Low Back Pain or Neck Pain: Does Treatment Help?
(6/25/13)- As we noted in our item dated 8/12/11, Medtronic Inc. awarded a grant of $2.5 million to Yale University to study the data in regards to the effectiveness of its spinal treatment called Infuse.
Infuse is a bio-engineered bone growth protein product that was first sold in 2002 in connection with spinal fusion operations. Many of the favorable medical reports about the product were written by medical professionals who were paid by Medtronic.
The controversy over the effectiveness of the product reached a head in 2011 when the medical publication, The Spine Journal devoted an issue to reports that derided the positive side of the equation.
The ensuing examination by Yale University involved two reports from separate teams of researchers. One of the teams, headed by researchers at Oregon Health and Science University in Portland reported that Infuse appeared to have no advantages over a bone graft, and might even pose patient risk, including possibility of a slight added risk of cancer.
The other team composed of researchers at the University of York in England, found that Infuse fused spinal vertebrae more quickly than a bone graft, but that the added speed appeared to lack clinical relevance.
(10/14/12)- Back pain continues to be the number one disabling condition for older Americans. Spinal epidural injections are one of the treatment protocols practiced by pain management physicians. The news lately has highlighted some deaths and serious illnesses due to fungal meningitis infections that resulted from contaminated serum used in the procedure
The CDC believes the contamination compound used for the spinal steroidal contizone serum has been isolated to a compounding drug company in Massachusettes. They have shut down the company
Another prescribed form of treatment is spinal fusion. This treatment has been shown to have adverse effects also, according to a recent study published in the journal Spine. "Nearly 20 percent of people who underwent low back fusion surgery developed post-traumatic stress disorder symptoms associated with that surgery", according to a recent Oregon Health & Science University study published in the journal Spine.
(1/11/12)- Neck pain ranks with back pain, as one of the most common afflictions of all of us. A recent study conducted by the Northwestern Health Sciences University in Bloomington, Minn. compared spinal manipulation performed by a chiropractor, home exercises and medication for effectiveness at relieving neck pain. The National Institutes of Health's center for complementary and alternative medicine funded the study and the results were published in a recent edition of the Annals of Internal Medicine.
The lead author of the study was Gert Bronfort, vice-president of research at the university. Dr. Bronfort said a neck-retraction exercise, or chicken-like maneuver of the head, in which a person pulls his/her head back and then tilts the chin slightly downward "seemed to be especially useful."
Using a chiropractor or physical therapist to release tense joints and muscles through spinal manipulation can provide relief from neck pain. Spinal manipulation and home exercise were about equally effective in relieving neck pain. Both were better than medication alone.
(8/12/11)- Medtronic Inc. announced that it was giving a $2.5 million grant to theYale Medical School to finance a study of its bone growth product Infuse. To see the background information on Infuse please see our item dated 10/13/08 below.
Under the grant, Yale will assemble a panel of outside experts, who will then commission two academically recognized research organizations to review the company's study data.
Dr. Harlan Krumhoz, a cardiologist at Yale will oversee the project. Access to the data will be given to other researchers along with the groups Yale retains.
The FDA due to concerns about possible cancer risks, recently rejected a stronger version of Infuse, called Amplify.The Justice Department is currently conducting a criminal investigation of the company's marketing of the product, and a Senate committee is also conducting an inquiry.
(6/12/11)- The results of a study that appeared in the American Medical Association last year found that complex spinal fusion, in which several vertebrae are fused together, increased 15-fold among Medicare patients with spinal stenosis between 2002 and 2007. Spinal fusions which cost Medicare $343 million in 1997 increased to cost $2,24 billion in 2008, according to a Wall St Journal analysis of Medicare claims data.
Does spinal fusion work in the majority of cases that it is used? Is it worth the cost involved? How about the length of time involved in recovery? The jury is out on all 3 of these questions. As they say: "Talk to your doctor" in addition to talking to the surgeon suggesting the procedure..
(8/24/10)- A Federal Drug Agency (FDA) advisory panel voted 8-6 in favor of expanding approved uses of Eli Lilly & Co.'s blockbuster antidepressant Cymbalta to include relief of chronic low-back pain. The vote in favor of usage for low-back pain was 8 to 5, but it voted 9 to 4 against the drug's use for osteoarthritis.
Financial analysts have estimated that the approval for relief of low-back pain could add as much as $500 million in yearly sales for Cymbalta, on top of the $3 billion in sales that the drug garnered last year.
The FDA approved the drug for major depression and diabetic nerve pain in 2004, generalized anxiety disorder in 2007 and fibromyalgia in 2008. Cymbalta was used by 2.8 million patients in 2009, according to an FDA staff report, about 400,000 of them off-label for musculoskeletal pain, headaches or nerve pain.
(7/16/10)- Does glucosamine help alleviate lower-back pain and osteoarthritis? Glucosamine is a natural compound found in healthy cartilage.
The July 7th issue of the Journal of the American Medical Association reported on the results of a study of 127 Norwegian patients with lower-back pain and osteoarthritis, who were given 1,500 mgs of oral glucosamine for six month, while a similar group received a placebo.
The patients were evaluated for pain, pain-related disability, and quality of life at the beginning of the study, then at six weeks, three months, six months and a year. Researchers at the Oslo University Hospital conducted the study.
The researchers concluded that the level of pain, disability and quality of life were no different for either group.
"The most likely explanation for the outcome, is simply that glucosamine probably offers little benefit for chronic lower-back pain with osteoarthritis beyond whatever placebo effect it may provide" said Dr. Andrew L. Avins of Northern California Kaiser-Permante' division of research.
