Question 1

What is the Accu-SPINA™ System?

Accepted Answer

The Accu-SPINA™ System is a unique method that delivers a treatment called IDD Therapy® (Intervertebral Differential Dynamics). IDD Therapy® is the most advanced non-invasive, non-surgical treatment for low back and neck conditions. It is a mechanized pain reduction and healing system that has, after many years of research, been shown to be up 86% successful in reduction of disc herniation.

Question 2

How Does the Accu-SPINA™ Work?

Accepted Answer

The combination of angle of pull and an air bladder create a fulcrum pinpointing treatment to the specific region that needs help. IDD Therapy® creates negative pressure between the discs, decreasing the herniation and healing the damaged area. The system supplies alternating decompression followed by a period of partial relaxation. Each session on the Accu-SPINA™ equipment is approximately 35-45 minutes long including set-up and take-off. The patient comes for 15-25 visits over a 4-6 week period.

Question 3

Who Can Benefit from Using Accu-SPINA™ Equipment?

Accepted Answer

People with the following conditions are ideal candidates for enrollment into the Accu-SPINA™ program and have the potential of achieving quality outcomes in the treatment of their back and neck pain: (1) Herniated or Bulging Discs; (2) Nerve Compression; (3) Lumbar or Cervical Disorders; (4) Low Back or Neck Strains; (5) Sciatic Neuralgia (Sciatica); (6) Injury of the Lumbar or Cervical Nerve Root; (7) Degenerative Discs (unresponsive to four weeks of conservative therapy); (8) Spinal Arthritis; (9) Low Back Pain w/ or w/o Sciatica; (10) Degenerative Joint Disease; (11) Facet Syndrome; (12) Myofasciitis Syndrome; (13) Disuse Atrophy; (14) Lumbar Instability; (15) Acute Low Back Pain; and (16) Post-Surgical Low Back Pain (recurrent pain from a failed back surgery lasting more than six months).

Patients with low back pain or neck pain who have had no success with conventional therapy and who are considering surgery should utilize the Accu-SPINA™. Surgery should be considered only following a reasonable trial of the Accu-SPINA™ System IDD Therapy® protocols. Patients who undergo the full four to six weeks of the treatment protocol will obtain the best results. A patient must be at least at least 18 years of age to undergo Accu-SPINA™ treatment.

Question 4

Is Treatment on the Accu-SPINA™ Safe?

Accepted Answer

IDD Therapy® on The Accu-SPINA™ System is a safe procedure that can be used on patients with Chronic Back and Neck Pain caused by Spinal Stenosis, Degenerative Disc Disease, Herniated Discs, Bulging Discs, Slipped Discs, and Sciatica.

Question 5

What conditions should not be treated with Accu-SPINA™?

Accepted Answer

Although IDD Therapy® on The Accu-SPINA™ System is an inherently safe procedure that can be used without complications, patients with the following problems or symptoms are usually excluded from using the Accu-SPINA™: Pregnancy, Prior lumbar surgical fusion, Metastatic cancer, Compression fracture of lumbar spine below L-1, Pars defect, Spina bifida, Aortic aneurysm, Pelvic or abdominal cancer, Disc space infections, Severe peripheral neuropathy, Hemiplegia, Paraplegia, Cognitive dysfunction, Cauda Equina syndrome, Tumors, Osteoid osteoma, Multiple myeloma, Osteosarcoma, Infection, Osteomyelitis, Meningitis, Virus, and HNP (sequestered/free floating or extruded fragment), Severe Osteoporosis, Spondylolysis, Spondylolisthesis (Grade 2 or higher), Vertebral fractures, Unstable post surgical conditions, any kind of surgical hardware, pathological lesions or congenital deformities of the vertebral column that disrupt the integrity of the vertebral and ligamentous structures.

Question 6

What is the difference between the Accu-SPINA™ system and traction?

Accepted Answer

Traction disperses the pull of weights among the majority of spinal segments reducing the actual amount of pull necessary to create negative pressure within each segment. Traction can also cause the adjacent muscles to spasm placing more pressure on the disc. The Accu-SPINA™ isolates the specific problem disc by its unique angle of distraction (or pull). It creates a negative pressure within the disc space, which draws fluid, nutrients and oxygen into the disc helping it to heal. The unique method by which it distracts the spinal segments eliminates the reaction of the neighboring muscles so that they do not spasm.

Question 7

What results can I expect?

Accepted Answer

Most patients are scheduled for 20 treatments over a 4 to 6-week period. The typical patient may feel relief as early as the first 5 to 8 treatments. However, it is important to finish the entire protocol to allow for proper healing. Pre and post treatment MRIs have shown 50% reduction in the size and extent of herniations after 6 weeks of treatment. Clinical studies confirm that 86% of patients with disc problems reported relief with Accu-SPINA™ treatment.

Question 8

What Happens after a patient completes the Accu-SPINA™ system/IDD Therapy® Protocol?

Accepted Answer

The Accu-SPINA™ protocol of 20-25 visits generally relieves the nerve compression syndrome and restores functional capacity. Experience has shown that the vast majority of patients who recover on the Accu-SPINA™ generally remain in remission. However, some individuals whose lifestyle or work environment tend to expose them to higher risk factors, have found that a follow-up or maintenance program of Accu-SPINA™ treatment sessions offers a measure of protection against disabling exacerbations of their back pain syndrome. Patients in this category usually develop, in consultation with their physicians, their own rhythm of maintenance visits that keeps them free of problems. The onset of osteoporosis, particularly in senior patients, may also necessitate maintenance treatments.

