Completed

NCT Number: NCT07791277

Precise AI-Controlled Radiofrequency Versus Biofeedback-Electrical Stimulation in Women With Myofascial Pelvic Pain Syndrome: A Comparative Study

Study Summary: Comparison of Two Treatments for Female Myofascial Pelvic Pain Syndrome The goal of this study is to compare two treatment methods-precise AI-controlled radiofrequency therapy versus biofeedback combined with electrical stimulation-for their clinical effectiveness in female Myofascial Pelvic Pain Syndrome . The study also evaluates the differences between the two therapies in relieving pain, improving sexual function, restoring pelvic floor muscle strength, and reducing anxiety.

The main questions it aims to answer are:

Does precise AI-controlled radiofrequency therapy outperform biofeedback combined with electrical stimulation in relieving pain and reducing pelvic floor hypertonicity?

Do the two therapies differ in their effects on improving patients' sexual function and anxiety levels?

Which treatment regimen is more effective in restoring pelvic floor muscle strength and stability?

Researchers randomly assigned 70 female MPPS patients into two groups (35 patients each). One group received precise AI-controlled radiofrequency therapy (5 sessions, completed over approximately 12 weeks), while the other group received biofeedback combined with electrical stimulation (10 sessions, completed over approximately 3 weeks). Treatment outcomes were compared using Glazer pelvic floor surface electromyography (sEMG) assessment, Visual Analogue Scale (VAS) pain scores, the Female Sexual Function Index (FSFI), and anxiety scores.

Participants will:

Receive pelvic floor physical therapy for 3 to 12 weeks, depending on their group assignment

Undergo Glazer pelvic floor surface electromyography (sEMG) assessment before and after treatment to measure resting tension and muscle strength of the pelvic floor muscles

Complete pain (VAS), sexual function (FSFI), and anxiety (HADS-A) questionnaires before and after treatment

Be guided throughout the treatment by professional pelvic floor rehabilitation therapists, who will adjust parameters (e.g., current intensity, radiofrequency temperature) based on the patient's subjective comfort level during treatment

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Key information

Conditions

Myofascial Pain Dysfunction Syndrome Fibromyalgia Muscular Diseases Musculoskeletal Diseases Myofascial Pelvic Pain Syndrome Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jiangxi Maternal and Child Health Hospital

Nanchang, Jiangxi, 330000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Female patients with a confirmed diagnosis of MPPS
Have signed the informed consent form
Aged over 18 years old and sexually active

Exclusion criteria

Concurrent vaginitis;
Pregnancy, pre-pregnancy, or within 6 months postpartum
Abnormal vaginal bleeding
Severe systemic conditions
Internal metallic implants
Skin lesions in the treatment region
Organic pelvic pathologies
Systemic or neuropathic pain syndromes
Concurrent use of pharmacological therapy
intolerance to the current treatment protocol.

Treatment and study plan

Intervention 1：Precision AI Temperature-Controlled Radiofrequency

Device

Precision AI temperature-controlled radiofrequency therapy is delivered using the MLD UR80 device with an intravaginal probe. The device applies controlled thermal energy (40-45°C, max 48°C) to deep pelvic floor tissues, promoting collagen remodeling, enhancing microcirculation, and relieving myofascial trigger points. An AI system monitors impedance and temperature in real time, automatically adjusting energy output and activating safety alerts at 45°C with mandatory shutdown at 48°C. Each 30-minute session includes audio-guided pelvic floor exercises. The complete protocol comprises five sessions over approximately 12 weeks (first three sessions at 14-day intervals; remaining two at 21-day intervals).

Other names: Precision AI Temperature-Controlled Radiofrequency

Intervention 2:Biofeedback Combined with Electrical Stimulation

Device

Biofeedback combined with electrical stimulation is delivered using the MLD B2 biofeedback stimulator (Nanjing Medlander Medical Co., Ltd.) with an intravaginal electrode and surface electrodes placed on the abdomen and knees. The device provides combined electrical stimulation (0-60 mA) with real-time biofeedback signals displayed on a screen, enabling patients to visualize pelvic floor muscle activity and perform guided Kegel and breathing relaxation exercises. Each 30-minute session integrates three intelligent stimulation protocols selected by the device based on prior treatment records. The complete course consists of 10 sessions performed every other day, totaling approximately 3 weeks. Patients may discontinue at any time upon request.

Other names: Active Comparator

Primary outcomes

visual analog scale (VAS)

Time frame: "Prior to treatment initiation or on Day 1 of treatment" "After the end of treatment or at a mean of 4 to 12 weeks"

Visual Analogue Scale (VAS): The scale ranges from 0 to 10.1-3 points: mild pain, tolerable, barely interfering with daily activities and sleep;4-6 points: moderate pain, obvious discomfort, may disturb sleep, analgesic intervention may be needed;7-10 points: severe pain, unbearable, significantly impairs sleep and daily activities.

Sponsors and collaborators

Lead sponsor

Jiangxi Women and Children's Medical Center

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Aug 27, 2026
Registry last updated: Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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