Effect of Bioptron on Primary Dysmenorrhea

Effect of Bioptron on Primary Dysmenorrhea: a Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dysmenorrhea
• Intervention / Treatment: Other: Vitamin D; Other: Bioptron Pro 1 Class II

Detailed Description

All females will be randomly divided into two equal groups:

Group A (control group):

lt will include 28 participants suffering from PD taking vitamin D (vitamin D) supplements for three consecutive menstrual cycles.

Group B (study group):

lt will include 28 participants suffering from PD who will take vitamin D (vitamin D) supplementations as in group A in addition to Bioptron for 20 min daily for 7 days before the menstrual cycle along with the first three days of menstrual flow for three consecutive menstrual cycles.

All females will be given a full explanation of the study protocol and a consent form will be signed by each female before entry in the study

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eman SA Eldeeb; Phone Number: 01012674761; Email: emansalehpt@gmail.com
• Study Contact Backup: Name: Manal A El-Shafei, Lecturer; Phone Number: 01220664518; Email: manal.ahmed@pt.cu.edu.eg

Study Locations

• Egypt
  • Giza, Egypt, 12511
    • Faculty of physical therapy
    • Contact: Eman SA Eldeeb; Phone Number: 0201012674761

Participation Criteria

Eligibility Criteria

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

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (control group); lt will include 28 participants suffering from PD who will take vitamin D (vit D) supplementations for three consecutive menstrual cycles.	Other: Vitamin D; All participants in both groups will take this supplements daily for 3 months
Experimental: Group B (study group); lt will include 28 participants suffering from PD who will take vitamin D (vit D) supplementations as in group A in addition to Bioptron for 20 min daily for 7 days before menstrual cycle along with the first three days of menstrual flow for three consecutive menstrual cycles.	Other: Vitamin D; All participants in both groups will take this supplements daily for 3 months; Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	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.	Three months
Pressure pain threshold (PPT)	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)	three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Progesterone level	Plasma progesterone for all participants in both groups (A&B )will be analyzed by Enzyme-Linked Immunosorbent Assay (ELISA), using Cayman Chemical Reagent Company kits before and after the treatment program.	Three months
Assessment of menstrual symptoms	The WaLIDD questionnaire: will be used to assess the symptoms of primary dysmenorrhea for all participants in both groups (A&B) before the treatment and after the end of the treatment program (throughout three consecutive menstrual cycles and during the follow-up period).	Three months
Quality of life enjoyment and satisfaction	The Quality-of-life enjoyment and satisfaction questionnaire Q-LES-QSF: will be used to assess health-related quality of life for all participants in both groups (A&B) before the treatment program and after the end of the treatment program (throughout three consecutive menstrual cycles).	Three months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Doaa A Osman, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2024
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: December 7, 2024
• First Submitted That Met QC Criteria: December 7, 2024
• First Posted (Estimated): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 7, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Pelvic Pain; Menstruation Disturbances; Dysmenorrhea; Physiological Effects of Drugs; Bone Density Conservation Agents; Micronutrients; Vitamins; Vitamin D
• Other Study ID Numbers: P.T.REC/012/005313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No