High Tone Pelvic Floor DysfunctionPhase 2/3NCT07404397
Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction
A Phase 2/3 study testing Cyclobenzaprine, Pelvic floor massage wand and Pelvic floor physical therapy in people with High Tone Pelvic Floor Dysfunction, run by University of Michigan at 1 site in United States.
Trial summary
The researchers are comparing two treatments for high tone pelvic floor dysfunction (HTPFD) in conjunction with pelvic floor physical therapy (PFPT). The goal of this study is to find out which of two extra treatments works better for people with HTPFD when they also do regular PFPT. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- High Tone Pelvic Floor Dysfunction
- What is being tested?
- Cyclobenzaprine, Pelvic floor massage wand and Pelvic floor physical therapy
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2026to Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported moderate to severe chronic pelvic pain for >6 months duration at time of screening visit. Moderate to severe chronic pain is defined as >4 on 0-10 (worst daily pain) for >14 days per month. Pelvic pain is defined as pain perceived to be located in the anatomic pelvis.
- Diagnosis of high tone pelvic floor dysfunction (HTPFD), defined as >12/60 summative pelvic floor tenderness score on standardized pelvic examination by chronic pelvic pain specialist (MD or NP) within the past year
- Referred to pelvic floor physical therapy (PFPT) by their chronic pelvic pain specialist for management of HTPFD
- Willing to undergo a 12-session course of PFPT for HTPFD, including internal/vaginal tissue manipulation per standardized protocol
- Willing to delay start of PFPT until Phase 2 of the trial
- Willing to be randomized to either daily use of cyclobenzaprine or use of vibrating pelvic floor muscle massage wand for total of 18 weeks
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- Willing to undergo standardized pelvic floor myofascial exam three times over the study period (baseline, end of Phase 1, end of Phase 2)
- Willing to undergo quantitative sensory testing (QST) two times over the study period (baseline, end of Phase 1)
- Willing to undergo blood draw two times over the study period (baseline, end of Phase 1)
- Ability to read and speak English to allow for written informed consent, phenotyping, and patient-reported outcome measures
- No plans for pregnancy within the next 12 months
Who cannot join
- Hypersensitivity or allergy to cyclobenzaprine or any component of cyclobenzaprine
- Underwent PFPT within 6 months of screening date
- Pregnancy at any point during study period (self-reported home urine pregnancy test or serum b-Hcg test, positive urine pregnancy test at baseline, post-Phase 1, or post-Phase 2 study visits).
- Currently breastfeeding at time of screening visit
- Scheduled for or are planning moderate/major gynecologic surgery (including hysterectomy, excision of endometriosis, ovarian cystectomy/oopherectomy, myomectomy) within the following 6 months of screening date
- Current (at time of screening visit) diagnosis of postural orthostatic tachycardia syndrome
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- Current significant neurologic or musculoskeletal conditions that would preclude participation in PFPT (cerebral palsy, severe hip/back osteoarthritis that would prevent lithotomy position during sessions)
- Unwilling to avoid or stop baseline use of cyclobenzaprine and other muscle relaxants (including methocarbamol, tizanidine, baclofen, carisoprodol, metaxalone)
- Current use of tricyclic antidepressants
- Current use of monoamine oxidase inhibitor
- Current use of vaginally delivered benzodiazepine such as diazepam (more than once per month) and unwilling to stop use of vaginally delivered benzodiazepine for the duration of this study
- Current diagnosis of hyperthyroidism
- Current diagnosis of moderate or severe hepatic impairment
- Myocardial infarction within prior 12 months
- Current diagnosis of congestive heart failure
- Current cardiac pacemaker in place
- Current diagnosis of closed angle glaucoma
- Current major psychiatric condition (including psychosis or suicidal ideation within past year)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Vilmarie Carmona, 269-760-7317, vilmarie@umich.edu
About this study
Official title: Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction: a Pilot Randomized Controlled Trial
The researchers are comparing two treatments for high tone pelvic floor dysfunction (HTPFD) in conjunction with pelvic floor physical therapy (PFPT). The goal of this study is to find out which of two extra treatments works better for people with HTPFD when they also do regular PFPT. First, the researchers will compare a muscle relaxant medicine (cyclobenzaprine IR) to using a vibrating pelvic floor massage wand. Everyone in the study will also do pelvic floor physical therapy. The researchers want to see how these treatments affect pain, sexual health, physical ability, and overall quality of life.
