1. Treatment Options and Supporting Clinical Evidence
Axial Back Pain
Treatment Options and Supporting Clinical Evidence
Welcome to this CE seminar entitled: Axial Back Pain: Treatment Options and Supporting Clinical Evidence.
Image: iStock doc

2. Continuing Education Provider
Funds Provided by
Continuing education (CE) credit is awarded by the approved provider, Pfiedler Education.
Funds for this learning activity are provided by Aesculap.
(Introduce yourself and disclose your affiliation with Aesculap.)

3. Objectives
Identify prevalence of axial, chronic low back pain (LBP) caused by degenerative disc disease (DDD)
Discuss relevant anatomy of lumbar spine and intervertebral discs
Explain clinical implications of DDD
Differentiate conservative versus surgical treatment options for patients with debilitating pain related to DDD
Discuss clinical considerations of lumbar arthrodesis and lumbar arthroplasty for these patients
Describe clinical evidence for lumbar arthrodesis and lumbar arthroplasty
Upon completion of this activity, you should be able to:
1. Identify the prevalence of axial low back pain.
2. Discuss the relevant anatomy of the lumbar spine and intervertebral discs.
3. Explain the clinical implications of DDD.
4. Differentiate conservative versus surgical treatment options for patients with pain related to DDD.
5. Discuss the clinical considerations of lumbar arthrodesis and lumbar arthroplasty for these patients.
6. Describe the clinical evidence for lumbar arthrodesis and lumbar arthroplasty.

4. Introduction LBP affects up to 80% of people at some point in life
Very common reason to see PCP
Progresses to chronic in only ~ 5% of patients
Most attributable to degenerative disc disease (DDD)
1-2% adults become disabled due to chronic LBP (leading cause of disability worldwide)
At some point in life, low back pain (LBP) alone affects up to 80% of the population; it is the second most common reason (after the common cold) that patients see their primary care physician. Approximately 5% of those individuals who experience LBP will progress to a condition of chronic back pain, a large majority of which is attributable to degenerative disc disease (DDD), which is the leading cause of pain and disability.2 In the United States, 1% to 2% of the adult population is disabled due to LBP3; additionally, LBP is the single leading cause of disability worldwide.4 Excluding pain related to trauma, DDD is the most common spinal disorder.
Image: blue back image - Clip art

5. Lumbar Spine Characteristics
L1-L5: largest unfused vertebrae
Support weight of torso
L4-L5 and L5-S1: lowest spinal segments
Bear most weight
Prone to injury and degeneration
L5-S1: lumbosacral joint
Rotation
Enables pelvis and hips to swing
The lumbar spine has three unique characteristics:
• The lower a vertebra is in the spinal column, the more weight it must bear. The five vertebrae of the lumbar spine (L1-L5) are the largest unfused vertebrae in the spinal column, which enables them to support the weight of the entire torso.
• The lowest two spinal segments in the lumbar spine (L4-L5 and L5-S1), which include the vertebrae and discs, bear the most weight and therefore are the most prone to both injury and degeneration.
• The lumbosacral joint (L5-S1) permits considerable rotation, enabling the pelvis and hips to swing during walking and running.
Image: istock spine #

6. Degenerative Disc Disease (DDD)

7. What is a Disc? Disc functions as hydraulic cylinder
Gelatinous nuclear material directs pressure outward
Annulus contains pressurized nucleus
From SpineHealth 2017: “The discs throughout the spine have three primary functions:
They act as a shock absorbers in the spine, positioned between each bony vertebra.
They act as tough ligaments that hold the vertebrae of the spine together.
They are cartilaginous joints that allow for slight mobility in the spine.
There are a total of twenty-three vertebral discs in the spinal column. Specific problems with any of these discs may prompt unique symptoms, including pain that originates in the disc itself and/or pain that is related to the disc pressing on a nearby nerve.”

8. What is DDD?
Describes the symptoms of axial back pain and possible radiating pain and / or weakness / numbness resulting from a degenerated disc(s) in the spine
Degenerative disc disease is a term that describes the symptoms of low back (or axial) pain, sometimes radiating pain, and/or weakness or numbness resulting from a degenerated disc in the spine.
Istock image: Stock photo #

9. DDD Overview Disc no longer functions normally Can lead to:
Arthritis, disc herniation, spinal stenosis
Pressure on nerve roots
Normally, the intervertebral discs provide the cushioning space that keeps the vertebrae separated.
With DDD, the disc no longer functions normally (i.e., they lose water content and may become thinner, both of which can change the strength and shape of one or more discs) because of aging, wear, or an injury to the back.
These changes can lead to arthritis, disc herniation, or spinal stenosis; in addition, pressure on the spinal cord and nerve roots may cause leg or back pain.
Image: Provided by Aesculap

