WITHDRAWN: Method and device for treating sinus pain at acupressure points

doi:10.21203/rs.3.rs-17297/v1

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WITHDRAWN: Method and device for treating sinus pain at acupressure points

https://doi.org/10.21203/rs.3.rs-17297/v1

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Sinusitis is an inflammation caused in the nasal passage due to cold, allergies or by nasal polyps. Sinusitis is a major problem among one in eight people around the world. People are interested more in ailment of natural treatments than antibiotic and other medicines. The objective of this work is to provide relief from sinusitis pain through acupressure points. The proposed methodology of sinusitis treatment can be done by applying heating cooling effect and massaging action simultaneously. This paper deals with both the methods of treating the sinusitis. This system integrates an android mobile application with a hardware device that serves this purpose. A face mask which consists of motors and heating and cooling system embedded which can be controlled using user friendly mobile application. The similar methodology can be used for other applications like back pain, muscular pain and knee pain relief.

Biomedical Engineering

Sinusitis

Acupressure

Natural treatment

massaging

pain relief

android mobile application

Sinusitis is an inflammation of the nasal passage tissue lining. Healthy sinuses are filled with air. But when they become blocked and filled with fluid, germs can grow and cause an infection. About 35 million Americans are affected by sinusitis at least once each year. It’s more likely if the person have swelling inside the nose like from a common cold, blocked drainage ducts and nasal polyps. The sinuses resemble packets or valleys. The passages that begin with nostril lead to a network of nasal passages and cavities in behind the face. These are known as sinuses. Technically as the paranasal sinuses are those in our face, most well-known. The sinuses are pockets of air, which are found in between the bones in face and skull. The paranasal sinuses are located on either side of the face. The four pair of sinuses shown in Figure.1 (a). Maxillary sinuses are found directly in behind the neck. Ethmoid sinuses are smaller pockets of air, often described as having the appearance of honeycomb. Frontal Sinuses are the uppermost sinuses and are directly behind the fore head. Sphenoid sinuses are further back, close to the brain [1].

When either the upper or lower sinuses are congested pressure can build causing referred pain. There are several ways to treat sinusitis like Nasal Decongestants that usually come in spray or pill form that have chemicals that are usually quite effective at drying the sinus, one can also breath in hot air or use heat pads on your nose and face to loosen mucus up or Antihistamines that are lifesavers if the sinuses are triggered by allergies. But treating the sinus at pressure points will give more relief. There are a number of sinus pressure points and pressure points relating to sinus conditions. These pressure points are found all over the body, including, the face, head, arms, hands and neck [2].

Sinus pressure points can be used to treat a number of sinus problems, from simple conditions, such as a runny nose or slight discomfort, to more serious sinus conditions, such as rhinitis, sinus pressure, sinus headaches, and blockages. Sinus pressure points are more reliable for reliving sinus pain than other medications [3]. A hot water bottle, wet compresses, or an electric heating pad applied over the inflamed area also can be comforting for treating sinus. The combination of these two procedures isn’t brought together due to their complications in designing. There are six acupressure points for sinus in face. Massaging at those acupressure points will reduce pain from that area. Figure.1(b) shows the acupressure points for sinus. To relieve from upper or frontal sinuses the pressure should be given at the point A which is located at the bridge of the nose where it meets the ridge of the eyebrows. To open the maxillary sinuses give pressure to the points B and C which are just below to the cheek bones [4–7]. The Pressure applied at these points should be gentle.

The user interface of the Android application is shown in the Figure.5.The mobile application was user friendly. The user can himself select the vibration levels with the help of the android application. The application contains buttons for selecting the vibration level as low or medium or high. This command will be sent via the mobile Bluetooth to the Bluetooth module attached to the prototype. This command will alter the level of voltage supplied to the motor with the help of microcontroller. The voltage level for the respective commands was shown in the Table.1.

Table.1: Voltage level of vibration motor

Bluetooth data	Voltage level
Low	0.5V
Medium	1.75V
High	3V

The prototype model is shown in the Figure.6. The Prototype model consists of the six vibration motors and the peltier module which were fixed inside a face mask at the respective points. The motors as well as the module were controlled by the microcontroller with user inputs from mobile app. The vibration motor worked effectively with required pressure at regular intervals until the patient himself feels relieved. Before the application of massaging action, heating and cooling given by the peltier module was helpful in aggregating the pressure points for better results. It also helped the patients feel better.

The voltage levels and its corresponding rpm values were shown in Table.2. These rpm values can be fixed based upon the doctor’s advice. The temperature of the peltier module was fixed and is denoted in the Table.3. The temperature was fixed at + 278 K (+ 5ºC) from normal body temperature for heating and subtract 283 K (10ºC) from normal body temperature for cooling.