Read the detailed description
Devices such as the Intimate Rose Vibrating Pelvic Floor Massage Wand are not required to indicate a phase for ClinicalTrials.gov. However, this study is marked as phase 2/3 considering the use of a study drug, Cyclobenzaprine.
- Conditions
- High Tone Pelvic Floor Dysfunction
- Being tested
- Cyclobenzaprine, Pelvic floor massage wand, Pelvic floor physical therapy
- Keywords
- pelvic floor physical therapy, cyclobenzaprine, vibrating pelvic floor massage wand
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclobenzaprineDrug
Also called Flexeril
Participants will be instructed to use cyclobenzaprine IR 5mg at bedtime. We will encourage participants to take the medication in the evening/before bed to minimize potential for bothersome sedation. Participants will be given the option to begin with ½ tablet (2.5mg) if preferred and titrate to 5mg dose, with goal of minimizing sedation side effects. Participants will be instructed that they may increase to 10mg at bedtime at Day 14 if desired based on perceived benefits and side effects.
Pelvic floor massage wandDevice
Participants will be instructed to use a commercially available vibrating pelvic floor massage wand for approximately 10-15 minutes at least 3 times per week, which can be titrated as needed (standard use recommendations per our pelvic physical therapists).
Pelvic floor physical therapyProcedure or surgery
Pelvic floor physical therapy for HTPFD uses manual manipulation to release localized muscle tension or trigger points, improve mobility of fascia, and address orthopaedic issues such as pelvic alignment and spine/hip mobility to reduce pain and improve function.
| Study group | Role | What they receive |
|---|---|---|
| Cyclobenzaprine PFPT | Experimental | During Phase 1, participants will be instructed to use cyclobenzaprine as detailed below. During Phase 2, participants will complete a course of pelvic floor physical therapy and will continue using cyclobenzaprine. Receives: Drug: Cyclobenzaprine; Procedure: Pelvic floor physical therapy |
| Pelvic floor massage wand & PFPT | Experimental | During Phase 1, participants will be instructed to use pelvic floor massage wand as detailed below. During Phase 2, participants will complete a course of pelvic floor physical therapy and will continue using pelvic floor massage wand. Receives: Device: Pelvic floor massage wand; Procedure: Pelvic floor physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference 4a score
PROMIS pain interference 4a score is from 4 questions with score ranging from 4-20. Higher scores indicate greater pain interference
Measured: Baseline, 18 weeks
PROMIS pain interference 4a score
PROMIS pain interference 4a score is from 4 questions with score ranging from 4-20. Higher scores indicate greater pain interference
Measured: Baseline, 6 weeks
Secondary outcomes (12)
50% reduction in PROMIS pain interference 4a score
PROMIS pain interference 4a score is from 4 questions with score ranging from 4-20. Higher scores indicate greater pain interference
Measured: 18 weeks compared to baseline
PROMIS pain intensity 1a score
PROMIS pain intensity 1a score is 1 question ranging from 0-10 and the higher the number the worse the pain.
Measured: Baseline, 18 weeks
PROMIS pain intensity 1a score
PROMIS pain intensity 1a score is 1 question ranging from 0-10 and the higher the number the worse the pain.
Measured: Baseline, 6 weeks
Female Sexual Function Index (FSFI)
Female Sexual Function Index (FSFI) overall score has six domains and a maximum score of 36, with a higher score indicating better functioning.
Measured: Baseline, 18 weeks
Female Sexual Function Index (FSFI)
Female Sexual Function Index (FSFI) overall score has six domains and a maximum score of 36, with a higher score indicating better functioning.
