Effect of Pulsed Electromagnetic Field Therapy on Pain After Cesarean Delivery
1 other identifier
interventional
84
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable postoperative-pain
Started Jan 2015
Longer than P75 for not_applicable postoperative-pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 11, 2015
CompletedFirst Posted
Study publicly available on registry
February 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2018
CompletedApril 4, 2019
April 1, 2019
2.7 years
February 11, 2015
April 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Narcotic Use
72 hours or hospital stay
Study Arms (2)
SofPulse nonfunctional device.
PLACEBO COMPARATORThe 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 COMPARATORThe 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.
Interventions
Pulsed Electomagnetic Field Therapy Device placed over incision and turned on and kept in place with tape.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 32871021DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donald C Phillibert, MD
Jacobi Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Phyisician/ Assistant Professor/ Principal Investigator
Study Record Dates
First Submitted
February 11, 2015
First Posted
February 19, 2015
Study Start
January 1, 2015
Primary Completion
September 17, 2017
Study Completion
October 31, 2018
Last Updated
April 4, 2019
Record last verified: 2019-04