10. Causes of DDD
Primarily related to natural, age-related changes in the discs:
May also be initiated or exacerbated by injury, cigarette smoking, genes
While there are several potential causes of DDD, most individuals are affected by natural, age-related changes in the intervertebral discs. The various causes of DDD are:
Age-related factors: With aging, the discs naturally undergo changes in their composition and structure, which make them more susceptible to damage. The primary change is the loss of water content in the nucleus pulposus of each disc; this dehydration leads to a reduction in disc height, which increases the likelihood that two or more vertebrae in the back will shift their position, rub against each other, and destabilize the spine. The body can respond to these changes by producing growths of new bone tissue (i.e., bone spurs) between adjacent spinal bones; unfortunately, bone spurs can significantly restrict the mobility of the back and compress spinal nerve roots or the spinal cord itself. Age-related degeneration also affects the annulus fibrosis. Under the stress of increasing pressure, these fibrous coverings can develop small fissures (i.e., partial tears) in their surfaces, which do not heal efficiently due to the lack of blood flow. As a result, each repaired tear makes the overall disc weaker and more prone to problems.
Injuries: Back injuries, typically due to motor vehicles accidents, contact sports, or poor posture during strenuous movements, may result in changes to the spine, which lead directly to the onset of disc degeneration. However, most individuals who are affected by injury-related problems generally have pre-existing age-related issues that make the discs weaker than usual.
Genetic inheritance: Some people inherit a tendency toward disc degeneration, which typically means that they have a higher chance of developing damaging disc changes during middle age or even before reaching middle age. This is particularly the case if multiple family members have been diagnosed with DDD in the past.
Cigarette smoking: In addition to the multiple harmful effects on overall health, habitual cigarette smoking reduces the amount of water contained in the nucleus pulposus. Although this lack of moisture is not a direct cause of DDD, it can increase the rate of age-related disc change and expose one to DDD symptoms at an earlier age.
Image: Elderly lady – clip art
Cartoon back pain – clip art

11. Normal Aging of the Spine
7 years
30 years
70 years
Over time:
The nucleus loses water and becomes less elastic, and
The annulus becomes more brittle and can develop cracks and tears
Image: Provided by Aesculap

12. Degenerative Cascade
Loss of Disc Height Loss of Motion Change in Spinal Balance Formation of Osteophytes Increased Load on the Facets/Ligaments Impingement on Spinal Cord or Nerves
Here is a good example of the cascade that can occur as a result of DDD

13. Diagnosing and Treating Lumbar DDD

14. Diagnosing Lumbar DDD History and Physical Plain Radiographs MRI
CT / Myelography
Diagnostic Spinal Injections
Discography
Physicians may use some or all of these methods to determine the scope of the degeneration and whether any of the discs require surgery. Discography is not utilized as often as it used to be, but is a test to help determine which disc is actually causing pain if no other tests can confirm that.

15. Treating with Conservative Care
Acute LBP tends to resolve within weeks to months
Goals are to decrease pain and spasms, provide conditioning for back, and manage other issues associated with back pain
In general, an episode of LBP for most patients tends to resolve over a period of two weeks to three months; during this time frame, or if the back pain is chronic, it is important that the appropriate course of conservative treatment is considered in order to:
• Decrease pain and spasms;
• Provide conditioning for the back; and
• Manage other issues that are often associated with back pain, such as depression or insomnia.
Image: Conservative sign - Clip Art
iStock Back pain #

