Effect of Pulsed Electromagnetic Field Therapy on Pain After Cesarean Delivery

NCT ID: NCT02365753

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-10-31

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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..

Group Type: PLACEBO_COMPARATOR

SofPulse

Intervention Type: DEVICE

Pulsed Electomagnetic Field Therapy Device placed over incision and turned on and kept in place with tape.

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.

Group Type: ACTIVE_COMPARATOR

SofPulse

Intervention Type: DEVICE

Pulsed Electomagnetic Field Therapy Device placed over incision and turned on and kept in place with tape.

Interventions

SofPulse

Pulsed Electomagnetic Field Therapy Device placed over incision and turned on and kept in place with tape.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

New York City Health and Hospitals Corporation

OTHER

Sponsor Role: lead

Responsible Party

Donald Phillibert

Attending Phyisician/ Assistant Professor/ Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donald C Phillibert, MD

Role: PRINCIPAL_INVESTIGATOR

Jacobi Medical Center

References

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.

Reference Type: DERIVED

PMID: 32871021 (View on PubMed)

Other Identifiers

Delivery2

Identifier Type: -

Identifier Source: org_study_id