(4/10/10)- The results of a study that was federally funded that appeared in a recent edition of the Journal of the American Medical Association concluded that the number of spinal fusion surgeries are increasing sharply, even though they are riskier, and are often done unnecessarily. The lower back pain often arose from the normal aging process or arthritis.
The study was conducted by examining the hospital records of Medicare patients.
The cost to Medicare just for the hospital charges for the three types of back surgery reviewed was about $1.6 billion a year, according to the researchers.
Eugene Carragee of the Stanford University Medical Center wrote an accompanying editorial in the Journal, wherein he stated: "You have one kind of operation that could cost $20,000, and another that could cost $80,000, and there's not good evidence the expensive one is being used appropriately in the majority of cases."
Dr. Carragee went on to state" This is exactly what the health-care debate has been dancing around."
(7/12/09)- Researchers who studied the results of a broad U.S. sample of 328,000 spine surgeries, from 2002 through 2006, concluded that the use of bone-growth proteins like Medtronic Inc.'s Infuse, has led to increased hospital charges from 11% to 41% above conventional surgical costs.
A recent edition of the Journal of the American Medical Association published the results of the study.
The researchers also concluded that by 2006, the use of the new bone proteins, especially Infuse, had increased to nearly 25% of all operations in which spinal vertebrae are fused together to alleviate back pain.
Kevin S. Cahill, a neurosurgeon at Brigham & Women's Hospital was the lead author for the article. The study also included researchers from Yale New Haven Hospital .
(5/17/09)- Anne Milgram, the New Jersey attorney general announced a settlement with Synthes, a West Chester, Pa., unit of a Swiss company with the same name that she accused of failing to disclose financial conflicts of interest among doctors researching its products. At the same time she announced that her office was continuing to investigate 5 other medical equipment companies for similar conflicts of interest violations.
The settlement called for the company, the maker of the ProDisc artificial spinal disk, to disclose any future payments or investment held by docotrs involved in researching its products. The company would also pay $236,000 to reimburse the attorney general's office for its investigation. The state pursued the case as a matter of consumer fraud.
To see more back ground on this see our item dated 3/27/06 below.
(12/19/08)- In Gina Kolata's December 9th article in the NY Times entitled, "The Pain May be Real, But the Scan is Deceiving" she stated: "After all, one-third of herniated disks disappear on their own in six weeks, and two -thirds in six months." I do not know where she got these figures, and therefore can not attest to the accuracy of the statement, but it sure is an interesting comment.
(10/13/08)-Both Senator Herb Kohl (D-Wis) who is chairman of the Committee on Aging, and Senator Charles Grassley, (R-Io.) who is the ranking Republican on the Finance Committee have asked Medtronic Inc. to make public its payments to surgeons who have used the company's Infuse Bone Graft product.
The Wall Street Journal reported last month on complications associated with off-label usage of the bone graft product to fuse spinal vertebrae. It is approved by the FDA for use in lower back surgery, but surgeons have used it in other parts of the spine.
According to the Journal's article off-label usage of the product has been associated with dangerous swelling in the neck. Infuse is a manufactured version of a naturally occurring protein that promotes bone growth.
Former employees of Medtronic allege that the company induced doctors to use Infuse and other spine products by sending them on lavish trips to resorts, paying them undeserved royalties and handing out lucrative consulting contracts that required very little work.
(7/1/08)- Roger Chou, MD, from the Oregon Health and Science University, director of the American Pain Society's Clinical Practice Guideline Program presented a draft of the expanded evidence-based clinical practice guidelines on the diagnosis and treatment of low back pain to include recommendations on surgery and interventional treatments. The guidelines were previewed at the American Pain Society 27th Annual Scientific Meeting, in Tampa, Florida.
Dr. Chou pointed out that "5% of back pain patients account for about 75% of the costs associated with taking care of people with back pain."
The following "bullets were extracted from Medscape Medical News accessed on May 14, 2008. We believe patients with persistent low back pain should be totally aware of the information presented below before undertaking any surgery or interventional techniques.
(2/25/08)- According to the findings of a recent study, the results of which were published in a recent edition of The Journal of the American Medical Association, Americans are spending more money to treat spinal problems, but our backs are not getting any better.
Spending on spinal treatments in the United States totaled nearly $86 billion in 2005, a rise of about 65% from 1997, after adjusting for inflation. "We're putting a lot of money into this problem, and it's a big investment in health care expenditures, but we're not seeing health status commensurate with those investments.", said Brook I. Martin, a research scientist at the Department of Orthopedics and Sports Medicine at the University of Washington, and lead author of the study.
The researchers looked at the annual household survey data from about 23,000 people from the Agency for Healthcare Research and Quality for the years 1997 to 2005. It included pharmacy and medical record data, and was used to estimate national spending and treatment practices for back and neck problems.
The researchers found that people with spine problems spent about $6,096 on medical care in 2005, compared with $3,516 in medical spending by those without spinal problems. Americans spent an estimated $20 billion on drug treatments for back and neck problems in 2005, an increase of 171% from 1997.
Outpatient treatment for back and neck problems increased 74% to about $31 billion during the period, while spending related to emergency room visits grew by 46% to $2.6 billion. Spending for surgical procedures and other inpatient costs grew by 25% to about $24 billion.
The researchers estimated that in 1997 about 21 % of the adult population suffered from back or neck problems that limited their function. By 2005 that number grew to about 26%, after adjusting the numbers for an aging population.
