mass (kg) measured using the InBody body composition analyzer. | Baseline, Week 3, Week 4, and Week 6 |
| Change in body fat percentage | Body fat percentage (%) measured using the InBody body composition analyzer. | Baseline, Week 3, Week 4, and Week 6 |
| Change in waist-to-hip ratio | Waist-to-hip ratio calculated from waist and hip circumference measurements. | Baseline, Week 3, Week 4, and Week 6 |
| Result |
| Heinemann LA, Potthoff P, Schneider HP. International versions of the Menopause Rating Scale (MRS). Health Qual Life Outcomes. 2003 Jul 30;1:28. doi: 10.1186/1477-7525-1-28. |
| 26425364 | Result | El-Mekawy HS, ElDeeb AM, Ghareib HO. Effect of laser acupuncture combined with a diet-exercise intervention on metabolic syndrome in post-menopausal women. J Adv Res. 2015 Sep;6(5):757-63. doi: 10.1016/j.jare.2014.08.002. Epub 2014 Aug 19. |
| 39138739 | Result | Kamal WM, Maged AM, AbdelAziz S, Mahmoud SI, Mohsen RA. The effects of laser acupuncture on metabolic syndrome in obese postmenopausal women: a randomized controlled study. Lasers Med Sci. 2024 Aug 14;39(1):215. doi: 10.1007/s10103-024-04158-0. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |