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Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Sponsor: SERGIO MONTERO NAVARRO
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. 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.
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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-10-30
Completion Date
2027-05-01
Last Updated
2026-10-30
Healthy Volunteers
No
Interventions
Capacitive-resistive radiofrequency
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 exercise
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.
Locations (1)
Cardenal Herrera - Ceu
Elche, Spain / Valencia, Spain