Effect of Laser Acupuncture on Insulin Resistance in Obese Women With Polycystic Ovarian Syndrome
NCT ID: NCT06549647
Last Updated: 2024-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2024-08-20
2024-12-20
Brief Summary
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Detailed Description
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Conventional interventions, such as oral contraceptives, metformin, and hormonal therapy, have been developed to address the effects of PCOS. However, these treatments can have adverse side effects, including an increased risk of estrogen-related cancers. Consequently, lifestyle modifications to prevent aberrant immune activation and minimize exposure to inflammatory agents have emerged as a more sustainable approach.
Emerging evidence suggests the potential of alternative physical therapy modalities, such as transcutaneous electrical nerve stimulation, electro-acupuncture, and laser acupuncture, in managing PCOS. Laser acupuncture, in particular, has been shown to reduce sympathetic activity, decrease ovarian androgen release, and modulate the activity of higher centers, ultimately influencing gonadotropin-releasing hormone secretion and the menstrual cycle. Additionally, laser acupuncture may reduce the levels of pro-inflammatory cytokines, which contribute to insulin resistance and atherosclerosis.
While a few studies have investigated the effects of laser acupuncture on insulin resistance in obese women with PCOS, further research is needed to provide deeper insights into the benefits of this intervention and its role in managing insulin resistance in this population, which could expand the clinical applications of laser therapy in physical therapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo laser on acpoints + low caloric diet
It will be consisted of 20 obese women diagnosed as having PCOS. Each will receive placebo laser on acupoints (3 sessions/week, 17 minutes/ session) in addition to low caloric diet for 3 months.
low caloric diet
A low caloric diet of 1200 Kcal will be followed by participant for 3 months. The dietary intervention follows a macronutrient ratio of 15% protein, 30% fat, and 55% carbohydrates. Participants are advised to consume 170-240g of complex carbohydrates, 60-100g of fat, and 55-93g of protein per day, with 20-35g of fiber. Patients are also advised to limit salt, tea, and caffeine intake, and receive supplemental vitamins to prevent deficiencies.
Placebo laser acupoint stimulation
Placebo laser acupoint stimulation will be used for all participants in group (A).
Laser acupuncture + low caloric diet
It will be consisted of 20 obese women diagnosed as having PCOS who will receive the same low caloric diet as in group (A) in addition to application of laser acupuncture on (REN 4,5), (ST 25,29,36,40), (CV 3,6,10,12),(SP 6), (L14), 1 minutes for each points (17 minutes/session), 3 times/week for 3 months.
low caloric diet
A low caloric diet of 1200 Kcal will be followed by participant for 3 months. The dietary intervention follows a macronutrient ratio of 15% protein, 30% fat, and 55% carbohydrates. Participants are advised to consume 170-240g of complex carbohydrates, 60-100g of fat, and 55-93g of protein per day, with 20-35g of fiber. Patients are also advised to limit salt, tea, and caffeine intake, and receive supplemental vitamins to prevent deficiencies.
Laser Acupuncture
Eazyone EZ1 level laser will be used for the treatment procedures for all participants in group (B) only. Every participant in group (B) will be instructed briefly about the effect of laser acupoints therapy to gain her confidence and co-operation. It will be applied with infrared laser with 830 nm wavelength, 5 W power output and 0.5 J energy on the following acupoints while the patient lie in supine lying position. The head of the machine will be applied perpendicularly on each point for 1 min (17 min total), 3 times/ week for 4 weeks.
Interventions
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low caloric diet
A low caloric diet of 1200 Kcal will be followed by participant for 3 months. The dietary intervention follows a macronutrient ratio of 15% protein, 30% fat, and 55% carbohydrates. Participants are advised to consume 170-240g of complex carbohydrates, 60-100g of fat, and 55-93g of protein per day, with 20-35g of fiber. Patients are also advised to limit salt, tea, and caffeine intake, and receive supplemental vitamins to prevent deficiencies.
Placebo laser acupoint stimulation
Placebo laser acupoint stimulation will be used for all participants in group (A).
Laser Acupuncture
Eazyone EZ1 level laser will be used for the treatment procedures for all participants in group (B) only. Every participant in group (B) will be instructed briefly about the effect of laser acupoints therapy to gain her confidence and co-operation. It will be applied with infrared laser with 830 nm wavelength, 5 W power output and 0.5 J energy on the following acupoints while the patient lie in supine lying position. The head of the machine will be applied perpendicularly on each point for 1 min (17 min total), 3 times/ week for 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* Their ages will be ranged from 20 to 35 years old.
* Their BMI will be ranged from 30-40 kg/m2
* Their waist/hip ratio will be \>0.8
* All of them should have at least two criteria of the Rotterdam diagnostic criteria of PCOS.
Exclusion Criteria
* Respiratory, renal and liver dysfunction.
* Skin diseases and any other condition that may prevent the usage of laser (skin cancer, active acne and skin infections).
* Malignancy
20 Years
35 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Mena Faiez Shenouda
Principal Investigator
Principal Investigators
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Azza Barmoud Nashed Kassab, PhD
Role: STUDY_CHAIR
Professor of Physical Therapy for Woman's Health, Cairo University
Central Contacts
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Manal Ahmed El-Shafei, PhD
Role: CONTACT
Other Identifiers
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P.T.REC/012/005182
Identifier Type: -
Identifier Source: org_study_id
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