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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hot Flashes
• Intervention / Treatment: Device: High power laser acupuncture; Other: Paced Respiration Exercise; Other: Placebo High power laser acupuncture

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Soheir Mahmoud El-Kosery, PhD
• Study Contact Backup: Name: Eman Saeed Mohamed Elgohary, M.Sc; Phone Number: +20 11 55883130; Email: emanelgohary1982@icloud.com

Study Locations

• Egypt
  • Cairo, Egypt
    • El Agoza police hospital
    • Contact: Eman Saeed Mohamed Elgohary, M.Sc; Phone Number: +20 11 55883130; Email: emanelgohary1982@icloud.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High power laser acupuncture + Paced respiration exercise; This group will consist of 30 postmenopausal women, who will receive High power laser acupuncture and paced respiration exercise for 15 minutes/sessions, 3 times/week for 4 weeks.	Device: 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.; Other: 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.
Placebo Comparator: Placebo High power laser acupuncture + Paced respiration exercise; This group will consist of 30 post menopausal women, who will receive placebo High power laser acupuncture and paced respiration exercise for 15 minutes /sessions, 3 times/ week for 4 weeks.	Other: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported hot flashes questionnaire	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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Follicular stimulating hormone analysis	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.	4 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Soheir Mahmoud El-Kosery, PhD, Professor, Cairo university; Study Director: Mohamed Fawzy Abu-Elenin, PhD, Consultant

Study record dates

Study Major Dates

• Study Start (Estimated): February 20, 2026
• Primary Completion (Estimated): April 20, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hot Flashes
• Other Study ID Numbers: P.T.REC/012/005136

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No