Table 2

Voltage level and speed of vibration motor
Bluetooth data	Voltage level	Speed (rpm)
Low	0.5V	1500
Medium	1.75V	5250
High	3V	9000

Table 3

Temperature level of the Peltier module
Heating/ Cooling	Temperature (ºC)	Time Period in seconds
Heating	Body temperature (38⁰C)	10
Cooling	Body temperature(10⁰C)	20

PSG Institute of Medical science and Research (PSGIMSR) Human Ethics Committee has reviewed and approved the research study entitled “sinusitis pain relief system”. The clinical trial was conducted at PSG Hospitals, Coimbatore for a period of one year.

Objectives: To determine sinusitis pain relief system can improve outcomes in patients with sinusitis pain.

Setting: one general practice in PSG Institute of Medical Sciences and Research.

Design: Factorial randomized controlled trial of two year duration.

Patients suffering from Sinusitis of ages between 6 and 60 were chosen. They were grouped into 2 categories based upon the cause of sinusitis. Patient suffering from sinusitis due to heat were grouped into ‘A’ and patient suffering from sinusitis due to cold were grouped into ‘B’. The Patients were given a pain scale and asked to choose the face which is indicated in the scale depends upon the severity of the pain. A pain scale measures a patient's pain intensity.

The Wong-Baker faces pain scale shown in the Figure.7 was used as a self-report of pain to assess a patient’s experience of pain. It can be used in children aged between 3 and 18 years of age and also for other patients above this age. The patient has to understand how much pain they have, and how this makes them feel. Based upon the pain severity, they have to choose the faces. Face 0 is very happy because he doesn't hurt at all (i.e. has no pain). Face 2 hurts just a little bit. Face 4 hurts a little more. Face 6 hurts even more. Face 8 hurts a whole lot. Face 10 hurts as much and the patient may cry at this level. Then the patient was asked to worn the mask and to set the vibration level by himself. The patient can change the level as well as choose the motor which has to be run at that time. At the same time heating and cooling was given in the specified intervals as in the Table.3.

After this treatment, both the group of patients were given again the pain scale and asked to choose the face depends upon how they feel. The patient who chose Face 8 in the first trial now chose Face 2. Thus, the pain level had been reduced. The alternate application of heating and cooling also provides us the best results in both the groups because for ‘A’ group of patients cooling will help to project the pressure points outside and for ‘B’ group of patients heating will help to project the pressure points outside.

The pain level observations for the Group A and Group B patients as shown in Table. 4 and Table. 5.

Table 4

Pain level before and after treatment with the device for Group A Patients
Group A Patients	Pain level before treatment	Pain level after treatment
1	6	2
2	8	2
3	8	4
4	4	0
5	10	4
6	6	0
7	10	2
8	6	4
9	6	0
10	8	2

Table 5

Pain level before and after treatment with the device for Group B Patients
Group B Patients	Pain level before treatment	Pain level after treatment
1	8	0
2	6	2
3	10	4
4	10	6
5	8	0
6	8	2
7	8	0
8	4	0
9	2	0
10	6	4

In Table.6, the pettier module heating and cooling temperature is shown which is of optimum level which ensures the safety of the patients.

Table 6

Temperature settings in the gadget
Cycle	Temperature (degree Celsius)
Highest temperature during heating	38
Lowest temperature during cooling	10

Thus, the Sinusitis Pain Relief System was developed along with the android application. The device provides better pain relief to patients those who are suffering from sinusitis. This device is also suitable for other body pains such as knee pain, muscle pain and back pain. This device provides point of care treatment and hence, it is very reliable and efficient.

The main objective of this work is to develop a device by which the patient can provide self-treatment for sinus pain. Point of care is at home. The patient themselves can relief from pain with the help of this device along with alternate heating and cooling at home.

A face mask has to be designed that will contain the vibrational motor setup peltier chip for pain relief at six acupressure points of sinus treatment. The operation of both the systems can be controlled with help of an android mobile application. The mobile application is designed through Massachusetts Institute of Technology (MIT) app inventor, an easy module for creating android applications.

This methodology is to provide a massaging action and heating- cooling effect at the acupressure points of sinus with the help of vibration motor and peltier module respectively shown in Figure.2. The combination of two technologies was used to provide relief from pain of sinusitis. To provide the massaging action, vibration motors were used at six acupressure points of sinuses and to provide the heating- cooling effect peltier module was used [9–11]. Both motors as well as peltier module were controlled with the help of a microcontroller ATmega338P. The patient can switch on the Bluetooth via the mobile application in the smart phone. The patient selects the required pressure level and heating and cooling level and that is send to the microcontroller via bluetooth. The microcontroller controls the motors and the peltier chip as per the inputs received from the patient’s smart phone. The effects are applied to the patient’s face by the mask. Figure.3 shows the simple workflow of the device. This device is user- friendly that the user can themselves specify the speed of rotation of vibration motor and also the heating or cooling. This can be controlled with the help of the mobile application which sends the data either “high” or “low” or “medium based upon the massaging level which controls the speed of the vibration motor via Bluetooth. Similarly, the user can specify the heating or cooling via Bluetooth. The voltage level of the vibration motor can be used to control the speed of the motor. When it is “Low” from Bluetooth, the voltage is 0.5 V. When it is “Medium”, the motors runs at 1.75 V and when “High” the voltage is 3V.

