Lumbar Artificial Disc Replacement: How Safe Are They?

Consumers may think that FDA approval of artificial disc replacements (ADRs) is a big, green light. Some doctors advise caution before jumping on the bandwagon. This article akes a closer look at the results so far with this new device for back pain patients.

Only one ADR has been approved: the CHARITÉ™ Artificial Disc. And it’s only for one kind of patient: chronic back pain from disc degeneration at one level. The good thing about these restrictions is that it makes research easier. The patients are fairly similar. Each surgeon must have extra training before doing ADR implants. The operation is close to the same from surgeon to surgeon.

But the success rate, according to this article, isn’t that good. Almost one-third of all patients end up with five degrees or less of motion at the implant site. That’s in the same range as a spinal fusion. Ads that say, “natural motion is back” are misleading. ADRs do not necessarily re-create a normal spine.

Among patients rated as a “success” more than half are still using strong painkillers two years later. Artificial joints don’t last forever. There will be wear and tear, debris around the implant site, and the chance of the implant coming loose.

Accordingly, the ADR isn’t a cure for back pain. Patients should approach this treatment option with caution.

Good Care Doesn’t Always Mean Good Results for Low Back Pain Patients

When patients say they are satisfied with physical therapy treatment, do they mean the treatment itself or the results they get? Patient satisfaction surveys often mix questions about treatment delivery and treatment effect. Researchers at the University of Florida look at patient symptoms to tell the difference.

Sixty-six patients with acute low back pain were included in this study. All were seen by a physical therapist for four weeks. Six months later they filled out a survey by mail. Patients were asked three questions. One question measured satisfaction with the effect of treatment. Two questions measured satisfaction with the way treatment was given.

Results of this study showed that patients were very satisfied with treatment delivery. They were not happy with the results of treatment (treatment effect). The authors conclude that it’s possible to be unhappy with treatment that didn’t work but happy with the care received.

Who Can Benefit From Stabilization Exercises for Low Back Pain?

Exercise is good for patients with low back pain. But not all exercises are for everyone. In this study physical therapists looked at stabilization exercises (SEs). The goal of SEs is to train muscles to increase stiffness and decrease motion in the spine.

Who should do these exercises? Is it possible to identify a subgroup of back pain patients who can benefit from this exercise program?

Fifty-four patients with low back pain did a program of spinal stabilization exercises for eight weeks. They went to physical therapy sessions twice a week during this time. They also did exercises at home everyday.

Four factors were found to predict success with SEs. These included age younger than 40 years, straight-leg raise greater than 91 degrees, abnormal lumbar motion, and a positive prone instability test. Patients who had three out of four of these factors had the best results.

Low Back Pain: Manipulation or Stabilization?

Physical therapists treat low back pain (LBP) patients with a wide range of increased and decreased motion in the spine. Treatment choice is often based on the idea that a spine with too much motion (hypermobility) should be treated with stabilization exercises.

And the reverse idea is also put into practice. Patients with a stiff spinal segment are treated with mobilization exercises. A stiff spine segment (not enough motion) is hypomobile. Therapists at the University of Utah tested these treatment ideas.

They used a special test called the posterior-anterior (PA) mobility test to look for hypermobility or hypomobility. One group of LBP patients was treated with manipulation and stabilization exercises. Results for patients in this group were compared with results of a stabilization exercise program used in a second group of LBP patients.

As they suspected, patients with hypermobility had much better results when treated with stabilization exercises. Patients with hypomobility responded better to a program of manipulation and stabilization.

The authors conclude using the PA mobility test can help direct treatment of LBP patients.

Disc Height and Type of Bone Graft: Do They Make a Difference in Spinal Fusion?

Does it matter how “collapsed” a disc is on the outcome of spinal fusion? The study looks at disc height measured before the spinal fusion as a factor in the final outcome.

All 392 patients in this study had a single-level anterior lumbar fusion. The disc was removed and two disc fusion cages were inserted in the disc space. Normal disc height was restored.

The group was divided into two groups based on what kind of graft material was used inside the fusion cages. Group one had bone protein made in the laboratory for their graft material. This protein causes bone to grow for a successful fusion. Group two used bone graft harvested from the patients’ own pelvic bone.

