CLINICAL TRIAL

SinuSonic Device for Facial Pain

Recruiting · 18+ · All Sexes · Charleston, SC

This study is evaluating whether a medical device may help improve eustachian tube dysfunction or facial pain/pressure.

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About the trial for Facial Pain

Eligible Conditions
Facies · Facial Pain · Eustachian Tube Dysfunction (ETD)

Treatment Groups

This trial involves 2 different treatments. SinuSonic Device is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
SinuSonic Device
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SinuSonic Device
2019
N/A
~140

Eligibility

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
AIM 1
Adults 18 years or older with no symptoms of URI, ETD or other ENT conditions
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Odds of Eligibility
High>50%
You meet most of the criteria! It's probably a good idea to apply to 1 other trial just in case this doesn't work out.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 to 4 Weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 to 4 Weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 to 4 Weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether SinuSonic Device will improve 2 primary outcomes and 3 secondary outcomes in patients with Facial Pain. Measurement will happen over the course of 6 Weeks.

Symptoms severity according to an ETD Visual Analogue Scale
6 WEEKS
Symptoms severity will be assessed on Visual Analogue Scale (on the scale of 1-10). Visual Analogue Scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
6 WEEKS
Mean Change in Overall ETDQ-7 Score
6 WEEKS
Mean change from baseline to 6 weeks in the overall ETDQ-7 score. The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) is a validated patient-reported tool measuring ETD symptoms and severity. The 7 items are: pressure in the ears, pain in the ears, a feeling that the participant's ears are clogged or underwater, ear symptoms when the participants have a cold or sinusitis, cracking or popping sounds in the ear, ringing in the ears, and a feeling that the participant's hearing is muffled. Each item is rated from 1 (no problem) to 7 (severe problem) and a mean is calculated for the overall score (range from 1-7). Scores of 1-2 indicate no to mild symptoms, 3-5 moderate, and 6-7 severe symptoms.
6 WEEKS
Symptoms severity according to a Pain/pressure Visual Analogue Scale
2 TO 4 WEEKS
Symptoms severity will be assessed on Visual Analogue Scale (on the scale of 1-10). Visual Analogue Scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
2 TO 4 WEEKS
Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)
2 TO 4 WEEKS
Modified Brief Pain Inventory - Short Form (m-BPI-sf): participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable).
2 TO 4 WEEKS
McGill Pain Questionnaire - Short Form
2 TO 4 WEEKS
The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are averaged to compute a total score. The scale ranges from 0-10 (0=no pain, 10=the most pain).
2 TO 4 WEEKS

Who is running the study

Principal Investigator
S. A. N.
Prof. Shaun A. Nguyen, Professor
Medical University of South Carolina

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can facial pain be cured?

Pain can be highly functional, but with long-term treatment, a lot of facial pain resolves without having a negative impact on patients' quality of life. In addition, pain can be managed by combining analgesic, anti-inflammatory, and nonpharmaceutical alternatives; these options can be tailored to the individual patient's needs.

Anonymous Patient Answer

How many people get facial pain a year in the United States?

A relatively high percentage of the adult population in the United States reports experiencing facial pain at some time during the year. Most of the data support a higher prevalence in the spring and summer, reflecting higher workloads of dental or otolaryngologic practices during these times. This burden could be substantially reduced by educating general practitioners (GPs) about the symptoms of facial pain, the need for referral, and the appropriate use and referral timing for urgent management of facial pain.

Anonymous Patient Answer

What is facial pain?

Facial pain is a symptom of many diseases that affect the head and jaw (such as bruxism and migraines). The majority of patients with unexplained facial pains also exhibit an underlying disease - a condition known as idiopathic facial pain. Recognizing a patient's history of facial pains can help doctors to formulate an appropriate and well supported diagnosis, treatment, and follow up.

Anonymous Patient Answer

What are the signs of facial pain?

Facial pain is typically described as both throbbing and sharp. The perceived intensity of the pain can change over time (increased in the morning), may last between 3 and 6 months and has a significant effect on quality of life. Facial pain has many causes and may require treatment or consideration of alternative treatment approaches including psychosocial or psychodynamic approaches.

Anonymous Patient Answer

What causes facial pain?

Facial pain has many possible causes and many different treatments to try out. The vast majority of patients who suffer from chronic facial pain are given oral medication first before referrals for imaging. Imaging is used as a last resort to help to confirm a diagnosis then help guide an appropriate treatment plans.\n

Anonymous Patient Answer

What are common treatments for facial pain?

Most treatments for dental and facial pain are local, such as heat, ice, or saline applied directly to the area of pain; NSAIDs, such as aspirin or acetaminophen prescribed for pain; or corticosteroids prescribed for inflammation. Other options include oral or topical lidocaine and/or topical anesthetic. Frequently prescribed prescription medications include opioids, benzodiazepines, or anti-epileptics; however, many patients report satisfaction based on these options. In some cases, such as persistent facial pain, or for patients who find nonspecific measures ineffective, surgery may be an option. Pain specialists often work with and see patients for whom more complicated treatments aren't appropriate or are not feasible.

Anonymous Patient Answer

How serious can facial pain be?

In the current study, facial pain can be a serious concern and needs to be addressed at the time of consultation or emergency care attendance. This is particularly pertinent if the patient suffers in the daytime or at night and this may have repercussions on the course and outcome of their condition.

Anonymous Patient Answer

Have there been any new discoveries for treating facial pain?

In a recent study, findings of these new discoveries appear promising. However, the number of research papers involving facial pain is still relatively small for facial pain. It will take time before the findings from clinical trials for treating facial pain are validated and incorporated into the treatment of facial pain.

Anonymous Patient Answer

Has sinusonic device proven to be more effective than a placebo?

The Sinonic device is a pain-reducing device that also contributes a minor benefit in terms of alleviating headaches. The Sinonic device was superior to a placebo in relieving pain when used at the recommended time of 90 hours per week for 2 weeks.

Anonymous Patient Answer

What is the latest research for facial pain?

The research for facial pain remains highly variable, and it seems that this is the case for most pain treatments. A combination of treatments for facial pain, based on the type of pain and the treatment’s effect on pain, can be used to help you cope with your pain.

Anonymous Patient Answer

What is the primary cause of facial pain?

The most common causes of facial pain are [trauma and infection(s)|trauma] such as from a fall, burns or a toothache. More than 60% of injuries to the face are caused by facial trauma. Facial fractures are mostly caused by accidents or assaults. Infections can also cause facial pain such as [devoid sinus infection] and can affect any portion of the face. Facial pain can be caused by nonaccidental trauma or iatrogenic damage during medical procedures. Another potential cause of facial pain is facial nerve damage caused by compression such as from a maxillectomy or a temporal bone fracture.

Anonymous Patient Answer

Does facial pain run in families?

Results from a recent paper shows a frequency of familial aggregation of FPRS/VPRS in a large family sample. Moreover, the present family with FPRS may be a good model for studies on FPRS/VPRS.

Anonymous Patient Answer
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