(10/3/07) In randomized, multicentered, blinded, parallel-group trial involving three groups of subjects, researcher Michael Haake, Ph.D, MD et al, looked at the effects of acupuncture treatment for low back pain (Arch Int Med 207;167:1892-1898). The researchers concluded that "low back pain improved after acupuncture treatment for at least 6 months. Effectiveness of acupuncture, either verum or sham was almost twice that of conventional therapy."
The population studied ranged from 18 to 86 with a history of chronic low back pain for a mean of 8 years. The acupuncture sessions were ten 30 minute sessions, generally twice per week.
In general, the researchers do not understand the mechanism of effectiveness of acupuncture, but suggest it may be superior to conventional therapy that includes medication, physical therapy and exercise.
The authors say the lack of difference between acupuncture groups "forces us to question the underlying action mechanism of acupuncture and to ask whether the emphasis placed on ... traditional Chinese acupuncture points may be superfluous."
(7/12/07)- Back exercises and advice on managing pain both are widely recommended for low back pain. Researchers tested whether these interventions, delivered at seven physiotherapy clinics in Australia and New Zealand, had any effect on pain and physical function 6 weeks and 12 months later. Subjects were 259 adults with low back pain for 6 to 12 weeks; about one third had radiation of the pain to the leg. Statistical models accounted for potential confounding variables such as pain medication use, prior surgery, and clinical site.
Compared with sham advice (empathy but no back pain advice), three sessions of physiotherapist advice over 4 weeks encouraging patients to return gradually to normal activities decreased pain at 6 weeks (by 0.7 on a 0 to 10 scale) but not at 12 months. Results were similar for a 12-session, 6-week exercise program (aerobic, stretch, and strengthening) compared with sham ultrasonography and sham short wave diathermy. Advice, but not exercise, significantly improved ability to perform physical activity, with improvement of 0.7 and 0.6 (on a 0 to 10 scale) at 6 weeks and 12 months, respectively. Compared with no intervention, advice and exercise together were associated with improved function (increases of 1.1 at 6 weeks and 12 months) and less pain (1.5 points at 6 weeks, and a nearly significant 0.8 points at 12 months).
Comment: The evidence from this trial should inform the management of low back pain. Although the benefits of these interventions appear to be small and short-lived, these data support advice and exercise for low back pain.
Richard Saitz, MD, MPH, FACP, FASA
Published in Journal Watch General Medicine July 10,
Citation(s): Pengel LHM et al. Physiotherapist-directed exercise, advice, or both for subacute low back pain: A randomized trial. Ann Intern Med 2007 Jun 5; 146:787-96.
(6/13/07)- In our item dated 5/28/07 below we wrote about the effectiveness of surgery in connection with back pain. Now we also have the results of the Spine Patient Outcomes Research Trial (Sport) which was launched in 2000.
This study was paid for the by NIH and involved about 2,500 patients at 13 treatment centers throughout this country. Patients were initially divided into two groups-surgery and non-surgery. Many of the patients in each of the groups voluntarily crossed over to the other group during the period of the study so researchers based their study results upon which group the patient ended up taking the treatment in.
James M. Weinstein, surgeon and chairman of the orthopedics at the Dartmouth School in Hanover, N.H. was the lead researcher for the study. The results of the study were published in a recent edition of the New England Journal of Medicine.
The final results involved 607 patients whose average age was 66. They were surveyed at various times during the study. The patients were asked to rate various aspects of their own pain and physical function on a scale of zero to one hundred.
Both groups improved over the two-year period of the study, but the patients in the surgery group average scores in the 60-point range, versus the 40-point range for those in the non-surgery group. Other smaller studies of the condition known as degenerative spondylolisthesis came to the same conclusion.
(6/2/07)- Medicare officials announced that the program would deny coverage for artificial disks implanted in the lower spines of persons over 60 years of age. This preliminary decision will be finalized in August and applies to all people over 60.
This ruling applies to the ProDisc-L made by Synthes, which the FDA had cleared, for sale last summer. The agency had previously announced that it would not cover Johnson & Johnson's Charite lumbar disk. It also signals that Medicare will not cover Medtronic's Maverick lumbar disk when that device reaches the market.
Medicare officials said that the comparisons that were used by the spinal disk implant companies were not decisive since it has not been proven that fusion is better than no treatment beyond rest and exercise in dealing with degenerative disk disease.
(5/28/07)- If you have ever gone to a doctor because of a back pain, in most cases you will become subject to so many different tests that you begin to rebel at them. Whether it is a CAT scan, MRI, x-rays, or whatever else, the testing seems endless.
A program called the Back Pain Recognition Program is aimed at reducing the number of superfluous tests and procedures, and to increase the adoption of treatments that are proven to work. The National Committee for Quality Assurance (NCQA), an organization that monitors health-care quality and accredits health plans is the organization behind the program.
Doctors and chiropractors will apply to the program and those who adhere to its treatment guidelines will be listed in the NCQA's searchable online directory and cited on consumer Web sites.
Studies show that most acute back pain usually is resolved in four to six weeks with pain management, minimal bed rest and a return to physical activity as soon as possible. Prolonged bed rest is not recommended except in the most extreme of cases.
Corporate America is teaming up with the NCQA program with a Bridges to Excellence plan, and its own SpinalCareLink program for doctors and other medical professionals. Top performers in the program can earn as much as $50 a year for each patient covered by a participating employer, and will be listed on the HealthGrades Physician Quality Ratings Web site for consumers (healthgrades.com).