All disc spaces or disc height were measured before surgery. The patients were divided into three groups: tall, intermediate, and collapsed. The tall group had the biggest disc space. The collapsed group had the smallest disc space. The intermediate group was in between tall and collapsed.

The authors report all patients got better in the first six weeks. Patients in all three groups continued to improve between six weeks and six months.

The collapsed disc group with the most disc space narrowing had the most improvement. Type of bone graft didn’t seem to make a difference in the results measured three months later.

Back Pain: It Doesn’t Just Affect the Spine

Standing up and sitting down are important movements in our everyday lives. In this study, researchers show that hip and spine motion needed for these activities are affected by low back pain (LBP).

Using a 3-D, real-time tracking device hip and spine motion was recorded for subjects in three groups. Sit-to-stand and stand-to-sit were the main activities studied.

Able-bodied adults with no back pain were in group one. Group two was made up of subjects with back pain only. Group three had back pain and pain down the leg when the leg was lifted up while lying on the back (positive straight leg raise or SLR).

The authors report signicant changes in the way the spine and hips work in subjects with back pain. Coordination was off even more for people with a positive SLR.

This study showed that people with LBP have less motion and slower speed of spinal motion. They also have altered coordination of movements between joints. Rehab should include exercises to restore the coordination between the spine and hips in patients with LBP.

Two Thumbs Up for CHARITE’™ Disc Replacement

Lumbar artificial disc replacement (ADR) is a new development in spinal care. So far results have been positive, but most studies have been small in number. In this study 304 patients from 14 centers around the United States compared patients treated with ADR versus spinal fusion.

Only one kind of ADR was used: the CHARITE’™ artificial disc. This ADR is made up of two cobalt-chromium endplates and a polyethylene core. The fusion group had an anterior (from the front) fusion using titanium cages. The damaged disc is removed. Donated bone from the pelvis is ground up and put inside the cage. The cage is inserted into the open space between two vertebrae.

Results were measured using pain and function. Patients were followed for up to two years after the operation. Here’s what they found:

  • Patients in both groups got better.
  • Patients in the ADR group got better faster.
  • Patients in the ADR group had more function at every follow-up check.
  • Patients in the ADR group were much happier with their treatment.
  • The hospital stay was much shorter for the ADR group.
  • More patients in the ADR group went back to work.

    The authors started out thinking the ADR group would do just as well as the fusion group. They found out the ADR group had superior results from day one up to two years later. They concluded that ADR is a safe and reliable alternative treatment to fusion for disc degeneration.

  • Getting Back Pain to Retreat

    Making sure back pain is coming from a disc problem can be difficult. Not all discs that cause pain show up on an MRI. There is one test that directly tests the disc but it’s expensive and painful. It’s called provocation discography.

    This study looks at a noninvasive test for disc problems called centralization. Centralization is described as a change in the pain pattern. Back pain that goes into the buttock or down the leg becomes just back pain. The pain “retreats” or moves to the central part of the low back.

    Researchers compared the centralization test to discography. They used the results to find out how reliable centralization is in predicting when the pain is coming from a disc. All patients were examined by a physical therapist and tested for centralization. Then they had a discography. Discography involves injecting a fluid into the disc. A positive discography is recorded when pain is caused by this test.

    The results showed that centralization is a good test to predict disc problems if the patient is not in great distress. Psychosocial factors and severe disability are linked with unclear results of the centralization test.

    The authors report that centralization is 100 percent accurate among patients who aren’t disabled or distressed. This means when centralization was present the discography was also positive, indicating a disc problem as the cause of pain.

    Physical therapists can treat centralization successfully in patients without severe disability or distress. In these cases, patients may be able to bypass the painful provocative discography test.

    Wrapping Up Back Pain

    New stick-on heat wraps have been shown to help decrease back pain. They also decrease muscle soreness. But do they improve function or decrease disability when worn during exercise? That’s the focus of this study.

    Heat and exercise are often used together in the treatment of low back pain. Usually heat is applied while the patient is lying down in a comfortable position. Exercise is added after the heat treatment is done.

    Research shows that activity and exercise work best with acute low back pain. Applying heat when a person is at rest goes against this advice. With the use of a low-level heat wrap, patients can use heat while remaining active. And the results of this study suggest it’s a good idea to do so.

