Trial · NCT07906431
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
NCT07906431, Not applicable, Not yet recruiting, SERGIO MONTERO NAVARRO
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction. Trials, record NCT07906431. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07906431
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
- NCT number
- NCT07906431
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 60 participants, estimated
- Lead sponsor
- SERGIO MONTERO NAVARRO
- Conditions
- Chronic Low Back Pain, Urinary Incontinence, Pelvic Floor Disorders
- Interventions
- Capacitive-resistive radiofrequency, Lumbopelvic-pelvic floor therapeutic exercise
- First posted
- 2026-10-30
- Last updated
- 2026-10-30
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Lumbar pain intensity (Visual Analogue Scale) | Baseline and 1 week after the end of the assigned intervention (week 10 in the radiofrequency arm; week 13 in the exercise and combined arms) | Lumbar pain intensity on a 10-cm visual analogue scale (0 = no pain, 10 = worst imaginable pain). Higher scores indicate worse pain. |
| Secondary | Lumbar pain intensity during follow-up (Visual Analogue Scale) | 1 month and 3 months after the end of the assigned intervention | 0-10 cm VAS as for the primary outcome, assessed during follow-up. Higher scores indicate worse pain. |
| Secondary | Lumbar pain intensity at a common calendar time point (VAS) | 13 weeks after randomisation | Pre-specified sensitivity analysis: 0-10 cm VAS compared among groups when all participants have completed their assigned programme. |
| Secondary | Pain quality (McGill Pain Questionnaire) | Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention. | McGill Pain Questionnaire scored from descriptors selected across the sensory and affective subclasses. Higher scores indicate greater pain. |
| Secondary | Low back disability (Oswestry Disability Index) | Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention. | ODI, 0-100%. Higher scores indicate greater disability; a change of about 10 points is considered clinically important. |
| Secondary | Pelvic floor symptom distress (PFDI-20) | Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention. | Pelvic Floor Distress Inventory-20 total score (0-300). Higher scores indicate greater symptom distress. |
| Secondary | Urinary incontinence (ICIQ-UI SF) | Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention. | ICIQ Urinary Incontinence Short Form total score (0-21), covering frequency, amount and impact on quality of life. Higher scores indicate greater severity. |
| Secondary | Pelvic floor muscle function (PERFECT scheme) | Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention. | Digital vaginal assessment in lithotomy after voiding and 3 minutes of seated rest: power, endurance (s), repetitions and fast contractions (number per 10 s). |
| Secondary | Pelvic floor muscle strength (Modified Oxford Scale) | Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention. | Best of three maximal voluntary contractions on digital palpation, graded 0 (no contraction) to 5 (strong). Higher grades indicate greater strength. |
| Secondary | Intravaginal pressure (manometry) | Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention. | Phenix Liberty manometer with an air-filled vaginal probe: resting tone and mean of three maximal 10-second contractions (cmH2O/mmHg). |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07906431
GET https://conductscience.org/api/trials/v1/NCT07906431/registered