There are currently more than 115 "early adopters" participating in the NCQA program which is open to physicians and chiropractors, who must pay fees of about $500 for the application and data-collection program that the organization will use to assess the performance.
Large health plans such as Aetna Inc. and Cigna Corp. are also participating in the program, and will steer health plan members to medical professionals in the NCQA program
The NCQA will rate doctors on whether they advised patients to maintain normal activities and avoid more than four days of bed rest. The organization will measure the percentage of patients with back pain who received an epidural steroidal injection without radiating pain. These injections are most effective for the treatment of pain that radiates along nerves caused by more serious conditions such as a herniated disk.
According to a Medicare advisory panel, spinal fusion as a treatment for lower-back pain associated with degenerative disc disease has a low confidence level in addressing the outcomes needed to determine whether fusion is effective. Lumbar fusions increased 250% from 1992 to 2003 (Spine 2006; 31:2704-2714). In that same period Medicare payments went from $75 million to $485 million
Based on a literature review, the American Academy of Neurology Therapeutics And Technology Assessment Subcommittee has drafted new guidelines on the role of steroid shots for lumbosacral pain. The lead author of the study was Dr. Carmel Armon, chief of neurology at Baystate Medical Center in Springfield, Mass, and professor of neurology at Tufts University in Boston. His search of the literature yielded 37 studies, but only 4 met the committees predetermined standards. All 4 of these studies concluded that the injections proved "no efficacy at 24 hours, some efficacy at 2-6 weeks, no difference or rebound worsening at 3 months and 6 months, and nodifference at 1 year."
Dr Armon is quotes as saying: "While some pain relief is a positive result in of itself, the extent of leg and back pain relief from epidural steroid injections, on the average, fell short of the values typically viewed as clinically meaningful."
Complications of epidural steroid injections are usually minor and transient. The most frequently reported symptom is a headache. Rare major complications include aseptic meningitis, epidural abscess, arachnoiditis, bacterial meningitis, and conusmedullaris syndrome.
According to Dr. J.D. Bartleson, a neurologist at the spine center of Mayo clinic in Rochester, Minn, "Epiduaral steroid injections are likely overused. There is a bias that they are extremely helpful, which is not bourne out by the data."
(12/1/06)- One of the more common problems associated with low back pains is the pain from sciatica. An estimated 300,000 Americans have surgery each year to relieve the pain associated with sciatica. The question arises however if it is better to have the operation, or if the patient can bear with the pain, is he/she better off by just letting it heal by itself over time?
The results of a recent study of this question were published in the latest edition of The Journal of the American Medical Association. The study found that although the patients who had the operation received relief sooner than those who were not operated on, most people recovered eventually, and that there was no harm in waiting.
The study involved 13 spine clinics in 11 states, and all of the patients had pain associated with herniated discs. The patients were asked if they would allow the researchers to decide their treatment at random. Those who did not get surgery generally received physical therapy, counseling and anti-inflammatory drugs.
About 40% of the patients assigned to the surgery group elected against getting the surgery. About 33% of the patients assigned to the wait-and-see group elected to have the surgery. The study did not include patients who had just lower back pain not associated with sciatica, which can have a variety of causes.
Although many of the patients did not stay with their assigned treatment, most fared well with whatever treatment they had. After two years, about 70% of the patients in the two groups said they had a "major improvement" in their symptoms. No one who waited had any serious consequences as a result of the waiting period, and no one who had surgery had a disastrous result.
(9/26/06)- An FDA advisory panel has recommended that the agency give its approval for the first artificial replacement for failing disks in the upper spine. The device from Medtronic Inc. performed at least as well in its clinical trials as spinal fusion. The Medtronic device goes under the name of Prestige ST.
The panel did, however attach certain conditions to its approval, including a requirement that the company perform additional safety tests before it would be allowed to sell the stainless steel device.
Analysts estimate that there are about 250,000 cervical fusion operations annually in the U.S. The artificial disks are intended to address conditions like numbness in the arms in addition to the severe pain and immobility associated with disk degeneration.
Johnson & Johnson's artificial disk for the lower, or lumbar part of the spine, named Charite was approved by the FDA over two years ago, but a safety issue has arisen in connection with this product. A second lumbar disk, the ProDisc from Synthes of Switzerland was approved by the FDA last month. The process of implanting a disk in the upper spine is called arthroplasty.
The device is intended to last for decades but there has not been a long enough period of time that has passed to test the validity of this claim. Only about 125 patients have received Prestige ST, so the data for the trials is very limited.
Medtronic has also begun a clinical trial for another, more compact version of the Prestige that is made of titanium ceramic that is held in place by two raised ridges on each plate. A separate Medtronic trial is testing an entirely different disk call the Bryan that sandwiches metal plates around a dense plastic core. Prestige is intended for cases where only one disk is being replaced while the other are meant to work with multiple disk procedures.
(9/17/06)- The nonprofit American Chronic Pain Association estimates that there are over 50 million Americans who suffer from chronic pain caused by lower back problems, repativieve stress injuries, neurological conditions, shingles, headaches and arthritis. Scientists have found that applying electrical current to the nerves and nerve fibers along the spinal column can sometimes disrupt the transmission of chronic pain signals.
Implantable spinal cord stimulation devices have been sold in this country for over 20 years now and the results are still unsure. The main manufacturers of these devices are Medtronic Inc., based in Minneapolis, Minn.; Boston Scientific Corp.'s Advanced Bionics unit located in Natick, Mass.; and St. Jude Medical Inc. of St. Paul, Minn.
