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Clinical Trials in Egypt / NCT06729749
Starting soon Not applicable

Effect of Bioptron on Primary Dysmenorrhea

NCT06729749 · tracked via the Priya Life Science Egypt tracker
Sponsor
Cairo University
Phase
Not applicable
Started
2024-12-15
Last updated
2024-12-11

Condition(s) studied

Dysmenorrhea

Investigational drug(s) / intervention(s)

Bioptron Pro 1 Class IIVitamin D

Bioptron Pro 1 Class II: Bioptron Pro 1 Class II: Made by Bioptron AG, Wollerau, Switzerland, a device with a floor stand emits a polarized light lamp. The device has an ergonomic table stand that can be combined with a functional floor stand, allowing flexible use in domestic and professional environments. easily adjustable height and head inclination and the ability to rotate the device head up to 360 allow a convenient usage of nearly any position. Treatments can easily be timed by a control panel down to 30 seconds, an integrated distance rod ensures the recommended distance from the skin surface It will be used for the treatment procedures for all participants in group B only with the following parameters, Wavelengths ranging from 480-3400 nm, Degree of polarization \>95% (590 - 1550 nm), Specific power density Av. 40 mW/cm2 Light energy per minute av.2.4 J/cm2, Light Intensity per min. 10.000 lux, Weight without stand 3.4 kg and Weight with stand7.8 kg ,Energy consumption in sleep mode0.5

Vitamin D: All participants in both groups will take this supplements daily for 3 months

Study summary

This study will be conducted to determine the effect of bioptron on PD through the assessment of serum progesterone level, and pain level measured by pressure algometry in addition to evaluation of the symptoms of PD and its effect on girl's quality of life through valid and reliable questionnaires which will be of valuable benefits in the women's health fields.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
24 Years
Healthy volunteers
No
Inclusion Criteria: All females will be clinically diagnosed by the gynecologist with primary dysmenorrhea. * Self-reported history of PD, at least moderate pain due to menstrual cramps (\>4 on VAS) * They have moderate symptoms of PD on the WaILDD questionnaire, (5-12) Teheran et al., 2018). * Their ages will be ranged from 18-24 years old. * Their BMI will be less than 30 kg/m². * Being a virgin. * Having regular menstruation for the last 6 months (every 28-30 days with no intermittent bleeding). * Voluntary acceptance to participate in the study. B) Exclusion Criteria: Participants will be excluded if they have: * Musculoskeletal or neurological disorders. * Patients with a history of phototherapy allergy. * Professional athletes (Jill et al., 2012). * Secondary dysmenorrhea pathology such as (endometriosis, fibroids, adenomyosis, and pelvic inflammatory disease) * Menstrual irregularity. * Using hormonal contraception (such as contraceptives or injections).

Primary outcome measure(s)

  • Pain intensity — Three months
    The pain intensity will be assessed through VAS for both groups (A\&B) before and after the end of the treatment program (throughout three consecutive menstrual cycle) and follow up period . Each female will be asked to mark a point on the line between the extreme that is related to her pain intensity.
  • Pressure pain threshold (PPT) — three months
    A pressure algometer will be used to measure pressure pain thresholds for all participants in both groups (A\&B) before and after the treatment program (throughout three consecutive menstrual cycles)

Trial sites (1)

FacilityCityRegionStatus
Faculty of Physical Therapy Giza Egypt

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Other trials for the same condition

Core Stability vs. Traditional Physical Therapy: A Comparative Study on Alleviating Low Back Pain in Dysmenorrhea Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06729749 on ClinicalTrials.gov ↗ ← All trials in Egypt