Abdominal Body Contouring SurgeryPhase 4PEMFNCT01762423
PEMF Effects on Pain After Abdominal Body Contouring
A Phase 4 study testing Active Device (IVIVI SofPulse) in people with Abdominal Body Contouring Surgery and Postoperative Pain, run by University of Pittsburgh at 1 site in United States.
Trial summary
Body contouring surgery has a higher potential for postoperative pain and wound healing complications. The purpose of this study is to determine if pulsed electromagnetic field (PEMF) devices can reduce the pain and complications associated with this type of surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Body Contouring Surgery, Postoperative Pain
- What is being tested?
- Active Device (IVIVI SofPulse)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Feb 2013
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 years and older and able to provide informed consent
- Eligible for and have agreed to be scheduled for elective abdominal body contouring surgery
- Willing and able to comply with all study procedures.
Who cannot join
- Inability to provide informed consent
- Patients having multiple procedures concurrently except liposuction.
- Current use of oral steroids as determined through patient history and medical record review
- Current narcotic use as determined through patient history or medical record review
- Current nerve or pain disorder.
- Recent (1 month) coronary stent or implanted medical device (e.g. pacemaker).
- Pregnancy (demonstrated by a positive result of a urine pregnancy test)
- Based upon surgeon judgement and the results of screening procedures, patient is not a suitable candidate for surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Center for Innovation in Restorative Medicine
Pittsburgh, Pennsylvania, 15213
About this study
Body contouring surgery has a higher potential for postoperative pain and wound healing complications. The purpose of this study is to determine if pulsed electromagnetic field (PEMF) devices can reduce the pain and complications associated with this type of surgery.
Pulsed electromagnetic field (PEMF) devices have been shown to be effective treatments to decrease healing time in nonunion fractures and pressure ulcers, and to reduce pain in whiplash injuries, persistent neck pain, and chronic lower back pain. These devices have been FDA approved for treatment of pain and edema (510(k) number: K070541). More recently, PEMF devices have been shown to decrease postoperative pain and narcotic use in breast augmentation patients. This study seeks to determine if PEMF will also cause similar effects in the more complex procedures performed on body contouring patients. The specific aims of this study are:
Read more
- Evaluate if adjunct PEMF therapy will accelerate the rate of postoperative pain reduction in abdominal body contouring patients.
- Evaluate if adjunct PEMF therapy will decrease the postoperative use of narcotic pain relievers in abdominal body contouring patients.
PEMF devices have been shown to be effective in reduction of pain and pain medication use in breast augmentation patients. No literature has shown if PEMF is an effective adjunct to decrease pain or pain medication use in the abdominal body contouring patient. A decrease in pain would result in a better experience for patients and a reduction in pain medication may decrease complications associated with these medications. The PEMF therapy device being used in this study is a non-significant risk device because it is noninvasive and does not present a potential for serious risk to the health, safety, or welfare of a subject.
- Being tested
- Active Device (IVIVI SofPulse), Sham Device
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Device (IVIVI SofPulse)Device
Also called IVIVI SofPulse
Sham DeviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Active Device | Experimental | Device Placement:
Upon completion of the subjects' standard of care body contouring surgery, the device will be placed directly on the operative dressings within an unobtrusive binder with Velcro strips and will be activated before the subject leaves the OR. Subjects will then be educated on the functionality and interpretation of the user interface of the device. They will be educated on the application, removal, and return of the device.
Active Devices The device will be activated at the time of placement. The active devices are programmed to automatically deliver treatment. Each treatment duration is 15 minutes. The active device delivers treatment every 2 hours. A light will flash on the device when the PEMF begins and will continue to flash every second until the end of the treatment. Between treatments the device will be in "sleep mode" and the light will flash every 5 seconds. Receives: Device: Active Device (IVIVI SofPulse) |
| Sham Device | Sham comparator | Device Placement:
Upon completion of the subjects' standard of care body contouring surgery, the device will be placed directly on the operative dressings within an unobtrusive binder with velcro strips and will be activated before the subject leaves the OR. Subjects will then be educated on the functionality and interpretation of the user interface of the device. They will be educated on the application, removal, and return of the device.
Sham Devices The sham devices mirror the active device with the exception of the delivery of the PEMF. The sham device will be "activated" at the time of placement. A light will flash on the device when the SHAM PEMF begins and will continue to flash every second until the end each treatment interval. While in "sleep mode" the device will not deliver treatment and the light will flash every 5 seconds. Receives: Device: Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Reduction
Evaluate if adjunct PEMF therapy will accelerate the rate of postoperative pain reduction in abdominal body contouring patients.
