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If spine surgery fails to relieve low back pain why is it increasing?

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complex spine surgery

Surgery has become a common therapy for low back pain (LBP) and degenerative disc disorders, but it often fails to relieve pain
The incidence rates of spine surgery are high and increasing and contribute to a US$10bn global spinal implant and devices market
We attempt to explain a paradox: If spine surgery fails to relieve LBP why is it increasing?

If spine surgery fails to relieve low back pain why is it increasing?

Low back pain (LBP) is a common age-related condition. In 2017, its point prevalence was ~7.5% of the global population, or ~0.58bn people. The condition is associated with degenerative disc disorders and is a leading cause of most years lived with disability. Spinal fusion is a common neurosurgical or orthopaedic surgical treatment to correct degenerative spinal disorders that can present as LBP. The procedure joins small bones in your spine (vertebrae), and can be performed at any level in your spine. The basic idea is to fuse together two or more vertebrae so that they heal into a single, solid bone. Such procedures have fuelled a global spinal implant and devices industry valued at ~US$10bn, growing at a compound annual growth rate (CAGR) of ~5% and concentrated in wealthy nations; the US, the EU-27 and Japan. Spinal fusion accounts for the largest share of this market, and is projected to reach ~US$8.5bn by 2026, exhibiting a CAGR of ~3.6%.

LBP is challenging to diagnose, and effective treatment is elusive, but surgical therapies have become commonplace with a significant proportion failing to relieve pain. So, why is spine surgery increasing?

In this Commentary

Surgery may be able to fix the condition of degenerative disc disorders, but not eliminate pain. After spine surgery, a percentage of patients still experience pain, called ‘failed back syndrome’, which is characterized by a continuation of pain and an inability to return to normal activities. This has led to the paradox: If spine surgery fails to relieve LBP why is it increasing? We suggest 7 factors, acting in concert, help to explain this paradox, but stress that the evidence we present is circumstantial.

1. Clinical guidelines for LBP

Clinical practice guidelines are developed by multi-disciplinary teams of health professionals using an evidence-based approach, combining the best research available with expert consensus on best practice. In the UK, the National Institute for Health and Care Excellence. (NICE) is the body responsible for producing such guidelines. In the US the Institute of Medicine (IOM) first recommended the development of guidelines in 1990. Soon afterwards, several professional healthcare organizations such as the North American Spine Association (NASS) began producing their own guidelines for specific disorders. For this Commentary we use clinical guidelines provided by NICE and NASS.

As a first line therapy for LBP, NICE recommends a treatment package of, “exercise in all its forms, - e.g., stretching, strengthening, aerobics or yoga - advice and education, and if necessary, the inclusion of manual and psychological therapies”.

According to Spine Health, in the US therapies for LBP and degenerative disc disorders, “are primarily to reduce baseline pain and prevent pain flare-ups as much as possible. Most cases of degenerative disc pain are manageable through a combination of pain management methods, exercise/physical therapy, and lifestyle modifications”.

NASS 2020 guidelines for the ‘Diagnosis and Treatment of Low Back Pain’ pose 12 critical questions on the efficacy of the use of surgical treatment versus medical/interventional treatment, and conclude that it is unable to answer the questions because of the dearth of evidence. Here inter alia is a flavour of the questions posed by NASS:

Q In patients with LBP, does surgical treatment versus medical/interventional treatment alone decrease the duration of the pain, decrease the intensity of the pain, increase the functional outcomes of treatment, and improve the return-to-work rate?
Q In patients undergoing surgery for low back pain, which fusion technique [the question lists 5 common techniques] results in the best outcomes for the following: decrease the duration of pain, increase the functional outcomes of treatment, and improve the return-to-work rate?
Q In patients undergoing fusion surgery for low back pain, does the use of bone growth stimulators (versus fusion alone), decrease the duration of pain, increase the functional outcomes of treatment, and improve the return-to-work rate?
Q In patients undergoing fusion surgery for low back pain, does the use of BMP [bone morphogenetic proteins] (versus fusion alone), decrease the duration of pain, increase the functional outcomes of treatment, and improve the return-to-work rate?
Q In patients with LBP are there predictive factors, which determine the benefit of initial treatment with surgical intervention versus initial medical/interventional treatment?

