An interventional study of Winback BACK4 - hands-on TECAR+EMS and Winback BACK4 - hands-free Pelvic+ in Endometriosis and Pelvic Pain, sponsored by SWIMS America Corp.. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by SWIMS America Corp. · Not applicable, Interventional, and Treatment
Among 169 studies in Endometriosis with a site in United States — 38 open to participants now, 48 under way, 5 of them phase 3. Endometriosis · United States.
Among the 169 studies in Endometriosis with a site in United States, this one is the 56th largest by planned enrollment of the 131 interventional ones that give a count, is one of 15 that started in 2026, is one of 39 with no phase, reaches primary completion later than 16 of the 47 other live ones, and was the 169th registered.
921 studies on the registry are indexed under Endometriosis; 267 are open to participants now.
Browse Endometriosis studies →38 of the 169 studies in Endometriosis with a site in United States are open now. Recruiting first, the newest first:
LOAM Science · Sites in United States
Ages 18–45 · Women only · Healthy volunteers
Milton S. Hershey Medical Center · Sites in United States
Ages 18–45
Staci Gruber, Ph.D. · Sites in United States
Ages 21+ · Women only
Samphire Group, Inc. · Sites in United States
Ages 18–65 · Women only · Healthy volunteers
Vanderbilt University Medical Center · Sites in United States
Ages 18+ · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 178 Endometriosis studies recruiting now, 52 (29%) set no upper age limit and 124 (70%) stop at 75 or younger; 18 take children under 18; 39 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
169 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 17 · Phase 2 45 · Phase 3 22 · Phase 4 14
First in 1998; this study’s year is marked. 15 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 72 is close to the median of 67 across 541 interventional studies indexed under Endometriosis.
Median enrollment 60 across the 131 interventional studies, 187 across the 38 observational. Of the 102 that completed or were terminated, 50 (49%) have results posted.
This tab as a report to print or save as PDF → With an account.
58 of 169 have an industry lead sponsor. The 10 most frequent:
SWIMS America Corp. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
SWIMS America Corp. has 1 study filed under Endometriosis — fewer than ten, so there is no comparison to draw.
21 of the studies in Endometriosis with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06375811Phase 3Yale UniversityPre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp | 2027-03-31 |
| NCT04333576Phase 3AbbVieStudy Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain | 2027-07 |
| NCT05245695Aspira Women's HealthDeep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck) | 2026-11-30 |
| NCT06477406Mclean HospitalEvaluating the Impact of a Novel Cannabinoid Product for Endometriosis | 2026-12 |
| NCT05059626Penn State UniversityEndometriosis and Microvascular Dysfunction; Simvastatin and Duavee | 2026-12-31 |
Add all 21 to your calendar (.ics) → With an account.
Among the 169 studies in Endometriosis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study compares two ways of delivering a combined radiofrequency (RET), muscle stimulation (Hi-EMS), and pulsed radiofrequency (Hi-TENS) therapy, hands-on by a physical therapist or hands-free using adhesive pads, and compares the combined therapy to hands-on manual therapy alone for pelvic pain in women with endometriosis. Participants attend 8 sessions over 6 weeks.
Prospective, randomized, controlled, three-arm, parallel-group, open-label study using a hierarchical (fixed-sequence) analysis. The primary comparison tests whether hands-free delivery (Arm B) is non-inferior to hands-on delivery (Arm A) for change in pelvic pain VAS, using a pre-specified non-inferiority margin. The key secondary comparison tests whether adding the combined modality to hands-on manual therapy (Arm A) reduces pelvic pain more than hands-on manual therapy alone (Arm C). Clinician contact time is matched across arms.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Winback BACK4 combined RET/Hi-EMS/Hi-TENS delivered hands-on by the treating clinician (conductive electrode technique) with manual therapy; patient education and home exercise program; 8 sessions over 6 weeks.
Device: Winback BACK4 - hands-on TECAR+EMS
Winback BACK4 combined RET/Hi-EMS/Hi-TENS delivered via adhesive electrode pads; clinician present for matched session time; patient education and home exercise program; 8 sessions over 6 weeks.
Device: Winback BACK4 - hands-free Pelvic+
Hands-on manual pelvic floor physical therapy without the device; matched session time; patient education and home exercise program; 8 sessions over 6 weeks.
Other: Hands-on manual pelvic floor physical therapy
Winback BACK4 combined RET/Hi-EMS/Hi-TENS delivered hands-on by the treating clinician (conductive electrode technique) together with manual therapy. 8 sessions over 6 weeks.
Winback BACK4 combined RET/Hi-EMS/Hi-TENS delivered hands-free via adhesive electrode pads, with the clinician present for matched session time. 8 sessions over 6 weeks.
Standard-of-care hands-on manual pelvic floor physical therapy without the device, with matched session time. 8 sessions over 6 weeks.
Change in pelvic pain, 0-10 Visual Analog Scale (VAS)
Change in self-reported pelvic pain intensity on a 0-10 Visual Analog Scale (0 = no pain, 10 = worst pain). Primary comparison: Arm B (hands-free) non-inferior to Arm A (hands-on) with a 2.0-point margin.
Time frame: Baseline to study exit (6 weeks)
EndoPain4D total and subscale scores
Endometriosis-specific pain questionnaire; total and subscale scores.
Time frame: Baseline and 6 weeks
Endometriosis Health Profile-5 (EHP-5)
Short-form endometriosis-specific quality of life questionnaire.
Time frame: Baseline and 6 weeks
Central Sensitization Inventory (CSI)
Validated 25-item self-report questionnaire of symptoms associated with central sensitization.
Time frame: Baseline and 6 weeks
Fatigue Severity Scale (FSS)
Self-report scale of fatigue severity.
Time frame: Baseline and 6 weeks
Working Alliance Inventory-Short Form (WAI-SF)
Participant-rated therapeutic alliance with the treating clinician.
Time frame: 6 weeks
Number of participants with adverse events
Adverse events assessed and documented at every session.
Time frame: Through 6 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Mar 2027, 4 months later.
Of 213 interventional studies with no phase under Endometriosis, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 44. This study's planned 4 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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SWIMS America Corp.