A maintenance program may consist of three rehabilitation visits per week for three to four weeks followed by two times a week for three to four weeks. These rehabilitation visits should include moist heat, stretching and strengthening of the lumbar spine and legs (or neck and arms), and Osteopathic manipulation as needed to maintain optimal spinal function.

Question 9

Why are there so many treatments and why do i have to come so frequently?

Accepted Answer

Each treatment builds on the progress made at the previous session. Treatments are scheduled 1 to 3 days apart so as not to lose ground on that progress, especially in the earlier sessions. Treatments at one day apart are optimal for best results.

Question 10

What Can I Do to Help My Recovery?

Accepted Answer

Attitude is a very important part of healing. Maintaining optimism is important for healing. Patients are asked to participate in their treatment by complying with the entire Accu-SPINA™ protocol, by following through with their exercise programs and by using good sense in terms of minimizing activities that worsen their pain.

Question 11

Does the Accu-SPINA™ System Work for Everyone?

Accepted Answer

Eighty-to-ninety percent of patients who have been properly selected and comply with the entire Accu-SPINA™ protocol will have good-to-excellent outcomes. Patient conditions that do not respond quickly to the therapy are often unable to be helped by anything quickly. Patients vary in age, sex and body type and may require counseling in weight loss, nutrition and other lifestyle changes for optimal results.

Question 12

What About Other Therapies?

Accepted Answer

Recent studies comparing Accu-SPINA™ to standard physical therapy including traction, exercise, muscle stimulation, ultrasound, massage, and heat and ice showed Accu-SPINA™ decompression to be twice as effective in terms of perceived pain reduction, debilitating pain reduction, cumulative strength index and overall outcome.

Question 13

Did the FDA Approve the Accu-SPINA™ System?

Accepted Answer

Yes, the Accu-SPINA™ has received two (2) FDA approvals as a Class II Medical Device with 510(k) listing: One is for providing decompression to the lower back (lumbar spine) and the other is for providing decompression to the neck (cervical spine). The Accu-SPINA™ is approved to provide treatment for relief from pain and disability for those patients suffering with low back pain and neck pain associated with herniated discs, degenerative disc disease, and posterior facet syndrome.

Question 14

Have There Been Clinical Trials And Studies Conducted on IDD Therapy® and the Accu-SPINA™ System?

Accepted Answer

Extensive clinical studies have been conducted to validate IDD Therapy® treatment. Thousands of back pain patients have been successfully treated. Nearly a full year practical in-the-field analysis by participating physicians nationwide has been conducted. The following are samples of the published studies:

Practical Pain Management Magazine:

C Norman Shealy, MD, PhD reviews the evolution of back pain technology and presents results of a study utilizing differential dynamics rehabilitation [IDD Therapy®].Based on author's review of recent study results, inter-vertebral differential dynamic rehabilitation appears to be the current optimal recommendation for most lumbar pain syndromes.

America Journal of Pain Management (AJPM) Vol. 15 No. 3 July 2005:

The study is called A Retrospective Clinical Pilot Study: Long-term Effect Analysis of IDD Therapy® in Low Back Pain. It was conducted by C. Norman Shealy, MD, PhD, Nirman Koladia, MD, and Merrill M. Wesemann, MD. The objectives of this study were (i) to produce a follow-up to the Shealy and Borgmeyer Study, (ii) to evaluate long-term benefits of IDD Therapy® treatment, and (iii) to determine any benefits of IDD Therapy® in comparison to other treatment options. The authors stated: "A direct conclusion that can be drawn from the data is that improvement in pain continues after the treatment sessions are completed.

Orthopedic Technology Review:

The study was titled: Surgical Alternatives: Spinal Decompression and conducted by Thomas A. Gionis, MD, JD, MBA, MHA, FICS, FRCS, and Eric Groteke, DC, CCIC. This clinical outcomes study was performed to evaluate the effect of spinal decompression on symptoms and physical findings of patients with herniated and degenerative disc disease. Results showed that 86% of the 219 patients who completed the therapy reported immediate resolution of symptoms, while 84% remained pain-free 90 days post-treatment. Physical examination findings showed improvement in 92% of the 219 patients, and remained intact in 89% of these patients 90 days after treatment.

6-Month IDD Therapy® Patient File Review:

Results of 6-month patient file review of patients who had IDD Therapy® at Monmouth Advanced Medicine Clinic showed 93.6% of their patients obtained total pain relief on the Accu-SPINA™ machine.
Emory University is currently conducting a single blind clinical trial and there are many more in the works.

Alf Nachemson, MD, PhD; MTG Newsletter, October 1998

Degenerative disc disease can be effectively treated with the Accu-SPINA™ system because repeated decompression promotes the diffusion of water, oxygen, and nutrients into the vertebral disc area, thereby naturally re-hydrating and rehabilitating degenerated discs. In the case of disc herniation, the negative pressure may induce the retraction of the herniated or bulging disc, leading to relief of pain. Multiple treatment sessions on the machine are required to achieve optimal results. *

Question 15

Who Manufactures the Accu-SPINA™ System?

Accepted Answer

North American Medical Corporation (NAM) is the sole manufacturer of IDD Therapy® certified medical devices, including the Accu-SPINA™ system. The Accu-SPINA™ is the most advanced technology available for IDD treatment.

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