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The Efficacy of Pulsed Electromagnetic Field Therapy for Management of Post-operative Pain Following Cesarean Delivery

Primary Purpose

Pain

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pulsed electromagnetic field device (ActiPatch TM)
Inactive pulsed electromagnetic field device (ActiPatch TM)
Sponsored by
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Pulsed electromagnetic field device, Cesarean section

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years or older
  • full term singleton pregnancy
  • undergoing elective cesarean delivery

Exclusion Criteria:

  • Patients who have refused, are unable to give or have withdrawn consent
  • Patients unable to communicate fluently in English
  • Patients with American Society of Anesthesiologists (ASA) classification of 3 or greater
  • Patients with chronic pain, or neuropathic analgesic drugs
  • Patients in use of antidepressant and psychotropic drugs
  • Patients with a history of opioid or intravenous drug abuse
  • Patients with known allergy or contra-indication to any other drugs used in this trial
  • Patients who have refused spinal anesthesia, or those in whom it is contra-indicated
  • Patients with a history of previous cesarean delivery and persistent pain

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active device

Placebo - inactive device

Arm Description

Functional pulsed electromagnetic field device

Inactive pulsed electromagnetic field device

Outcomes

Primary Outcome Measures

Pain score by visual analogue scale (VAS) on movement at 48 hours postoperatively

Secondary Outcome Measures

Pain at rest and on movement by VAS, and maternal satisfaction at 24 & 48 hours postoperatively
Opioid consumption at 24 & 48 hours postoperatively
Assessment of side effects: nausea, vomiting, sedation & itchiness
Presence of pain 6 weeks postoperatively

Full Information

First Posted
June 24, 2011
Last Updated
March 23, 2012
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01383122
Brief Title
The Efficacy of Pulsed Electromagnetic Field Therapy for Management of Post-operative Pain Following Cesarean Delivery
Official Title
The Efficacy of Pulsed Electromagnetic Field Therapy for Management of Post-operative Pain Following Cesarean Delivery: a Randomised, Double-blind, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
Planned interim analysis-no statistical significance for the primary outcome.
Study Start Date
May 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Pain following Cesarean delivery remains the most common post-operative complaint, and the provision of effective and safe analgesia is very important. Pain can impede the mother's ability to mobilise, and to care for and breastfeed her newborn baby. Pulsed electromagnetic field (PEMF) devices have been used in various clinical settings, especially after plastic surgeries, to reduce postoperative swelling and pain, as well as to accelerate wound repair. PEMF therapy is simple to use, cost-effective and has no known side effects. Despite advances in post-operative analgesia, pain relief and maternal satisfaction remain inadequate in some patients. Improving the quality of post-Cesarean analgesia while limiting undesirable side effects will enhance maternal satisfaction and reduce the risk of post-operative complications. The investigators hypothesize that the continuous use of a PEMF device for 48 hours after Cesarean delivery will result in decreased post-operative pain scores on movement at 48 hours.
Detailed Description
Currently, at our institution, analgesic regimens are multimodal, in that they combine analgesic drugs with differing mechanisms of action, with the aim of producing effective analgesia while minimising adverse effects. They include opioid drugs, administered both neuro-axially and systemically, as well as paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs). Opioids, while effective, have significant adverse effects, including sedation, nausea, vomiting and constipation. Non-steroidal anti-inflammatory drugs (NSAIDs) can reduce opioid consumption, but also have side effects, and are contra-indicated in a significant number of patients. Therefore there remains considerable scope to improve post-Cesarean analgesia. Pulsed electromagnetic field (PEMF) technology relieves edema, inflammation and pain by stabilizing leaking cell membranes. The short bursts of electrical current do not produce heat or interfere with nerve or muscle function. The pulsed energy drives out edematous fluid along with by-products of the damaged tissue, which reduces swelling and helps re-establish cell-cell communication. The device is easily applied over the wound dressing, and has no known side effects for either the mother or the infant. As the rate of Cesarean delivery continues to increase, and there remain significant problems with current analgesic regimens, the use of pulsed electromagnetic field therapy has the potential to considerably improve acute and chronic post-Cesarean pain management, and lead to a widespread change in clinical practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Pulsed electromagnetic field device, Cesarean section

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active device
Arm Type
Active Comparator
Arm Description
Functional pulsed electromagnetic field device
Arm Title
Placebo - inactive device
Arm Type
Placebo Comparator
Arm Description
Inactive pulsed electromagnetic field device
Intervention Type
Device
Intervention Name(s)
Pulsed electromagnetic field device (ActiPatch TM)
Other Intervention Name(s)
ActiPatch TM
Intervention Description
Wire loop of pulsed electromagnetic field device is taped around the wound for 48 hours.
Intervention Type
Device
Intervention Name(s)
Inactive pulsed electromagnetic field device (ActiPatch TM)
Other Intervention Name(s)
ActiPatch TM
Intervention Description
Wire loop of pulsed electromagnetic field device is taped around the wound for 48 hours.
Primary Outcome Measure Information:
Title
Pain score by visual analogue scale (VAS) on movement at 48 hours postoperatively
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Pain at rest and on movement by VAS, and maternal satisfaction at 24 & 48 hours postoperatively
Time Frame
48 hours
Title
Opioid consumption at 24 & 48 hours postoperatively
Time Frame
48 hours
Title
Assessment of side effects: nausea, vomiting, sedation & itchiness
Time Frame
48 hours
Title
Presence of pain 6 weeks postoperatively
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years or older full term singleton pregnancy undergoing elective cesarean delivery Exclusion Criteria: Patients who have refused, are unable to give or have withdrawn consent Patients unable to communicate fluently in English Patients with American Society of Anesthesiologists (ASA) classification of 3 or greater Patients with chronic pain, or neuropathic analgesic drugs Patients in use of antidepressant and psychotropic drugs Patients with a history of opioid or intravenous drug abuse Patients with known allergy or contra-indication to any other drugs used in this trial Patients who have refused spinal anesthesia, or those in whom it is contra-indicated Patients with a history of previous cesarean delivery and persistent pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose CA Carvalho, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
32871021
Citation
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.
Results Reference
derived

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The Efficacy of Pulsed Electromagnetic Field Therapy for Management of Post-operative Pain Following Cesarean Delivery

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