NASS answers all 12 questions with the same statement: “A systematic review of the literature yielded no studies to adequately address this question”. This emphasises the absence of clinical evidence to confidently determine efficacious surgical therapies for LBP. NASS stresses that its guidelines are not intended to be viewed as a “standard of care”, but as “recommendations to assist in delivering optimum, efficacious treatment and functional recovery from nonspecific low back pain”.

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2. Poor prognostic indicators for spinal surgery

This dearth of evidence makes therapy decisions challenging for clinicians. A study published in the 2018 edition of the Asian Spine Journal suggests that a proportion of the large and increasing spine fusion surgeries performed to reduce LBP and degenerative disc disorders fails because of weak prognostic indicators. Researchers stress that, “spine surgeons need to be well aware of the many poor prognostic indicators for spinal surgery”. The lack of high-quality evidence to support the use of spinal fusion for LPB fosters disagreement among physicians as to when spinal fusion should be performed.

In the video below Nick Thomas, a consultant neurosurgeon at King’s College Hospital, London, describes some of the challenges of poor prognostic indicators for LBP: “Dilemmas of managing low back pain arise because we (clinicians) have precious few pre-operative investigations that give us a clear idea as to whether a spinal fusion may or may not work. When an MRI is taken it can be very difficult to determine whether the degenerative discs one sees on the scan are normal age-related changes or whether they truly reflect a problem that might be generating the back pain”, says Thomas.

Such dilemmas in the management of LBP are not made easier by the fact that there are few studies, which compare spinal fusion to a placebo procedure. Most spine surgery research compares one fusion technique to another or to a form of non-surgical treatment. According to a study published in the March 2020 edition of The Lancet , “Over the past 10 years there has been increasing recognition of the importance of the placebo effect, particularly how strong this effect could be for a surgical procedure that involves high-intensity medical care, strong analgesia, and often physiotherapy”. Findings of recent placebo-controlled surgical trials for common vertebroplasty procedures [a procedure for stabilizing compression fractures in the spine], in which special cement is injected into a fractured vertebra, “have been shown to be largely ineffective, but continue to be in common use”. Further, randomised clinical studies, which are regarded as providing the highest-quality evidence, suggest that spinal fusion has little advantage over a well-structured rehabilitation programme for LBP.

A study published in the December 2018 edition of the Journal of Internal Medicine analysed data from 33 randomized controlled trials and other studies comparing spinal fusion to nonoperative solutions for LBP and degenerative spine conditions, and concluded that, “The overwhelming evidence simply doesn’t support spinal fusion (and its high costs and risks) for back pain and degenerative spine conditions over nonoperative solutions”. A 2019 WHO Bulletin entitled ‘Care for low back pain: can health systems deliver?’ suggests that, “many healthcare systems are not designed to support physical and psychological therapies for LBP”, and stresses that, “major international clinical guidelines now recognize that many people with low back pain require little or no formal treatment”.

3. Uncertainties of diagnosing LBP

Adding to poor prognostic indicators are the difficulties of diagnosing LBP. The aetiology of LBP is rarely precisely identified. Findings also suggest that a pathoanatomical diagnosis of LBP can only be made in ~5% to 7% of patients. LBP in patients where no such diagnosis is possible is often labelled, unscientifically, “chronic LBP”.

A 2016 study suggests that in ~80% to 95% of patients with LBP the cause cannot be determined despite the existence of sophisticated imaging techniques and a plethora of diagnostic tests. It seems reasonable to suggest that challenges associated with diagnosing LBP could provide tacit support for clinicians to continue carrying out surgical procedures they were trained to perform.

4. Rapidly ageing populations

A rapidly increasing global geriatric population is a significant factor driving the growth of the spinal fusion market. According to the United Nations, ~16% of the world’s population will be ≥65 by 2050. In North America and Europe, ~25% of their respective populations will be aged ≥65 by 2050. Common disorders of old age include LBP and degenerative disc disorders.

Age is significant because most spinal fusion procedures are performed on individuals ≥60 living in wealthy nations. This age cohort is the fastest-growing demographic in the principal spine markets of the US, Western Europe, and Japan. For example, the US has ~49m people (~15% of the population) who are aged ≥65. This cohort is projected to reach ~84m by 2050. The EU-27 has ~90m people (~20% of the population) ≥65. By 2050 the EU population ≥65 is expected to reach ~130m. The population structure of the UK is similar to that generally observed in the EU-27 with ~12m people aged ≥65, ~18.5% of the population, which is projected to double by 2050. Japan has the oldest population in the world with ~36m people (~29% of the population) who are ≥65. By 2025, Japan’s ≥65 population is expected to decrease to ~33m, but the percentage of the population ≥65 is projected to increase to ~32%. It seems reasonable to suggest that these vast and rapidly increasing older population cohorts are significant drivers of the growth of age-related LBP and the consequent increasing incidence rates of spine surgeries.

