Effect of Laser Acupuncture on Insulin Resistance in Obese Women With Polycystic Ovarian Syndrome

Cairo University (CU)

Status: Not yet enrolling

Conditions: Polycystic Ovary Syndrome

Treatments: Other: low caloric diet; Other: Placebo laser acupoint stimulation; Other: Laser Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06549647

P.T.REC/012/005182

Details and patient eligibility

About

This study will be conducted to investigate the effect of laser acupuncture on insulin resistance in obese women with polycystic ovarian syndrome.

Full description

Women with Polycystic Ovary Syndrome (PCOS) face an increased risk of various health issues, including glucose intolerance, type 2 diabetes, hypertension, dyslipidemia, and subfertility. The prevalence of insulin resistance (IR) in PCOS can range from 44% to 70%, with longitudinal studies indicating that worsening IR over time in obese women with PCOS is associated with an increased risk of early-onset type 2 diabetes.

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Forty obese women with PCOS as clinically diagnosed by gynecologist.
• 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

• Cushing syndrome, diabetes mellitus, Thyroid dysfunction, Hypothalamic amenorrhea, Ovarian hyperplasia
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Placebo laser on acpoints + low caloric diet

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo laser acupoint stimulation

Other: low caloric diet

Laser acupuncture + low caloric diet

Experimental group

Description:

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.

Treatment:

Other: Laser Acupuncture

Other: low caloric diet