Measured: Baseline, 6 weeks
PROMIS Self Efficacy for Managing Symptoms SF 4a
PROMIS Self Efficacy for Managing Symptoms SF 4a is 4 questions with scores ranging from 4-20. Highter scores indicate higher confidence in symptom management
Measured: Baseline, 18 weeks
PROMIS Self Efficacy for Managing Symptoms SF 4a
PROMIS Self Efficacy for Managing Symptoms SF 4a is 4 questions with scores ranging from 4-20. Highter scores indicate higher confidence in symptom management
Measured: Baseline, 6 weeks
Summative pelvic floor myofascial tenderness to palpation
For Bilateral pubococcygeus, Bilateral iliococcygeus, and Bilateral obturator internus
Measured: Baseline, 18 weeks
Summative pelvic floor myofascial tenderness to palpation
For Bilateral pubococcygeus, Bilateral iliococcygeus, and Bilateral obturator internus
Measured: Baseline, 6 weeks
Patient Global Impression of Change
The Patient Global Impression of Change is scored on a scale of 1 - 7, with a score of 1 representing that the patient was very much worse following the trial, and a score of 7 representing that the patient was very much improved following the course of the trial.
Measured: 18 weeks
Patient Global Impression of Change
The Patient Global Impression of Change is scored on a scale of 1 - 7, with a score of 1 representing that the patient was very much worse following the trial, and a score of 7 representing that the patient was very much improved following the course of the trial.
Measured: 6 weeks
Number of pelvic floor physical therapy (PFPT) sessions attended
PFPT session attendance will be tracked by patient self-report
Measured: Up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start18 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Tone Pelvic Floor DysfunctionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- The American Association of Obstetricians and Gynecologists Foundation
- Responsible party
- Principal investigator, Sara Till, MD, MPH, University of Michigan
- Investigators
- Sara Till, MD, MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404397
- Sponsor's protocol ID
- HUM00280388
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Final de-identified, anonymized data sets underlying all publications resulting from the proposed research involving human subjects will be shared with legitimate academic researchers and other community members with a legitimate scientific interest in the research. Where practicable, sharing will take place under a written agreement between the principal investigators prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the datasets. The aim is to permit others to validate and replicate research findings described in the Aims while protecting participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07404397
- Acronym / sponsor ID
- HUM00280388
- Conditions
- High Tone Pelvic Floor Dysfunction
- Keywords
- pelvic floor physical therapy, cyclobenzaprine, vibrating pelvic floor massage wand
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- The American Association of Obstetricians and Gynecologists Foundation
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Feb 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.
The researchers are comparing two treatments for high tone pelvic floor dysfunction (HTPFD) in conjunction with pelvic floor physical therapy (PFPT). The goal of this study is to find out which of two extra treatments works better for people with HTPFD when they also do regular PFPT. First, the researchers will compare a muscle relaxant medicine (cyclobenzaprine IR) to using a vibrating pelvic floor massage wand. Everyone in the study will also do pelvic floor physical therapy. The researchers want to see how these treatments affect pain, sexual health, physical ability, and overall quality of life.
Detailed description
Devices such as the Intimate Rose Vibrating Pelvic Floor Massage Wand are not required to indicate a phase for ClinicalTrials.gov. However, this study is marked as phase 2/3 considering the use of a study drug, Cyclobenzaprine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclobenzaprine PFPT | Experimental | Drug: Cyclobenzaprine, Procedure: Pelvic floor physical therapyDuring Phase 1, participants will be instructed to use cyclobenzaprine as detailed below. During Phase 2, participants will complete a course of pelvic floor physical therapy and will continue using cyclobenzaprine. |
| Pelvic floor massage wand & PFPT | Experimental | Device: Pelvic floor massage wand, Procedure: Pelvic floor physical therapyDuring Phase 1, participants will be instructed to use pelvic floor massage wand as detailed below. During Phase 2, participants will complete a course of pelvic floor physical therapy and will continue using pelvic floor massage wand. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Self-reported moderate to severe chronic pelvic pain for >6 months duration at time of screening visit. Moderate to severe chronic pain is defined as >4 on 0-10 (worst daily pain) for >14 days per month. Pelvic pain is defined as pain perceived to be located in the anatomic pelvis.
- Diagnosis of high tone pelvic floor dysfunction (HTPFD), defined as >12/60 summative pelvic floor tenderness score on standardized pelvic examination by chronic pelvic pain specialist (MD or NP) within the past year
- Referred to pelvic floor physical therapy (PFPT) by their chronic pelvic pain specialist for management of HTPFD
- Willing to undergo a 12-session course of PFPT for HTPFD, including internal/vaginal tissue manipulation per standardized protocol
- Willing to delay start of PFPT until Phase 2 of the trial
Key exclusion criteria (18 listed)
- Hypersensitivity or allergy to cyclobenzaprine or any component of cyclobenzaprine
- Underwent PFPT within 6 months of screening date
- Pregnancy at any point during study period (self-reported home urine pregnancy test or serum b-Hcg test, positive urine pregnancy test at baseline, post-Phase 1, or post-Phase 2 study visits).
