Laser Acupuncture for Postpartum Weight Retention

NCT ID: NCT02840916

Last Updated: 2017-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-12-31

Brief Summary

Objective: To determine the therapeutic effect of acupuncture on postpartum weight retention.

Methods: 66 subjects after delivery with postpartum weight retention will be randomly divided into laser acupuncture and control group. A single-blind clinical trial will be conducted and the subjects will be treated with verum or sham laser acupuncture 5 sessions per week. After about 3 weeks of treatment, the differences of the subjects' body weight, body mass index, and waist circumference will be analyzed with ANOVA between laser acupuncture and control group.

Detailed Description

Objective: Gestational weight gain and weight retention at 1 year after delivery are associated with long-term obesity. The investigators aimed to investigate the effect of laser acupuncture therapy (LAT) on postpartum weight control.

Methods: The investigators randomly assigned 66 subjects with postpartum weight retention to a laser acupuncture group and control group. The subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25 (Tianshu), ST28 (Shuidao), ST40 (Fenglong), SP15 (Daheng), CV9 (Shuifen), and SP6 (Sanyinjiao) by using verum or sham laser acupuncture over 5 sessions per week. After 12 treatment sessions, the differences in the body mass index (BMI), body fat percentage (BFP), and waist-to-buttocks ratio (WBR) of the patients were analyzed, and compared between the laser acupuncture and control groups via analysis of variance, chi-square tests, and stepwise regression tests.

Conditions

Postpartum Weight Retention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

verum laser acupuncture

verum laser acupuncture

Group Type: EXPERIMENTAL

laser acupuncture

Intervention Type: PROCEDURE

Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total.

sham laser acupuncture

sham laser acupuncture (no laser output)

Group Type: SHAM_COMPARATOR

sham laser acupuncture

Intervention Type: PROCEDURE

Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group.

Interventions

laser acupuncture

Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total.

Intervention Type: PROCEDURE

sham laser acupuncture

Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group.

Intervention Type: PROCEDURE

Other Intervention Names

low-level laser therapy

Eligibility Criteria

Inclusion Criteria

• postpartum duration of <1 month;
• body mass index (BMI) > 25;
• age > 20 years;
• did not use any other medications for weight loss during the study period; and
• provided informed consent.

Exclusion Criteria

• presence of a pacemaker;
• history of seizure or epilepsy;
• taking immunosuppressant medication;
• cancer;
• infectious disease of the skin;
• taking medications for weight loss, including Chinese herbal preparations, during the study period;
• receiving other treatment, including supplements, herbs, and medications for weight gain prior to entering the study;
• comorbidities (hypothyroidism, renal disease, etc.) that the physician believes would affect the findings;
• unable to undergo LAT due to other medical conditions; and
• lack of informed consent.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wen-Long Hu

Deputy director, Department of Chinese Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Countries

Taiwan

References

Hu WL, Chang CH, Hung YC. Clinical observations on laser acupuncture in simple obesity therapy. Am J Chin Med. 2010;38(5):861-7. doi: 10.1142/S0192415X10008305.

Reference Type: RESULT

PMID: 20821818 (View on PubMed)

Other Identifiers

CMRPG8C0691

Identifier Type: -

Identifier Source: org_study_id