Measured: Immediately postoperatively through 6 days postoperative
Secondary outcomes (1)
Postoperative Narcotic Use
Evaluate if adjunct PEMF therapy will decrease the postoperative use of narcotic pain relievers in abdominal body contouring patients.
Measured: Immediately postoperative through 6 day postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Funding issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Abdominal Body Contouring SurgeryStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Peter Rubin, MD, University of Pittsburgh
- Investigators
- J. Peter Rubin, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762423
- Sponsor's protocol ID
- PRO12070504
- Acronym
- PEMF
- Status last verified
- Feb 2013
- First submitted
- 3 Jan 2013
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Akai M, Hayashi K. Effect of electrical stimulation on musculoskeletal systems; a meta-analysis of controlled clinical trials. Bioelectromagnetics. 2002 Feb;23(2):132-43. doi: 10.1002/bem.106.
PubMed 11835260Akai M, Kawashima N, Kimura T, Hayashi K. Electrical stimulation as an adjunct to spinal fusion: a meta-analysis of controlled clinical trials. Bioelectromagnetics. 2002 Oct;23(7):496-504. doi: 10.1002/bem.10041.
PubMed 12224053Griffin XL, Warner F, Costa M. The role of electromagnetic stimulation in the management of established non-union of long bone fractures: what is the evidence? Injury. 2008 Apr;39(4):419-29. doi: 10.1016/j.injury.2007.12.014. Epub 2008 Mar 5.
PubMed 18321512Heden P, Pilla AA. Effects of pulsed electromagnetic fields on postoperative pain: a double-blind randomized pilot study in breast augmentation patients. Aesthetic Plast Surg. 2008 Jul;32(4):660-6. doi: 10.1007/s00266-008-9169-z. Epub 2008 May 28.
PubMed 18506512Greco JA 3rd, Castaldo ET, Nanney LB, Wendel JJ, Summitt JB, Kelly KJ, Braun SA, Hagan KF, Shack RB. The effect of weight loss surgery and body mass index on wound complications after abdominal contouring operations. Ann Plast Surg. 2008 Sep;61(3):235-42. doi: 10.1097/SAP.0b013e318166d351.
PubMed 18724119Coon D, Gusenoff JA, Kannan N, El Khoudary SR, Naghshineh N, Rubin JP. Body mass and surgical complications in the postbariatric reconstructive patient: analysis of 511 cases. Ann Surg. 2009 Mar;249(3):397-401. doi: 10.1097/SLA.0b013e318196d0c6.
PubMed 19247025Nagai M, Ota M. Pulsating electromagnetic field stimulates mRNA expression of bone morphogenetic protein-2 and -4. J Dent Res. 1994 Oct;73(10):1601-5. doi: 10.1177/00220345940730100401.
PubMed 7929974Liboff AR, Williams T Jr, Strong DM, Wistar R Jr. Time-varying magnetic fields: effect on DNA synthesis. Science. 1984 Feb 24;223(4638):818-20. doi: 10.1126/science.6695183.
PubMed 6695183Ozawa H, Abe E, Shibasaki Y, Fukuhara T, Suda T. Electric fields stimulate DNA synthesis of mouse osteoblast-like cells (MC3T3-E1) by a mechanism involving calcium ions. J Cell Physiol. 1989 Mar;138(3):477-83. doi: 10.1002/jcp.1041380306.
PubMed 2538484Miura M, Takayama K, Okada J. Increase in nitric oxide and cyclic GMP of rat cerebellum by radio frequency burst-type electromagnetic field radiation. J Physiol. 1993 Feb;461:513-24. doi: 10.1113/jphysiol.1993.sp019526.
PubMed 7688808Diniz P, Soejima K, Ito G. Nitric oxide mediates the effects of pulsed electromagnetic field stimulation on the osteoblast proliferation and differentiation. Nitric Oxide. 2002 Aug;7(1):18-23. doi: 10.1016/s1089-8603(02)00004-6.
PubMed 12175815Witte MB, Thornton FJ, Efron DT, Barbul A. Enhancement of fibroblast collagen synthesis by nitric oxide. Nitric Oxide. 2000 Dec;4(6):572-82. doi: 10.1006/niox.2000.0307.
PubMed 11139365Liboff AR, Cherng S, Jenrow KA, Bull A. Calmodulin-dependent cyclic nucleotide phosphodiesterase activity is altered by 20 microT magnetostatic fields. Bioelectromagnetics. 2003 Jan;24(1):32-8. doi: 10.1002/bem.10063.
