Treatments That Have Questionable or Controversial Evidence

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Wisconsin Rehabilitation Medicine Professionals, Milwaukee, WI, USA

Note about this chapter:

This chapter does not address the treatment of patients with acute and subacute pain. It does not address patients with a herniated disk with nerve compression and radiculopathy (pain down a nerve distribution in the arms below the elbow and in the legs below the knee) who, on the basis of objective neurological findings of these conditions can benefit from an epidural injection and/or discectomy, if properly selected and motivated. Nor does this chapter address patients with pain from malignant sources, patients receiving appropriate physical or chiropractic therapy who may require opioids to increase participation in their treatment/rehabilitation process or patients who require surgical treatment for traumatic fracture of the limbs or spine to stabilize the fracture towards healing.

What this chapter does address is the use of surgery, injections, other interventions and chronic opioid therapy for patients with chronic pain as we have described and defined it in earlier chapters. For these patients there is questionable evidence despite their widespread use.

If one fact unifies all the advances in chronic nonmalignant pain research in the last 40 years, it is that pain is complex. There is rarely a single cause or treatment much as we and our patients would wish.

For years, pain was viewed through a simplistic theory of peripheral nociception initiating a neural impulse transmitted to the brain. However, we now know pain is modulated not just in the peripheral but in the central nervous system. The Gate Theory of pain (Melzack and Wall 1988), discussed in Chap. 2, led to the intense study of the dorsal horn of the spinal cord in neuromodulation. We know now that neurotransmitters like substance P, norepinephrine, serotonin, GABA, and endorphins are involved in pain, providing us a mechanistic approach in using pharmacological and physical agents to relieve pain.

Medical professionals treating pain also know now that a patient’s pain experience is greatly affected by social, familial, cultural, vocational, and financial factors as well as emotional states like depression, anger, fear, anxiety, and feelings of powerlessness and victimization.

Sadly, even as we appreciate chronic pain’s complexity and the validity of the Biopsychosocial model, treatments are reverting to a single-cause biological model thanks to the way health care is delivered and reimbursed. Contemporary chronic pain treatment, especially in the United States, is characterized by expensive, often uncoordinated treatments that produce poor outcomes and often lack evidence base as shown in Table 5.1. This system has largely phased out multidisciplinary care for chronic pain which is incorrectly viewed as more costly than unimodal treatments despite superior long-term outcomes in pain, disability, return to work, reduction in narcotic use, and repeat hospitalizations and surgery (Meier 2013). Ironically, in countries other than the United States, multidisciplinary pain treatment is expanding.

Table 5.1

Common pain interventions in patients with chronic pain

Treatment	Short-term relief	Long-term relief	Costly	Need to be repeated
Surgeries	Maybe	Maybe	Yes	Maybe
Injections/blocks	Yes	No	Yes	Yes
Spine stimulators	Yes	Maybe	Yes	No
Denervation/ablation	Yes	Maybe	Yes	Maybe
Opioids	Yes	No	No	Yes
Multidisciplinary pain rehabilitation	Maybe	Yes	Maybe	No

In 2014, the Obama administration announced that it will begin “coordinating” some Medicare services, an admission of how uncoordinated care has become. While physicians have often coordinated and managed care for their patients without being compensated, they will now be paid “to coordinate the care of Medicare beneficiaries, amid growing evidence that patients with chronic illnesses suffer from disjointed, fragmented care,” according to an administration announcement (Pear 2014). Officials said such coordination of care could “pay for itself by keeping patients healthier and out of hospitals.”

One indication of the extent to which non-EBM (Evidence-Based Medicine) treatments for chronic pain and the uncoordinated care in which they flourish have become established is the phenomenon of “failed back surgery syndrome” or FBSS. The term applies to an estimated 10–40 % of patients who receive only modest improvement after back surgery or none at all (Lee and Vasudevan 2012). FBSS is an umbrella term that does not specify the patient’s prior diagnosis, the reason for surgery failure or any present symptoms. Several studies list spinal stenosis, disk disruption or retained disk and epidural fibrosis as the most common causes of FBSS followed by recurrent disk herniations, iatrogenic instability, facet pain, and sacroiliac joint pain.

