Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

March 18, 2026 updated by: Chang Gung Memorial Hospital

Effects of a Multi-acupoint Laser Therapy Device on Body Shape and Body Composition in Obese Menopausal Women

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

*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

  • Secondary Endpoints: Menopausal symptoms (Menopause Rating Scale, MRS), Satiety levels (Visual Analog Scale, VAS)
  • Assessments:

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

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Taiwan
      • Keelung, Taiwan, Taiwan
        • Recruiting
        • Chang Gung Memorial Hospital, Keelung Medical Center
        • Contact:
          • Yu Wei Chang
          • Phone Number: +886 975360678

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female participants aged 45 to 55 years
  • No cognitive impairment or major psychiatric disorder
  • Able to understand the study procedures and communicate with research staff
  • Body mass index (BMI) > 24 kg/m² OR waist-to-hip ratio > 0.88

Exclusion Criteria:

  • Pregnant or possibly pregnant women
  • Diagnosed chronic diseases currently under active treatment, including hepatitis, chronic kidney disease, chronic gastrointestinal disease, cardiovascular disease, or cancer
  • Systemic diseases such as hyperthyroidism, hypothyroidism, compensated liver cirrhosis, or autoimmune disorders
  • Currently receiving weight control treatment, including bariatric surgery or weight-loss medications
  • History of epilepsy or seizure disorder
  • Coagulation disorders or current use of anticoagulant therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser Acupuncture Group
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.
Device: Multi-acupoint low-level laser therapy
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).
Behavioral: Diet and exercise guidance
WHO guideline-based diet and exercise counseling; weekly 5-10 minute sessions including waist, hip, and body composition monitoring.
Sham Comparator: Control Group
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.
Behavioral: Diet and exercise guidance
WHO guideline-based diet and exercise counseling; weekly 5-10 minute sessions including waist, hip, and body composition monitoring.
Device: Sham Laser irradiation
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body fat mass
Time Frame: Baseline, Week 3, Week 4, and Week 6
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body weight
Time Frame: Baseline, Week 3, Week 4, and Week 6
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)
Time Frame: Baseline and Week 6
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)
Time Frame: Baseline and Week 6
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
Time Frame: Baseline
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
Time Frame: Baseline, Week 3, Week 4, and Week 6
Skeletal muscle mass (kg) measured using the InBody body composition analyzer.
Baseline, Week 3, Week 4, and Week 6
Change in body fat percentage
Time Frame: Baseline, Week 3, Week 4, and Week 6
Body fat percentage (%) measured using the InBody body composition analyzer.
Baseline, Week 3, Week 4, and Week 6
Change in waist-to-hip ratio
Time Frame: Baseline, Week 3, Week 4, and Week 6
Waist-to-hip ratio calculated from waist and hip circumference measurements.
Baseline, Week 3, Week 4, and Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2026

Primary Completion (Estimated)

January 24, 2029

Study Completion (Estimated)

January 24, 2029

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202501462A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not applicable - this is a small, non-commercial pilot study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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