PubMed 12483663Korhonen R, Lahti A, Kankaanranta H, Moilanen E. Nitric oxide production and signaling in inflammation. Curr Drug Targets Inflamm Allergy. 2005 Aug;4(4):471-9. doi: 10.2174/1568010054526359.
PubMed 16101524Reale M, De Lutiis MA, Patruno A, Speranza L, Felaco M, Grilli A, Macri MA, Comani S, Conti P, Di Luzio S. Modulation of MCP-1 and iNOS by 50-Hz sinusoidal electromagnetic field. Nitric Oxide. 2006 Aug;15(1):50-7. doi: 10.1016/j.niox.2005.11.010. Epub 2006 Feb 7.
PubMed 16455275
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEMF Effects on Pain After Abdominal Body Contouring
- ClinicalTrials.gov ID
- NCT01762423
- Acronym / sponsor ID
- PEMF / PRO12070504
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 7 Jan 2013 (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.
Body contouring surgery has a higher potential for postoperative pain and wound healing complications. The purpose of this study is to determine if pulsed electromagnetic field (PEMF) devices can reduce the pain and complications associated with this type of surgery.
Pulsed electromagnetic field (PEMF) devices have been shown to be effective treatments to decrease healing time in nonunion fractures and pressure ulcers, and to reduce pain in whiplash injuries, persistent neck pain, and chronic lower back pain. These devices have been FDA approved for treatment of pain and edema (510(k) number: K070541). More recently, PEMF devices have been shown to decrease postoperative pain and narcotic use in breast augmentation patients. This study seeks to determine if PEMF will also cause similar effects in the more complex procedures performed on body contouring patients. The specific aims of this study are:
- Evaluate if adjunct PEMF therapy will accelerate the rate of postoperative pain reduction in abdominal body contouring patients.
- Evaluate if adjunct PEMF therapy will decrease the postoperative use of narcotic pain relievers in abdominal body contouring patients.
PEMF devices have been shown to be effective in reduction of pain and pain medication use in breast augmentation patients. No literature has shown if PEMF is an effective adjunct to decrease pain or pain medication use in the abdominal body contouring patient. A decrease in pain would result in a better experience for patients and a reduction in pain medication may decrease complications associated with these medications. The PEMF therapy device being used in this study is a non-significant risk device because it is noninvasive and does not present a potential for serious risk to the health, safety, or welfare of a subject.
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 | Experimental | Device: Active Device (IVIVI SofPulse)Device Placement: Upon completion of the subjects' standard of care body contouring surgery, the device will be placed directly on the operative dressings within an unobtrusive binder with Velcro strips and will be activated before the subject leaves the OR. Subjects will then be educated on the functionality and interpretation of the user interface of the device. They will be educated on the application, removal, and return of the device. Active Devices The device will be activated at the time of placement. The active devices are programmed to automatically deliver treatment. Each treatment duration is 15 minutes. The active device delivers treatment every 2 hours. A light will flash on the device when the PEMF begins and will continue to flash every second until the end of the treatment. Between treatments the device will be in "sleep mode" and the light will flash every 5 seconds. |
| Sham Device | Sham comparator | Device: Sham DeviceDevice Placement: Upon completion of the subjects' standard of care body contouring surgery, the device will be placed directly on the operative dressings within an unobtrusive binder with velcro strips and will be activated before the subject leaves the OR. Subjects will then be educated on the functionality and interpretation of the user interface of the device. They will be educated on the application, removal, and return of the device. Sham Devices The sham devices mirror the active device with the exception of the delivery of the PEMF. The sham device will be "activated" at the time of placement. A light will flash on the device when the SHAM PEMF begins and will continue to flash every second until the end each treatment interval. While in "sleep mode" the device will not deliver treatment and the light will flash every 5 seconds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18 years and older and able to provide informed consent
- Eligible for and have agreed to be scheduled for elective abdominal body contouring surgery
- Willing and able to comply with all study procedures.
Key exclusion criteria (8 listed)
- Inability to provide informed consent
- Patients having multiple procedures concurrently except liposuction.
- Current use of oral steroids as determined through patient history and medical record review
- Current narcotic use as determined through patient history or medical record review
- Current nerve or pain disorder.
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 |
|---|---|---|
| Active Device (IVIVI SofPulse)Also: IVIVI SofPulse | Device | Active Device |
| Sham Device | Device | Sham Device |
Primary outcome
Postoperative Pain Reduction
Time frame: Immediately postoperatively through 6 days postoperative
Evaluate if adjunct PEMF therapy will accelerate the rate of postoperative pain reduction in abdominal body contouring patients.