Global life expectancy has continued rising and is expected to reach 77 years by 2050, up from 70 in 2015. The number of people ≥65, who account for most spine surgeries, will climb by >60% in the next 15 years: from ~0.6bn in 2015 to ~1bn by 2030. The phenomena of aging and shrinking populations, means that every year, a shrinking pool of working-age people are forced to support an expanding pool of ageing patients with LBP and degenerative disc disorders. In the medium to long term such support seems unsustainable.

5. Obesity

The prevalence of LBP in individuals ≥65 who are also obese is significantly higher than in people who are of average weight. Not only are the populations in the principal spine markets ageing, but they are also experiencing rising incidence rates of obesity. According to the World Health Organisation, obesity throughout the world has nearly tripled since 1975. Today, there are ~2bn adults overweight, of those, ~650m are obese [body mass index (BMI) ≥30 kg/m²]. In England ~28% of adults are obese and a further 36% are overweight. In the US, 43% of people ≥60 is obese. From 2000 to 2018, the prevalence of obesity in the US increased from 31% to 42%, and the prevalence of extreme obesity [BMI ≥40 kg/m²] increased from 5% to 9%.

6. High costs of spine surgeries

Most spine surgeries in the US have been covered by health insurance operating a fee-for-service model. A future Commentary describes how this model is changing. Notwithstanding, fee-for-service has meant that healthcare providers have been able to charge significant amounts for their services and oblige insurance companies to reimburse them, while inflicting minimal costs on patients. Although there is a paucity of studies which analyse recent trends in spinal fusion volume, utilization, and reimbursements, Medicare [a US national health insurance programme] payment trends have seen a decreasing allocation of reimbursements for surgeons generally. Research published in the October 2020 edition of The Spine Journal suggests that this, “may be the effect of value-based cost reduction measures, especially for high-cost orthopaedic and spine surgeries”.

Each year in the US, >$90bn is spent on low-back pain alone and ~1.6m spinal surgeries are performed. The cost of a single-level spinal fusion in a less expensive region of the US is ~US$65,000 for Medicare or ~US$100,000 with private insurance. In more expensive areas, such as New York or Los Angeles, these costs can grow by 2 to 3 times. In remote regions, such as eastern Wyoming and Alaska, high costs of surgical procedures can be a function of the scarcity of specialist clinicians. Such high costs could be an incentive for physicians to perform surgery. Research supports this by suggesting that clinicians are more likely to recommend surgery, even though it is neither the optimum nor the only treatment option available.

7. Benign reimbursement policies

Historically, in the US, third-party payors have tended to reimburse spine surgery for LBP more than non-invasive therapies. Insurers have also tended to reimburse surgical services rather than patient outcomes, although this is changing. For decades, the overwhelming percentage of patients bore little responsibility for the cost of spine surgeries. However, a 2016 New York Times article reported that reimbursement policies for spine surgery were beginning to change, and suggested that, “financial disincentives accomplished something that scientific evidence alone didn’t”. The Times article drew on findings of research published in the June 2016 edition of the journal Spine, which argued that, “spinal fusion rates continued to soar in the US until 2012, shortly afterwards Blue Cross of North Carolina said it would no longer pay”. It seems reasonable to assume that benign reimbursement policies helped to drive the increase in spine surgeries. However, following the Blue Cross decision other insurers followed, and US payors started to move away from a fee-for-service model towards reimbursing “value”. This shift, which is expected to continue, has slowed the growth rate of common spine surgeries.

Takeaways

Over the past three decades, the escalating prevalence of LBP, the challenges of diagnosing the condition, rapidly ageing populations, rising incidence rates of obesity, high costs of spine surgeries, and benign reimbursement policies, have all contributed to what has become a global spinal implant and devices industry. Such conditions encouraged an ecosystem in which the incidence rates of spine surgeries have soared, while LBP has persisted in a significant percentage of patients following surgery. Although the spine market is beginning to transform itself by moving away from a fee-for-service model towards a value-based model, which aims at providing patients with the best outcomes at the lowest cost, do not underestimate the time it will take for this transformation to succeed. Indeed, it seems reasonable to suggest that, given the structure and nature of the industry, the paradox that this Commentary attempts to explain will persist, at least for the near to medium term.