16. Conservative Care Options
Education
Heat / ice
Physical therapy
Chiropractic care
Medications
Pain management program
There are several options for conservative treatment of DDD and LBP. (Italics can be read for additional information)
Back education: teaches the patient how to help him/herself in managing back pain. Topics covered include normal spine anatomy and biomechanics, the mechanisms of injury, the patient’s specific diagnosis, basic body mechanics, and the proper and improper approaches for sitting, bending forward, lying down, coughing, or sneezing when he/she is experiencing back pain.
Hot or cold therapy: Hot or cold packs may help alleviate pain and reduce inflammation, allowing greater mobility in some patients; however, they have never been proven to quickly resolve low back injury.
Activity: Patients should begin stretching exercises and resume normal activities of daily living as soon as possible, while avoiding movements that aggravate their pain; bed rest should be limited. Patients who continue their activities without bed rest after the onset of low back pain appear to have better back flexibility than those who rest in bed for a week.
Chiropractic care: Spinal manipulation and spinal mobilization are approaches in which doctors of chiropractic care use their hands to adjust, mobilize, massage, or stimulate the spine and the surrounding tissues. These techniques have been shown to provide small to moderate short-term benefits in patients with chronic LBP; however, neither manipulation or mobilization are appropriate in the presence of an underlying medical cause for the back pain, such as osteoporosis, spinal cord compression, or arthritis.
Medications: Various medications may be ordered to treat acute and chronic LBP; these include Analgesic agents (OTC and prescription opioids), Nonsteroidal anti-inflammatory drugs (NSAIDS) , and anticonvulsants may be useful in treating patients with radiculopathy and radicular pain.
Pain management program: Typically includes a number of approaches managed by a pain management physician and with a team to complement the health care services, such as psychologists, occupational therapists, nurses, etc.
Images: iStock doctor holding anatomical model #
Person in bed, hot/cold therapy, and chiropractic image – clip art

17. More Invasive Options Nerve blocks Epidural steroid injections
No more than 2-4 annually
Spinal cord stimulator
Nerve block therapy: intended to relieve chronic pain by blocking nerve conduction from specific areas of the body. Nerve block 15 approaches range from injections of local anesthetics, botulinum toxin, or steroids into the affected soft tissues or joints to more complex nerve root blocks and spinal cord stimulation.
Epidural steroid injections: commonly used short-term therapeutic option for treating low back pain and sciatica due to inflammation. There is wide variation in the type and dosage of steroid used. Even when a satisfactory response occurs, no more than 4 injections should be given over a one year period. Not advised for long-term use.
Spinal cord stimulator: Implantable neurostimulation technology to deliver low-voltage electrical current continuously to the spinal cord to block the sensation of pain in patients with chronic pain.
Image: Pill bottle – Clip Art
Needle in spine – Clip art

18. Surgical Treatment Criteria
Small percentage of patients unresponsive to conservative treatment:
Extended period of pain, despite conservative treatment
Unsatisfactory function in daily activities
Diagnostic tests indicate structural changes
Lumbar herniation and nerve root compression
It is estimated that approximately 10-20% of people with lumbar DDD will be unresponsive to conservative treatment; for these patients, surgical treatment may be considered.
Other criteria for which surgical intervention is considered include:
If the patient’s LBP and/or leg pain persists over an extended period of time (over 6 months typically)
If the patient cannot satisfactorily maintain his/her ability to function in daily activities at work or home
When diagnostic tests indicate structural changes for which corrective surgical procedures have been developed
Lumbar herniation resulting in the loss of bowel or bladder control, or major lower extremity deficit. These symptoms are caused by nerve root compression and require immediate surgery.

19. Surgical Treatment Options
Lumbar Arthrodesis (Fusion)
Removing disc and fusing vertebrae
Standard for LBP surgery
-or-
Lumbar Arthroplasty (also known as Total Disc Replacement or TDR)
Removing disc and replacing it with an artificial one
Alternative to fusion for subset of patients
No bone graft or other instrumentation needed
Traditionally, the management of lumbar DDD had been limited to either non-surgical treatment or fusion of the affected level.
Lumbar arthrodesis (i.e., fusion) is the process of fusing or joining two bones; it is considered the standard of care in surgical treatment for DDD.
Lumbar arthroplasty, also known as Total Disc Replacement or TDR is the replacement of the degenerated intervertebral disc with an artificial disc in patients with DDD who have been unresponsive to conservative treatments for at least 6 months and is considered an alternative to arthrodesis in a subpopulation of DDD patients.
TDR preserves movement of the spine, which is thought to reduce or prevent the development of adjacent segment degeneration.
In addition, a bone graft is not needed and therefore decreases associated complications such as bone graft donor site pain and pseudoarthrosis.

20. Overview of Lumbar Fusion
Eliminates motion at one or more vertebral segments to relieve pain and correct instability, with goals to:
Decompress spinal nerves to eliminate pain
Restore disc height/appropriate space between vertebrae
Eliminate mobility of affected vertebra by fusing it with grafts/implants
Arthrodesis is performed to eliminate motion at one or more vertebral segments in order to relieve pain and correct the instability of the spine; the goals of fusion are to:
• Decompress the spinal nerves that are causing the pain,
• Restore the appropriate space between the vertebrae that surround the diseased disc, and
• Eliminate mobility of the affected vertebral segment.

