Primary DysmenorrheaRdismenorreaNCT06200506
Efficacy of Radiofrequency in Primary Dysmenorrhea
A study testing Transabdominal radiofrecuency application and Intracavitary radiofrequency application in people with Primary Dysmenorrhea, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
The main objective of the study is to evaluate the effect of radiofrequency on pain associated with primary dysmenorrhea. The data collected will be: Intensity of pain with the Numeric Pain Rating Scale (NPRS), pressure pain at three points of referred pain from the gynecological system, need or not to take… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Transabdominal radiofrecuency application and Intracavitary radiofrequency application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jan 2024to 20 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-35 years.
- Menstrual pain: During bleeding and/or the previous 48 hours.
- Nulliparous.
- Regular menstrual cycles (24-38 days according to FIGO).
Who cannot join
- Currently using contraceptives that prevent intracavitary application (hormonal intrauterine devices and vaginal rings).
- Have any recent abdominal or pelvic surgery that prevents the application of intra/extracavitary heat.
- Dysmenorrhea secondary to other gynecological pathologies (endometriosis, adenomyosis, uterine fibroids...)
- Pregnancy.
- Have received physiotherapy treatment for the painful episode in the six months prior to the study.
- To present situations of contraindication of diathermy, radiofrequency or tecartherapy: implanted devices that work with batteries (pacemakers), metallic implants near the lumbopelvic region, uncontrolled or recent cancer processes, recent hemorrhages, alterations in sensitivity in the area to be treated , local active infections near the region to be treated, febrile states, skin wounds and epileptic processes.
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of the study is to evaluate the effect of radiofrequency on pain associated with primary dysmenorrhea.
The data collected will be: Intensity of pain with the Numeric Pain Rating Scale (NPRS), pressure pain at three points of referred pain from the gynecological system, need or not to take medication, general quality of life with the SF-12 (short form 12) and quality of life in relation to menstruation with the CVM-22. They will be collected at the start of treatment, after the first post-intervention menstruation and after the second post-intervention menstruation.
Read more
This study is a randomized clinical trial with two intervention groups and a control group, whose study population is women with primary dysmenorrhea.
The sample size has been calculated with the G* Power 1.9.7 software using repeated measures ANOVA, assuming a two-sided significance level (α=0.05) and 90% power (β=0.10) and 10% losses. A sample of 45 participants (n) was determined to detect a significant change of 1.5 points in the variable measured with the NRS. Forty-five participants were included in this study. In the two intervention groups, radiofrequency will be applied (20 minute sessions for 3 weeks with a frequency of 3 times/week), transabdominal in one group and intravaginal in the other.
Participants must be women between 18 and 35 years old, with regular menstrual cycles (22-38 days according to FIGO), be nulliparous and also not present any of the exclusion criteria detailed in the study.
The data obtained will be analyzed and compared between the different groups in order to draw conclusions.
Read the detailed description
Dysmenorrhea is a gynecological clinical entity that can be defined as menstrual pain. It usually begins a couple of days before the bleeding or coinciding with the start of the bleeding and usually lasts between 8 and 72 hours.
The main symptom is pelvic and / or abdominal pain that can spread to the lower back or lower limbs. On a psychological level, it associates pictures of depression, anxiety or irritability. It also affects in a very negative way the quality of life, work and / or academic performance (causing episodes of absenteeism) and the social sphere of the women who suffer from it.
In recent years, alternative treatments to pharmacological treatments have been gaining strength, among which physiotherapy stands out. Techniques such as manual therapy, transcutaneous electrical nerve stimulation (TENS), thermotherapy, kinesiology tape, stretching, therapeutic exercises ... are applied in women with primary dysmenorrhea and have been evaluated in numerous studies, most of which are of poor methodological quality.
In clinical practice, one of the physiotherapy modalities that has been applied the most in urogynecological pathologies in women is radiofrequency. Radiofrequency is a physiotherapy intervention that consists of the transfer of energy to the tissues in a resistive or capacitive way using wave frequencies between 0.5 and 1.5 megahertz (MHz). However, at present, there are no clinical trials randomized and controlled that evaluates the effectiveness of radiofrequency in any urogynecological pathology, including primary dysmenorrhea.
