pulsetto app provides

Revolutionizing Ankylosing Spondylitis (Bechterew disease) Treatment with Pulsetto

Assessing the Benefits of Non-Invasive Vagus Nerve Stimulation for Pain Relief and Mobility Enhancement

ABSTRACT

Bechterew disease, also known as ankylosing spondylitis, is a chronic inflammatory condition affecting the spine and sacroiliac joints, causing pain, stiffness, and reduced mobility. This study aimed to explore the potential benefits of non-invasive vagus nerve stimulation (nVNS) for pain management in Bechterew disease patients. nVNS is a method that involves electrical stimulation of the vagus nerve through the skin, without the need for surgical implantation. Existing research suggests that nVNS may be effective in reducing pain and inflammation in various conditions.

In this study, participants followed a clinical trial test protocol using the Pulsetto device for nVNS, with 20-minute sessions twice daily. The effectiveness of the treatment was assessed through a daily quiz addressing pain intensity, spinal stiffness, range of motion, sleep quality, and mood. Results demonstrated a significant improvement in joint pain, spinal stiffness, and sleep quality for a majority of participants, while also revealing an overall positive effect on well-being and mood.

Despite these promising results, there are potential risks, challenges, and limitations associated with nVNS, such as possible side effects, varying individual responses, and the need for further optimization of stimulation parameters. Future research directions should focus on optimising nVNS parameters, exploring long-term effects, and assessing the treatment’s effectiveness in larger, more diverse patient populations to better understand and optimise its application in Bechterew disease patients.

1. INTRODUCTION:

Bechterew disease, or ankylosing spondylitis (AS), is a chronic, progressive, and systemic inflammatory rheumatic disease that predominantly affects the axial skeleton, leading to pain, stiffness, and restricted mobility. The main symptoms include persistent lower back pain, morning stiffness, and a gradual loss of spinal flexibility. Although pharmacological interventions, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and disease-modifying antirheumatic drugs (DMARDs), have been used to manage pain and inflammation in AS patients, they are often accompanied by side effects and may not provide adequate relief for all patients.

Non-invasive vagus nerve stimulation (nVNS) has emerged as a promising alternative treatment for various pain and inflammatory conditions. It involves delivering electrical stimulation to the vagus nerve through the skin, without the need for surgical implantation. The vagus nerve plays a vital role in the regulation of pain and inflammatory responses, making nVNS a potential therapeutic option for Bechterew disease patients.

This study aims to investigate the potential benefits of nVNS in pain management for Bechterew disease patients, using the Pulsetto device for twice-daily 20-minute stimulation sessions. The effectiveness of the treatment was assessed through self-reported measures, including pain intensity, spinal stiffness, range of motion, sleep quality, and mood. Additionally, this study explores the potential risks, challenges, and limitations of nVNS in the context of Bechterew disease and suggests future research directions to better understand and optimize its application for these patients.

2. METHODOLOGY:

2.1. Study Design:

A single-center, prospective, open-label pilot study was conducted to evaluate the potential benefits of non-invasive vagus nerve stimulation (nVNS) for pain management in Bechterew disease patients.
2.2. Participants:

A total of 7 patients diagnosed with Bechterew disease, aged between 18 and 65 years, were enrolled in the study. Inclusion criteria comprised a confirmed diagnosis of Bechterew disease, persistent pain despite conventional pharmacological treatments, and the ability to provide informed consent.
2.3. Intervention:

Participants were instructed to use the Pulsetto nVNS device twice daily, with 20-minute pain management stimulation sessions in the morning and evening. If no improvement was observed after the morning stimulation, patients were advised to repeat the stimulation after 1 hour for another 20 minutes.
2.4. Assessments:

Participants were asked to complete a daily quiz to assess the effectiveness of nVNS on various outcome measures, including pain intensity, spinal stiffness, range of motion, sleep quality, and mood. The quiz consisted of the following questions:

  1. Has the morning stiffness of the spine decreased? (Yes/No)
  2. Rate the joint pain before the stimulation from 1 to 10, where 1 – I did not feel any pain at all, 10 – the pain was very severe.
  3. Rate the joint pain after stimulation from 1 to 10, where 1 – I did not feel any pain at all, 10 – the pain was very severe.
  4. Did the spinal range of motion increase/decrease after stimulation? (increased/decreased)
  5. Rate your well-being and mood after stimulation? (Neutral, mood improved, mood worsened, other [open answer])
  6. Have you noticed changes in the quality of your sleep? (Sleep improved, sleep worsened, neutral, other [open question])
  7. How do you feel immediately after the stimulation? First thoughts, experiences (open question)
  8. Do you have difficulty concentrating and completing daily tasks?
  9. Did you have a hard time sleeping at night?
2.5. Data Analysis:

Descriptive statistics were used to analyse the data, including frequencies, percentages, means, and standard deviations. Paired t-tests were conducted to compare pre- and post-stimulation pain intensity scores. The changes in spinal stiffness, range of motion, sleep quality, and mood were assessed using appropriate statistical tests based on the data distribution.

