Trial Outcomes & Findings for Laser Acupuncture for Postpartum Weight Retention (NCT NCT02840916)
NCT ID: NCT02840916
Last Updated: 2017-01-16
Results Overview
The BMI was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks, and 3 months after study completion.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
66 participants
Primary outcome timeframe
up to 3 weeks, 3 months after study completion
Results posted on
2017-01-16
Participant Flow
Participant milestones
| Measure |
Verum Laser Acupuncture
verum laser acupuncture
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.
|
Sham Laser Acupuncture
sham laser acupuncture (no laser output)
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.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
32
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Laser Acupuncture for Postpartum Weight Retention
Baseline characteristics by cohort
| Measure |
Verum Laser Acupuncture
n=32 Participants
verum laser acupuncture
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.
|
Sham Laser Acupuncture
n=30 Participants
sham laser acupuncture (no laser output)
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.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34.88 years
STANDARD_DEVIATION 4.31 • n=5 Participants
|
35.70 years
STANDARD_DEVIATION 3.72 • n=7 Participants
|
35.28 years
STANDARD_DEVIATION 4.02 • n=5 Participants
|
|
Gender
Female
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Gender
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
32 participants
n=5 Participants
|
30 participants
n=7 Participants
|
62 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 3 weeks, 3 months after study completionThe BMI was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks, and 3 months after study completion.
Outcome measures
| Measure |
Verum Laser Acupuncture
n=32 Participants
verum laser acupuncture
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.
|
Sham Laser Acupuncture
n=30 Participants
sham laser acupuncture (no laser output)
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.
|
|---|---|---|
|
Body Mass Index (BMI)
baseline
|
33.62 kg/m^2
Standard Deviation 3.19
|
28.03 kg/m^2
Standard Deviation 3.04
|
|
Body Mass Index (BMI)
up to 3 weeks
|
26.90 kg/m^2
Standard Deviation 2.29
|
26.99 kg/m^2
Standard Deviation 3.45
|
|
Body Mass Index (BMI)
3 months after study completion
|
26.16 kg/m^2
Standard Deviation 2.40
|
26.64 kg/m^2
Standard Deviation 3.40
|
SECONDARY outcome
Timeframe: up to 3 weeksThe WBR was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks.
Outcome measures
| Measure |
Verum Laser Acupuncture
n=32 Participants
verum laser acupuncture
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.
|
Sham Laser Acupuncture
n=30 Participants
sham laser acupuncture (no laser output)
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.
|
|---|---|---|
|
Waist-to-buttock Ratio (WBR)
baseline
|
0.93 ratio
Standard Deviation 0.06
|
0.92 ratio
Standard Deviation 0.06
|
|
Waist-to-buttock Ratio (WBR)
up to 3 weeks
|
0.92 ratio
Standard Deviation 0.05
|
0.90 ratio
Standard Deviation 0.05
|
SECONDARY outcome
Timeframe: up to 3 weeksThe BFP was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks.
Outcome measures
| Measure |
Verum Laser Acupuncture
n=32 Participants
verum laser acupuncture
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.
|
Sham Laser Acupuncture
n=30 Participants
sham laser acupuncture (no laser output)
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.
|
|---|---|---|
|
Body Fat Percentage (BFP)
baseline
|
36.94 % of body weight
Standard Deviation 2.65
|
36.02 % of body weight
Standard Deviation 3.87
|
|
Body Fat Percentage (BFP)
up to 3 weeks
|
35.75 % of body weight
Standard Deviation 3.05
|
35.37 % of body weight
Standard Deviation 3.90
|
Adverse Events
Verum Laser Acupuncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Laser Acupuncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Wen-Long Hu
Kaohsiung Chang Gung Memorial Hospital
Phone: +886-7-731-7123
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place