SWIMS America Corp.
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.
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 wo…
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.
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