    Patients using the heat wrap alone were compared with other groups using the heat wrap and exercise, exercise only, and an educational booklet. Using function, disability, and pain as measures of success, the patients in the heat and exercise group had the best results.

    They reported greater function, decreased pain, and less disability than any other group. Patients using only heat or only exercise did better than those who just received a booklet. Maximum benefits of heat and exercise appear to occur on day seven after starting the treatment.

    The authors conclude that doctors and physical therapists can use this new information. Patients with acute low back pain may get the best results with early treatment using heat and exercise together.

    Is Age a Factor in Spinal Fusion?

    People are living longer, which means more aches and pains as we get older. Older adults have just as many back problems as anyone else. Spinal fusion is a common way to treat chronic low back pain. Are adults over 65 years of age more likely to have problems after this operation? In this report, researchers say age alone is no reason to withhold spinal fusion from patients who need it.

    They compared two groups of spinal fusion patients by age (younger than 65 and 65 and older). Patients were matched in each group by number of operations, type of fusion, and number of levels fused.

    The same surgeon treated all patients. A posterior approach (from the back of the body) was used for everyone. All patients had a spinal fusion for a degenerative condition. Everyone was followed for at least one month after the operation.

    Measures included operative time, amount of blood lost, and number of days in the hospital. Number of minutes under anesthesia was defined as the operative time. Any problems during or after surgery were recorded and compared.

    The authors found that even though the older group had more health problems, they had just as good results as younger patients. Older patients had longer hospital stays but no more blood loss during the operation. Complications after surgery were the same between the two groups.

    The results of this study suggest withholding lumbar spine fusion on the basis of age isn’t needed.

    Lumbar Traction: Guidelines versus Practice

    Very few studies support the use of traction for low back pain (LBP). But according to healthcare researchers this may have more to do with poor study methods than to poor results with traction. As a result there are no clinical guidelines to help physical therapists know how and when to use traction.

    In this study therapists in the United Kingdom (UK) were surveyed about their use of traction. Almost half use lumbar traction for LBP patients with sciatica. Traction was not used right after a back injury (acute phase) or for chronic LBP patients. Patients receiving traction were labeled subacute.

    Most patients were treated two to three times a week for four weeks. Length of time (minutes) for the treatment was based on how severe the condition was. For example, traction was used longer for stiffness (up to 20 minutes) than for nerve root irritation (less than 10 minutes). Traction was never used alone as the only treatment. It was usually combined with other treatments such as mobilization, advice, and exercise.

    The authors conclude that physical therapists in the UK use traction even though the research doesn’t support its use. Future studies on traction should divide LBP patients into groups by diagnosis. Those with nerve root irritation should be separate from patients with nonspecific LBP. Traction should be studied alone as the only treatment and compared with combined treatments.

    Lumbar Disc Replacement Linked with Improved Function

    The main reason for lumbar disc replacement (LDR) instead of a fusion is to keep the motion in the spine. But does the long-term result depend on motion? If it doesn’t, what’s the point of using LDRs? That’s the focus of this study from France.

    More than 5000 LDRs have been done around the world now. Enough time has passed to gather some long-term data. In this study patients with single or two-level LDRs were followed for up to 8.6 years. X-rays of spine motion were taken, and motion was compared with pain and function.

    The authors report a weak to moderate link between range of motion and results. Patients with low motion (less than five degrees) had poor results compared to patients with more than five degrees of motion after surgery. This makes sense since fusion with no motion often leads to disc degeneration at the next level.

    The authors think that since none of the patients with more than five degrees of motion had degeneration at the next level, this amount of motion may protect the spine. Longer-term follow-up is needed to see if increased motion may cause problems later. The 8.6 years of this study is about the halfway mark for the life of the LDRs.

    Scaling a Mountain of Pain

    Physical therapists need ways to measure the success of treatment. If pain is used as a measure, how much improvement is enough to say the treatment worked? In this study therapists used the standard numeric pain scale (NPS) with low back pain (LBP) patients to determine how much change was meaningful.

