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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pulsed Electromagnetic Fields for Postoperative Pain: a Randomized Controlled Clinical Trial in Patients Undergoing Mandibular Third Molar Extraction

Conditions
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Pain, Oral Surgery, Third Molar Extraction

Intervention / Treatment
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* Device: RecoveryRx™


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group (no device)<br>No devices were delivered after third molar tooth extraction | |
| Placebo Comparator: Placebo group (Inactivated device)<br>Inactivated devices were delivered after third molar tooth extraction | Device: RecoveryRx™<br>* Appliance of the device after surgery<br>* Other names: Pulsed electromagnetic fields;|
| Experimental: Test (activated device)<br>Activated devices were delivered after third molar tooth extraction | Device: RecoveryRx™<br>* Appliance of the device after surgery<br>* Other names: Pulsed electromagnetic fields;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog scale |  | up to day 7 post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of healing | 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. | day 7 post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulsed electromagnetic fields, post operative morbidity, third molar, extraction, pain