Effect of High Power Laser Acupuncture on Post Menopausal Hot Flashes

Обзор

The aim of this study will be to determine the effect of high power laser acupuncture on post menopausal hot flashes.

Подробное описание

There are several conflicting reports surrounding the efficacy of acupuncture for hot flashes, and several reviews exist. For example, in 2009 there were 2 reviews of acupuncture for hot flashes was performed. One evaluated 6 randomized controlled trials conducted in women without cancer. The second evaluated 6 randomized controlled trials performed in women with breast cancer.

Conclusions in 2 reviews were that existing studies suffered from methodological weaknesses, major limitation of our study due to the small size of the group, the psycho physiological, social and culture level of each woman. and there was an overall lack of supporting evidence for the use of acupuncture for the treatment of hot flashes in these population.

From previous studies , there was lack studies about effect of acupuncture on postmenopausal hot flashes.

So this study end to investigate the effect of high power laser acupuncture on postmenopausal hot flashes.

Вмешательства

• Устройство High power laser acupuncture
  Participants will lie supine while receiving high-power laser therapy (1064 nm wavelength, 150 mJ max pulse energy, 6 W average power, 760 mJ/cm² frequency, \<150 ms pulse duration). A pulsed waveform (5000 W/cm², 1 W output, 0.2 cm² spot size) will be applied perpendicularly to acupuncture points for 30 s (×3), totaling 15 min/session. Sessions: 3×/week for 4 weeks. Paced respiration exercises will also be performed for 15 min/session over the same period.
• Другое Placebo High power laser acupuncture
  Participants assigned to the placebo group will receive sham high-power laser therapy following the same treatment protocol used in the active intervention group, including identical positioning, probe placement, session duration, and frequency. The laser device will appear operational; however, it will be switched off during application and will not emit therapeutic laser energy. Sessions will last 15 minutes, three times per week, for four consecutive weeks.
• Другое Paced Respiration Exercise
  All participants in both groups will perform paced respiration exercises during each treatment session. The exercise will consist of slow, controlled breathing at a predetermined rhythm, emphasizing diaphragmatic inhalation and prolonged exhalation. Breathing cycles will be guided verbally or by timing cues to maintain a consistent rate throughout the 15-minute session. The exercise will be performed three times per week for four consecutive weeks under supervision.

Первичные конечные точки

• Patient reported hot flashes questionnaire [Срок оценки: 4 weeks]

Вторичные конечные точки (1)

• Follicular stimulating hormone analysis [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• Sixty post menopausal women suffering from hot flashes.
• Their age will range from 50 to 60 years.
• Their body mass index (BMI) will range(> 30kg/m2).

Критерии исключения

• Breast cancer.
• Myocardial infarction.
• Pulmonary embolism.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• El Agoza police hospital — Cairo

Идентификаторы

NCT: NCT07419542 · P.T.REC/012/005136

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