Effect of Pulsed Electromagnetic Field Therapy on Pain After Cesarean Delivery

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Device: SofPulse

• Registration Number: NCT02365753
• Lead Sponsor: New York City Health and Hospitals Corporation

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-11
• Study First Submitted QC: 2015-02-18
• Study First Posted: 2015-02-19
• Primary Completion: 2017-09-17
• Study Completion: 2018-10-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

• Age 18 to 45 years
• Female
• Undergoing lower transverse cesarean delivery or cesarean delivery with bilateral tubal ligation.
• Pfannenstiel Skin incision
• Consent to the study and willing to comply with study methods

Exclusion Criteria

• • Subjects who have any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverterdefibrillator)

  • Patients undergoing additional procedures at the time of their cesarean delivery such as cesarean hysterectomy or myomectomy.
  • Patients with vertical skin or uterine incisions.
  • Patients who forget to, or decide not to, replace PEMF device

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	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.
SofPulse nonfunctional device.	SofPulse	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..

Primary Outcome Measures

Name	Time	Method
Pain, assessed by patients using a pain scale	72 hours or hospital stay	Patient uses pain scale to give subjective assesment of pain after cesarean delivery

Secondary Outcome Measures

Name	Time	Method
Narcotic Use	72 hours or hospital stay	An assesment of the amount of narcotics uses for pain control after cesarean delivery