The devices, which are the size of a cell phone or smaller, are implanted in the body in place where they are unlikely to cause discomfort, such as the side of the buttocks or in the lower abdomen. The electrodes are placed near the nerves or nerve fibers that lead to the area of pain. The surgery to implant the device is performed under a local anesthetic, and usually requires an overnight stay in the hospital.
Before the device is implanted, the patient tries it out for a few weeks with only the wires inserted through a minimally invasive surgical procedure, with the battery pack remaining outside the skin. About 50% to 70% of the patients who try out the device go on to have the rest of the device implanted in their bodies, according to Medtronics, the market leader in the U.S.
The device and the surgery can cost between $20,000 to $30,000, and is generally covered by insurance. The life of the device is between 5 years to 9 years, after which the surgical procedure would have to be repeated if the patient feels it has helped to alleviate the pain.
(4/11/06)- Can electric stimulation help alleviate back pain? This has been a question that has arisen over the years, and there still is no conclusive answer to this question. Makers of transcutaneous electical nerve stimulation (TENS) units argue that their devices definitely help.
Many health professional favor the devices because they say it does appear to provide temporary relief for many of their patients. In other words it helps at a time when anything that gives the patient relief is a blessing as far as that patient is concerned.
The TENS devices have electrodes which you attach to the skin on your back. You clip the unit to your belt or any item of clothing that you are wearing controls the delivery timing for the electric shock to be administered. The electric impulse that comes from the electrodes attached to your back feel like a tingling or buzzing on your skin.
Most units allow the wearer to adjust the timing and intensity level of the electric shock that is administered. Prices generally range from $100 to $750 for the devices, and it is covered by most insurance plans. Most of the devices require a doctor's prescription, but two brands, Medisana and BlueWave are available as over-the-counter items. Both of the approved over-the-counter units feature a wide belt for your lower back with electrodes pre-positioned so you don't need instructions from your doctor.
The device can be worn for as long a period of time each day as the user feels is necessary for the relief being afforded. We once again caution that these devices are only to be used as a short-term, temporary relief device.
(3/27/06)- In spite of intensive lobbying by J&J, it looks like the company will not receive approval for its Charite disk surgery to be paid for by Medicare. As we discussed in our item dated 2/24/06 the 30-day period for comment has now passed. A final ruling will be set by the Centers for Medicare and Medicaid Services (CMS) within 60 days.
Up to now some locally administered Medicare plans pay for the spinal surgery procedure, which can cost as much as $50,000, while many private insurers are refusing to cover the procedure. Over 3,000 surgeons have been trained in the procedure to implant Charite since it received approval from the FDA in October 2004.
Part of the problem impeding the approval is the fact that the trials to get Charite evaluated compared the device to a form of spinal surgery that is no longer considered state of the art. The trials for Charite did not provide convincing evidence that the device left patients with substantially more range of motion over time.
A question has also arisen as to whether or not the device harms neighboring disks. J&J said that 60 insurers now cover Charite, but only 2 are nationwide. About 25% of the regional coverage comes from workers' compensation companies, because it seems as if the procedure enables workers to return to their jobs faster than does the usual spinal operation.
A Swiss company Synthis is expected to receive final approval shortly for its ProDisc-1 by September of this year, which will compete, with Charite. Medtronic and Stryker are also expected to enter this market with their own products by early next year.
2/24/06)- The Centers for Medicare and Medicaid Services (CMS) has concluded that there is inadequate evidence to show that Johnson & Johnson's Charite disk surgery is "reasonable and necessary". This means that Medicare will not pay for J & J's artificial spinal-disk implant under its health insurance program. The agency now opens up for a 30-day period of time public comments on this proposal.
A final decision from the CMS will be due within 60 days after the comment period expires. Charite is designed to replace the natural cushion between vertebrae of the lower back. The list price for Charite is $11,500, and the total cost for the implantation ranges from $35,000 to $50,000.
Private insurance companies usually follow the proposals from the CMS, so there is a good chance that they too will deny coverage for the procedure.
(10/26/05)- In her Personal Health column of October 4, 2005, Jane Brody wrote and excellent article entitled "What You Can Do About That Aching Back". Although the article is entitled to the aching back ailment, it dealt mainly with spinal stenosis. In my own particular case it was not the back that caused me the excruciating pain, but rather the pain in my left leg that was incapacitating me.
I would like to quote from her article because of all the interesting items that she pointed out in the article:
"Arthritis-the wear-and-tear kind- is by far the most common cause of a potentially debilitating disorder called spinal stenosis, a narrowing of the passageways for spinal nerves. The problem is most common in people over 50, though the young are sometimes affected through injury of a birth defect.
Not everyone with spinal stenosis has symptoms, but 250,000 to 500,000 American do, and with age as the leading risk factor, the number afflicted is expected to grow significantly as the population ages .
The spine houses all the nerves that enable the brain to tell the rest of the body what to do. The spine is a column of 26 bones, 24 of them vertebrae-7 in the neck (cervival), 12 in the upper back (thoracic0 and 5 in the lower back (lumbar). The other two are fused vertebrae that form the sacrum in the hip region and the coccyx at the base of the spine.
Vertebrae are linked by facet joints that stabilize the spine and, at the same time, allow it to bend. Ligaments keep the vertebrae in place during movements, and fibrous disks with jellylike centers provide cushioning between them.
