Postoperative PainNCT02365753
Effect of Pulsed Electromagnetic Field Therapy on Pain After Cesarean Delivery
A study testing SofPulse in people with Postoperative Pain, run by New York City Health and Hospitals Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- SofPulse
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- • 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
About this study
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.
Read the 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
- Being tested
- SofPulse
- Keywords
- lower transverse cesarean delivery, Pregnant women
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SofPulseDevice
Pulsed Electomagnetic Field Therapy Device placed over incision and turned on and kept in place with tape.
| Study group | Role | What they receive |
|---|---|---|
| SofPulse nonfunctional device. | Placebo comparator | 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.. Receives: Device: SofPulse |
| Active | Active comparator | 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. Receives: Device: SofPulse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, assessed by patients using a pain scale
Patient uses pain scale to give subjective assesment of pain after cesarean delivery
Measured: 72 hours or hospital stay
Secondary outcomes (1)
Narcotic Use
An assesment of the amount of narcotics uses for pain control after cesarean delivery
Measured: 72 hours or hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startJan 2015
- Primary completion17 Sep 2017
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York City Health and Hospitals Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donald Phillibert, New York City Health and Hospitals Corporation
- Investigators
- Donald C Phillibert, MD, Principal investigator, Jacobi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365753
- Sponsor's protocol ID
- Delivery2
- Status last verified
- Apr 2019
- First submitted
- 11 Feb 2015
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 32871021
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulsed Electromagnetic Field Therapy on Pain After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT02365753
- Acronym / sponsor ID
- Delivery2
- Conditions
- Postoperative Pain
- Keywords
- lower transverse cesarean delivery, Pregnant women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- New York City Health and Hospitals CorporationUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 17 Sep 2017 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SofPulse nonfunctional device. | Placebo comparator | Device: SofPulseThe 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.. |
| Active | Active comparator | Device: SofPulseThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- • Subjects who have any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverterdefibrillator)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SofPulsePulsed Electomagnetic Field Therapy Device placed over incision and turned on and kept in place with tape. | Device | Active, SofPulse nonfunctional device. |
Primary outcome
Pain, assessed by patients using a pain scale
Time frame: 72 hours or hospital stay
Patient uses pain scale to give subjective assesment of pain after cesarean delivery
1 secondary outcome
Narcotic Use
Time frame: 72 hours or hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Derived from this study: PubMed 32871021Zimpel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald C Phillibert, MD principal investigator
Jacobi Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing SofPulse in people with Postoperative Pain, run by New York City Health and Hospitals Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain, assessed by patients using a pain scale (time frame: 72 hours or hospital stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02365753, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.