Medtronic Initiates Landmark Study Of Neurostimulation Therapy For Failed Back Surgery Syndrome

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Main Category: Back Pain
Article Date: 29 Jan 2013 - 2:00 PST Current ratings for:
Medtronic Initiates Landmark Study Of Neurostimulation Therapy For Failed Back Surgery Syndrome

First Patients Treated in Global Clinical Trial Evaluating Impact of Therapy on Predominant Low Back Pain

Medtronic, Inc. (NYSE: MDT) have announced the start of PROMISE, a Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain. This is the first-ever, large-scale study comparing the effectiveness of Medtronic neurostimulation therapy with Specify® 5-6-5 multicolumn surgical leads plus optimal medical management (OMM) to the administration of OMM alone in patients with failed back surgery syndrome (FBSS) and predominant low back pain.

"Chronic pain is a clinically challenging and often debilitating condition for which oral medications may provide insufficient relief," said Bart Edmiston, M.D., principal investigator for the PROMISE study at The Neuroscience Center in Ocean Springs, Mississippi, which enrolled the study's first patient on January 8. "The PROMISE study will add to the growing body of evidence supporting Medtronic neurostimulation therapy, a well-established therapeutic approach, for the patients worldwide who continue to experience low back pain following back surgery."

It is estimated that more than 100 million U.S. adults1 and one in five European adults2 live with chronic pain. Back pain is the most prevalent type of chronic pain, affecting approximately 10 percent of the U.S. population alone.3 FBSS is defined as persistent or recurring pain in the back or legs following one or more spine surgeries. The majority of FBSS patients receive physical rehabilitation and/or oral medications to help manage their pain, but studies and clinical experience find that many of these patients will not sufficiently improve and will require additional interventions.4

Medtronic neurostimulation therapy (also known as spinal cord stimulation, or SCS) is a widely established treatment option for chronic back and/or leg pain that has been used to treat more than 250,000 people worldwide. It uses a medical device to deliver mild electrical impulses to the spinal cord to block pain signals from reaching the brain.

PROMISE is a prospective, randomized, open-label, parallel-group, clinical study enrolling up to 300 individuals suffering from predominant chronic low back pain due to FBSS at 30 centers in the United States , Canada and Europe (Belgium, France, Germany, Spain, The Netherlands and The United Kingdom). It is the first large-scale, randomized, controlled clinical trial designed to assess the value of SCS for predominant low back pain with leg pain using a surgical lead, in contrast to previous studies of this technology, which have focused on predominant leg pain.

"Spinal cord stimulation has become an increasingly valued treatment approach in chronic pain, and we look forward to participating in the latest study," said Philippe Rigoard, M.D., the study's global principal investigator, who started enrolling patients January 14 at Poitiers University Hospital in Poitiers, France. "If the PROMISE results are positive, they will provide critically needed relief for those patients suffering from chronic low back pain associated with FBSS." PROMISE participants will be randomized 1:1 to receive treatment with either SCS with OMM or OMM only. After a six-month observational phase, the study will compare the proportion of participants in the SCS group who report more than 50 percent reduction in low back-pain intensity, as measured by the Numeric Pain Rating Scale, with those in the OMM-only group.

Health care utilization data collected will be used to develop cost analysis models for potential use in future studies evaluating the long-term economic impact of SCS.

"Medtronic is committed to advancing the understanding of its neurostimulation therapy in patients with low back pain resulting from FBSS," said Julie Foster, general manager and vice president, Pain Stimulation and Targeted Drug Delivery in the Neuromodulation business of Medtronic, Inc. "PROMISE provides the opportunity to assess not only the degree of pain relief provided by SCS plus OMM compared to OMM alone in failed back surgery patients, but also to evaluate the economic and quality of life impact of this treatment by looking at such important measures as sleep, ability to work and changes in pain medication."

More information about the PROMISE study, including enrollment information, can be obtained here.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our back pain section for the latest news on this subject. 1 Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research; Consensus Report, Institute of Medicine (IOM), June 2011. Page 1.