Now for the crux of the problem: The spinal cord, a long bundle of nerves from the base of the brain to the second lumbar vertebra, passes through a bony channe called the spinal canal.
On its way, two spinal nerves-one to the left side of the body and the other to the right- emerge between the vetebrae, and another bundle of nerves, the cauda equina, extends from the end of the spinal cord.
If the channel for the spinal cord and its many extensions becomes narrowed, pressure on the nerves can cause pain, cramping, tingling or numbness in the area served by the nerve .
Arthritis is also associated with deterioration of the spinal disks, which flatten, become brittle and may develop tiny rips that allow the jellylike substance to leak and press on the nerves. The ligaments too, degenerate with age, becoming stiff and thick, shortening the spine,narrowing the canal and sometimes compressing nerves.
Other causes of spinal stenosis are tumors, trauma, Paget's disease of the bone, and a genetic disorder called achondroplasia .
Various diagnostic tests are sued to check for spinal stenosis or other problems that cause similar symptoms. Among then are spinal X-rays, CT scans, a CT myellogram, a bone scan and best of all, an M.R.I .
Drug remedies include over-the-counter or prescription painkillers like acetaminophen (Tylenol and the like) and nonsteroidal antiinflammaroty drugs (Nsaaids) like aspirin, ibuprofen, Celebrex or Mobic.
In conclusion I would like to reiterate my personal opinion that the most important therapy available to sufferers from spinal stenosis is the stretching exercises, that are painful to do, but I believe are worth all the pain and suffering that they cause. At the same time I have to admit that there are days that I pass up doing them because of how tough mentally as well as physically they are to do on a daily basis.
(4/29/05)- Although I have not had to use any heat pads or spinal electrical stimulation in connection with my spinal stenosis it may be helpful to some of you to be aware as to some devices now available to consumers to help you with pain management. Researchers feel that heat affects certain nerve endings, which send signals to help block the sensation of pain. Heat also relaxes muscles and increases blood flow.
Modern science has come up with several devices to improve on delivering heat to the body by methods better than the old heat pad that confined your mobility. One of the latest heat wrap pads contain gel or beads that are heated in the microwave and can stay warm for between 30 to 60 minutes. It is a moist heat, which some doctors believe is more effective as a pain reliever than other types of heat. Many of these same gel products can be frozen and used to reduce swelling after an acute injury such as a sprained ankle.
Proctor & Gamble has a disposable eight-hour wrap product called ThermaCare that contains iron, which produces continuous, low-level heat when exposed to air. The price for these disposable products is about $3.50 apiece. Heat should not be used if there is bruising or swelling.
Medtronic Inc. has received FDA approval for an implantable rechargeable spine stimulator that can last up to nine years. Advanced Neuromodulation Systems Inc. has also received FDA approval for its implantable rechargeable spine stimulator called Eon Neurostimulation System, and Boston Scientific's product in this medical equipment area is called Precision.
(11/3/04)- Johnson & Johnson announced that its DePuy Spine Inc. unit, which is based in Ranynham, Mass., had received permission from the FDA to market the first spinal-disc implant as a new form of treatment for people with severe lower back pain. Orthopedic surgeons say the device, which consists of a high-density plastic sandwiched between two metal plates, can be used only on patients with relatively strong bones, which in effect therefore limits the procedure to those 45 and younger. The procedure is meant to replace spinal fusion as a method of treatment for spinal disc deterioration in the lower back.
The disc, called Charite was developed in Berlin at the Charite Disc Clinic and by Waldemar Link GimbH.Overseas. J&J acquired rights to the device in 2003 when it paid $325 million for the Link Spine Group Inc., a closely held firm based in Branford, CT. More than 200,000 Americans underwent spinal fusion operations in 2003 for pain relief from disc degeneration in the lower spine.
The device will cost about $11,500, not including the surgery. Other companies including Medtronic Inc. are working on similar devices. The device was studied in 205 patients, comparing them with 99 patients who had spinal fusions. Additional safety data was collected on 71 patients who received the implants when surgeons were trained in the procedure.
The study showed that two years later, patients who got the artificial disc did no worse than patients who had their spines fused. The most common complications were inadequate pain relief, wound infection and mild numbness. The rates of complications were similar to those reported for the spinal fusion group.
(2/27/04)-Back problems are the leading reason for visits to neurologists and orthopedists and the eighth leading reason for visits to doctors overall. The three most frequent causes for visits to the doctors are general checkup, progressive visits and coughs. Researchers at the University of Duke using national data from 1998, estimated that treating back pain costs Americans over $26 billion a year, and that does not include the cost for worker's compensation and lost wages. Dr. Xeumei Luo led the researchers at Duke.
Sadly we report to you that most studies show that in the majority of cases it is impossible to say why a person's back hurts. Most of the time, the pain goes away with or without medical treatment. According to Dr. Richard Deyo, a professor of medicine and health services at the University of Washington "Nearly everyone gets better, nearly everyone improves." But he went on to say, "Getting better doesn't necessarily mean pain-free." Even when a herniated disc causes the pain, the problem was found to go away by itself over time.
A national study is now underway at 11 medical centers to see if active treatment helps in treating back pain. About 1,000 patients with back problems that most often lead to surgery will be randomly assigned to have surgery or not. The problems under study are herniated discs, spinal stenosis, and degenerative spondylolithesis, a slipped vertabra. Dr. James N. Weinstein, a Dartmouth professor of orthopedics and community and family medicine will head the study group. Incidentally, it is estimated that about 10% of back-pain cases are intractable. For those who have their back pain for over three or four months, there is only a 10% to 20% chance of getting better within the next year.
