Efficacy of Radiofrequency in Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

— Rdismenorrea  

Official title:

Efficacy of Radiofrequency in Primary Dysmenorrhea

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06200506
• Other study ID #: UCompluMadrid
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 20, 2024
• Est. completion date: May 20, 2024

Study information

• Verified date: March 2024
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: May 20, 2024
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Age: 18-35 years.

• Menstrual pain: During bleeding and/or the previous 48 hours.

• Nulliparous.

• Regular menstrual cycles (24-38 days according to FIGO).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Device:
• Transabdominal radiofrecuency application
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
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.

Locations

Country	Name	City	State
Spain	Universidad Complutense de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	One month
Primary	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.	Two month
Secondary	Quality of life during menstruation.	Quality of life during menstruation, assessed with the previously validated Spanish version of the CVM-22 questionnaire.	Baseline
Secondary	Quality of life during menstruation.	Quality of life during menstruation, assessed with the previously validated Spanish version of the CVM-22 questionnaire.	One month
Secondary	Quality of life during menstruation.	Quality of life during menstruation, assessed with the previously validated Spanish version of the CVM-22 questionnaire.	Two month
Secondary	Quality of life (General)	Quality of life during, assessed with the previously validated Spanish version of the SF-12 questionnaire.	Baseline
Secondary	Quality of life (General)	Quality of life during, assessed with the previously validated Spanish version of the SF-12 questionnaire.	One month
Secondary	Quality of life (General)	Quality of life during, assessed with the previously validated Spanish version of the SF-12 questionnaire.	Two month
Secondary	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.	Baseline
Secondary	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.	One month
Secondary	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.	Two month
Secondary	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.	Baseline
Secondary	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.	One month
Secondary	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.	Two month