An interventional study of SofPulse in Postoperative Pain, sponsored by New York City Health and Hospitals Corporation. Completed. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-04.
Sponsored by New York City Health and Hospitals Corporation · Not applicable, Interventional, and Treatment
A double-blinded randomized control study using a pulsed electromagnetic field therapy to establish whether this device decreases patient pain and decreases narcotic use in women who have undergone cesarean delivery.
This prospective, double-blind, randomized, sham-controlled clinical trial will investigate the effectiveness of PEMF using the Ivivi SofPulse on postoperative pain severity and narcotic use in women after cesarean delivery at Jacobi Medical Center. On admission to labor and delivery or in the obstetrical outpatient office, potential subjects will complete questions related to inclusion / exclusion criteria and sign a consent to participate in the study. If eligible, patients will receive a Ivivi Sofpulse device which will be placed over the incisional area and turned on. The devices are randomized into functional and sham groups. The device will be left around the incision site unless the patient needs to shower. In an effort to minimize bias, the patients, providers and investigators will not be aware if the device is functional or not. Lot numbers will accompany the device. After completion of the study, the Lot numbers, which will be provided by the manufacturer, will reveal which devices were functional devices or shams. These lot numbers will only be provided on completion of the trial. Wong-Baker Faces pain assessment tool will be evaluated by the Principal Investigator (PI) or co-investigator for determination of subjective postoperative pain at 0, 2, 6, 12, 24, 48, and 72 hours after cesarean delivery. Amount of oxycodone in milligrams consumed by patients will be recorded 24, 48, 72 hours after cesarean delivery. Postoperative anesthesia type (Duramorph or morphine patient controlled anesthesia pump) will be recorded as well. Subjects will be randomized to PEMF treatment (functional), or sham treatment. All subjects will be followed for the duration of their stay in the hospital following their cesarean delivery.
No follow-up is required. The goal is to recruit one hundred patients over the course of four months. Patient data will be identified by use of medical record number and will be kept private on the Jacobi Medical Center Obstetrics and Gynecology server which is password protected. Access will only be for the investigator and co-investigators in the study. Nurse on labor and delivery have already received an in-service on the proper use of this device.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 84 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →New York City Health and Hospitals Corporation is the lead sponsor of 27 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Subjects who have any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverterdefibrillator)
The Sofpulse non-functional device is placed over the incision after cesarean delivery and then turned on. The device only appears to be function correctly because the lights turn on, but does not emit a pulsed electromagnetic frequency..
Device: SofPulse
The Sofpulse Pulsed electromagnetic frequency device is placed over the incision after cesarean delivery and then turned on. Device appears to be operational and functions correctly.
Device: SofPulse
Pulsed Electomagnetic Field Therapy Device placed over incision and turned on and kept in place with tape.
Pain, assessed by patients using a pain scale
Patient uses pain scale to give subjective assesment of pain after cesarean delivery
Time frame: 72 hours or hospital stay
Narcotic Use
An assesment of the amount of narcotics uses for pain control after cesarean delivery
Time frame: 72 hours or hospital stay
No study locations are listed for this record.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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New York City Health and Hospitals Corporation