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Pulsed Electromagnetic Fields for Postoperative Pain: a Linical Trial in Humans

Sponsor
University of Padova, School of Dental Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT02273999
Collaborator
(none)
120
Enrollment
3
Arms
24
Duration (Months)

Study Details

Study Description

Brief Summary

This randomized clinical trial was designed to assess the clinical efficacy of Pulsed electromagnetic field PEMF delivered with a wearable device in terms of postoperative pain and quality of healing after mandibular third molar extraction.

The sample included 120 patients undergoing unilateral mandibular third molar extraction. The devices were positioned over the area corresponding to the extraction site and wearers were asked to keep them in place for 7 days. All patients were asked to record pain (on a visual analog scale [VAS]), hours of wearing the device (groups T and P), and any use of analgesics. At 7 days, healing complications (dehiscence, tumefaction, pus, local lymphadenopathy, pain on palpation, postoperative bleeding, alveolitis) were recorded blindly.

Condition or Disease Intervention/Treatment Phase
  • Device: RecoveryRx™
 N/A

Detailed Description

Introduction: Pulsed electromagnetic field (PEMF) therapy is a noninvasive method for delivering pulsed radiofrequency energy to tissues to treat postoperative pain and edema. This randomized clinical trial was designed to assess the clinical efficacy of PEMF delivered with a wearable device in terms of postoperative pain and quality of healing after mandibular third molar extraction.

Materials and methods: The sample included 120 patients undergoing unilateral mandibular third molar extraction. At the end of the surgical procedure, patients were randomly assigned to a test (T) or placebo (P) group and fitted with enabled or disabled PEMF devices, respectively, or to a control (C) group not fitted with a PEMF device. The devices were positioned over the area corresponding to the extraction site and wearers were asked to keep them in place for 7 days. All patients were asked to record pain (on a visual analog scale [VAS]), hours of wearing the device (groups T and P), and any use of analgesics. At 7 days, healing complications (dehiscence, tumefaction, pus, local lymphadenopathy, pain on palpation, postoperative bleeding, alveolitis) were recorded blindly.

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Pulsed Electromagnetic Fields for Postoperative Pain: a Randomized Controlled Clinical Trial in Patients Undergoing Mandibular Third Molar Extraction
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Sep 1, 2014

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control Group (no device)

No devices were delivered after third molar tooth extraction
Placebo Comparator: Placebo group (Inactivated device)

Inactivated devices were delivered after third molar tooth extraction

Device: RecoveryRx™
Appliance of the device after surgery
Other Names:
  • Pulsed electromagnetic fields

    		•
    Experimental: Test (activated device)

    Activated devices were delivered after third molar tooth extraction

    Device: RecoveryRx™
    Appliance of the device after surgery
    Other Names:
  • Pulsed electromagnetic fields

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual Analog scale [up to day 7 post intervention]

    Secondary Outcome Measures

    1. Quality of healing [day 7 post intervention]

      The quality of healing will be measured by scoring the presence of the following: dehiscence, tumefaction, pus, local lymphadenopathy, pain on palpation, postoperative bleeding, alveoli tis will be recorded blindly for each patients. Frequency of complications (per patients) at 7 days. Numerical values and p-values of comparisons will be recorded.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • patients who needs third molar extraction,

    • good oral hygiene,

    • no contraindications to treatment.

    Exclusion Criteria:

    • age under 14 years;

    • poor oral hygiene (plaque index less then 20%);

    • contraindications for surgery (or anesthesia);

    • infectious or systemic diseases;

    • immunosuppressant therapy;

    • pregnancy or breastfeeding;

    • mental disorders.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Padova, School of Dental Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stefano Sivolella, Clinical Faculty department of oral surgery, University of Padova, School of Dental Medicine
    ClinicalTrials.gov Identifier:
    NCT02273999
    Other Study ID Numbers:
    • 2976P
    First Posted:
    Oct 24, 2014
    Last Update Posted:
    May 8, 2018
    Last Verified:
    May 1, 2018
    Keywords provided by Stefano Sivolella, Clinical Faculty department of oral surgery, University of Padova, School of Dental Medicine
    pulsed electromagnetic fields
    post operative morbidity
    third molar
    extraction
    pain
    Additional relevant MeSH terms:
    Pain, Postoperative

    Study Results

    No Results Posted as of May 8, 2018