PainNCT01383122
The Efficacy of Pulsed Electromagnetic Field Therapy for Management of Post-operative Pain Following Cesarean Delivery
A study testing Pulsed electromagnetic field device (ActiPatch TM) and Inactive pulsed electromagnetic field device (ActiPatch TM) in people with Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Pulsed electromagnetic field device (ActiPatch TM) and Inactive pulsed electromagnetic field device (ActiPatch TM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to Mar 2012
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 years or older
- full term singleton pregnancy
- undergoing elective cesarean delivery
Who cannot join
- Patients who have refused, are unable to give or have withdrawn consent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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Pulsed electromagnetic field device (ActiPatch TM), Inactive pulsed electromagnetic field device (ActiPatch TM)
- Keywords
- Pulsed electromagnetic field device, Cesarean section
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed electromagnetic field device (ActiPatch TM)Device
Also called ActiPatch TM
Wire loop of pulsed electromagnetic field device is taped around the wound for 48 hours.
Inactive pulsed electromagnetic field device (ActiPatch TM)Device
Also called ActiPatch TM
Wire loop of pulsed electromagnetic field device is taped around the wound for 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Active device | Active comparator | Functional pulsed electromagnetic field device Receives: Device: Pulsed electromagnetic field device (ActiPatch TM) |
| Placebo - inactive device | Placebo comparator | Inactive pulsed electromagnetic field device Receives: Device: Inactive pulsed electromagnetic field device (ActiPatch TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score by visual analogue scale (VAS) on movement at 48 hours postoperatively
Measured: 48 hours
Secondary outcomes (4)
Pain at rest and on movement by VAS, and maternal satisfaction at 24 & 48 hours postoperatively
Measured: 48 hours
Opioid consumption at 24 & 48 hours postoperatively
Measured: 48 hours
Assessment of side effects: nausea, vomiting, sedation & itchiness
Measured: 48 hours
Presence of pain 6 weeks postoperatively
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2012
- Study completionMar 2012
Why it stopped: Planned interim analysis-no statistical significance for the primary outcome.
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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jose CA Carvalho, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383122
- Sponsor's protocol ID
- 11-01
- Status last verified
- Mar 2012
- First submitted
- 24 Jun 2011
- Last updated
- 26 Mar 2012
- 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 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01383122
- Acronym / sponsor ID
- 11-01
- Conditions
- Pain
- Keywords
- Pulsed electromagnetic field device, Cesarean section
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Planned interim analysis-no statistical significance for the primary outcome.
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 28 Jun 2011 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active device | Active comparator | Device: Pulsed electromagnetic field device (ActiPatch TM)Functional pulsed electromagnetic field device |
| Placebo - inactive device | Placebo comparator | Device: Inactive pulsed electromagnetic field device (ActiPatch TM)Inactive pulsed electromagnetic field device |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 years or older
- full term singleton pregnancy
- undergoing elective cesarean delivery
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Pulsed electromagnetic field device (ActiPatch TM)Also: ActiPatch TMWire loop of pulsed electromagnetic field device is taped around the wound for 48 hours. | Device | Active device |
| Inactive pulsed electromagnetic field device (ActiPatch TM)Also: ActiPatch TMWire loop of pulsed electromagnetic field device is taped around the wound for 48 hours. | Device | Placebo - inactive device |
Primary outcome
Pain score by visual analogue scale (VAS) on movement at 48 hours postoperatively
Time frame: 48 hours
4 secondary outcomes
Pain at rest and on movement by VAS, and maternal satisfaction at 24 & 48 hours postoperatively
Time frame: 48 hours
Opioid consumption at 24 & 48 hours postoperatively
Time frame: 48 hours
Assessment of side effects: nausea, vomiting, sedation & itchiness
Time frame: 48 hours
Presence of pain 6 weeks postoperatively
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Planned interim analysis-no statistical significance for the primary outcome.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
- 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.
Jose CA Carvalho, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed electromagnetic field device (ActiPatch TM) and Inactive pulsed electromagnetic field device (ActiPatch TM) in people with Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: Planned interim analysis-no statistical significance for the primary outcome.). Results are not available in the source record.
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 score by visual analogue scale (VAS) on movement at 48 hours postoperatively (time frame: 48 hours). 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 NCT01383122, 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 26 Mar 2012.