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Effect of Laser Acupuncture on Metabolic Syndrome in Obese Postmenopausal Women

Primary Purpose

Metabolic Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laser acupuncture
energy-restricted diet
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Metabolic Syndrome

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kasr Alainy medical school

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Laser acupuncture group

Diet regimen group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Lipid profile TG
Triglycerides in mmol/L will be measured
Lipid profile HDL
High density lipoprotein in mmol/L will be measured

Secondary Outcome Measures

Full Information

First Posted
December 6, 2022
Last Updated
December 13, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05651451
Brief Title
Effect of Laser Acupuncture on Metabolic Syndrome in Obese Postmenopausal Women
Official Title
Effect of Laser Acupuncture on Metabolic Syndrome in Obese Postmenopausal Women. A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laser acupuncture group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Diet regimen group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Laser acupuncture
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
energy-restricted diet
Intervention Description
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
Primary Outcome Measure Information:
Title
Lipid profile TG
Description
Triglycerides in mmol/L will be measured
Time Frame
8 weeks after treatment
Title
Lipid profile HDL
Description
High density lipoprotein in mmol/L will be measured
Time Frame
8 weeks after treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Maged
Phone
+201005227404
Email
Ahmedmaged@cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Wafaa Kamal
Phone
+201006914119
Email
wafaa_kamal37@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Maged
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Laser Acupuncture on Metabolic Syndrome in Obese Postmenopausal Women

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