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NCT07906431
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Conditions: Chronic Low Back Pain, Urinary Incontinence, Pelvic Floor Disorders
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: SERGIO MONTERO NAVARRO
Location: Cardenal Herrera - Ceu Elche Spain / Valencia
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.
Eligibility Criteria
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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.
* 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.
Source: ClinicalTrials.gov (NCT07906431). StuddyBuddy aggregates publicly available trial information.