Efficacy of Radiofrequency in Primary Dysmenorrhea

NCT06200506 | Completed

• 1 other identifier: UCompluMadrid
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Dysmenorrhea

Keywords

Dysmenorrhea; Physical therapy modality; Diathermy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (12)

• Quality of life during menstruation.

  Baseline

• Quality of life during menstruation.

  One month

• Quality of life during menstruation.

  Two month

• Quality of life (General)

  Baseline

• Quality of life (General)

  One month

Study Arms (3)

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

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

Device: Intracavitary radiofrequency application

Control Group

NO INTERVENTION

Not treatment received

Interventions

Transabdominal radiofrecuency application DEVICE

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

Transabdominal radiofrequency application

Intracavitary radiofrequency application DEVICE

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.

Intracavitary radiofrequency application

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: women with menstrual pain
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-35 years.
• Menstrual pain: During bleeding and/or the previous 48 hours.
• Nulliparous.
• Regular menstrual cycles (24-38 days according to FIGO).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Universidad Complutense de Madrid

Madrid, Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Dysmenorrhea; Fever

Condition Hierarchy (Ancestors)

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

Study Officials

• MARÍA JOSÉ DÍAZ-ARRIBAS, PhD

  UCM

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study of a prospective longitudinal clinical trial: two intervention groups and a control group

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: January 11, 2024
• Study Start: January 20, 2024
• Primary Completion: May 20, 2024
• Study Completion: July 20, 2024
• Last Updated: September 3, 2024

Record last verified: 2024-03

Locations

ES (1)