2 Breivik H, Collett B, Ventafridda V, Cohen R, Gallagher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain 2006;10:287-333.

3 Hardt J, Jacobsen C, Goldberg J, Nickel R, Buchwald D.: Prevalence of chronic pain in a representative sample in the United States. Pain Medicine 2008; 9:7: 803-812.

4 Chan C, Peng P. Review Article: Failed Back Surgery Syndrome. Pain Medicine 2011; 12: 577-606.

Source: Medtronic, Inc.

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Chiropractic Care of Short Leg Syndrome, Low Back and Neck Pain

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The basic premise of Chiropractic medicine is twofold; (1) to be as minimally invasive to the body as possible and (2) to potentiate the body's ability to heal itself. This is what is meant by the chiropractic professional when they say, "without the use of drugs or surgery." It must be kept in mind that chiropractic physicians are trained to recognize when the patient's ailment is beyond his or her scope of practice or expertise. When appropriate, Doctors of Chiropractic (DC) refer patients to other healthcare specialists for consultation.

Low Back Pain: Functional and Structural Short Leg
A patient presents with low back pain. Usually pain is right- or left-sided in the sacroiliac joint. The sacroiliac joint is found by two dimples on the low back. Most of the time, the right leg is functionally short. This means the leg is apparently short because of postural or environmental stress; such as tighter muscles on one side of the body or a fallen arch in the foot.

Functional short leg is different from structural short leg. A structural short leg is anatomically short because of a hip disorder, less knee joint space, or fracture history. This type of short leg length is managed simply by using a heel lift.

Functional short leg length is managed using a chiropractic side posture lumbar adjustment. The patient stands on, and is weighed on two separate scales simultaneously. The patient will be heavier on the short leg side because they must lean into the right side to maintain balance. The author has seen the weight distribution between right and left to average 5-10 pounds; usually heavier on the right side. In some extreme cases, the difference has been up to 60 pounds!

The patient is then placed onto their side with the short leg side facing up; a lumbar roll is performed to rotate the pelvis. The adjustment should not be painful. The patient is then placed face down and leg length is re-measured. Leg length discrepancy will usually be corrected. When the patient is re-weighed, the prior difference usually balances out between right and left.

Neck (Cervical) Pain
Whiplash is a term that is used to describe what happens to the cervical spine during a vehicular rear-end collision. More appropriately, today whiplash is called a CAD - Cervical Acceleration Deceleration injury. The head and neck are forced (accelerated) forward, slows down (decelerates), and then forced backward. A similar condition can occur in the low back.

Symptoms include severe pain and muscle spasm that can actually alter the normal curvature (lordosis) of the cervical spine. Some patients report numbness, tingling sensations, and even weakness in their shoulders and arms, which may be associated with disc herniation and nerve compression or damage. Chiropractic treatment, including traction, reverses abnormal lordosis and helps to relieve pain and other symptoms associated with CAD.

Cervicogenic neck pain is a leading cause of headache in about 85% of patients who seek professional care. Unlike vascular headaches, cervicogenic neck pain is caused by tension and nerve irritation. Chiropractic care, including manipulation is proven to help eliminate symptoms associated with this type of headache in most patients.

Conclusion
In the United States there are more than 50,000 licensed Doctors of Chiropractic. Today, chiropractic medicine is the third largest area of medicine - next only to dentistry and is the largest Complementary and Alternative Medicine (CAM) health profession. The success of chiropractic is attributed to its ability to treat back and neck problems, recent research, and changing attitudes.

Chiropractic is considered by many to be part of mainstream Western medicine and primary care. Similar to other medical professions, many chiropractors have extensive postgraduate training and become board certified in certain areas such as diagnostic radiology, neurology, nutrition, orthopaedics, physical rehabilitation, and sports medicine.

With the technological advances in medicine, some chiropractors are broadening their scope of practice to include: (1) prescription privileges for non-narcotic pharmaceuticals (drugs) such as penicillin (2) procedures including minor surgery and injectable nutrients and (3) co-admitting hospital privileges. Chiropractic medicine recently was added to the Veterans' Administration (VA) plan in VA hospitals across the United States.