Yet despite the growth of FBSS in the United States, it is an ailment that “does not exist in most of the world,” writes Peter Abaci in Take Charge of Your Chronic Pain (2010) because “Most other countries don’t perform spine surgeries at the high rate that we do in the United States.” Comparable conditions like “failed hip surgery syndrome” or “failed knee surgery syndrome” don’t exist. The rate of back surgery in the United States is five times that in the United Kingdom according to the American Pain Society’s Guideline for the Evaluation and Management of Low Back Pain Evidence Review (2007). It is reported to be double that of Australia, Canada, and Finland (Lee and Vasudevan 2012).

The pendulum has swung back to the time when there was little awareness that a patient’s experience of pain was affected by his mental and emotional state, family and finances, and legal and vocational factors. While treatments like spinal fusions and disk surgery, spinal cord stimulators, steroid and painkiller injections, nerve ablation and of course long-term prescription of narcotics have greatly increased in the United States in the last decade, so has the incidence of adults who report chronic pain, which has actually doubled (Wells-Federman 1999; IOM 2011). Clearly, the newer methods are not working.

Dr. John Loeser, Professor Emeritus of neurological surgery, anesthesiology and pain medicine at the University of Washington who developed the Loeser Model of pain reviewed in Chap. 3, has also noted that the “purely medical” approach that dominates current chronic pain treatment, disregards “psychological and social factors” (IASP 2013). Others are also addressing the US’s drift away from treating the person in preference for treating the “pain” with expensive but often ineffective treatments.

“We don’t use our expensive drugs and technologies appropriately. Instead of using these interventions to benefit patients, we use them to maximize revenues, and often harm patients,” writes Otis Webb Brawly, M.D., chief medical officer of the American Cancer Society and author of How We Do Harm (Brawley 2011). As it stands, says Dr. Brawley, “abominable” care is often the rule not the exception because “the patient knows the science but chooses to ignore it,” physicians often gravitate to the most expensive care and “the insurance company has no access to adequate information.”

An especially controversial area in chronic pain care is surgical treatment of back pain. Lower back pain (LPB) is the second most frequent reason to visit a physician for a chronic condition, the fifth most common cause of hospitalization, and the third most frequent reason for a surgical procedure (Wheeler et al. 2013). It is the most common cause of disability in Americans younger than 45. In fact, LBP is so prevalent, the patient without it is actually more rare than the patient who has it.

Many back surgeries have shockingly low success rates. Second operations on the lumbar spine caused by new or recurrent pain, device failures and complications following the first operation are remarkably common and second and subsequent operations on lumbar spine are even less likely to be successful (Deyo and Mirza 2009). “One study on the Workers’ Compensation population found that the success rate after a second lumbar surgical procedure was only 53 %, after a third operation it was 35 % and after a fourth or fifth operation it was reported being worse than being improved,” reports a study in European Spine Journal.

“Even if the back surgery is successful in relieving pain, it can cause other problems,” says Dr. Abaci (Abaci 2010). “People who have had spine surgery age differently over time. The support structures of their spines seem to wear out quicker in the areas where they had the surgery, leading to advanced degeneration of the disks and joints needed to support the back.”

Nor is spine surgery the only procedure getting a second look. In 2014, a study, published in Arthritis & Rheumatology found that more than a third of total knee replacements performed in the United States were “inappropriate.”

Spinal Fusion

Some time ago, a complex operation called spinal fusion in which metal rods are screwed into the spine to stabilize it emerged as the treatment of choice for many kinds of back pain. Yet researchers questioned and continue to question whether spinal fusions are preferable to lower cost laminectomies, from which patients recover more quickly or preferable to having no surgery at all as shown in Table 5.2 (Abelson and Petersen 2003).

Table 5.2

Limitations of spinal fusion surgery

Drawback	Details
Highly expensive surgery	4 × cost of discectomy or laminectomy
A year required for recovery	Other surgeries require only weeks
May be overused; not always appropriate	Financial incentives/marketing to surgeons
Complications in 20 % of patients	Screws break loose, grafts/cages migrate
High rate of repeat surgeries	Fusion breakdown; other repairs

An article in the European Spine Journal (Deyo and Mirza 2009) finds a dramatic increase in fusion rates after 1996 when intervertebral interbody fusion cage hardware used to hold two vertebrae apart while the fusion becomes solid were introduced, correlating with a 100 % increase in spine fusions paid by Medicare. “During the last 5 years of the 1990s, spine surgery rates in the Medicare population increased 40 %; spine fusion rates increased 70 %; and instrumented spinal fusions increased 100 %,” write the authors. Some physicians suggested that fewer than half of fusions were appropriate and the expensive hardware employed could be driving the procedures’ popularity.