3. RESULTS:

A total of 7 Bechterew disease patients completed the study. The results of the daily quizzes are as follows:

  1. Morning stiffness of the spine decreased in 82.05% of patients (n=64), while 17.95% (n=14) did not notice any change.
  2. Joint pain before stimulation had a mean score of 4.18 (SD = 1.87). The distribution of pain intensity scores was:
  3. Joint pain after stimulation had a mean score of 2.10 (SD = 1.29). The distribution of pain intensity scores was:
  4. Spinal range of motion increased in 71.79% of patients (n=56), decreased in 2.56% (n=2), and remained unchanged in 25.65% (n=20).
  5. Well-being and mood after stimulation improved in 51.3% of patients (n=40), remained neutral in 46.2% (n=36), and worsened in 2.6% (n=2).
  6. Sleep quality improved in 43.6% of patients (n=34), remained neutral in 51.3% (n=40), and worsened in 5.1% (n=4).
  7. Most patients reported feeling relaxed, calm, or energised immediately after the stimulation. A smaller proportion of patients experienced mild discomfort or dizziness, which subsided shortly after the stimulation session.
  8. 63.5% of patients (n=49) reported improved concentration and ability to complete daily tasks, 30.8% (n=24) experienced no change, and 5.7% (n=5) reported worsened concentration and task completion.
  9. At night, 87% of patients (n=68) experienced no trouble sleeping, 11.5% (n=9) had difficulty falling asleep, and 1.5% (n=1) experienced frequent awakenings or poor sleep quality.

A significant reduction in pain intensity was observed following nVNS (t(77) = 12.64, p < 0.001).

Please see the graphic data below.

4. DISCUSSION:

This pilot study demonstrated promising results for the use of non-invasive vagus nerve stimulation in Bechterew disease patients, with significant improvements in pain intensity, spinal stiffness, range of motion, sleep quality, and mood. The majority of patients reported decreased morning stiffness and increased spinal range of motion, which may contribute to better overall functioning and quality of life.

The positive impact of nVNS on sleep quality and mood is particularly noteworthy, as sleep disturbances and mood disorders are common comorbidities in Bechterew disease patients. Improved sleep and mood may further contribute to better pain management and overall well-being.

Despite the encouraging findings, several limitations should be acknowledged. The open-label design and the absence of a control group may have introduced bias, and the study relied on self-reported outcomes, which can be subjective. Additionally, the sample size was relatively small, and the study duration was limited to two weeks, which may not capture long-term effects or potential adverse events.

Future research should employ randomised controlled trials with larger sample sizes and longer study durations to further investigate the effectiveness and safety of nVNS in Bechterew disease patients. Optimising stimulation parameters, assessing long-term effects, and exploring potential predictors of treatment response may help improve the application of nVNS for pain management in this population.

5. REFERENCES:

  1. Braun, J., & Sieper, J. (2007). Ankylosing spondylitis. Lancet, 369(9570), 1379-1390. https://doi.org/10.1016/S0140-6736(07)60635-7
  2. Taurog, J. D., Chhabra, A., & Colbert, R. A. (2016). Ankylosing spondylitis and axial spondyloarthritis. New England Journal of Medicine, 374(26), 2563-2574. https://doi.org/10.1056/NEJMra1406182
  3. O’Connor, A. B., & Dworkin, R. H. (2009). Treatment of neuropathic pain: An overview of recent guidelines. The American Journal of Medicine, 122(10), S22-S32. https://doi.org/10.1016/j.amjmed.2009.04.007
  4. Chakravarthy, K., Chaudhry, H., Williams, K., & Christo, P. J. (2015). Review of the uses of vagal nerve stimulation in chronic pain management. Current Pain and Headache Reports, 19(11), 54. https://doi.org/10.1007/s11916-015-0528-6
  5. Yuan, H., & Silberstein, S. D. (2016). Vagus nerve and vagus nerve stimulation, a comprehensive review: Part I. Headache, 56(1), 71-78. https://doi.org/10.1111/head.12647
  6. Frangos, E., Ellrich, J., & Komisaruk, B. R. (2015). Non-invasive access to the vagus nerve central projections via electrical stimulation of the external ear: fMRI evidence in humans. Brain Stimulation, 8(3), 624-636. https://doi.org/10.1016/j.brs.2014.11.018
  7. Straube, A., Ellrich, J., Eren, O., Blum, B., & Ruscheweyh, R. (2015). Treatment of chronic migraine with transcutaneous stimulation of the auricular branch of the vagal nerve (auricular t-VNS): a randomized, monocentric clinical trial. The Journal of Headache and Pain, 16(1), 543. https://doi.org/10.1186/s10194-015-0543-3
joint pain before stimulation graph
motion of spine pie chart
sleep quality pie
trouble sleeping graph
morning stiffness graph
difficulty concentrating raph
mood after stimulation pie chart
join pain after stimulation graph