- Currently breastfeeding at time of screening visit
- Scheduled for or are planning moderate/major gynecologic surgery (including hysterectomy, excision of endometriosis, ovarian cystectomy/oopherectomy, myomectomy) within the following 6 months of screening date
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 |
|---|---|---|
| CyclobenzaprineAlso: FlexerilParticipants will be instructed to use cyclobenzaprine IR 5mg at bedtime. We will encourage participants to take the medication in the evening/before bed to minimize potential for bothersome sedation. Participants will be given the option to begin with ½ tablet (2.5mg) if preferred and titrate to 5mg dose, with goal of minimizing sedation side effects. Participants will be instructed that they may increase to 10mg at bedtime at Day 14 if desired based on perceived benefits and side effects. | Drug | Cyclobenzaprine PFPT |
| Pelvic floor massage wandParticipants will be instructed to use a commercially available vibrating pelvic floor massage wand for approximately 10-15 minutes at least 3 times per week, which can be titrated as needed (standard use recommendations per our pelvic physical therapists). | Device | Pelvic floor massage wand & PFPT |
| Pelvic floor physical therapyPelvic floor physical therapy for HTPFD uses manual manipulation to release localized muscle tension or trigger points, improve mobility of fascia, and address orthopaedic issues such as pelvic alignment and spine/hip mobility to reduce pain and improve function. | Procedure or surgery | Cyclobenzaprine PFPT, Pelvic floor massage wand & PFPT |
Primary outcome
Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference 4a score
Time frame: Baseline, 18 weeks
PROMIS pain interference 4a score is from 4 questions with score ranging from 4-20. Higher scores indicate greater pain interference
PROMIS pain interference 4a score
Time frame: Baseline, 6 weeks
PROMIS pain interference 4a score is from 4 questions with score ranging from 4-20. Higher scores indicate greater pain interference
12 secondary outcomes
50% reduction in PROMIS pain interference 4a score
Time frame: 18 weeks compared to baseline
PROMIS pain intensity 1a score
Time frame: Baseline, 18 weeks
PROMIS pain intensity 1a score
Time frame: Baseline, 6 weeks
Female Sexual Function Index (FSFI)
Time frame: Baseline, 18 weeks
Female Sexual Function Index (FSFI)
Time frame: Baseline, 6 weeks
PROMIS Self Efficacy for Managing Symptoms SF 4a
Time frame: Baseline, 18 weeks
PROMIS Self Efficacy for Managing Symptoms SF 4a
Time frame: Baseline, 6 weeks
Summative pelvic floor myofascial tenderness to palpation
Time frame: Baseline, 18 weeks
Summative pelvic floor myofascial tenderness to palpation
Time frame: Baseline, 6 weeks
Patient Global Impression of Change
Time frame: 18 weeks
Patient Global Impression of Change
Time frame: 6 weeks
Number of pelvic floor physical therapy (PFPT) sessions attended
Time frame: Up to 18 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: Yes. Final de-identified, anonymized data sets underlying all publications resulting from the proposed research involving human subjects will be shared with legitimate academic researchers and other community members with a legitimate scientific interest in the research. Where practicable, sharing will take place under a written agreement between the principal investigators prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the datasets. The aim is to permit others to validate and replicate research findings described in the Aims while protecting participant confidentiality.
Related trials for High Tone Pelvic Floor Dysfunction
Recruiting
HIFEM in Pospartum (High Intensity Focused Electro-Magnetic Technology)
Pelvic Floor Muscle Dysfunction
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.
Sara Till, MD, MPH principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cyclobenzaprine, Pelvic floor massage wand and Pelvic floor physical therapy in people with High Tone Pelvic Floor Dysfunction, run by University of Michigan at 1 site in United States.
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 11 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 20 Feb 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 United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vilmarie Carmona (269-760-7317, vilmarie@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference 4a score (time frame: Baseline, 18 weeks). The study lists 2 primary outcomes in all. 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 20 Feb 2026.