In a presidential address for the Scoliosis Research Society, orthopedic surgeon Harry Shufflebarger cited a “fusion cage explosion,” and stated that “the efficacy of these stand-alone devices is very questionable” after 4 years of use (Deyo and Mirza 2009). Patients with fusion instrumentation have a substantially higher likelihood of repeat surgery, higher rates of nerve injury, greater blood loss, longer operative time, and a higher rate of overall complications than seen with “decompression alone” write the authors. Early complications following fusion occur in up to 20 % of patients, say American Pain Society guidelines (2007) and the rate of in- hospital mortality is <1 %.

Many patients “who have had one fusion surgery require at least one more back operation at some point in their lives, often because the areas above and below the fusion break down and need repair,” says Dr. Abaci (Abaci 2010).

The debate over the appropriateness of spinal fusions has spilled over from the pain field into general discussion of health care policy and allocation of resources. In How Doctors Think, Jerome Groopman, M.D. (2007) Professor of Medicine at Harvard Medical School and Chief of Experimental Medicine at Beth Israel Deaconess Medical Center observes that “the financial incentive tips heavily toward fusion” because the hardware generates “high profits” for the manufacturers and “the hospitals that use them” (Groopman 2007). At one hospital, for example, the surgeon’s full fee for a simple discectomy is around $5000, writes Dr. Groopman, while compensation for a fusion surgery is $20,000. “For the majority of patients with chronic lumbar pain, fusion surgery has no dramatic impact on either their pain or their mobility. Yet many surgeons pay scant attention to the poor results,” charges Dr. Groopman.

Nortin Hadler, Attending Rheumatologist at the University of North Carolina Hospitals and a graduate of Yale College and Harvard Medical School, concurs. “There is not a hint that surgery for regional back pain is helpful. There is barely a hint that surgery for radicular pain might be helpful,” he writes in Worried Sick (Hadler 2008). In Stabbed in the Back: Confronting Back Pain in an Overtreated Society, Dr. Hadler disputes whether low back pain is an “injury” at all and traces its historical roots as a patient complaint and a medical diagnosis.

Dr. Hadler reserves particular criticism for what he calls a lucrative franchise built around back injuries in the Workers’ Compensation system, noting the United States is the “first in the ‘advanced’ world” in surgically treating “the lumbosacral spines of workers.”

“These claimants are victims of social iatrogenesis [physician-caused maladies]…seduced into thinking that their regional low back pain is a disabling injury consequent to a workplace accident. They are forced to use the painfulness to validate their request for indemnified health care.” There is something profoundly wrong with a system that forces a patient to exhibit pain behaviors, continues Dr. Hadler. “If you have to prove you are ill, you can’t get well.” (Chapter 7 addresses disability and worker-related insurance systems in depth.)

Driving the popularity of fusions are companies like Medtronic, one of the biggest makers of spinal hardware, originally based in Minneapolis but seeking to reincorporate in Ireland in 2014. A lawsuit filed against Medtronic in 2001 and settled, accused the company of offering surgeons first-class plane tickets to Hawaii, nights at the finest hotels, consulting contracts that involved no work and outright kickbacks for their spinal hardware business (Abelson and Petersen 2003).

In affidavits provided to the press, about 80 surgeons were shown to have consulting agreements with Medtronic that paid as much as $400,000 a year and sales representatives even took surgeon prospects to strip clubs. At the University of Wisconsin in Madison, Thomas Zdeblick, M.D., chairman of the medical school’s orthopedic department and a prominent spine surgeon received more than $25 million from Medtronic between 2003 and 2011 and the university hospital spent $27 million for Medtronic spinal products from 2004 to 2010 (Fauber 2011). The hospital equipped 179 patients with Medtronic devices between 2008 and 2011. Clearly, financial incentives can drive the choice of one surgery over another.

When the US Agency for Health Care Policy and Research attempted to establish back surgery guidelines that recommended a conservative approach and discouraged surgery, Medtronic successfully sued to have the recommendations kept from the public. The North American Spine Society, the main professional group for back surgeons, “launched an assault on the methods used by the AHCPR experts, charging that the agency had wasted taxpayer dollars on the study” according to press reports and almost succeeded in eliminating its funding (Brownlee 2007).

