Your MD and non-surgical spinal decompression
If you ask your MD about non-surgical decompression, his first reflex, in most cases, will be to prevent you from using this type of treatment: He will probably say that spinal decompression is not scientifically proven or that it is dangerous.
What your MD does not know about non-surgical spinal decompression:
- The equipment and treatment protocol was invented by Dr. Allan Dyer, MD, PhD.
- The equipment is FDA approved
- In order to get approved by the FDA, the manufacturer has to prove the device is safe and effective
- It has to go through clinical research
What does it mean when FDA “clears” or “approves” a medical device?
When FDA review is needed prior to marketing a medical device, FDA will either
- “clear” the device after reviewing a premarket notification, otherwise known as a 510(k) (named for a section in the Food, Drug, and Cosmetic Act), that has been filed with FDA, or
- “approve” the device after reviewing a premarket approval (PMA) application that has been submitted to FDA.
Whether a 510(k) or a PMA application needs to be filed depends on the classification of the medical device.
To acquire clearance to market a device using the 510(k) pathway, the submitter of the 510(k) must show that the medical device is “substantially equivalent” to a device that is already legally marketed for the same use.
To acquire approval of a device through a PMA application, the PMA applicant must provide reasonable assurance of the device’s safety and effectiveness.
Souce: FDA website www.fda.gov
So if the device and treatment protocol was invented by an MD, had to go through clinical reasearch in order to get approved by the FDA as a safe and effective medical device, what else does your MD need to considered non-surgical spinal decompression as a safe alternative to surgery ?
What your MD will not tell you is that Non-Surgical Spinal Decompression Therapy gives patients a more conservative treatment option that can eliminate the need for surgery altogether.
It becomes clear that spinal decompression is a safe and effective form of treatment for disc-related pain. It is not a miracle cure touted by its promoters nor a shameless scam claimed by its detractors. Like most things, the truth about spinal decompression lies somewhere in the middle. Despite the overall effectiveness of non-surgical spinal decompression, it does not work for every patient.
With careful patient pre-selection, a realistic success rate for non-surgical spinal decompression would probably be around 70- 75% as a stand-alone treatment, and somewhat higher (85%) when combined with other therapies such as mild manipulation of adjacent articulations. This success rate seems to hold up in the long run for most patients as well, with very few reported recurrences of symptoms a year after treatment. But even at a 70% success rate, non-surgical spinal decompression is more effective than the most common disc-related treatments currently in use, such as spinal injections and surgery, which most studies have found provide long-term benefits in only about 50% of patients.