1 secondary outcome
Postoperative Narcotic Use
Time frame: Immediately postoperative through 6 day postoperative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
- Background: PubMed 11835260Akai M, Hayashi K. Effect of electrical stimulation on musculoskeletal systems; a meta-analysis of controlled clinical trials. Bioelectromagnetics. 2002 Feb;23(2):132-43. doi: 10.1002/bem.106.
- Background: PubMed 12224053Akai M, Kawashima N, Kimura T, Hayashi K. Electrical stimulation as an adjunct to spinal fusion: a meta-analysis of controlled clinical trials. Bioelectromagnetics. 2002 Oct;23(7):496-504. doi: 10.1002/bem.10041.
- Background: PubMed 18321512Griffin XL, Warner F, Costa M. The role of electromagnetic stimulation in the management of established non-union of long bone fractures: what is the evidence? Injury. 2008 Apr;39(4):419-29. doi: 10.1016/j.injury.2007.12.014. Epub 2008 Mar 5.
- Background: PubMed 18506512Heden P, Pilla AA. Effects of pulsed electromagnetic fields on postoperative pain: a double-blind randomized pilot study in breast augmentation patients. Aesthetic Plast Surg. 2008 Jul;32(4):660-6. doi: 10.1007/s00266-008-9169-z. Epub 2008 May 28.
- Background: PubMed 18724119Greco JA 3rd, Castaldo ET, Nanney LB, Wendel JJ, Summitt JB, Kelly KJ, Braun SA, Hagan KF, Shack RB. The effect of weight loss surgery and body mass index on wound complications after abdominal contouring operations. Ann Plast Surg. 2008 Sep;61(3):235-42. doi: 10.1097/SAP.0b013e318166d351.
- Background: PubMed 19247025Coon D, Gusenoff JA, Kannan N, El Khoudary SR, Naghshineh N, Rubin JP. Body mass and surgical complications in the postbariatric reconstructive patient: analysis of 511 cases. Ann Surg. 2009 Mar;249(3):397-401. doi: 10.1097/SLA.0b013e318196d0c6.
- Background: PubMed 7929974Nagai M, Ota M. Pulsating electromagnetic field stimulates mRNA expression of bone morphogenetic protein-2 and -4. J Dent Res. 1994 Oct;73(10):1601-5. doi: 10.1177/00220345940730100401.
- Background: PubMed 6695183Liboff AR, Williams T Jr, Strong DM, Wistar R Jr. Time-varying magnetic fields: effect on DNA synthesis. Science. 1984 Feb 24;223(4638):818-20. doi: 10.1126/science.6695183.
- Background: PubMed 2538484Ozawa H, Abe E, Shibasaki Y, Fukuhara T, Suda T. Electric fields stimulate DNA synthesis of mouse osteoblast-like cells (MC3T3-E1) by a mechanism involving calcium ions. J Cell Physiol. 1989 Mar;138(3):477-83. doi: 10.1002/jcp.1041380306.
- Background: PubMed 7688808Miura M, Takayama K, Okada J. Increase in nitric oxide and cyclic GMP of rat cerebellum by radio frequency burst-type electromagnetic field radiation. J Physiol. 1993 Feb;461:513-24. doi: 10.1113/jphysiol.1993.sp019526.
- Background: PubMed 12175815Diniz P, Soejima K, Ito G. Nitric oxide mediates the effects of pulsed electromagnetic field stimulation on the osteoblast proliferation and differentiation. Nitric Oxide. 2002 Aug;7(1):18-23. doi: 10.1016/s1089-8603(02)00004-6.
- Background: PubMed 11139365Witte MB, Thornton FJ, Efron DT, Barbul A. Enhancement of fibroblast collagen synthesis by nitric oxide. Nitric Oxide. 2000 Dec;4(6):572-82. doi: 10.1006/niox.2000.0307.
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Clinical Evaluation of Linear Z for Body Contouring
Non Invasive Body Contouring
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.
J. Peter Rubin, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Active Device (IVIVI SofPulse) in people with Abdominal Body Contouring Surgery and Postoperative Pain, run by University of Pittsburgh at 1 site in United States.
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 8 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: withdrawn, as of the sponsor's last update on 20 Feb 2013. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Postoperative Pain Reduction (time frame: Immediately postoperatively through 6 days postoperative). 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 NCT01762423, which also lists 26 linked publications.
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 20 Feb 2013.