Objective: The aim of this study is to assess the effect of radiofrequency on pain associated with primary dysmenorrhea.
Study Type: Randomized controlled clinical trial with two intervention groups and one control group. In the two intervention groups, radiofrequency will be applied (20-minute sessions for 3 weeks with a frequency of 3 times / week). In one of the two groups the application of radiofrequency will be intracavitary and in the other group it will be transabdominal. The control group will not receive any intervention, with the commitment to treat once the study is finished.
Study subjects: Women between 18 and 35 years old, nulliparous, with menstrual pain attributable to primary dysmenorrhea (self-reported pain in most menstrual cycles and at least in the last three menstrual cycles).
Sample size: The sample size was calculated to identify clinically relevant effects on the primary outcome, numerical pain rating scale.
The sample size has been calculated with the G* Power 1.9.7 software using repeated measures ANOVA, assuming a two-sided significance level (α=0.05) and 90% power (β=0.10) and 10% losses. A sample of 45 participants (n) was determined to detect a significant change of 1.5 points in the variable measured with the NRS. Forty-five participants would be required to detect a significant change, 15 in each group.
Interventions:
Intervention group 1 (G1): A transabdominal application (fixed plate at the sacral level) will be performed.
Intervention group 2 (G2): A vaginal intracavitary application (fixed plate at the sacral level) will be performed.
Control group (C): No intervention will be carried out, with the commitment to carry out a postponed intervention in case of having positive results in the study.
Outcomes:
Primary Outcome Measure:
- Numerical Pain Rating Scale.
Secondary Outcome Measures:
- Questionnaire on quality of life in relation to menstruation (CVM-22), validated in Spanish.
- Pressure Pain Threshold (PPT) in the abdominal region recorded in previous studies.
- Number and quantity of analgesics, anti-inflammatories taken to alleviate the pain.
Key words: Dysmenorrhea, physical therapy modality, diathermy, thermotherapy
- Conditions
- Primary Dysmenorrhea
- Being tested
- Transabdominal radiofrecuency application, Intracavitary radiofrequency application
- Keywords
- Dysmenorrhea, Physical therapy modality, Diathermy
- Medical subject headings
- Dysmenorrhea, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transabdominal radiofrecuency applicationDevice
A transabdominal radiofrequency application will be performed, with a suprapubic active plate and a passive plate at the sacral level.
Patient position: Supine position. Sessions:9 Duration: 20 minutes Total intervention: 3 weeks.
Frequency: 3 times a week sessions will be held three times a week for three weeks
Intracavitary radiofrequency applicationDevice
An intracavitary vaginal radiofrequency application will be performed, with an active intracavitary head and with a fixed plate at the sacral level.
Patient position: Supine position. Sessions:9 Duration: 20 minutes Total intervention: 3 weeks. Frequency: 3 times a week sessions will be held three times a week for three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Transabdominal radiofrequency application | Experimental | Tecartherapy equipment (Capenergy CM500) specially designed for Uro-Gynecological Physiotherapy will be used.
A transabdominal radiofrequency application will be performed, with a suprapubic active plate and a passive plate at the sacral level.
Patient position: Supine position. Sessions:9 Duration: 20 minutes Total intervention: 3 weeks Frequency: 3 times a week sessions will be held three times a week for three weeks Receives: Device: Transabdominal radiofrecuency application |
| Intracavitary radiofrequency application | Experimental | Tecartherapy equipment (Capenergy CM500) specially designed for Uro-Gynecological Physiotherapy will be used.
An intracavitary vaginal radiofrequency application will be performed, with an active intracavitary head and with a fixed plate at the sacral level.
Patient position: Supine position. Sessions:9 Duration: 20 minutes Total intervention: 3 weeks Frequency: 3 times a week sessions will be held three times a week for three weeks Receives: Device: Intracavitary radiofrequency application |
| Control Group | No intervention | Not treatment received |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysmenorrheal pain intensity
Dysmenorrheal pain intensity (measured using the NPRS scale) at rest. It will be evaluated three times with 1 minute between the three evaluations and the average will be noted.
Measured: Baseline
Dysmenorrheal pain intensity
Dysmenorrheal pain intensity (measured using the NPRS scale) at rest. It will be evaluated three times with 1 minute between the three evaluations and the average will be noted.