    The NPS is used to measure pain by asking patients to rate their pain from zero (no pain) to 10 (worst pain). LBP patients at eight different clinics around the United States were included. Everyone rated their pain using the NPS before treatment was started. Other tools were used to measure function and disability.

    Patients were put into one of two treatment groups. The first group received spinal manipulation and an exercise program. The second group just did lumbar stabilization exercises. Everyone was retested after one week of treatment and again after four weeks. The therapists also rated change in the patient since beginning treatment.

    The results of this study show that a two-point change on the NPS is enough to be significant. It’s not the result of some error in math. Therapists can use this scale to assess the results of treatment.

    Promising New Treatment for Low Back Pain

    This study reports the results of one surgeon using the Maverick disc implant for 64 patients. All patients had chronic low back pain (LBP) for more than one year. The Maverick device is a metal-on-metal implant. It has a posterior center of rotation.

    Results were measured by pain levels, nerve function, and overall physical function. Everyone was followed every few months for 18 months up to three years.

    A special focus of this study was to look at the results of disc replacement in patients with facet joint damage and loss of muscle fat. The facet joints are part of the vertebral bones. This is where spinal motion takes place. Joint breakdown and other changes occur from osteoarthritis.

    Early results show the Maverick disc replacement has equal results as a spinal fusion. In fact, the long-term results may even be better if the next disc up or down doesn’t get damaged from stress and extra loading. Since the disc allows near normal motion, there’s less compressive force through the spine.

    Facet degeneration and the loss of fatty tissue in the muscles don’t seem to make a difference in results for this device.

    Turning up the Sound on Abdominal Muscle Action

    Muscle contractions can be measured using ultrasound. This is one way to see if certain exercises are working specific muscles. In this study physical therapists used ultrasound biofeedback along with abdominal muscle exercises for low back pain (LBP).

    Two groups of patients with LBP were included. One group did the standard drawing-in exercise of the abdominal muscles. This exercise is called the abdominal drawing-in maneuver (ADIM). The second group did the same exercises with visual ultrasound feedback. Both groups did the ADIMs in three positions: lying down, sitting up, and on hands and knees.

    Ultrasound measures of muscle thickness were done before and after muscle training in both groups. The authors report a two-fold increase in thickness of the transverse abdominal muscles in both groups. The ultrasound biofeedback group didn’t have better results.

    The authors conclude that ultrasound imaging can be used to measure the thickness of muscles. This imaging shows changes from before to after treatment. It doesn’t appear to be needed as a treatment tool to help improve muscle contraction.

    The Future of Spinal Surgery is Here

    The gold standard treatment for chronic back pain from disc degeneration is spinal fusion. The goal is to stop spinal motion causing the pain. Now artificial disc replacement (ADR) offers pain relief by keeping spinal motion.

    In this article Dr. Thomas Errico from the New York University Hospital for Joint Diseases reviews the use of ADRs. Disc replacement is also known as lumbar disc arthroplasty. The ADR is designed to allow normal or near normal spine motion. It also keeps the space or height between the two vertebral bones and acts as a shock absorber.

    Newer ADR designs are trying to overcome problems with the earlier ADRs. More studies are needed to find out which patients are best suited for ADRs. Surgeons must learn new surgical methods. It takes time to learn how to use new tools made to install these implants.

    Types of implants and the materials they are made of are described in this review. Dr. Errico calls the new ADRs the “promising beginning of a new era in spine treatment.” Lumbar arthroplasty is in its infancy stages. Current studies will help guide patient selection and the best timing for disc replacement. The future of spinal health care is here.

    Stabilizing the Spine While Preserving Motion

    Surgeons continue to look for better ways than spinal fusion to treat chronic low back pain (LBP). In this study, a new method called the fulcrum assisted soft stabilization (FASS) was tested on human cadavers and on wood and rubber spine models.

    Spinal fusion gives a stable spine but limits motion at that level. The goal of this dynamic stabilization is to hold the spine stable while keeping normal motion. Taking abnormal loads off the disc is also important.

    Stainless steel screws were placed into the pedicles on both sides of the vertebra. The pedicles are the bony projections on either side of the vertebra that form the arch around the spinal canal. Screws were placed in the vertebra above the damaged disc and in the vertebra below the damaged disc. A plastic rod was placed vertically between the two screws. Then a rubber “O” ring was wrapped vertically around the ends of the screws.