Anyone who has suffered through the intensity of an acute attack of low back pain knows the disabling effect of this disorder. At what point should it be considered chronic? And what are the results of treatment?
A recent study conducted under the leadership of Dr. Scott F. Nadler, of the University of Medicine and Dentistry of New Jersey in Newark concluded that "core conditioning" hasn't proven to be worthwhile in counteracting lower back pain.
The study involved strengthening the muscles of the abdomen, lower back and buttocks. The exercises included sit-ups, pelvic tilts, squats and lunges. These aforementioned exercises form the core of what is known as "core conditioning". In theory these exercises improve your posture and also give the back more support by strengthening the muscles involved in body movements.
The literature suggests that back pain of less than three weeks be considered an acute low back pain. Research statistics (1) indicate that 33% of all individuals will be free of this pain within one week regardless of the type of intervention, including no intervention. By the third week close to 75% of individuals will recover and at two months 90% will recover. Put another way, 90% of the time back pain is a brief time limited condition for which the treatment chosen appears irrelevant to the outcome.
When symptoms last seven weeks or more, then the condition is considered chronic. Chronic low back pain is the number one cause of disability in the working population. Recovery to pre-injury status for chronic low back pain diminishes with the passage of time. A study (2) indicated that anyone who cant work and remains symptomatic beyond one year would have less than a 2% chance of returning to his or her job. Low back pain represents 16% of all Workers Compensation claims, but accounts for 33% of the costs.
Most treatment for low back pain involves ruling out serious underlying conditions such as tumor, infections etc., controlling symptoms and gradually improving the activity tolerance of the individual. However, the main factor for successful treatment appears to be allowing nature to take her course.
Low back pain is probably multfactorial in origin. While mechanical factors such as heavy physical work, prolonged static load and motor vehicle driving have been implicated in low back pain, most research investigators believe they contribute a small fraction to the etiology of low back pain. The literature of low back pain contains more reference to psychological factors with a consistent relationship shown between work-related psychosocial factors such as stress, lack of social support as well as physical and behavioral indicators. A general population study (3) suggested that increased risk for non-specific low back pain appears related to prior back injury, occupational physical and mental stress and smoking.
1. Anderson G, Svensson H (1983). The intensity of work recovery in low back pain. Spine 8:880-884.
2. Spengler D, Bigos S, Martin N, Zeh J, Nachemson A (1986). Back injuries in industry: a retrospective study 1. Overview and cost analysis. Spine 11:241-246.
3. Helivaara M, Malela M, Knekt P (1991). Determination of sciatica and low back pain. Spine 16:608-614
The following is an exchange of emails between Jason Kavountzis, MPT, CPT and Harold Rubin concerning this article. We want to thank Mr. Kavountzis for taking the time to write us on this topic and found his viewpoint very informative and accurate. We make no claim to knowing the answers especially when it comes to backs and pains, so we appreciate his giving us his approval to reproduce his emails in this article. The emails are reproduced as written with only some minor editing for some typing errors. We think our readers will find it quite informative:
Dated May 14, 2002 from Jason Kavountzis:
I came across your article on this
topic. As a physical therapist, I was suprised by your statement
" the main factor for successful treatment appears to be
allowing nature to take her course". There are numerous peer
reviewed articles that show the importance of early intervention
to avoid disability in low back pain patients. Here are a few
from the Spine journal. 1995;20(4) 473-477. Results found that
LBP patients who were given a mini back school at 3 year
follow-up had 19% long term disability vs 41% for the control.
1998;23(23):2616-2624. exercise group vs control with chronic low
back pain showed exercise group had significantly less pain,
increased functional ability, better patient satisfaction , less
sick leave and less costs associated with LBP. 1996:21:2763-2769
showed multifidus muscle recovery was not spontaneous on
remission of painful symptoms and concluded that this may be the
reason for the high recurrence rate of LBP. There are numerous
other studies that show the benefit of exercise especially lumbar
stablilization programs or "core" exercise programs for
the treatment and more importantly the prevention of low back
pain. The readers of your article need to know that they should
see a doctor if pain persists for greater than 7 days and begin
an early rehabilitation program if appropriate not simply let
mother nature take its course.
J Kavountzis MPT, CPT
Dated May 16, 2002-Reply from Harold Rubin, co-editor of therubins:
Dear J Kavountzis MPT, CPT:
Sorry for the delay in answering your email. Thank you for reflecting your thoughts about the articles we wrote on LBP. We hope you will continue to read our articles and send us your ideas on them.
At the outset, let me state that I feel your statements are as correct as the statements in our article. It is just a matter of how you view the studies being done in the field. It is hard for us to understand what you are advocating. We do not dispute the value of PT. In fact, it has helped one of our editors as well as chiropractic treatment helping.
You are correct in stating that if low back pain persists after seven days, you should consult a physician. A large cohort group of LBP patients consult physicians (<7 days) because of the pain and are given :"treatment" that may not be needed. Time may be the healer. The figures we cite about "the main factor..." are from research studies that indicate that the majority of LBP patients go into remission during that seven days (inflammatory etiology of the pain may recede). We are trying to tract down the citation and will let you know when we find it. We believe it is from some association's guidelines for back pain.
A "wait and see" tactic is contraindicated if one cannot tolerate the felt pain. There are obvious causes of LBP including tumor which call for immediate visitation. It is most probable that most people who feel LBP do not go to a physician immediately. Back pain is also attributed as secondary to subjective stress, physical environment incidents, accident or viral disease. A wait and see tactic is adopted.
