Dysmenorrhea PrimaryNCT06992349
Bioptron Light Therapy for Dysmenorrhea in Obese Adolesences: RCT
A study testing bioptron light therapy in people with Dysmenorrhea Primary and Obesity and Overweight, run by Alaa Noureldeen Kora at 1 site in Egypt.
Trial summary
Dysmenorrhea is the most common health problem in women in the reproductive age(Bakhsh et al., 2022). The primary dysmenorrhea starts shortly after the menarche the pain lasting 1 to 3 days that start just before or at the onset of menstruation with the absence of other gynecological symptoms (Itani et al., 2022). Read more about this study
- Who is it for?
- Ages 16 to 18 years, women only
- Conditions the study is for
- Dysmenorrhea Primary, Obesity and Overweight
- What is being tested?
- bioptron light therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 144 female adolescences suffering from primary dysmenorrhea pain determined according to the sample size calculation adapted from (Gu et al., 2022).
- They will be selected from the outpatient's clinic of the faculty of Physical Therapy Sinai University.
- Their chronological age ranged from 16 to 18 years old.
Who cannot join
- Those who were taking anti-psychotic or anti-depressant medications, patients with any skin lesion or infection.
- Gynecological disorders included cervical cancer, ovarian tumors, endometriosis, uterine fibroids, polycystic ovarian syndrome, and other conditions that can affect menstruation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sinai University
Ismailia, 11749
Alaa Kora, PhD, 01002701815, alaan.kora@gmail.com
About this study
Official title: Evaluating the Efficacy of Bioptron° Light Therapy in Managing Primary Dysmenorrhea Among Obese Adolescence: Double Blinded Randomized Control Trial
Dysmenorrhea is the most common health problem in women in the reproductive age(Bakhsh et al., 2022). The primary dysmenorrhea starts shortly after the menarche the pain lasting 1 to 3 days that start just before or at the onset of menstruation with the absence of other gynecological symptoms (Itani et al., 2022). Primary dysmenorrhea can reduce the quality of life and social activities of women(Esan et al., 2024).
There is a relationship between body mass composition and primary dysmenorrhea and as the value of body mass index and body fat percentages goes on increasing in females, the severity of primary dysmenorrhea also increased (Wu et al., 2022).
Read more
BIOPTRON® Light therapy system is a device that contains an optical unit. This unit emits light with an electromagnetic spectrum produced by the sun, but without the ultraviolet rays and it is significant with four main characteristics which are Polarization, Polychromatic, Incoherence and low energy light (Raeissadat et al., 2014).
The Purpose of the Study The aim of the study is to investigate the effect of bioptron© light therapy on primary dysmenorrhoea outcomes as pain and quality of life among obese adolescence.
- Conditions
- Dysmenorrhea Primary, Obesity and Overweight
- Being tested
- bioptron light therapy
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioptron light therapyDevice
BIOPTRON® Hyperlight is a proprietary, optimized blend of visible and infrared light properties that Bio-stimulate cells and speeding up the healing process of a wide range of medical diseases.
Bioptron© light therapy has been utilized as a non-invasive treatment for wound healing, skin ulcers, and various musculoskeletal conditions(Abd Elhamid et al., 2020).
| Study group | Role | What they receive |
|---|---|---|
| Group 1: women with BMI more than 30 and receive active bioptron© | Experimental | Not described Receives: Device: bioptron light therapy |
| Group 2: women with BMI between 18.5 to 25 and receive active bioptron©. | Experimental | Not described Receives: Device: bioptron light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of anatomical pain locations, pain range, number of days of pain during menstruation (and frequency of disabling pain to perform their activities.
Measured: At the end of Cycle 1 (each cycle is 28 days)".
Secondary outcomes (3)
Numerical Rating Scale (NRS): is a single-item question that asks the patient to rate the pain on a scale of 0 to 10.
Measured: At the end of Cycle 1 (each cycle is 28 days)".
Algometer is an objective measurement of the degree of pressure required to evoke a painful response over selected trigger points.
Measured: At the end of Cycle 1 (each cycle is 28 days)".
