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

NCT07791277 | Completed

• 1 other identifier: EC-KYZZ-20260514
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myofascial Pain Dysfunction Syndrome; Myofascial Pelvic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• visual analog scale (VAS)

  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.

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

Study Arms (2)

Precision AI temperature-controlled radiofrequency group

EXPERIMENTAL

Device: Intervention 1：Precision AI Temperature-Controlled Radiofrequency

Biofeedback combined with electrical stimulation group

ACTIVE COMPARATOR

Biofeedback combined with electrical stimulation group

Device: Intervention 2:Biofeedback Combined with Electrical Stimulation

Interventions

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).

Also known as: Precision AI Temperature-Controlled Radiofrequency

Precision AI temperature-controlled radiofrequency group

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.

Also known as: Active Comparator

Biofeedback combined with electrical stimulation group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangxi Women and Children's Medical Center: lead

Study Sites (1)

Jiangxi Maternal and Child Health Hospital

Nanchang, Jiangxi, 330000, China

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2026
• First Posted: August 27, 2026
• Study Start: May 14, 2026
• Primary Completion: August 10, 2026
• Study Completion: August 16, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

CN (1)