Post Scriptum

Findings of a 2016 study in the peer reviewed Malaysian Orthopaedic Journal conclude that, “The spine, unfortunately, has been labelled as a profit centre and there are allegations of conflicts of interest in the relationship of doctors with the multi-billion-dollar spinal devices industry. The spine industry has a significant influence not only on research publications in peer review journals, but also on decisions made by doctors, which can have a detrimental effect on the welfare of the patient”.

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Age of the aged and low back pain

HealthPad

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Neurosurgery

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minimally invasive spinal fusion

spinal fusion

In high-income countries populations are aging
By 2050 the world population of people over 60 is projected to reach 2bn
Age-related low back pain is the highest contributor to disability in the world
Over 80% of people will experience back pain at some point in their life
Older people with back pain have a higher chance of dying prematurely
The causes of back pain are difficult to determine which presents challenges for the diagnosis and management of the condition
The US $100bn-a-year American back pain industry is “ineffective”
Each year 10,000 and 300,000 spine fusion surgeries are carried out in the UK and US respectively
20% of spinal fusion surgeries are undertaken without good evidence
In 10 to 39% of spine surgery patients pain continues or worsens after surgeries

Age of the aged and low back pain

A triumph of 20^th century medicine is that it has created the “age of the aged”. By 2050 the world population of people aged 60 and older is projected to be 2bn, up from 900m in 2015. Today, there are 125m people aged 80 and older and by 2050 there is expected to be 434m people in this age group worldwide. The average age of the UK population has reached 40. Some 22% will be over 65 by 2031, and this will exceed the percentage of the UK population under 25. 33% of people born today in the UK can expect to live to 100. However, this medical success is the source of rapidly increasing age-related disorders, which present significant challenges for the UK and other high-income nations. Low back pain (LBP) is the most common age-related pain disorder, and ranked as the highest contributor to disability in the world.

At some point back pain affects 84% of all adults in developed economies. Research published in 2017 in the journal Scoliosis Spinal Disorders suggests that LBP is the most common health problem among older adults that results in pain and disability. The over 65s are the second most common age group to seek medical advice for LBP, which represents a significant and increasing workload for health providers. Each year back pain costs the UK and US Exchequers respectively some £5bn and more than US635bn in medical treatment and lost productivity. LBP accounts for 11% of the total disability of the respective populations. This Commentary discusses therapies for LBP, and describes the changing management landscape for this vast and rapidly growing condition.

Your spine and LBP

Your spine, which supports your back, consists of 24 vertebrae, bones stacked on top of one another. At the bottom of your spine and below your vertebrae are the bones of your sacrum and coccyx. Threading through the entire length of your vertebrae is your spinal cord, which transmits signals from your brain to the rest of your body. Your spinal cord ends in your lower back, and continues as a series of nerves, which resemble a horse’s tail, hence its medical name, ‘cauda equine’. Between each vertebra are discs. In younger people discs contain a high degree of water. This gives them the ability to act like shock absorbers. During the normal aging process discs lose much of their water content and degenerate. Such degenerative spinal structures may result in a herniated disc when the disc nucleus extrudes through the disc’s outer fibres, or a compression of nerve roots, which may lead to radiculopathy. This is a condition more commonly known as sciatica, which is pain caused by compression of a spinal nerve root in the lower back that is often associated with the degeneration of an intervertebral disc, and can manifest itself as pain, numbness, or weakness of the buttock and outer side of the leg.

Challenges in diagnosis

Because your back is comprised of so many connected tissues, which include bones, muscles, ligaments, nerves, tendons, and joints, it is often difficult for doctors to say with confidence what causes back pain even with the help of X-rays and MRI scans. Usually, LBP does not have a serious cause. In the majority of cases LBP will reduce and often disappear within 4 to 6 weeks, and therefore can be self-managed by keeping mobile and taking over-the-counter painkillers. However, in a relatively small proportion of people with LBP, the pain and disability can persist for many months or even years. Once LBP has been present for more than a year few people return to normal activities. There is not sufficient evidence to suggest definitive management pathways for this group that accounts for the majority of the health and social costs associated with LBP.

Assessing treatment options for back pain

Ranjeev Bhangoo, a consultant neurosurgeon at Kings’ College Hospital Trust, London, and the London Neurosurgery Partnership describes the nature and role of intervertebral discs and how treatment options should be assessed.

