Effect of High Power Laser Acupuncture on Post Menopausal Hot Flashes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High power laser acupuncture, Placebo High power laser acupuncture, Paced Respiration Exercise.
- Who it may be relevant to
- Registry conditions: Hot Flashes. Basic parameters: 50 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The aim of this study will be to determine the effect of high power laser acupuncture on post menopausal hot flashes.
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.
Interventions
- 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 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. - 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.
Primary outcome measures
- Patient reported hot flashes questionnaire [Time frame: 4 weeks]
Secondary outcome measures (1)
- Follicular stimulating hormone analysis [Time frame: 4 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- El Agoza police hospital — Cairo
Identifiers
NCT: NCT07419542 · P.T.REC/012/005136