Frequently Asked Questions

Want to know more? Email us any time! Please reach out to info@pulsetto.tech and we’ll be in touch.

How to use the device?

It’s very easy. Apply a generous amount of gel to your neck. Put the device on your neck, then pair it with the Pulsetto app. Choose your desired program, then start the device via the app. For more detailed information on how to use our device, check this out.
What is vagus nerve stimulation?

The vagus nerve is the major highway between your brain and internal organs. It releases neurotransmitters that reduce blood pressure and heart rate and increase alertness and focus.

The purpose of Pulsetto is to provide stress resilience and well-being to people from all walks of life by utilizing effective methodologies and cutting-edge
technology.

Based on decades of expertise working with stress and trauma-related conditions, we are bringing to the mainstream market a vagus nerve activation technology that will enable customers to treat conditions such as stress, poor sleep, and anxiety.

You can find additional information here: https://pulsetto.tech/science/
Are there any additional costs or subscription fees?

The Pulsetto device is a one-time purchase that comes without any additional fees, subscriptions, or charges. Enjoy the full functionality of your Pulsetto without worrying about ongoing costs. 

However, for users seeking enhanced features and personalized experiences, we offer optional add-ons such as the Premium app subscription and other programs designed to support you on your journey to a healthier life. These additional offerings are entirely optional, allowing you to tailor your Pulsetto experience based on your preferences and wellness goals.
How can I make sure the vagus nerve is stimulated?

Stimulating the vagus nerve increases its activity, resulting in a drop in heart rate, an increase in HRV (heart rate variability) within 3–4 weeks, and the activation of the parasympathetic nervous system. This makes you calmer, less stressed, less anxious, and results in better sleep.  

Some factors could affect your results, however. If your HRV is under 50, it is too low, meaning you can have issues with your gut, ability to relax, blood pressure, and a bunch of other things. If it is around 80 – it is very good. And 100, of course, means it’s perfect.
When can I start feeling the effect?

The use effect varies depending on the individual’s health condition and severity of the symptoms but usually occurs within 1–30 days. The elderly with severe body imbalances and people with severe symptoms experience rapid effects within 1–3 days, while healthy people may experience the effects after 30 days.

80% of Pulsetto customers see a substantial improvement in their stress and anxiety levels after 3–4 weeks. The time necessary to see a difference varies from person to person and might range from 1–2 days to 4–6 weeks.
What's included in Pulsetto app?

It includes 5 UNLIMITED stimulation programs for sleep improvement, anxiety and stress reduction, burnout and pain management. Also Pulsetto app has a sound library – the soundscapes are engineered solely for Pulsetto – using frequency harmonics with auditors’ stimuli and frequency following responses. Pulsetto continually adds new features and functionality directly to the app without the need to buy new hardware.
What happens after I order?

After you place your order, we will send you our Pulsetto hardware device and user manual. 

You will need to download the Pulsetto app via Google Play or the App Store to get started.

If you don’t receive a link with further instructions within 2 hours, please check your spam folder.
Is Pulsetto safe to use?

The device provided by Pulsetto is FCC certified. This means that Pulsetto is approved for well-being use and compliant with the strict laws of the Federal Communication Commission. 

The FCC certification ensures that:

  • Pulsetto is based on scientific evidence
  • The Pulsetto is safe to use

For additional information, please refer to disclaimer.
Pulsetto technology uses the lowest bluetooth energy ultra low radiofrequency energy (ULRE) – which safely passes into the body.
How long can I use Pulsetto after it's fully charged?

The battery life of Pulsetto is about a week with daily use. When the indicator turns blinking green, you must recharge.
Can Pulsetto increase HRV?

Yes, Pulsetto can increase HRV (Heart Rate Variability) by stimulating the vagus nerve, which activates the parasympathetic nervous system. This activation helps the body enter a state of rest and digest, promoting a calmer, less stressed state and resulting in better sleep, all of which can contribute to an increased HRV.