Effect of Pulsed Electromagnetic Field Therapy on Pain After Cesarean Delivery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

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.
    

Intervention name(s): SofPulse
Intervention type(s): Device
Intervention description(s): Pulsed Electomagnetic Field Therapy Device placed over incision and turned on and kept in place with tape.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: lower transverse cesarean delivery; Pregnant women