Effect of Bioptron on Primary Dysmenorrhea

NCT06729749 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005313
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysmenorrhea

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Plasma Progesterone level

  Three months

• Assessment of menstrual symptoms

  Three months

• Quality of life enjoyment and satisfaction

  Three months

Study Arms (2)

Group A (control group)

ACTIVE COMPARATOR

lt will include 28 participants suffering from PD who will take vitamin D (vit D) supplementations for three consecutive menstrual cycles.

Other: Vitamin D

Group B (study group)

EXPERIMENTAL

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: Bioptron Pro 1 Class II; Other: Vitamin D

Interventions

Bioptron Pro 1 Class II OTHER

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

Group B (study group)

Vitamin D OTHER

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

Group A (control group); Group B (study group)

Eligibility Criteria

• Age: 18 Years - 24 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, Egypt, 12511, Egypt

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Doaa A Osman

  Cairo University

  STUDY CHAIR

Central Study Contacts

Eman SA Eldeeb

CONTACT

01012674761; emansalehpt@gmail.com

Manal A El-Shafei, Lecturer

CONTACT

01220664518; manal.ahmed@pt.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master student at Faculty of Physical Therapy, Cairo University

Study Record Dates

• First Submitted: December 7, 2024
• First Posted: December 11, 2024
• Study Start: December 15, 2024
• Primary Completion: June 15, 2025
• Study Completion: June 30, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)