21. Risks with Lumbar Fusion
Permanent changes in back mechanics/balance
Irreversible
Adjacent segment disease seen in up to 80% of patients
Reoperation of 10-30% within 5 years
The potential risks that accompany spinal arthrodesis are related to both medical outcomes and personal health preferences, including:
Results in permanent changes in the mechanics of the back and is NOT reversible
Results in adjacent segment pressure and therefore degeneration and disease
Reoperation rates of 10-30% over follow up of 5 years have been reported because of complications noted above
Image: Risk - Clip Art

22. Lumbar Arthroplasty/Total Disc Replacement (TDR)

23. Overview of Lumbar TDR
“New” alternative to fusion – available in Europe for 30+ years, US since 2004
Symptomatic disc removed and replaced with artificial disc (reconstruction vs. fusion)
Restores height and movement between vertebrae
Replacing disc maintains more normal motion
Reduction of adjacent level degeneration
Total disc replacement is considered a relatively new alternative to lumbar arthrodesis for the treatment of a subset of DDD patients with severely damaged discs; this procedure involves removing the affected disc and replacing it with a synthetic disc that helps restore height and movement between the vertebrae.
The theory behind this surgical option is that by replacing the disc, instead of fusing the disc space together, more of the normal motion in the lumbar spine is maintained, thereby reducing the likelihood that adjacent levels of the spine will break down due to increased stress.
Image: Alternative sign - Clip Art

24. Overview of Lumbar TDR (cont.)
5 FDA IDE trials with 5-year follow-up
3 compared to fusion
2 compared to other discs
Multiple studies with 5- to 10-year and ≥10- year follow-up
Although lumbar arthroplasty is a new procedure when compared to fusion, there is actually fifteen years of data reported from regions around the world, including multiple 5- to 10-year studies of lumbar arthroplasty and studies with greater than 10-year follow-up. Additionally, there are 5 FDA investigational device exemption trials with 5-year follow-up for lumbar artificial discs such as ProDisc, Charite, activL Artificial Disc etc. FDA investigation device exemption trials are clinical studies meant to collect safety and effectiveness of devices based on measurable clinical outcomes. The majority of these investigational device exemption trials compare lumbar arthroplasty versus fusion, and over 5 meta-analyses have demonstrated that TDR was effective in treating lumbar degenerative disc disease based on results found in these randomized controlled trials. There have also been two 5-year randomized control trials of mixed artificial discs.

25. 3 Generations of Lumbar Discs
Charité
ProDisc-L
activL
The first artificial disc, Charite from DePuy, had an unconstrained core, which led to issues with expulsion. As we as an industry learned over time, more constraint but not too much was the key to success. Now in its third generation, the disc is highly engineered for success. Since 2011, Charite has been removed from the market.

26. 3 Generations of Lumbar Discs (cont.)
Charité
ProDisc-L
activL

27. TDR Implants Today Cobalt chromium endplates
Polyethylene inlay core (shows less wear than hips/knees)
Affix to vertebrae with bone-sparing spikes or keel
The disc on the bottom is ProDisc-L (which uses a keel to anchor the device the disc on the top is an activL, which uses “spikes” to anchor the device. These discs are both constructed of cobalt chromium endplates which affix to the vertebrae. Both show wear less than hips/knees.
Image: Provided by Aesculap

28. FDA Indications for Lumbar TDR
Alternative to lumbar fusion for patients with discogenic LBP:
18 to 60 years of age (studies)
Advanced, single-level degeneration of lumbar spine at L3-4, L4-5 & L5-S1
No more than Grade 1 spondylolisthesis
Symptoms ≥ 6 months, not responding to conservative treatment
Primarily back pain, leg pain can be secondary
Lumbar artificial disc replacement is indicated as an alternative to lumbar fusion for patients with discogenic low back pain who meet all of the following criteria:
• The patient is 18 to 60 years of age.
• The patient has advanced, single-level disease of the lumbar spine at the L3-4, L4-5 or L5-S1 level, as seen on plain radiographs of the lumbar spine or on magnetic resonance imaging (MRI), which is characterized by moderate to severe disc degeneration.
• There is no significant spondy or facet arthropathy at the operative level.
• The patient’s symptoms have been present for at least 6 months and have not responded to multi-modal conservative treatment, including but not limited to pain management, injections, and exercise/physical therapy programs.
• Axial pain is the patient’s primary complaint; possible secondary complaint is lower extremity pain.
Images: Checklist - Clip Art
Surgical instrument – Provided by Aesculap

