An interventional study of Capacitive-resistive radiofrequency and Lumbopelvic-pelvic floor therapeutic exercise in Chronic Low Back Pain, Urinary Incontinence and Pelvic Floor Disorders, sponsored by SERGIO MONTERO NAVARRO. Not yet recruiting at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by SERGIO MONTERO NAVARRO · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn whether capacitive-resistive radiofrequency, a supervised core and pelvic floor exercise programme, or both together reduce low back pain in premenopausal women with chronic non-specific low back pain and pelvic floor dysfunction. The main question it aims to answer is: do the three treatments differ in lumbar pain intensity (0-10 visual analogue scale) 1 week after the treatment ends? Researchers will also compare pain quality, low back disability, pelvic floor symptoms, urinary incontinence, pelvic floor muscle function and lumbar mobility up to 3 months after treatment.
Sixty women will be randomly assigned to one of three groups:
Background. Non-specific chronic low back pain (CLBP) is a leading cause of disability and is more prevalent in women than in men. Pelvic floor muscle (PFM) dysfunction frequently coexists with CLBP, and PFM training can reduce lumbar pain intensity. Capacitive-resistive radiofrequency (RF) improves pain and function when applied to the lumbar region and can reduce pelvic floor symptoms when applied vaginally. However, no randomised trial has tested pelvic-floor RF for CLBP or compared RF, lumbopelvic-PFM exercise and their combination.
Design. Single-centre, three-arm, parallel-group, assessor-blinded randomised controlled trial with 1:1:1 allocation, conducted at Centre Osmose Saint-Loup (Marseille, France). There is no untreated control arm; the trial compares three active conservative strategies. The protocol follows the SPIRIT 2025 statement.
Randomisation and blinding. After the baseline assessment, an independent investigator will generate the allocation sequence with SAS 9.4. Treatment codes will be stored in a restricted database accessible only to the clinician delivering the intervention. Outcome assessors and the trial statistician will be blinded to allocation. Participants and treating physiotherapists cannot be blinded.
Interventions. RF will be delivered with a Capenergy C500 Urogyne capacitive-resistive device in nine weekly sessions. Each session includes a lumbar application (prone; pulsed emission, 840 kHz, 30 V; dynamic application over active myofascial trigger points of quadratus lumborum, multifidus and iliocostalis; 20 minutes). It also includes a simultaneous intravaginal application with a covered, lubricated electrode, sweeping the vaginal walls by clock-face quadrants for 20 minutes at a high but non-burning thermal sensation. The exercise programme consists of 36 supervised 30-minute group sessions (maximum five participants) over 12 weeks. It progresses from isolated PFM and transversus abdominis activation to combined core, gluteal and synergistic work in static and dynamic positions, with load increases after weeks 4 and 8. The combined arm receives both interventions concurrently.
Outcomes. The primary outcome is lumbar pain intensity (10-cm VAS) 1 week after the last session of the assigned intervention. Secondary outcomes are the McGill Pain Questionnaire, Oswestry Disability Index, PFDI-20, ICIQ-SF, PFM function (PERFECT scheme, modified Oxford scale, intravaginal manometry) and lumbar mobility. All are assessed at baseline and at 1 week, 1 month and 3 months after the end of the intervention.
Sample size. The sample size was calculated in G*Power for a one-way ANOVA with a large effect (Cohen's f = 0.50), two-sided α = 0.05 and 15% attrition, giving 60 participants (20 per arm).
Statistical analysis. Intention-to-treat analysis with repeated-measures ANOVA, or a linear mixed model if imbalance or missingness requires it (group × time). A pre-specified sensitivity analysis compares VAS among groups 13 weeks after randomisation. Multiple imputation will be used where appropriate, with complete-case sensitivity analyses.
Ethics and funding. Approved by the Biomedical Research Ethics Committee of Universidad CEU Cardenal Herrera (CEEI25/763, 19 January 2026). The trial has no specific funding. Capenergy Medical (Barcelona, Spain) loans the RF device in kind and has no role in design, data collection, analysis, interpretation or publication.
983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 739 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →SERGIO MONTERO NAVARRO is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nine weekly sessions of capacitive-resistive radiofrequency applied simultaneously to the lumbar region (20 min) and intravaginally to the pelvic floor (20 min).
Device: Capacitive-resistive radiofrequency
Supervised lumbopelvic core and pelvic floor muscle exercise programme: three 30-minute group sessions per week for 12 weeks (36 sessions).
Behavioral: Lumbopelvic-pelvic floor therapeutic exercise
Both interventions delivered concurrently, with the same dose, progression and recording forms as the single-modality arms.