Measured: One month
Dysmenorrheal pain intensity
Dysmenorrheal pain intensity (measured using the NPRS scale) at rest. It will be evaluated three times with 1 minute between the three evaluations and the average will be noted.
Measured: Two month
Secondary outcomes (12)
Quality of life during menstruation.
Quality of life during menstruation, assessed with the previously validated Spanish version of the CVM-22 questionnaire.
Measured: Baseline
Quality of life during menstruation.
Quality of life during menstruation, assessed with the previously validated Spanish version of the CVM-22 questionnaire.
Measured: One month
Quality of life during menstruation.
Quality of life during menstruation, assessed with the previously validated Spanish version of the CVM-22 questionnaire.
Measured: Two month
Quality of life (General)
Quality of life during, assessed with the previously validated Spanish version of the SF-12 questionnaire.
Measured: Baseline
Quality of life (General)
Quality of life during, assessed with the previously validated Spanish version of the SF-12 questionnaire.
Measured: One month
Quality of life (General)
Quality of life during, assessed with the previously validated Spanish version of the SF-12 questionnaire.
Measured: Two month
Pressure Pain Threshold
Painful sensitivity to pressure at three points in the abdominal region (suprapubic, at the oblique minor reference points according to the protocol), recorded with a digital algometer, Jtech Medical Commander algometer.
Measured: Baseline
Pressure Pain Threshold
Painful sensitivity to pressure at three points in the abdominal region (suprapubic, at the oblique minor reference points according to the protocol), recorded with a digital algometer, Jtech Medical Commander algometer.
Measured: One month
Pressure Pain Threshold
Painful sensitivity to pressure at three points in the abdominal region (suprapubic, at the oblique minor reference points according to the protocol), recorded with a digital algometer, Jtech Medical Commander algometer.
Measured: Two month
Number and quantity of drugs.
Consumption of drugs due to the current episode. The patient was asked what drugs he was taking, and the second investigator from the Complutense University of Madrid will classify the dosage as "non-use", "occasional use", "regulated use", "use greater than the prescribed". This same researcher classified each drug according to its action as: analgesics, anti-inflammatories, muscle relaxants, psychoactive drugs (anxiolytics, antidepressants) and other drugs.
Measured: Baseline
Number and quantity of drugs.
Consumption of drugs due to the current episode. The patient was asked what drugs he was taking, and the second investigator from the Complutense University of Madrid will classify the dosage as "non-use", "occasional use", "regulated use", "use greater than the prescribed". This same researcher classified each drug according to its action as: analgesics, anti-inflammatories, muscle relaxants, psychoactive drugs (anxiolytics, antidepressants) and other drugs.
Measured: One month
Number and quantity of drugs.
Consumption of drugs due to the current episode. The patient was asked what drugs he was taking, and the second investigator from the Complutense University of Madrid will classify the dosage as "non-use", "occasional use", "regulated use", "use greater than the prescribed". This same researcher classified each drug according to its action as: analgesics, anti-inflammatories, muscle relaxants, psychoactive drugs (anxiolytics, antidepressants) and other drugs.
Measured: Two month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start20 Jan 2024
- Primary completion20 May 2024
- Study completion20 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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
- Model description
- Study of a prospective longitudinal clinical trial: two intervention groups and a control group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MARÍA JOSÉ DÍAZ-ARRIBAS, PhD, Study director, UCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200506
- Sponsor's protocol ID
- UCompluMadrid
- Acronym
- Rdismenorrea
- Status last verified
- Mar 2024
- First submitted
- 28 Nov 2023
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Radiofrequency in Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06200506
- Acronym / sponsor ID
- Rdismenorrea / UCompluMadrid
- Conditions
- Primary Dysmenorrhea
- Keywords
- Dysmenorrhea, Physical therapy modality, Diathermy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 11 Jan 2024 (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.
The main objective of the study is to evaluate the effect of radiofrequency on pain associated with primary dysmenorrhea.
The data collected will be: Intensity of pain with the Numeric Pain Rating Scale (NPRS), pressure pain at three points of referred pain from the gynecological system, need or not to take medication, general quality of life with the SF-12 (short form 12) and quality of life in relation to menstruation with the CVM-22. They will be collected at the start of treatment, after the first post-intervention menstruation and after the second post-intervention menstruation.
