Understanding FDA not Cleared for Fibromyalgia

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Fibromyalgia (FM) is a chronic condition characterized by widespread musculoskeletal pain, accompanied by fatigue, sleep disturbances, cognitive difficulties (often called "fibro fog"), and mood issues.


Unlike pain stemming from direct tissue damage or inflammation, Fibromyalgia is believed to involve abnormalities in how the brain and spinal cord process pain signals, leading to amplified pain sensations. 



This central sensitization means that even light touch or pressure can be perceived as painful.



However, a highly relevant article that discusses Deep TMS for Weight Loss is https://www.brainsway.com/knowledge-center/deep-tms-augmentation-treatment-for-fibromyalgia-a-safety-and-feasibilitystudy/



Prescription drugs include pain relievers, antidepressants (which can help with pain, sleep, and mood), and anti-seizure drugs (which can reduce pain). 


However, these can come with various side effects and may not provide complete relief for all symptoms.   



The results from clinical studies on Deep TMS offer compelling evidence that this non-invasive therapy can be a game-changer. 


These studies have demonstrated significant and lasting benefits that go beyond simple pain management. 


Reduce Pain Intensity 

Studies suggest Deep TMS can help decrease subjective pain sensation by influencing the brain's pain pathways.


Improve Functioning

Alleviating pain can lead to improved physical functioning and the ability to engage more fully in daily activities.


Address Associated Symptoms  

Beyond pain, Deep TMS may also help alleviate common co-occurring symptoms of Fibromyalgia, such as fatigue, sleep disturbances, and cognitive impairments, by impacting the underlying brain networks responsible for these issues. 

Importantly, some research indicates pain reduction from Deep TMS may occur independently of antidepressant effects, suggesting a direct impact on pain mechanisms.


Offer a Non-Pharmacological Option  

As a non-systemic treatment, Deep TMS generally avoids the systemic side effects often associated with oral medications, providing a well-tolerated alternative, especially for those who have not found adequate relief from conventional pharmacological treatments.


The benefits of Deep TMS extend well beyond pain scores. 


Clinical data indicates that functional improvements in daily life, as measured by a Fibromyalgia Impact Questionnaire (FIQ), can be sustained for up to 16 weeks after the treatment concludes. 



In summary

For individuals seeking an alternative for fibromyalgia, Deep TMS offers a powerful and non-invasive pathway to relief.


Clinical studies have demonstrated compelling benefits, showcasing its potential to significantly improve quality of life. 

Curious about How BrainsWay Deep TMS® could transform your Health?

BrainsWay Deep TMS® offers innovative approaches not only for neurological and psychiatric conditions. 


Important disclaimer

BrainsWay Deep TMS® Treatment for Fibromyalgia is not intended for individuals in the United States as it HAS NOT BEEN FULLY CLEARED by the FDA for safety and efficacy for these specific indications. 


 "It is important to note that while these specific indications may not be FDA-cleared in the United States, some BrainsWay Deep TMS® treatments for certain conditions may have received CE Mark approval in Europe, indicating compliance with European health, safety, and environmental protection standards. Always verify the regulatory status of any treatment in your specific region."