Device: Capacitive-resistive radiofrequency · Behavioral: Lumbopelvic-pelvic floor therapeutic exercise
Capenergy C500 Urogyne device (Capenergy Medical, Barcelona, Spain). Lumbar application: participant prone; pulsed emission at 840 kHz and 30 V, applied dynamically over active myofascial trigger points of quadratus lumborum, multifidus and iliocostalis; active plate on the lumbar region and return plate on the abdomen; 20 minutes. Simultaneous pelvic application: covered, lubricated intravaginal electrode with return plate on the lumbar region, sweeping the vaginal walls by clock-face quadrants (0-3, 3-6, 6-9, 9-12) for 20 minutes at a high but non-burning thermal sensation. Nine sessions at 7-day intervals. Delivered energy (kJ) and temperature are recorded each session.
Also known as: CRET, TECAR therapy, Monopolar capacitive-resistive diathermy
36 supervised 30-minute group sessions (maximum five participants) over 12 weeks, led by physiotherapists experienced in pelvic floor rehabilitation. Week 1 begins with an individual session on anatomy, breathing and technique, with digital checking of PFM contraction. Sessions progress from isolated PFM and transversus abdominis activation to combined core, gluteal and synergistic work in static and dynamic positions, including resisted expiration and brief apnoea. Load increases after weeks 4 and 8. Stretching and relaxation are included. Typical dose: 3 sets of 10 repetitions, adjusted to the baseline PERFECT profile. Attendance is logged.
Also known as: Core stabilization exercise, Pelvic floor muscle training
Lumbar pain intensity (Visual Analogue Scale)
Lumbar pain intensity on a 10-cm visual analogue scale (0 = no pain, 10 = worst imaginable pain). Higher scores indicate worse pain.
Time frame: 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 during follow-up (Visual Analogue Scale)
0-10 cm VAS as for the primary outcome, assessed during follow-up. Higher scores indicate worse pain.
Time frame: 1 month and 3 months after the end of the assigned intervention
Lumbar pain intensity at a common calendar time point (VAS)
Pre-specified sensitivity analysis: 0-10 cm VAS compared among groups when all participants have completed their assigned programme.
Time frame: 13 weeks after randomisation
Pain quality (McGill Pain Questionnaire)
McGill Pain Questionnaire scored from descriptors selected across the sensory and affective subclasses. Higher scores indicate greater pain.
Time frame: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
Low back disability (Oswestry Disability Index)
ODI, 0-100%. Higher scores indicate greater disability; a change of about 10 points is considered clinically important.
Time frame: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
Pelvic floor symptom distress (PFDI-20)
Pelvic Floor Distress Inventory-20 total score (0-300). Higher scores indicate greater symptom distress.
Time frame: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
Urinary incontinence (ICIQ-UI SF)
ICIQ Urinary Incontinence Short Form total score (0-21), covering frequency, amount and impact on quality of life. Higher scores indicate greater severity.
Time frame: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
Pelvic floor muscle function (PERFECT scheme)
Digital vaginal assessment in lithotomy after voiding and 3 minutes of seated rest: power, endurance (s), repetitions and fast contractions (number per 10 s).
Time frame: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
Pelvic floor muscle strength (Modified Oxford Scale)
Best of three maximal voluntary contractions on digital palpation, graded 0 (no contraction) to 5 (strong). Higher grades indicate greater strength.
Time frame: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
Intravaginal pressure (manometry)
Phenix Liberty manometer with an air-filled vaginal probe: resting tone and mean of three maximal 10-second contractions (cmH2O/mmHg).
Time frame: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
Lumbar flexion mobility (Modified Schober test)
Lumbar flexion mobility measured with the modified Schober test (cm).
Time frame: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
Lumbar extension
Passive lumbar extension test (positive/negative)
Time frame: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
Kinesiophobia (Tampa Scale for Kinesiophobia, TSK-17)
TSK-17 total score (17 items; range 17-68). Higher scores indicate greater fear of movement or re-injury.
Time frame: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
Pain catastrophising (Pain Catastrophizing Scale, PCS)
PCS total score (13 items; range 0-52). Higher scores indicate greater pain catastrophising.
Time frame: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
lateral flexion
bilateral side-bending fingertip-to-thigh distance (cm; difference below 10 cm classified as restricted).
Time frame: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
Adverse events
Number of participants with adverse events (e.g. burns, marked irritation, persistent pain), by group, relatedness and seriousness.
Time frame: From first intervention session to 3 months after the end of the assigned intervention
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — After publication of the primary results, a de-identified participant-level dataset and the statistical analysis code may be shared with qualified researchers on reasonable request to the principal investigator, subject to a data-use agreement and to ethics and data-protection review.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Beginning after publication of the primary results.
Access criteria: Qualified researchers, on reasonable request to the principal investigator, with a signed data-use agreement and ethics and data-protection approval.
Start is estimated for Oct 2026; primary completion for Mar 2027, 5 months later.
Of 301 non-industry interventional studies with no phase under Urinary Incontinence, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 5 months is below that.
Counting every sponsor, half of 364 studies reached it within 15 months; a quarter within 7 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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