Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
NCT07921381, Not applicable, Not yet recruiting, SERGIO MONTERO NAVARRO
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea | ClinicalTrials.gov |
| NCT number | NCT07921381 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 120 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | SERGIO MONTERO NAVARRO | ClinicalTrials.gov |
| Conditions | Primary Dysmenorrhea | ClinicalTrials.gov |
| Interventions | Capacitive radiofrequency, Pelvic floor and core exercise programme | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Menstrual pain intensity (Visual Analogue Scale) | Baseline and 1 week after the end of the 8-week intervention | Menstrual pain on a 0-10 cm visual analogue scale (0 = no pain, 10 = worst pain). Higher scores indicate worse pain | ClinicalTrials.gov |
| Secondary | Menstrual pain intensity during follow-up (VAS) | 6 months and 1 year after the end of the intervention | Menstrual pain intensity measured with a 10-cm Visual Analogue Scale (VAS), from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain. | ClinicalTrials.gov |
| Secondary | Pain quality (McGill Pain Questionnaire) | Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention. | McGill Pain Questionnaire (MPQ). Participants select one descriptor from each of 20 subclasses that applies to their menstrual pain; each descriptor has a rank value. The total Pain Rating Index ranges from 0 to 78, with higher scores indicating greater pain. | ClinicalTrials.gov |
| Secondary | Analgesic consumption | Each menstrual cycle during the 8-week intervention | Number of analgesic doses taken for menstrual pain per cycle, recorded in a diary (date, time, drug and amount). | ClinicalTrials.gov |
| Secondary | Health-related quality of life (EQ-5D) | Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention. | EuroQol-5D, five dimensions scored at 3 levels, plus a 0-100 visual analogue scale of health status. Higher VAS scores indicate better health. | ClinicalTrials.gov |
| Secondary | Sexual function (FSFI) | Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention. | Female Sexual Function Index, total score (range 2-36) over the previous 4 weeks. Scores of 26.55 or lower indicate sexual dysfunction; higher scores indicate better function. | ClinicalTrials.gov |
| Secondary | Premenstrual symptoms (PSST) | Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention. | Premenstrual Symptoms Screening Tool: 14 symptom items (total 0-42; higher scores indicate more severe symptoms) and 5 items on functional impact. | ClinicalTrials.gov |
| Secondary | Pelvic floor muscle function (PERFECT scheme and modified Oxford scale) | Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention. | Digital vaginal assessment: power (modified Oxford 0-5), endurance (s), repetitions and fast contractions (number per 10 s). | ClinicalTrials.gov |
| Secondary | Intravaginal pressure (manometry) | Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention. | Phenix Liberty manometer with an air-filled probe: resting tone and mean of three maximal contractions held for 10 sec. | ClinicalTrials.gov |
| Secondary | Treatment satisfaction | 1 week after the end of the intervention | Five-point Likert scale (1 = very dissatisfied, 5 = very satisfied). | ClinicalTrials.gov |
| Other | Adverse events | From the first session to 1 year after the intervention | Number of participants with adverse events (e.g. burns, marked irritation or persistent pain), by group. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)