Chronic Low Back PainNCT07906431
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
A study testing Capacitive-resistive radiofrequency and Lumbopelvic-pelvic floor therapeutic exercise in people with Chronic Low Back Pain and Urinary Incontinence, run by SERGIO MONTERO NAVARRO at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chronic Low Back Pain, Urinary Incontinence, Pelvic Floor Disorders
- What is being tested?
- Capacitive-resistive radiofrequency and Lumbopelvic-pelvic floor therapeutic exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 30 Oct 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 years or older.
- Non-specific low back pain located between T12 and the iliac crest, with or without referred pain to the lower limb.
- Pain duration of more than 12 consecutive weeks.
- Pain intensity of 3/10 or higher on a 0-10 visual analogue scale at screening.
- Pelvic floor dysfunction, defined as a score above 0 on the Pelvic Floor Distress Inventory-20 (PFDI-20) or the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF).
Who cannot join
- Perimenopause or menopause.
- Chronic pain in regions other than the lumbar and pelvic areas.
- Current pregnancy or breastfeeding.
- Physiotherapist-supervised pelvic floor muscle training in the previous 12 months.
- Pharmacological treatment for any pelvic floor disorder.
- Radiofrequency applied to the pelvic floor muscles in the previous 12 months.
Show all 12Show fewer
- Inability to understand study information (cognitive impairment).
- Cardiac, metabolic or autoimmune disease.
- Peripheral or central neurological disorder.
- Previous abdominal, lumbar or pelvic surgery.
- Skin disease or open wounds in the treatment area.
- Active urinary tract or vaginal infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Cardenal Herrera - Ceu
Elche, Spain / Valencia, 46113
SERGIO MONTERO-NAVARRO, PhD, +34 965426486 ext. 67604, sergio.montero@uchceu.es
MARIE RIQUIER, MsC
About this study
Official title: Effectiveness of Capacitive-Resistive Radiofrequency and Lumbopelvic-Pelvic Floor Exercise, Alone or Combined, for Chronic Low Back Pain in Premenopausal Women With Pelvic Floor Dysfunction: a Three-Arm Randomised Controlled Trial.
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:
- Radiofrequency: nine weekly 20-minute sessions applied to the lower back and, through a vaginal electrode, to the pelvic floor.
- Exercise: a 12-week programme of supervised group sessions (three 30-minute sessions per week) for the core and pelvic floor muscles.
- Combined: both treatments at the same time. Participants will complete questionnaires and a physical examination before treatment and 1 week, 1 month and 3 months after treatment ends.
Read the detailed description
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.
- Being tested
- Capacitive-resistive radiofrequency, Lumbopelvic-pelvic floor therapeutic exercise
- Keywords
- Capacitive-resistive electric transfer, Radiofrequency, TECAR therapy, Pelvic floor muscle training, Core stabilization exercise, Physiotherapy, Premenopausal women
- Medical subject headings
- Urinary Incontinence, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capacitive-resistive radiofrequencyDevice
Also called CRET, TECAR therapy, Monopolar capacitive-resistive diathermy
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.
Lumbopelvic-pelvic floor therapeutic exerciseBehavioural
Also called Core stabilization exercise, Pelvic floor muscle training
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.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency | Experimental | Nine weekly sessions of capacitive-resistive radiofrequency applied simultaneously to the lumbar region (20 min) and intravaginally to the pelvic floor (20 min). Receives: Device: Capacitive-resistive radiofrequency |
| Therapeutic exercise | Active comparator | Supervised lumbopelvic core and pelvic floor muscle exercise programme: three 30-minute group sessions per week for 12 weeks (36 sessions). Receives: Behavioral: Lumbopelvic-pelvic floor therapeutic exercise |
| Radiofrequency + therapeutic exercise | Experimental | Both interventions delivered concurrently, with the same dose, progression and recording forms as the single-modality arms. Receives: Device: Capacitive-resistive radiofrequency; Behavioral: Lumbopelvic-pelvic floor therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
Lumbar extension
Passive lumbar extension test (positive/negative)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm, parallel-group randomised controlled trial with 1:1:1 allocation comparing radiofrequency, supervised lumbopelvic-pelvic floor exercise, and their combination.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SERGIO MONTERO NAVARRO
- Sponsor type
- University, hospital or other
- Collaborators
- Cardenal Herrera University
- Responsible party
- Sponsor-investigator, SERGIO MONTERO NAVARRO, Cardenal Herrera University
- Investigators
- Jesús Sánchez-Mas, PhD, Study director, Cardenal Herrera CEU University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906431
- Sponsor's protocol ID
- CEEI25/763
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Capacitive-Resistive Radiofrequency and Lumbopelvic-Pelvic Floor Exercise, Alone or Combined, for Chronic Low Back Pain in Premenopausal Women With Pelvic Floor Dysfunction: a Three-Arm Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT07906431
- Acronym / sponsor ID
- CEEI25/763
- Keywords
- Capacitive-resistive electric transfer, Radiofrequency, TECAR therapy, Pelvic floor muscle training, Core stabilization exercise, Physiotherapy, Premenopausal women
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- SERGIO MONTERO NAVARROUniversity, hospital or other
- Collaborators
- Cardenal Herrera University
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Radiofrequency: nine weekly 20-minute sessions applied to the lower back and, through a vaginal electrode, to the pelvic floor.
