PEMF Effects on Pain After Abdominal Body Contouring

Postoperative Pain Clinical Trial

— PEMF  

Official title:

PEMF Effects on Pain After Abdominal Body Contouring

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01762423
• Other study ID #: PRO12070504
• Status: Withdrawn
• Phase: Phase 4
• First received: January 3, 2013
• Last updated: February 19, 2013
• Start date: December 2012
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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:

1. Evaluate if adjunct PEMF therapy will accelerate the rate of postoperative pain reduction in abdominal body contouring patients.

2. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Body Contouring Surgery
• Pain, Postoperative
• Postoperative Pain

Intervention

Device:
• Active Device (IVIVI SofPulse)

• Sham Device

Locations

Country	Name	City	State
United States	UPMC Center for Innovation in Restorative Medicine	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain Reduction	Evaluate if adjunct PEMF therapy will accelerate the rate of postoperative pain reduction in abdominal body contouring patients.	Immediately postoperatively through 6 days postoperative	No
Secondary	Postoperative Narcotic Use	Evaluate if adjunct PEMF therapy will decrease the postoperative use of narcotic pain relievers in abdominal body contouring patients.	Immediately postoperative through 6 day postoperative	No