Myofascial Pain Dysfunction SyndromeNCT07791277
Precise AI-Controlled Radiofrequency Versus Biofeedback-Electrical Stimulation in Women With Myofascial Pelvic Pain Syndrome: A Comparative Study
A study testing Intervention 2:Biofeedback Combined with Electrical Stimulation in people with Myofascial Pain Dysfunction Syndrome and Myofascial Pelvic Pain Syndrome, run by Jiangxi Women and Children's Medical Center at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Myofascial Pain Dysfunction Syndrome, Myofascial Pelvic Pain Syndrome
- What is being tested?
- Intervention 2:Biofeedback Combined with Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2026to 16 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Female patients with a confirmed diagnosis of MPPS
- Have signed the informed consent form
- Aged over 18 years old and sexually active
Who cannot join
- 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
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- Organic pelvic pathologies
- Systemic or neuropathic pain syndromes
- Concurrent use of pharmacological therapy
- intolerance to the current treatment protocol.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, 330000
About this 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:
Read more
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
- Being tested
- Intervention 1：Precision AI Temperature-Controlled Radiofrequency, Intervention 2:Biofeedback Combined with Electrical Stimulation
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1：Precision AI Temperature-Controlled RadiofrequencyDevice
Also called Precision AI Temperature-Controlled Radiofrequency
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).
Intervention 2:Biofeedback Combined with Electrical StimulationDevice
Also called Active Comparator
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.
| Study group | Role | What they receive |
|---|---|---|
| Precision AI temperature-controlled radiofrequency group | Experimental | Not described Receives: Device: Intervention 1：Precision AI Temperature-Controlled Radiofrequency |
| Biofeedback combined with electrical stimulation group | Active comparator | Biofeedback combined with electrical stimulation group Receives: Device: Intervention 2:Biofeedback Combined with Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "Prior to treatment initiation or on Day 1 of treatment" "After the end of treatment or at a mean of 4 to 12 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start14 May 2026
- Primary completion10 Aug 2026
- Study completion16 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain Dysfunction SyndromeStudies 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
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangxi Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791277
- Sponsor's protocol ID
- EC-KYZZ-20260514
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precise AI-Controlled Radiofrequency Versus Biofeedback-Electrical Stimulation in Women With Myofascial Pelvic Pain Syndrome: A Comparative Study
- ClinicalTrials.gov ID
- NCT07791277
- Acronym / sponsor ID
- EC-KYZZ-20260514
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Jiangxi Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 14 May 2026 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- 16 Aug 2026 (actual)
- First posted
- 27 Aug 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precision AI temperature-controlled radiofrequency group | Experimental | Device: Intervention 1：Precision AI Temperature-Controlled Radiofrequency |
| Biofeedback combined with electrical stimulation group | Active comparator | Device: Intervention 2:Biofeedback Combined with Electrical StimulationBiofeedback combined with electrical stimulation group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients with a confirmed diagnosis of MPPS
- Have signed the informed consent form
- Aged over 18 years old and sexually active
Key exclusion criteria (10 listed)
- Concurrent vaginitis;
- Pregnancy, pre-pregnancy, or within 6 months postpartum
- Abnormal vaginal bleeding
- Severe systemic conditions
- Internal metallic implants
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 |
|---|---|---|
| Intervention 1：Precision AI Temperature-Controlled RadiofrequencyAlso: Precision AI Temperature-Controlled RadiofrequencyPrecision 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). | Device | Precision AI temperature-controlled radiofrequency group |
| Intervention 2:Biofeedback Combined with Electrical StimulationAlso: Active ComparatorBiofeedback 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. | Device | Biofeedback combined with electrical stimulation group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 2:Biofeedback Combined with Electrical Stimulation in people with Myofascial Pain Dysfunction Syndrome and Myofascial Pelvic Pain Syndrome, run by Jiangxi Women and Children's Medical Center at 1 site in China.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 27 Aug 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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"). 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 27 Aug 2026.