The EuroQol-5 Dimension (EQ-5D), developed in 1990, is a most widely used generic tool to measure health-related quality of life.
Measured: At the end of Cycle 1 (each cycle is 28 days)".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysmenorrhea PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alaa Noureldeen Kora
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alaa Noureldeen Kora, Sinai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992349
- Sponsor's protocol ID
- SU.REC.2024 (26 H)
- Status last verified
- May 2025
- First submitted
- 19 Feb 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Bioptron° Light Therapy in Managing Primary Dysmenorrhea Among Obese Adolescence: Double Blinded Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06992349
- Acronym / sponsor ID
- SU.REC.2024 (26 H)
- Conditions
- Dysmenorrhea Primary, Obesity and Overweight
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Alaa Noureldeen KoraUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dysmenorrhea is the most common health problem in women in the reproductive age(Bakhsh et al., 2022). The primary dysmenorrhea starts shortly after the menarche the pain lasting 1 to 3 days that start just before or at the onset of menstruation with the absence of other gynecological symptoms (Itani et al., 2022). Primary dysmenorrhea can reduce the quality of life and social activities of women(Esan et al., 2024).
There is a relationship between body mass composition and primary dysmenorrhea and as the value of body mass index and body fat percentages goes on increasing in females, the severity of primary dysmenorrhea also increased (Wu et al., 2022).
BIOPTRON® Light therapy system is a device that contains an optical unit. This unit emits light with an electromagnetic spectrum produced by the sun, but without the ultraviolet rays and it is significant with four main characteristics which are Polarization, Polychromatic, Incoherence and low energy light (Raeissadat et al., 2014).
The Purpose of the Study The aim of the study is to investigate the effect of bioptron© light therapy on primary dysmenorrhoea outcomes as pain and quality of life among obese adolescence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: women with BMI more than 30 and receive active bioptron© | Experimental | Device: bioptron light therapy |
| Group 2: women with BMI between 18.5 to 25 and receive active bioptron©. | Experimental | Device: bioptron light therapy |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 144 female adolescences suffering from primary dysmenorrhea pain determined according to the sample size calculation adapted from (Gu et al., 2022).
- They will be selected from the outpatient's clinic of the faculty of Physical Therapy Sinai University.
- Their chronological age ranged from 16 to 18 years old.
Key exclusion criteria (2 listed)
- Those who were taking anti-psychotic or anti-depressant medications, patients with any skin lesion or infection.
- Gynecological disorders included cervical cancer, ovarian tumors, endometriosis, uterine fibroids, polycystic ovarian syndrome, and other conditions that can affect menstruation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bioptron light therapyBIOPTRON® Hyperlight is a proprietary, optimized blend of visible and infrared light properties that Bio-stimulate cells and speeding up the healing process of a wide range of medical diseases. Bioptron© light therapy has been utilized as a non-invasive treatment for wound healing, skin ulcers, and various musculoskeletal conditions(Abd Elhamid et al., 2020). | Device | Group 1: women with BMI more than 30 and receive active bioptron©, Group 2: women with BMI between 18.5 to 25 and receive active bioptron©. |
Primary outcome
number of anatomical pain locations, pain range, number of days of pain during menstruation (and frequency of disabling pain to perform their activities.
Time frame: At the end of Cycle 1 (each cycle is 28 days)".
3 secondary outcomes
Numerical Rating Scale (NRS): is a single-item question that asks the patient to rate the pain on a scale of 0 to 10.
Time frame: At the end of Cycle 1 (each cycle is 28 days)".
Algometer is an objective measurement of the degree of pressure required to evoke a painful response over selected trigger points.
Time frame: At the end of Cycle 1 (each cycle is 28 days)".
The EuroQol-5 Dimension (EQ-5D), developed in 1990, is a most widely used generic tool to measure health-related quality of life.
Time frame: At the end of Cycle 1 (each cycle is 28 days)".
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bioptron light therapy in people with Dysmenorrhea Primary and Obesity and Overweight, run by Alaa Noureldeen Kora at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of anatomical pain locations, pain range, number of days of pain during menstruation (and frequency of disabling pain to perform their activities. (time frame: At the end of Cycle 1 (each cycle is 28 days)".). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.