- Exercise: a 12-week programme of supervised group sessions (three 30-minute sessions per week) for the core and pelvic floor muscles.
- Combined: both treatments at the same time. Participants will complete questionnaires and a physical examination before treatment and 1 week, 1 month and 3 months after treatment ends.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm, parallel-group randomised controlled trial with 1:1:1 allocation comparing radiofrequency, supervised lumbopelvic-pelvic floor exercise, and their combination.
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency | Experimental | Device: Capacitive-resistive radiofrequencyNine weekly sessions of capacitive-resistive radiofrequency applied simultaneously to the lumbar region (20 min) and intravaginally to the pelvic floor (20 min). |
| Therapeutic exercise | Active comparator | Behavioral: Lumbopelvic-pelvic floor therapeutic exerciseSupervised lumbopelvic core and pelvic floor muscle exercise programme: three 30-minute group sessions per week for 12 weeks (36 sessions). |
| Radiofrequency + therapeutic exercise | Experimental | Device: Capacitive-resistive radiofrequency, Behavioral: Lumbopelvic-pelvic floor therapeutic exerciseBoth interventions delivered concurrently, with the same dose, progression and recording forms as the single-modality arms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged 18 years or older.
- Non-specific low back pain located between T12 and the iliac crest, with or without referred pain to the lower limb.
- Pain duration of more than 12 consecutive weeks.
- Pain intensity of 3/10 or higher on a 0-10 visual analogue scale at screening.
- Pelvic floor dysfunction, defined as a score above 0 on the Pelvic Floor Distress Inventory-20 (PFDI-20) or the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF).
Key exclusion criteria (12 listed)
- Perimenopause or menopause.
- Chronic pain in regions other than the lumbar and pelvic areas.
- Current pregnancy or breastfeeding.
- Physiotherapist-supervised pelvic floor muscle training in the previous 12 months.
- Pharmacological treatment for any pelvic floor disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capacitive-resistive radiofrequencyAlso: CRET, TECAR therapy, Monopolar capacitive-resistive diathermyCapenergy 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. | Device | Radiofrequency, Radiofrequency + therapeutic exercise |
| Lumbopelvic-pelvic floor therapeutic exerciseAlso: Core stabilization exercise, Pelvic floor muscle training36 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. | Behavioural | Radiofrequency + therapeutic exercise, Therapeutic exercise |
Primary outcome
Lumbar pain intensity (Visual Analogue Scale)
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 on a 10-cm visual analogue scale (0 = no pain, 10 = worst imaginable pain). Higher scores indicate worse pain.
14 secondary outcomes
Lumbar pain intensity during follow-up (Visual Analogue Scale)
Time frame: 1 month and 3 months after the end of the assigned intervention
Lumbar pain intensity at a common calendar time point (VAS)
Time frame: 13 weeks after randomisation
Pain quality (McGill Pain Questionnaire)
Time frame: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
Low back disability (Oswestry Disability Index)
Time frame: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
Pelvic floor symptom distress (PFDI-20)
Time frame: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
Urinary incontinence (ICIQ-UI SF)
Time frame: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
Pelvic floor muscle function (PERFECT scheme)
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)
Time frame: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
Intravaginal pressure (manometry)
Time frame: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
Lumbar flexion mobility (Modified Schober test)
Time frame: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
Lumbar extension
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)
Time frame: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
Pain catastrophising (Pain Catastrophizing Scale, PCS)
Time frame: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
lateral flexion
Time frame: Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jesús Sánchez-Mas, PhD study director
Cardenal Herrera CEU University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capacitive-resistive radiofrequency and Lumbopelvic-pelvic floor therapeutic exercise in people with Chronic Low Back Pain and Urinary Incontinence, run by SERGIO MONTERO NAVARRO at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SERGIO MONTERO-NAVARRO, PhD (+34 965 42 64 86 ext. 67604, sergio.montero@uchceu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar pain intensity (Visual Analogue Scale) (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.