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NCT Number: NCT07419542

Effect of High Power Laser Acupuncture on Post Menopausal Hot Flashes

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

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Key information

Conditions

Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

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

Treatment and study plan

High power laser acupuncture

Device

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.

Placebo High power laser acupuncture

Other

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.

Paced Respiration Exercise

Other

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.

Primary outcomes

  1. Patient reported hot flashes questionnaire

    Time frame: 4 weeks

    It will be used to determine the level of the hot flashes for each post menopausal women before starting as well as after the end of the study. Patient reported hot flashes questionnaire used to measure hot flashes frequency during the day and night .Hot flashes questionnaire score ranged from 0 (Not at all) to 10(very much). The numbers from 0 to 10 indicate the average amount of hot flashes which bothers the patient. This questionnaire include questions about number of hot flashes during day, number of hot flashes during night and duration of single hot flashes episode.

Secondary outcomes

  1. Follicular stimulating hormone analysis

    Time frame: 4 weeks

    Participants will rest in a semi-recumbent position with proper back and arm support. The antecubital area will be disinfected with alcohol, and approximately 5 cubic centimeters of venous blood will be drawn from the antecubital vein using a sterile disposable syringe. Blood samples will be collected twice, before the start and after completion of the study. All samples will be obtained in the morning before breakfast to ensure standardization.

Study contacts

Contact information is provided by the study sponsor or research team.

Eman Saeed Mohamed Elgohary, M.Sc

CONTACT

[email protected]

+20 11 55883130

Soheir Mahmoud El-Kosery, PhD

CONTACT

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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