PainNCT02273999
Pulsed Electromagnetic Fields for Postoperative Pain: a Linical Trial in Humans
A study testing RecoveryRx™ in people with Pain and Oral Surgery, run by University of Padova, School of Dental Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Oral Surgery, Third Molar Extraction
- What is being tested?
- RecoveryRx™
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Sep 2014
- 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 14 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- patients who needs third molar extraction,
- good oral hygiene,
- no contraindications to treatment.
Who cannot join
- 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.
About this study
Official title: Pulsed Electromagnetic Fields for Postoperative Pain: a Randomized Controlled Clinical Trial in Patients Undergoing Mandibular Third Molar Extraction
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.
Read the 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.
- Conditions
- Pain, Oral Surgery, Third Molar Extraction
- Being tested
- RecoveryRx™
- Keywords
- pulsed electromagnetic fields, post operative morbidity, third molar, extraction, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RecoveryRx™Device
Also called Pulsed electromagnetic fields
Appliance of the device after surgery
| Study group | Role | What they receive |
|---|---|---|
| Control Group (no device) | No intervention | No devices were delivered after third molar tooth extraction |
| Placebo group (Inactivated device) | Placebo comparator | Inactivated devices were delivered after third molar tooth extraction Receives: Device: RecoveryRx™ |
| Test (activated device) | Experimental | Activated devices were delivered after third molar tooth extraction Receives: Device: RecoveryRx™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog scale
Measured: up to day 7 post intervention
Secondary outcomes (1)
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.
Measured: day 7 post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startSep 2012
- Primary completionJun 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova, School of Dental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Sivolella, University of Padova, School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273999
- Sponsor's protocol ID
- 2976P
- Status last verified
- May 2018
- First submitted
- 15 Oct 2014
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Electromagnetic Fields for Postoperative Pain: a Randomized Controlled Clinical Trial in Patients Undergoing Mandibular Third Molar Extraction
- ClinicalTrials.gov ID
- NCT02273999
- Acronym / sponsor ID
- 2976P
- Conditions
- Pain, Oral Surgery, Third Molar Extraction
- Keywords
- pulsed electromagnetic fields, post operative morbidity, third molar, extraction, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Padova, School of Dental MedicineUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 24 Oct 2014 (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.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group (no device) | No intervention | –No devices were delivered after third molar tooth extraction |
| Placebo group (Inactivated device) | Placebo comparator | Device: RecoveryRx™Inactivated devices were delivered after third molar tooth extraction |
| Test (activated device) | Experimental | Device: RecoveryRx™Activated devices were delivered after third molar tooth extraction |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- patients who needs third molar extraction,
- good oral hygiene,
- no contraindications to treatment.
Key exclusion criteria (7 listed)
- age under 14 years;
- poor oral hygiene (plaque index less then 20%);
- contraindications for surgery (or anesthesia);
- infectious or systemic diseases;
- immunosuppressant therapy;
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 |
|---|---|---|
| RecoveryRx™Also: Pulsed electromagnetic fieldsAppliance of the device after surgery | Device | Placebo group (Inactivated device), Test (activated device) |
Primary outcome
Visual Analog scale
Time frame: up to day 7 post intervention
1 secondary outcome
Quality of healing
Time frame: day 7 post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing RecoveryRx™ in people with Pain and Oral Surgery, run by University of Padova, School of Dental Medicine.
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 7 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: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analog scale (time frame: up to day 7 post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2018; AzTrials last refreshed its copy on 3 Nov 2026.