Effect of Laser Acupuncture on Metabolic Syndrome in Obese Postmenopausal Women

Metabolic Syndrome Clinical Trial

Official title:

Effect of Laser Acupuncture on Metabolic Syndrome in Obese Postmenopausal Women. A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05651451
• Other study ID #: 67
• Status: Completed
• Phase: N/A
• Start date: December 22, 2022
• Est. completion date: September 15, 2023

Study information

• Verified date: May 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Thirty postmenopausal women were collected from outpatient clinic of faculty of physical therapy in Benha University to participate in this study. Their ages were ranged from 55-65 years old and their body mass index (BMI) ranged from 30 to 34.9 Kg/m2. They were divided randomly into 2 equal groups; Group A: received diet regimen, Group B: received diet regimen and treated with laser acupuncture for 30 minutes, 3 sessions per week for two months

Description:

-Group A (control group): All post-menopausal women followed an energy-restricted diet for 8 weeks. Meal plan that creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat, sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as vitamins A, C and E.

II-Group B (study group):

All women in group (B) were received 24 activated laser acupuncture treatments. Treatments was performed 3 times per week for 8 weeks.Laser acupuncture was applied withwavelength of 810 nm, power output of 150 mW in continuous wave mode and energy density laser of 4 J/cm2 with irradiation time 3 min/point. Total duration of the training session was 30 minutes.Before starting the first treatment session, each woman was instructed briefly about the nature of the treatment to gain her confidence and cooperation. The surface of the treated skin was cleaned with alcohol wipe in order to remove any material that could absorb or disperse the radiationon the surface.The laser handheld device (laser beam spot size ≤ 36 mm2) was applied directly and perpendicularly to avoid scattering the beam, The Laser probe was applied to the surface of skin before switching on apparatus.

Laser acupuncture was applied on:

• Cv4 (Guanyuan) (3 cun inferior to the center of the umbilicus);

• Cv9 (Shuifen) (1 cun above the center of the umbilicus);

• Cv12 (Zhongwan) (4 cun above the center of the umbilicus);

• St25 (Tianshu) (2 cun lateral to the midline of the umbilicus);

• St36 (Zusanli) (one finger width lateral from the anterior crest of the tibia);

• Sp6 (Sanyinjiao) (3 cun directly above the tip of the medial malleolus);

• St40 (Fenglung) (8 cun superior to the tip of the external malleolus);

• LI4 (Hegu) (on the highest spot of the muscle when the thumb and index fingers are brought close together);

• LI11 (Quchi) (on the outside end of the crease on the elbow);

• and PC6 (Neiguan)( three finger breadths below the wrist on the inner forearm in between the two tendons.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 15, 2023
• Est. primary completion date: July 18, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

Inclusion Criteria:

• prehypertension and hypertension stage I

• overweight or obesity class I

• age 55 to 65 years

Exclusion Criteria:

• systolic blood pressure exceeding 159 mm Hg

• diastolic blood pressure exceeding 99 mm Hg,

• diabetic neuropathy disease,

• patients with mental or psychological disorders,

• skin disorders

• bleeding disorders

• musculoskeletal disorders

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Device:
• Laser acupuncture
24 activated laser acupuncture treatments. Treatments was performed 3 times per week for 8 weeks.Laser acupuncture was applied withwavelength of 810 nm, power output of 150 mW in continuous wave mode and energy density laser of 4 J/cm2 with irradiation time 3 min/point

Dietary Supplement:
• energy-restricted diet
All post-menopausal women followed an energy-restricted diet for 8 weeks. Meal plan that creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat, sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as vitamins A, C and E

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipid profile TG	Triglycerides in mmol/L will be measured	8 weeks after treatment
Primary	Lipid profile HDL	High density lipoprotein in mmol/L will be measured	8 weeks after treatment