“When a person presents with a problem in the lower back, which might manifest as leg or arm pain, you need to ask 3 questions: (i) is the history of the pain compatible with a particular disc causing the problem? (ii) Does an examination suggest that a particular disc is causing a problem? And (iii) does a scan show that the disc you thought was the problem is the problem? If all 3 answers align, then there maybe some good reason to consider treatment options. If the 3 answers are not aligned, be weary of a surgeon suggesting intervention because 90% of us will experience back pain at some point in our lives, and 90% of the population don’t need back surgery.”

Back pain requiring immediate medical attention

Although the majority of LBP tends to be benign and temporary, people should seek immediate medical advice if their back pain is associated with certain red flags such as loss of bladder control; loss of weight, fever, upper back or chest pain; or if there is no obvious cause for the pain; or if the pain is accompanied by weakness, loss of sensation or persistent pins and needles in the lower limbs. Also, people with chronic lifetime conditions such as cancer should pay particular attention to back pain.

Epidemiology of LBP

Back pain affects approximately 700m people worldwide. A 2011 report by the US Institute of Medicine, estimates that 100m Americans are living with chronic back pain, which is more than the total affected by heart disease, cancer, and diabetes combined. This represents a vast market for therapies that include surgery and the prescription of opioids. Estimates of the prevalence of LBP vary significantly between studies. There is no convincing evidence that age affects the prevalence of back pain, and published data do not distinguish between LBP that persists for more than, or less than, a year. Each year LBP affects some 33% of UK adults, and around 20% of these - about 2.8m - will consult their GP. One year after a first episode of back pain, 62% of people still experience pain, and 16% of those initially unable to work are not working after 1 year. Typically in about 60% of cases pain and disability improve rapidly during the first month after onset.

Non-invasive therapies for LBP

The most common non-invasive treatment for LBP is non-steroidal anti-inflammatory drugs (NSAIDs), but also other pain medication may include paracetamol, oral steroids, gabapentin/pregabalin, opioids and muscle relaxants, antidepressants, chiropractic manipulation, osteopathy, epidural injections, transcutaneous electrical nerve stimulation (TENS), ultrasound that uses vibration to deliver heat and energy to parts of the lower back, physiotherapy, massage, and acupuncture.

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Prelude to surgery

Despite the range of non-invasive therapies for LBP, the incidence of lumbar spinal fusion surgery for ordinary LBP increased significantly over the past 2 decades without definitive evidence of the efficacy of the procedure. Recent guidelines from UK and US regulatory bodies have instructed doctors to consider more conservative therapies for the management of back pain, and this has resulted in the reduction in the incidence of spinal fusion surgeries.

Notwithstanding, because there has been clear recognition of the paucity of evidence for reliable rates of improvement following fusion for back pain surgery, it does not necessarily follow that fusions should never be done and indeed there are many instances where fusions are strongly supported by evidence. The gold standard for diagnosing degenerative disc disease is MRI evidence, which has formed the principal basis for surgical decisions in older adults. However, studies suggest that although MRI evidence indicates that degenerative change in the lumbar spine is common among people over 60, the overwhelming majority do not have chronic LBP.

Increasing prevalence of spinal fusion surgery

Each year, NHS England undertakes some 10,000 spinal surgeries for LBP at a cost of some £200m, which is in addition to the large and growing number of patients receiving epidurals that cost the NHS about £9bn a year, and they too have low evidence as to their efficacy. In the US more than 300,000 back surgeries are performed each year. In 10 to 39% of these cases, pain may continue or even worsen after surgery; a condition known as ‘failed back surgery syndrome’. In the US, about 80,000 new cases of failed back surgery syndrome are accumulated each year. Pain after back surgery is difficult to treat, and many patients are obliged to live with pain for the rest of their lives, which causes significant disability.

Back pain and premature death

A study by researchers from the University of Sydney published in 2017 in the European Journal of Pain found that older people with persistent chronic back pain have a higher chance of dying prematurely. The study examined the prevalence of back pain in nearly 4,400 Danish twins over 70. They then compared their findings with the death registry and concluded that, "Older people reporting spinal pain have a 13% increased risk of mortality per year lived, but the connection is not causal." According to lead author Matthew Fernandez, “This is a significant finding as many people think that back pain is not life-threatening.” Previous research has suggested that chronic pain can wear down peoples’ immune systems and make them more vulnerable to disease.