Medtronic has also been in the news over Infuse, its aggressively marketed bone graft material used in spine surgeries. An article in the Bone & Joint Journal by paid Medtronic consultant, Timothy R. Kuklo, a former surgeon at Walter Reed Army Medical Center, was retracted (Wilson and Meier 2009) due to falsified data. According to an Army investigation, Dr. Kuklo reported much higher success rates in healing the shattered legs of wounded soldiers than was accurate.

“During his time at Walter Reed, Dr. Kuklo was extensively involved in research and writing about various Medtronic products, including editing two books published by the company [Medtronic] and conducting three studies that were approved by his Army superiors, according to his list of publications and an Army report,” reported the New York Times.

In 2008, Infuse received a Food and Drug Administration safety alert based on 38 reports of “life-threatening” complications when Infuse was used in neck surgeries, an unapproved use, received over 4 years (FDA 2008). Since then, Infuse has been linked to sterility in men, cancer (Wilson and Meier 2009) and other serious complications (Fauber 2012a, b, c). In 2012, a 16-month congressional investigation found that Medtronic “paid a total of approximately $210 million to physician authors of Medtronic-sponsored studies” in 14 years and “violate[d] the trust patients have in their medical care.”

Interventional Pain Management

Early efforts at interventional pain date all the way back to 1899 when the first therapeutic nerve block was described in France (Manchikanti et al. 2003). Today, interventional pain medicine is a thriving subspecialty of pain management that encompasses techniques that include epidural injections, epidural and root blocks, facet injections and medical branch blocks, sympathetic blocks, spinal cord stimulation, and radio-frequency denervation (also called nerve ablation or “burning”).

Interventional pain techniques are analogous to surgery in that their outcome is partially dependent on the experience and skill of the operator. While growing in popularity, especially in the United States, there is “insufficient data to speak for the efficacy of many…commonly performed procedures” (Zhao and Cope 2013). Other limitations to interventional pain techniques are the pain relief is short-lived, there is the risk of complications, sometimes serious and “pain reduction does not necessarily translate into improved function and return to work.” Nonetheless, American spent $23 billion on interventional pain techniques in 2011, including epidurals, implants of spinal cord stimulators, and injections of painkillers (Armstrong 2011). Interventional pain techniques have grown by 231 % since 2002.

Injections/Nerve Blocks

The use of injections for chronic pain, whether corticosteroids, anesthetic painkillers or both, increased by 159 % between 2000 and 2010 in Medicare patients with 9 million Americans receiving pain injections in 2010 alone (Armstrong 2011). The surge was driven by the aging of the US population and the financial remuneration behind the injections themselves. Epidural injections, which deliver corticosteroid via a catheter into the space between the dura and the spine, are especially popular. Medicare paid about $200 for a typical epidural steroid injection given in a physician’s office, $400 for the procedure at a surgery center and about $600 when performed at a hospital.

Despite their wide use, the efficacy of epidural is not overwhelming as we see in Table 5.3. “Data addressing the effects of epidural steroid injection on pain from spinal stenosis, low back pain without radicular pain and failed back surgery is sparse” and “no long-term efficacy of epidural procedures for chronic spinal pain has been established,” say Zhao and Cope in Springer’s Handbook of Pain and Palliative Care (2013). Guidelines from the American Society of Anesthesiologists, American Pain Society, the American Academy of Pain, the American College of Occupational and Environmental Medicine and the American Society of Interventional Pain Physicians concur that epidural injections with or without local anesthetics provide pain relief from 2 weeks to 3 months but that the magnitude of their pain reduction is “modest.”

Table 5.3

Limitations of epidural injections

Short-term pain relief (a few weeks)

Little improvement of function

Do not obviate need for surgery

Stroke, paralysis among risks

Quality problems from pharmacies

In 2014, the New England Journal of Medicine published an article and editorial questioning the benefit of using steroid injections for spinal stenosis at all (Friedly et al. 2014). Six weeks of injections with a steroid and the anesthetic lidocaine were no more effective than injections with lidocaine, said researchers. “This study shows that the steroid is not the reason why patients are getting this significant relief. It could just be the lidocaine itself,” Dr. Nick Shamie of the UCLA Spine Center explained (CBS 2014). The journal’s conclusion angered interventional pain physicians who wrote that there were “severe limitations to this study, manuscript, and accompanying editorial. The design, inclusion criteria, outcomes assessment, analysis of data and interpretation, and conclusions of this trial point to the fact that this highly sophisticated and much publicized randomized trial may not be appropriate and lead to misinformation” (Manchikanti et al. 2014a, b).

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