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

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ClinicalTrials.gov Identifier: NCT01383122
Recruitment Status : Terminated (Planned interim analysis-no statistical significance for the primary outcome.)
First Posted : June 28, 2011
Last Update Posted : March 26, 2012
Sponsor:
Information provided by:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

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.


Condition or disease Intervention/treatment Phase
Pain Device: Pulsed electromagnetic field device (ActiPatch TM) Device: Inactive pulsed electromagnetic field device (ActiPatch TM) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Active device
Functional pulsed electromagnetic field device
Device: Pulsed electromagnetic field device (ActiPatch TM)
Wire loop of pulsed electromagnetic field device is taped around the wound for 48 hours.
Other Name: ActiPatch TM

Placebo Comparator: Placebo - inactive device
Inactive pulsed electromagnetic field device
Device: Inactive pulsed electromagnetic field device (ActiPatch TM)
Wire loop of pulsed electromagnetic field device is taped around the wound for 48 hours.
Other Name: ActiPatch TM




Primary Outcome Measures :
  1. Pain score by visual analogue scale (VAS) on movement at 48 hours postoperatively [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Pain at rest and on movement by VAS, and maternal satisfaction at 24 & 48 hours postoperatively [ Time Frame: 48 hours ]
  2. Opioid consumption at 24 & 48 hours postoperatively [ Time Frame: 48 hours ]
  3. Assessment of side effects: nausea, vomiting, sedation & itchiness [ Time Frame: 48 hours ]
  4. Presence of pain 6 weeks postoperatively [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01383122


Locations
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Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
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Principal Investigator: Jose CA Carvalho, MD MOUNT SINAI HOSPITAL
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Jose C.A. Carvalho, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01383122    
Other Study ID Numbers: 11-01
First Posted: June 28, 2011    Key Record Dates
Last Update Posted: March 26, 2012
Last Verified: March 2012
Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Pulsed electromagnetic field device
Cesarean section
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations