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CompletedNCT05651451Updated May 31, 2024

Effect of Laser Acupuncture on Metabolic Syndrome in Obese Postmenopausal Women

An interventional study of Laser acupuncture and energy-restricted diet in Metabolic Syndrome, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 50 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-31.

Sponsored by Cairo University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
50 Years to 65 Years
Sex
Female
01

Study 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

Read the detailed 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.
02

Conditions studied

  • Metabolic Syndrome

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03

In context

Metabolic Syndrome

2,011 studies on the registry are indexed under Metabolic Syndrome; 334 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 1,494 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • prehypertension and hypertension stage I
  • overweight or obesity class I
  • age 55 to 65 years

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Laser acupuncture 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.

    Device: Laser acupuncture · Dietary Supplement: energy-restricted diet

  • Active comparator
    Diet regimen 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

    Dietary Supplement: energy-restricted diet

Interventions

  • DeviceLaser 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 supplementenergy-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

06

What researchers measure

Primary outcomes

  1. Lipid profile TG

    Triglycerides in mmol/L will be measured

    Time frame: 8 weeks after treatment

  2. Lipid profile HDL

    High density lipoprotein in mmol/L will be measured

    Time frame: 8 weeks after treatment

07

Study locations

1 site
  • Kasr Alainy medical school
    Cairo, 12111, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05651451
Lead sponsor
Cairo University
Responsible party
Ahmed M Maged, MD (professor, Cairo University) — Principal investigator
First posted
Dec 15, 2022
Start date
Dec 22, 2022
Primary completion
Jul 18, 2023
Completion
Sep 15, 2023
Last update
May 31, 2024

Study contacts

Ahmed M Maged
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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