29. Contraindications for Lumbar TDR
<18 or >60 years
Advanced, multi-level disease
Spinal stenosis, spondylolisthesis, or scoliosis
Previous major spine surgery (laminectomy/discectomy not included)
Neurologic symptoms
Disease above L3
Significant facet arthropathy at operative level
Infection or tumor
Significant psychiatric disorder
Lumbar TDR is contraindicated in any of the above scenarios, which are all common sense.
Image:
Stop guy/contraindication – Clip art

30. Clinical Evidence for Lumbar TDR
Guyer, et al, 2009:
No statistical differences in clinical outcomes
Higher rate of part- and full-time employment
Lower rate of long-term disability
Gornet, et al, 2010:
TDR patients returned to work 21 days sooner
87% would have surgery again
Superior to fusion in terms of improved physical function, patient satisfaction, and pain
With ongoing experience in lumbar TDR, clinical evidence is now being reported; the results of relevant studies are summarized in the next two slides.
Guyer, et al, conducted a randomized controlled follow-up study of 90 lumbar spinal arthroplasty patients and 43 lumbar fusion patients to compare the efficacy and safety at the five-year follow-up interval of lumbar TDR with ALIF .
There were no statistical differences in clinical outcomes between the two groups. However, the TDR patients achieved a higher rate of both part- and full-time employment and lower rate of long-term disability, compared with the ALIF patients.
Gornet, et al, presented their 5-year interim outcomes for patients who had undergone lumbar disc arthroplasty with an investigational device versus ALIF. Arthroplasty patients returned to work 21 days sooner than the fusion patients.
At 5 years postoperatively, 87.0% of the arthroplasty patients said that they would have the surgery again, versus 82.7% for the fusion patient.
The authors concluded that treatment of single-level lumbar DDD with total disc arthroplasty resulted in outstanding clinical outcomes 5 years after surgery; patients had improved physical function, less pain, and improved patient satisfaction.
Image: Stamp - Clip Art

31. Clinical Evidence for Lumbar TDR
Zigler, et al, 2012: 5-Yr FU Lumbar TDR versus Fusion
Follow up rate of 82% on 236 patients out to 5 years
Both groups improved significantly on VAS (pain) and ODI (function) at 24 months, then maintained changes out through 5 years
Most importantly, at 5 years, observed adjacent segment disease in 29% of fusion patients vs 9% of TDR patients = 3:1 ratio (p = .004)
In the 5-year ProDisc-L follow up, patients did well with both procedures (fusion and disc), but the real differential began to show more over time. As predicted with this motion-preserving device, patients had less adjacent segment disease with disc than with fusion by a 3:1 ratio.

32. Clinical Evidence for Lumbar TDR
Zigler, et al, 2018: 5-Yr FU Lumbar TDR ASD Rates:
Adjacent segment disease in 9% of activL patients, which continues to prove out the theory behind artificial discs over time
This difference was also illustrated in the recently published activL 5-year follow up, in which about 9% of patients developed ASD with activL over time,

33. Clinical Evidence for Lumbar TDR
Zigler, et al, 2017: Meta-Analysis of 5-Year Outcomes from Randomized Trials (fusion vs. disc only):
Studies
ODI
Back Pain
Reoperation
Patient Satisfaction
Guyer 2009  
Gornet 2010
Zigler 2012
Skold 2013
5-Year Meta-Analysis

34. Narcotic Usage over 5 Years
Data from 2 Lumbar TDR Devices Compared in Clinical Study
In a clinical trial comparing one lumbar disc to two others, data showed for all of the devices that narcotic usage decreased dramatically after lumbar TDR surgery, to the point of almost no use of narcotics by five years post-surgery.

35. Return to Work with Lumbar TDR
Garcia, et al, 2015, 2-YR Follow-Up:
As part of the activL study, Garcia et al tracked the working status of study participants. Of those who were working before the onset of their back injury (about 300 patients total between the control and activL groups), 30 percent were not working as a result of their injury. About 50 percent were not working immediately after their procedure (to be expected), but more importantly the number of patients who were still off work at the end of the 2 year evaluation period was reduced to just 8.5 percent of patients.

36. Return to Work with Lumbar TDR
Mattei, et al., 2017, Retrospective Analysis:
Retrospective, controlled study of patients with lumbar DDD who had lumbar TDR or ALIF at a single hospital from followed out for one year
Patients who had lumbar TDR had significantly lower VAS pain and ODI disability scores out through one year
Lumbar TDR patients also returned to work on average 65 days sooner than ALIF patients

37. Summary of TDR Results TDR patients, when compared to fusion:
Are more satisfied
Have less pain / improved function
Return to work more quickly and return to full duty more often
Require fewer reoperations / have a lower incidence of adjacent segment disease over the medium- and long-term

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