Spinal fusion

While recognizing that a relatively small group of elite spine surgeons, mostly from premier medical institutions, regularly carry out essential complex surgeries required for dire and paralysis-threating conditions such as traumatic injuries, spinal tumors, and congenital spinal abnormalities, the majority of procedures undertaken by a significant number of spine surgeons have been elective fusion procedures for people diagnosed with pain, which is referred to as “axial”, “functional” and “ non-specific”. People most likely to benefit from spine surgery are the young, fit and healthy. This is according to a study undertaken by the American Spine Research Association. Notwithstanding, the study also suggests that the typical American candidate for spinal fusion surgery is an overweight, over 55 year old smoker on opioids.

Steady growth projected for the spinal fusion market

The spine surgery market is relatively mature and dominated by a few global corporations: Medtronic, DePuy, Stryker, and Zimmer-Biomet. According to a 2017 report from the consulting firm GlobalData the market for spinal fusion, which includes spinal plating systems, interbody devices, vertebral body replacement devices, and pedicle screw systems is set to rise from approximately US$7bn in 2016 to US$9bn by 2023, representing a compound annual growth rate of 3.4%. The increasing prevalence of age-related degenerative spinal disorders, and continued technological advances in spinal fusion surgeries, such as expandable interbody cages and navigation systems, and the increased adoption of minimally invasive techniques, have driven this relatively steady market growth.

Spinal fusion surgery

Lumbar spinal fusion surgery has been performed for decades. It is a technique, which unites - fuses - 1 or more vertebrae to eliminate the motion between them. The procedure involves placing a bone graft around the spine, which, over time, heals like a fracture and joins the vertebrae together. The surgery takes away some spinal flexibility, but since most spinal fusions involve only small segments of the spine the surgery does not limit motion significantly.

Lumbar spinal fusion

Fusion using bone taken from the patient - autograft - has a long history of use, results in predictable healing, and currently is the “gold standard” source of bone for a fusion. One alternative is an allograft, which is cadaver bone that is typically acquired through a bone bank. In addition, several artificial bone graft materials have been developed, and include: (i) demineralized bone matrices (DBMs), which are created by removing calcium from cadaver bone. Without the mineral the bone can be changed into putty or a gel-like consistency and used in combination with other grafts. Also it may contain proteins that help in bone healing; (ii) bone morphogenetic proteins (BMPs), which are powerful synthetic bone-forming proteins that promote fusion, and have FDA approval for certain spine procedures, and (iii) ceramics, which are synthetic calcium/phosphate materials similar in shape and consistency to the patient’s own bone.

Different approaches to fusion surgery

Spinal fusion surgery can be either minimally invasive (MIS) or open. The former is easily marketable to patients because smaller incisions are often perceived as superior to traditional open spine surgery. Notwithstanding, open fusion surgery may be performed using surgical techniques that are considered "minimally invasive", because they require relatively small surgical incisions, and do minimal muscle or other soft tissue damage. After the initial incision, the surgeon moves the muscles and structures to the side to see your spine. The joint or joints between the damaged or painful discs are then removed, and then screws, cages, rods, or pieces of bone grafts are used to connect the discs and keep them from moving. Generally, MIS decreases the muscle retraction and disruption necessary to perform the same operation, in comparison to the traditional open spinal fusion surgery, although this depends on the preferences of individual surgeons. The indications for MIS are identical to those for traditional large incision surgery. A smaller incision does not necessarily mean less risk involved in the surgery.

There are three main approaches to fusion surgery, (i) the anterior procedure, which approaches your spine from the front and requires an incision in the lower abdomen, (ii) a posterior approach is done from your back, and (iii) a lateral approach from your side.

Difficulty identifying source of back pain

A major obstacle to the successful treatment of spine pain by fusion is the difficulty in accurately identifying the source of a patient’s pain. The theory is that pain can originate from spinal motion, and fusing the vertebrae together to eliminate the motion will get rid of the pain. Current techniques to precisely identify which of the many structures in the spine could be the source of a patient’s back pain are not perfect. Because it can be challenging to locate the source of pain, treatment of back pain alone by spinal fusion is somewhat controversial. Fusion under these conditions is usually viewed as a last resort and should be considered only after other nonsurgical measures have failed.