This study is a randomized clinical trial with two intervention groups and a control group, whose study population is women with primary dysmenorrhea.
The sample size has been calculated with the G* Power 1.9.7 software using repeated measures ANOVA, assuming a two-sided significance level (α=0.05) and 90% power (β=0.10) and 10% losses. A sample of 45 participants (n) was determined to detect a significant change of 1.5 points in the variable measured with the NRS. Forty-five participants were included in this study. In the two intervention groups, radiofrequency will be applied (20 minute sessions for 3 weeks with a frequency of 3 times/week), transabdominal in one group and intravaginal in the other.
Participants must be women between 18 and 35 years old, with regular menstrual cycles (22-38 days according to FIGO), be nulliparous and also not present any of the exclusion criteria detailed in the study.
The data obtained will be analyzed and compared between the different groups in order to draw conclusions.
Detailed description
Dysmenorrhea is a gynecological clinical entity that can be defined as menstrual pain. It usually begins a couple of days before the bleeding or coinciding with the start of the bleeding and usually lasts between 8 and 72 hours.
The main symptom is pelvic and / or abdominal pain that can spread to the lower back or lower limbs. On a psychological level, it associates pictures of depression, anxiety or irritability. It also affects in a very negative way the quality of life, work and / or academic performance (causing episodes of absenteeism) and the social sphere of the women who suffer from it.
In recent years, alternative treatments to pharmacological treatments have been gaining strength, among which physiotherapy stands out. Techniques such as manual therapy, transcutaneous electrical nerve stimulation (TENS), thermotherapy, kinesiology tape, stretching, therapeutic exercises ... are applied in women with primary dysmenorrhea and have been evaluated in numerous studies, most of which are of poor methodological quality.
In clinical practice, one of the physiotherapy modalities that has been applied the most in urogynecological pathologies in women is radiofrequency. Radiofrequency is a physiotherapy intervention that consists of the transfer of energy to the tissues in a resistive or capacitive way using wave frequencies between 0.5 and 1.5 megahertz (MHz). However, at present, there are no clinical trials randomized and controlled that evaluates the effectiveness of radiofrequency in any urogynecological pathology, including primary dysmenorrhea.
Objective: The aim of this study is to assess the effect of radiofrequency on pain associated with primary dysmenorrhea.
Study Type: Randomized controlled clinical trial with two intervention groups and one control group. In the two intervention groups, radiofrequency will be applied (20-minute sessions for 3 weeks with a frequency of 3 times / week). In one of the two groups the application of radiofrequency will be intracavitary and in the other group it will be transabdominal. The control group will not receive any intervention, with the commitment to treat once the study is finished.
Study subjects: Women between 18 and 35 years old, nulliparous, with menstrual pain attributable to primary dysmenorrhea (self-reported pain in most menstrual cycles and at least in the last three menstrual cycles).
Sample size: The sample size was calculated to identify clinically relevant effects on the primary outcome, numerical pain rating scale.
The sample size has been calculated with the G* Power 1.9.7 software using repeated measures ANOVA, assuming a two-sided significance level (α=0.05) and 90% power (β=0.10) and 10% losses. A sample of 45 participants (n) was determined to detect a significant change of 1.5 points in the variable measured with the NRS. Forty-five participants would be required to detect a significant change, 15 in each group.
Interventions:
Intervention group 1 (G1): A transabdominal application (fixed plate at the sacral level) will be performed.
Intervention group 2 (G2): A vaginal intracavitary application (fixed plate at the sacral level) will be performed.
Control group (C): No intervention will be carried out, with the commitment to carry out a postponed intervention in case of having positive results in the study.
Outcomes:
Primary Outcome Measure:
- Numerical Pain Rating Scale.
Secondary Outcome Measures:
- Questionnaire on quality of life in relation to menstruation (CVM-22), validated in Spanish.
- Pressure Pain Threshold (PPT) in the abdominal region recorded in previous studies.
- Number and quantity of analgesics, anti-inflammatories taken to alleviate the pain.