    The authors explained how the use of the plastic fulcrum is to unload the disc. This also helps keep the spine in a position of extension or lordosis. The “O” ring acting as a ligament applies a compressive force to open up the disc space slightly. Using the fulcrum and ligament together holds the spine in its proper position and spreads the load across the disc and joints. Normal motion occurs without abnormal slipping and sliding.

    The spines with the FASS in place were connected to a special machine to test motion and loading. Using trial and error the researchers were able to find the length of the screw that unloaded the disc by 50 percent and then by 100 percent. They found that range of motion decreased and stiffness increased as the disc was unloaded more and more.

    The new FASS system can unload the disc by using a fulcrum in front of a ligament wrapped around the pedicles. The system controls motion and maintains the lumbar spine in lordosis. With the ligament alone, the lordosis was present but the disc pressure increased. This is another step toward a future means of treating LBP without fusion. The FASS may be perfected to the point it can stabilize the spine yet still allow normal motion and position.

    Low Back Pain Got You Down? Good News From a Five-Year Study

    Two facts are well-known about chronic low back pain (LBP). 1) Exercise helps. 2) People quit exercising after a while. In this study researchers from the University of Vienna in Austria look at the long-term effect of combining exercise with a motivational program for patients with LBP.

    Two groups of patients were included in this study. One group (control) did the standard exercise program. The second group was given the same exercises plus counseling. They also were given information, positive feedback, and a treatment contract. And they kept an exercise diary.

    Everyone was seen one-on-one by a physical therapist for 10 sessions. Everyone was rechecked at three and a half weeks, four months, 12 months, and five years. Measures of success included pain, disability, and working ability.

    The authors reported a big difference between the two groups. Both groups had better function and less disability. But the motivational group had more than twice the improvement. Patients in the motivational group were the only ones to show improved work ability after five years.

    It appears that unsupervised exercise at home just doesn’t work for people with low back pain. Motivation and support does increase compliance with an exercise program.

    The authors suggest two reasons for this finding. First, patients had a set of tools that could be used easily in the future. Second the extra motivational program may have helped patients do the exercises correctly instead of just doing them regularly.

    The Fear of Back Pain

    Fear of pain and avoiding activities is common with patients who have low back pain (LBP). A survey called the Fear Avoidance Beliefs Questionnaire (FABQ) can be used to see if patients’ activities are controlled by their fears. In this study researchers looked to see if FABQ scores can predict the results of treatment with exercise.

    All patients were from a Middle Eastern culture. Everyone was enrolled in a 10-week program of muscle strengthening. The low back muscles were the targeted area. No one was on worker’s comp. In other words none of the patients were injured workers. All patients completed a strength test of the lumbar extension muscles before and after treatment.

    The results of this study showed two things. First, expected pain and actual pain got better for patients who finished treatment. Second, the amount of actual pain was not as much as expected. Results were the same for men as for women.

    The authors point out that using the FABQ for people who don’t have worker’s compensation may not be helpful in predicting outcome. If we rely on the FABQ results before treatment it would look like patients would fail to improve after treatment. Therapists can still use the FABQ to identify patients who have high pain expectations.

    Patterns of Analgesic Prescriptions for Low Back Pain

    Low back pain (LBP) can be very disabling. Prescription drugs are often used for pain relief in cases of acute LBP. These include opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), and COX-2 inhibitors. In this study the patterns of analgesic use for LBP is described.

    Doctors at the University of Pittsburgh Health System conducted this study. This is a large system with more than 5,000 physicians and 255,958 members. In one year (2001) about half the patients receiving back care were given a prescription drug. Opioids were used almost 40 percent of the time.

    Opioids are strong pain relievers related to opium. Natural forms include codeine and morphine. COX-2 inhibitors (a special NSAID that’s easier on the stomach) were only used for six percent of the back pain patients. The rest of the patients got a standard NSAID. Patients who were given an opioid also had other services for their LBP.

    The authors aren’t sure if the use of opioids by this many patients was appropriate. They do suggest this rate of usage is higher than reported in the past. The results point out the need for this hospital system to develop patient education programs.