Physical therapy can help certain kinds of back pain, but this treatment is never sure of which person it would help. This is even shown in the studies you cited. Not all people were helped by the physical therapy/exercise, nor for that matter are all helped by the wait and see nontreatment approach. Anyone who can find a finite treatment for chronic LBP will get the Nobel prize. The money it would save in health costs are unimaginable, aside from the individual being saved from pain, a not insignificant factor. Let us hope that this comes sooner than later. This is especially true for the elderly.
Our reading of the research literature leads us to believe that exercise is an optimal treatment. Of course, the nature of the exercise will vary with the individual and ability to tolerate pain (learned behavior).
Let us hear from you further. We are thinking of putting this exchange on our web site, if we get your permission. We will stay in touch.
Follow up to his reply from
Harold Rubin, dated May 22, 2002
Dear Mr. Kavountzis:
I have found the references that I referred to in the article and am including the comments in the article. It is always enriching to share ideas with other professionals. We thank you for permission to use this correspondence for an article we may post on our site.
The dominant role of psychosocial risk factors in the development of chronic low back pain disability. Robert J. Gotchel, Ph.D. SPINE VOL.20,#24, 2702-2709, 1995.
The influence of intensification by Workers' Compensation Insurance on recovery from acute backache. Nortin M. Hadler, MD SPINE VOL 20, #24, 2710-2715, 1995
"90% OF THE TIME BACK PAIN IS A BRIEF TIME LIMITED CONDITION FOR WHICH THE TREATMENT CHOSEN OFTEN APPEARS TO BE IRRELEVANT TO THE OUTCOME. From the onset of symptoms, about 50% of the patients with acute low back pain are no longer disabled within two weeks; 705 recover in one month and about 90% recover within 3-4 months. Of those whose symptoms persist for, more than 3-4 months, the majority will continue to be disabled and unable to work at the end of the year, and the greatest number of these individuals will continue to be disabled after 2 years. Extrapolating from the experience of one major insurer, low back pain represents 16% of all Workers' Compensation claims, but 33% of all costs. 55% of cases of compensable low back pain receive medical payments only; they do not receive indemnity payments for lost time."
The literature of low back pain contains more reference to psychological factors with a consistent relationship shown between work-related psychosocial factors such as stress, lack of social support as well as physical and behavioral indicators. What I cannot understand is your broad brushed statement: "all patients can benefit from PT unless contraindicated" and then you refer to "overall functional ability and strength" as useful in all cases. If you are saying exercise in general is helpful to all of us, who could disagree. Even one would be hard pressed not to agree that PT can help in functional ability based on much of the research literature, but might not time alone be helpful in many cases of acute back pain (note quoted statement above) and might not just the attention of the therapist (TLC) be the critical factor of help? The same may be true of acupuncture and chiropractry. At the same time, one might conclude that these types of treatments may prove harmful to certain individuals (including allowing time to pass i. e. no treatment). The literature is clear in not being able to predict who can be helped. This is the dilemma faced by the professional in dealing with back pain in situations devoid of financial consequences for the professional. As professional, we all tend to see our profession as helpful and necessary in all standard situations. Does the evidence-based research totally support this stance? Does invested interest cloud our research in unconscious ways? This is all we are trying to say in our articles.
As I have told you previously, I have used both PT and chiropractry and found both helpful. All I am saying is that would time alone have provided the same results? What role does my temperment and personality play in my recovery? how do I tease these factors out from the hands on treatment process? Could all kinds of treatments for back problems really be deqaling with the "psychological " component of pain and time dealing with teh physical component?
Response from Jason Kavountzis date May 22, 2002
Dear Mr. Rubin,
Thank you for the reply. It is nice to discuss topics such as LBP and research with other professionals. I try to keep current with research that is being done in the rehabilitation field and use evidence based treatments with all of my patients.
Basically, I am advocating early intervention with low back pain to avoid possible chronic pain situations, recurrence of LBP and disability. Early intervention as a PT means patient education, postural awareness, stabilization and stretching exercises and spinal mobilization or manipulation (depending where I practice). You are right that physical therapy does not help all patients with back pain, no treatment does. But considering the fact that in a large percentage of cases the cause of LBP is unknown (correlation between diagnostic tests and clinical findings is poor ) all patients can benefit from physical therapy unless contraindicated. That benefit may not always mean decreases in pain, it may mean improvements in overall functional ability and strength.
Hopefully upcoming research will offer us a better insight into the perplexing topic of LBP. Thank you again for the reply and feel free to contact me about any PT related questions that you may have. You have my permission to use our exchange on your website.
Follow up email from Jason Kavountzis dated May 24, 2002
Just to clarify what I meant about
contraindicated is that the patient may exhibit either
progressive motor weakness or loss of bowel/bladder control which
both are indications for surgery. Other than that do I feel that
most low back pain patients can benefit from PT in the form of
education/back school and exercise and there is research backing
the benefits of conditioning, exercise and education in the
treatment and prevention of LBP. I will be in touch.
See article on Tips on How to Keep Your
Spinal Stenosis: A Personal Story
FOR AN INFORMATIVE AND PERSONAL ARTICLE ON PRACTICAL SUGGESTIONS WHEN SELECTING A NURSING HOME SEE OUR ARTICLE "How to Select a Nursing Home"
by Allan Rubin and Harold Rubin, MS, ABD, CRC, Guest Lecturer
updated June 25, 2013
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