Patent Application
20210322247
The present invention pertains generally to protocols that combine physical and pharmaceutical therapies for the treatment of a disease. More particularly, the present invention pertains to protocols for the treatment of lumbosacral spine disease. The present invention is particularly, but not exclusively, useful as a treatment for lumbosacral spine disease that periodically imposes traction forces on the spine of a patient, in conjunction with a daily regimen of selected pharmaceuticals.
It is well known that lumbosacral spine disease causes low back, hip and/or leg pain. In general, it is thought by many that these ailments typically result from different causes that are directly or indirectly associated with physical activity. More specifically, these causes can include: i) the movement of discs or vertebral bodies that compress inflamed nerves exiting from the spinal cord; ii) the pull from muscles on vertebral bodies that affect spinal alignment; and iii) the repetitive firing of inflamed motor nerves that cause muscles attached to the spine to contract and thereby affect spinal alignment and the compression of sensory nerves.
Heretofore, noninvasive evaluations of lumbosacral spine disease have been accomplished using radiographic technologies that involve x-ray, gamma rays or similar radiation. Although surgeries that are performed to correct radiographically detected alignment problems have been generally successful, adverse symptoms will often persist for extended periods of time after surgery. Quite likely, these symptoms persist because radiographs taken from a supine patient do not accurately reflect the structure of the spine when the patient is otherwise sitting, or erect, or engaged in some form of activity. For these reasons, the present invention envisions that a satisfactory relief for a patient, from the symptoms of lumbosacral disease, will often require pain medications, acupuncture or some other form of continuing therapy for their discomfort.
In light of the above, it is an object of the present invention to provide a protocol for the treatment of lumbosacral disease that includes a combination of physical and pharmaceutical therapies. Another object of the present invention is to provide a treatment for lumbosacral spine disease that periodically imposes traction forces on the spine of a patient, in conjunction with a daily regimen of selected pharmaceuticals. Still another object of the present invention is to provide a symptom driven protocol for relieving the pain associated with lumbosacral spine disease which can be monitored to evaluate efficacy in terms of symptom alleviation. It is also an object of the present invention to provide a protocol for the treatment of lumbosacral disease that is easy to follow, is efficacious, and is cost effective.
In accordance with the present invention, a protocol for treating a lumbosacral spine disease of a patient requires the combination of physical and pharmaceutical therapies. For the physical therapy aspect of the protocol, a device is preferably used once or twice daily to apply a traction force along the spine of the patient that will open up the space between vertebrae. Depending on the needs of a patient, the traction force will have a predetermined magnitude, and it will be applied for a predetermined time interval. For the pharmaceutical therapy aspect of the protocol, the patient is expected to ingest a nonsteroidal anti-inflammatory drug (NSAID), a muscle relaxant, and an antiarrhythmic drug in accordance with a clinically prescribed regimen.
As envisioned for the present invention, a device for applying a traction force on the patient will preferably be an inversion table of a type well known in the pertinent art. When an inversion table is used, it is the weight W of the patient under the influence of gravity that will cause the traction force to be generated. Using an inversion table, the physical therapy aspect of the protocol begins with the patient being supported and held horizontally on the inversion table in a supine position. He/she is then rotated on the inversion table from the horizontal orientation around a horizontal axis, through a predetermined rotation angle θ. With the inversion table at the rotation angle θ the patient is held in a head down orientation for a predetermined time interval. At the end of this time interval the inversion table is rotated back to a horizontal orientation and the physical therapy aspect of the protocol is ended.
An alternate embodiment of the present invention uses a traction bed of a type well known in the pertinent art for purposes of the protocol. For the alternate embodiment, rather than relying on the patient's body weight W, predetermined weights can be arranged on the traction bed and connected to the patient (e.g. legs) for use as an alternative device for purposes of generating a traction force.
As envisioned for purposes of the present invention, the rotation angle θ for an inversion table will preferably be in a range between 40° and 60°. Further, the predetermined time interval will preferably be in a range between 2 minutes and 5 minutes (e.g. 3-4 minutes). It is also to be noted that for a patient having a weight W, the predetermined angle θ is preferably selected to create a traction force on the patient that is greater than approximately 0.5 W. Using these general parameters, the physical therapy aspect of the protocol is accomplished at least once or twice daily.
It is an important aspect of the present invention that for a complete protocol, which may last several months, there should be a continuing, systematic clinical monitoring of the patient. Specifically, the severity of the symptoms associated with lumbosacral spine disease that are experienced by the patient needs to be periodically evaluated (e.g. monthly). The purpose here is to ascertain the degree to which these symptoms have been alleviated. With this monitoring, changes in the severity of symptoms can be used as an indicator of protocol efficacy.
The novel features of this invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying drawings, taken in conjunction with the accompanying description, in which similar reference characters refer to similar parts, and in which:
Referring initially to
Once the patient 16 is positioned in a head down orientation at the angle θ, as shown in
With specific regard to the pharmaceutical therapy aspect of the protocol of the present invention,
For purposes of the present invention, several different pharmaceuticals within each type of pharmaceutical may be appropriately used. Moreover, it is appreciated by the present invention that each pharmaceutical will individually have a specific dosage efficacy. Accordingly, as indicated in
While the particular Treatment Protocol for Low Back Syndrome as herein shown and disclosed in detail is fully capable of obtaining the objects and providing the advantages herein before stated, it is to be understood that it is merely illustrative of the presently preferred embodiments of the invention and that no limitations are intended to the details of construction or design herein shown other than as described in the appended claims.