Components And Specification

Linear resonant actuator (LRA) contains a small internal magnetic mass attached to a spring [8]. This mass will create a force when the motor is driven which is then converted into a form of vibrations. The LRA motor is shown in Figure.3. In this work, LRA was used to provide the massaging action at the acupressure points. The specifications of LRA are a Coin Flat Type, 10 × 3 mm size, voltage supply of 3V, current of 70 mA and 9000+/- 3000 rpm (revolution per minute) speed.

Peltier module is a thermoelectric module which is used to produce alternate heating and cooling effect. This module uses the basic principle of Peltier effect. The Peltier effect is a temperature difference created by applying a voltage between two electrodes connected to a sample of semiconductor material. This is useful for transforming heat from one medium to another medium. This effect is named after the Physicist Jean- Charles Athanase Peltier who discovered it. The heat will flow from one side of the module through another when low voltage DC Power is applied to the Thermoelectric (TE) Module. The one face of the module will be heated and the other face will be simultaneously cooled. This can be reversed by changing the polarity of the applied DC voltage.

The basic thermoelectric module consists of n and p- type doped semiconductor material that is connected electrically in series and thermally in parallel. The arrangement of the semiconductor materials in the TE module causes the heat to flow through the TE materials. The electrons in the N- material and the holes in the P- material are acting like carriers to move the heat energy. For this work, TEC1- 13706 Peltier module was used to provide alternate heating and cooling effect. TEC1-13706 is of size 40 mm x 40 mm x 4 mm and gives a voltage of 0–13 V at the current rating of 0–6 A. The operating temperature of the Peltier module is 243 to 343 K (-30 to 70ºC). Figure.4 shows the TEC- 14706 peltier chip.

Arduino Uno R3 Atmega 338p is used to control the vibration motor and peltier module. The high- performance Atmel pico power 8- bit AVR microcontroller was used. This microcontroller is basically RISC based architecture combines with 33 KB Flash Memory. Even though the power was switched off, the code will be there inside the memory. It contains 1034B EEPROM, 3 KB SRAM, 33 GPIO Pins, 33 Registers, along with Timers, Counters, ADC’s etc. This microcontroller also contains PWM Pins. The device operates between 1.8–5.5 volts [12–14].

The ULN2003 is a driver IC used to drive both the vibration motor and the peltier module. This Driver IC consists of an array of Transistors which will act like a switch to on and off the motors and TE modules at an input voltage of 30 V and peak collector current of 500 mA.

Bluetooth HC- 05 module is a Serial Port Protocol module used for a transparent wireless serial communication application. It uses 3.5 GHz frequency band. The connection can be point- to- point or multipoint where the maximum range of acceptability is 10 meters. The data transfer rate is 1Mbps. The operating temperature of this module is around 303 K (30ºC). It needs 3.3 V DC power supply for operation [15].

LRA Linear resonant actuator

TE Thermoelectric

RPM revolution per minute

EEPROM Electrically erased programmable read only memory

SRAM Static random access memory

GPIO General-purpose input/output

PWM Pulse width modulation

ADC Analog to digital converter

PSGIMSR PSG Institute of Medical science and Research

MIT Massachusetts Institute of Technology (MIT)

Acknowledgements

The authors are grateful to all study participants.

Funding

Not applicable.

Author information

1.Dr.L.Priya Ph.D, Associate Professor, Biomedical Engineering, Department of Electronics and Communication Engineering, VIGNAN’s Foundation for Science, Technology & Research,Guntur, Andhrapradesh.

2.Dr.S.Ramesh Ph.D, Associate Professor, Department of Electronics and Communication Engineering, VIGNAN’s Foundation for Science, Technology & Research,Guntur, Andhrapradesh.

3.Preethi. S. M., Student, Biomedical Engineering at PSG College of Technology, Coimbatore, Tamilnadu, India.

4.Aarthi. S Student, Biomedical Engineering at PSG College of Technology, Coimbatore, Tamilnadu, India.

5.Monisha. T, Student, Biomedical Engineering at PSG College of Technology, Coimbatore, Tamilnadu, India.

Contributions

All authors read and approved the final manuscript.

Ethics declerations

Ethics approval and consent to participate

Non-Invasive Clinical Research Ethical Approval was obtained from the Institutional Human Ethics Committee of PSG IMS&R on 10.01.2018, PSG Hospitals, Coimbatore.

Ref.: Your Study titled: sinusitis pain relief system (16/338), 10.01.2018.
Consent for publication

Not applicable.

Competing interests

The authors of this article declare that there is no conflict of interest.

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WITHDRAWN: Method and device for treating sinus pain at acupressure points

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