Spinal fusion surgery is only appropriate for a very small group of back pain sufferers

Nick Thomas, also a consultant neurosurgeon at King’s College Hospital Trust, London and the London Neurosurgery Partnership suggests there are a scarcity of preoperative tests to indicate whether spinal lumbar fusion surgery is appropriate, and stresses that spinal fusion is appropriate only for a small group of patients who present with back pain.

“The overwhelming majority of patients who present with low back pain will be treated non operatively. In a few very select cases, spinal fusion may be appropriate. A challenge in managing low back pain is that there are precious few pre-operative investigations that give a clear indication of whether a spinal fusion may or may not work. Even with MRI evidence it can be very difficult to determine whether changes in a disc are the result of the normal process of degeneration or whether they reflect a problem that might be generating the back pain. If patients fail to respond to non-operative treatments they may well consider spinal fusion. A very small group of patients, who present with a small crack in one of the vertebrae bones - pars defect - or slippage of the vertebrae - spondylolisthesis - may favorably respond to spinal fusion. In patients where the cause of the back pain is less clear the success rate of spinal fusion is far less.” See video:

Back pain industry

In a new book entitled Crooked published in 2017, investigative journalist Cathryn Jakobson Ramin suggests that the US $100bn a year back pain industry is, “often ineffective, and sometimes harmful”. Ramin challenges the assumptions of a range of therapies for back pain, including surgery, epidurals, chiropractic methods, physiotherapy, and analgesics. She is particularly damning about lumbar spinal fusion surgery. In the US 300,000 of such procedures are carried out each year at a cost of about $80,000 per surgery. Ramin suggests these have a success rate of 35%.

Over a period of 6 years Ramin interviewed spine surgeons, pain specialists, physiotherapists, and chiropractors. She also met with patients whose pain and desperation led them to make life-changing decisions. This prompted her to investigate evidence-based rehabilitation options and suggest how these might help back pain sufferers to avoid the range of current therapies, save time and money, and reduce their anxiety. According to Ramin people in pain are poor decision makers, and the US back pain industry exemplifies the worst aspects of American healthcare. But this is changing.

New Guidelines for LBP

In February 2017, the American College of Physicians published updated guidelines, which recommended surgery only as a last resort. Also, it said that doctors should avoid prescribing opioid painkillers for relief of back pain, and suggested that before patients try anti-inflammatories or muscle relaxants, they should try alternative therapies such as exercise, acupuncture, massage therapy or yoga. Doctors should reassure their patients that they would get better no matter what treatment they try. The guidelines also said that steroid injections were not helpful, and neither was paracetamol, although other over-the-counter analgesics such as aspirin or ibuprofen could provide some relief. The UK’s National Institute for Health and Care Excellence (NICE) has also updated its guidelines (NG59) for back pain management. These make it clear that in a significant proportion of back pain surgeries is not efficacious. The new guidelines instruct doctors to recommend various aerobic and biomechanical exercise, NHS England and private health insurers are changing their reimbursement policies. As a consequence the incidence of back surgeries have fallen significantly.

In perspective

Syed Aftab, a Consultant Spinal Orthopaedic Surgeon at the Royal London, Barts Health NHS Trust, welcomes the new guidelines, but warns that, “We should be careful that an excellent operation preformed by some surgeons on some patients does not get ‘vilified’. If surgeons stop preforming an operation because of the potential of being vilified, patients who could benefit from the procedure lose out”.

Surgical cycle

“There seems to be a 20-year cycle for surgical procedures such as lumbar fusion. The procedure starts, some patients benefit and do well. This encourages more surgeons to carry out the procedure. Over time, indications become blurred, and the procedure is more widely used by an increasing number of surgeons. Not all patient do well. This leads to surgeons being scrutinized, some vilified, the procedure gets a bad name, surgeons stop preforming the operation, and patients who could benefit from the procedure lose out,” says Aftab, who is also a member of Complex Spine London, a team of spinal surgeons and pain specialists who focus on an evidence based multidisciplinary approach to spinal pathology.

Takeaway

LBP is a common disabling and costly health challenge. Although therapies are expensive, not well founded on evidence, and have a relatively poor success rate, their prevalence has increased over the past 2 decades, and an aging population does not explain this entirely. Although the prevalence of lumbar spinal fusion surgery has decreased in resent years, the spine has become a rewarding source of income for global spine companies, and also there have been allegations of conflicts of interest in this area of medicine. With the new UK and US guidelines the tide has changed, but ethical questions albeit historical still should be heeded.

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10 years, 11 months ago