Key words: Dysmenorrhea, physical therapy modality, diathermy, thermotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Study of a prospective longitudinal clinical trial: two intervention groups and a control group
| Arm | Type | Receives |
|---|---|---|
| Transabdominal radiofrequency application | Experimental | Device: Transabdominal radiofrecuency applicationTecartherapy equipment (Capenergy CM500) specially designed for Uro-Gynecological Physiotherapy will be used. A transabdominal radiofrequency application will be performed, with a suprapubic active plate and a passive plate at the sacral level. Patient position: Supine position. Sessions:9 Duration: 20 minutes Total intervention: 3 weeks Frequency: 3 times a week sessions will be held three times a week for three weeks |
| Intracavitary radiofrequency application | Experimental | Device: Intracavitary radiofrequency applicationTecartherapy equipment (Capenergy CM500) specially designed for Uro-Gynecological Physiotherapy will be used. An intracavitary vaginal radiofrequency application will be performed, with an active intracavitary head and with a fixed plate at the sacral level. Patient position: Supine position. Sessions:9 Duration: 20 minutes Total intervention: 3 weeks Frequency: 3 times a week sessions will be held three times a week for three weeks |
| Control Group | No intervention | –Not treatment received |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18-35 years.
- Menstrual pain: During bleeding and/or the previous 48 hours.
- Nulliparous.
- Regular menstrual cycles (24-38 days according to FIGO).
Key exclusion criteria (6 listed)
- Currently using contraceptives that prevent intracavitary application (hormonal intrauterine devices and vaginal rings).
- Have any recent abdominal or pelvic surgery that prevents the application of intra/extracavitary heat.
- Dysmenorrhea secondary to other gynecological pathologies (endometriosis, adenomyosis, uterine fibroids...)
- Pregnancy.
- Have received physiotherapy treatment for the painful episode in the six months prior to the study.
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 |
|---|---|---|
| Transabdominal radiofrecuency applicationA transabdominal radiofrequency application will be performed, with a suprapubic active plate and a passive plate at the sacral level. Patient position: Supine position. Sessions:9 Duration: 20 minutes Total intervention: 3 weeks. Frequency: 3 times a week sessions will be held three times a week for three weeks | Device | Transabdominal radiofrequency application |
| Intracavitary radiofrequency applicationAn intracavitary vaginal radiofrequency application will be performed, with an active intracavitary head and with a fixed plate at the sacral level. Patient position: Supine position. Sessions:9 Duration: 20 minutes Total intervention: 3 weeks. Frequency: 3 times a week sessions will be held three times a week for three weeks. | Device | Intracavitary radiofrequency application |
Primary outcome
Dysmenorrheal pain intensity
Time frame: Baseline
Dysmenorrheal pain intensity (measured using the NPRS scale) at rest. It will be evaluated three times with 1 minute between the three evaluations and the average will be noted.
Dysmenorrheal pain intensity
Time frame: One month
Dysmenorrheal pain intensity (measured using the NPRS scale) at rest. It will be evaluated three times with 1 minute between the three evaluations and the average will be noted.
Dysmenorrheal pain intensity
Time frame: Two month
Dysmenorrheal pain intensity (measured using the NPRS scale) at rest. It will be evaluated three times with 1 minute between the three evaluations and the average will be noted.
12 secondary outcomes
Quality of life during menstruation.
Time frame: Baseline
Quality of life during menstruation.
Time frame: One month
Quality of life during menstruation.
Time frame: Two month
Quality of life (General)
Time frame: Baseline
Quality of life (General)
Time frame: One month
Quality of life (General)
Time frame: Two month
Pressure Pain Threshold
Time frame: Baseline
Pressure Pain Threshold
Time frame: One month
Pressure Pain Threshold
Time frame: Two month
Number and quantity of drugs.
Time frame: Baseline
Number and quantity of drugs.
Time frame: One month
Number and quantity of drugs.
Time frame: Two month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
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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. This study is not recruiting at the moment.
MARÍA JOSÉ DÍAZ-ARRIBAS, PhD study director
UCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transabdominal radiofrecuency application and Intracavitary radiofrequency application in people with Primary Dysmenorrhea, run by Universidad Complutense de Madrid at 1 site in Spain.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 3 Sep 2024. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysmenorrheal pain intensity (time frame: Baseline). The study lists 3 primary outcomes in all. 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 3 Sep 2024.