Effect of Pulsed Electromagnetic Field Therapy on Pain After Cesarean Delivery

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Device: SofPulse

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 Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: SofPulse nonfunctional device.; 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; Pulsed Electomagnetic Field Therapy Device placed over incision and turned on and kept in place with tape.
Active Comparator: Active; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Narcotic Use	An assesment of the amount of narcotics uses for pain control after cesarean delivery	72 hours or hospital stay

Collaborators and Investigators

• Sponsor: New York City Health and Hospitals Corporation
• Investigators: Principal Investigator: Donald C Phillibert, MD, Jacobi Medical Center

Publications and helpful links

General Publications

• Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): September 17, 2017
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: February 11, 2015
• First Submitted That Met QC Criteria: February 18, 2015
• First Posted (Estimate): February 19, 2015

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Pregnant women; lower transverse cesarean delivery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Delivery2