Recruiting

RET, Hi-EMS, Hi-TENS vs. Manual TherapyCombined TECAR/EMS Therapy vs. Standard Manual Therapy for Endometriosis Pelvic Pain

Sponsor:

SWIMS America Corp.

Code:

NCT07933094

Conditions

Endometriosis

Pelvic Pain

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Winback BACK4 - hands-on TECAR+EMS

Winback BACK4 - hands-free Pelvic+

Hands-on manual pelvic floor physical therapy

Study Details

Brief summary:

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.

Conditions

Endometriosis

Pelvic Pain

Study ID

NCT07933094

Start date

Nov, 2026

Status verified date

Nov, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Women age 18 or older with a diagnosis of endometriosis (surgical/histologic or imaging-based)
Pelvic pain attributable to endometriosis
Able to attend the 8-session outpatient schedule
Able to provide written informed consent

Exclusion Criteria:

Clinical concern for or diagnosis of May-Thurner syndrome with associated risk of deep vein thrombosis (DVT)
Presence of a cardiac pacemaker, implantable cardioverter-defibrillator, or other active implanted electronic device
Active or suspected deep vein thrombosis or other uncontrolled clotting disorder
Open wound, active infection, or compromised skin integrity at planned electrode sites (suprapubic/lower abdominal region and sacral/gluteal region)
Known malignancy in the region to be treated
Current pregnancy
Inability to tolerate electrical stimulation per participant report during device calibration

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: Hands-On TECAR+EMS

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.

experimental: Arm B: Hands-Free Pelvic+

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.

active comparator: Arm C: Standard of Care

Hands-on manual pelvic floor physical therapy without the device; matched session time; patient education and home exercise program; 8 sessions over 6 weeks.

Interventions

Winback BACK4 - hands-on TECAR+EMS

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 - hands-free Pelvic+

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.

Hands-on manual pelvic floor physical therapy

Standard-of-care hands-on manual pelvic floor physical therapy without the device, with matched session time. 8 sessions over 6 weeks.

Primary outcome measure

Change in pelvic pain, 0-10 Visual Analog Scale (VAS) [ Time Frame: Baseline to study exit (6 weeks) ]

Central Contacts and Locations

Central contacts

Melanie Carminati, PT, DPT, GTS, NCPT

929-295-6566 melanie@inspirapt.com

Locations

Inspira Physical Therapy

Recruiting

Brooklyn, New York, United States, 11215

Contacts

Melanie Carminati, PT, DPT, GTS, NCPT

929-295-6566 melanie@inspirapt.com

More Information

Sponsor

SWIMS America Corp.

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Keywords

TECAR
radiofrequency
electrical muscle stimulation
manual therapy
pelvic floor physical therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by SWIMS America Corp. on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.