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The Clinical Journal of Pain

18:355–365 © 2002 Lippincott Williams & Wilkins, Inc., Philadelphia

Clinical Effectiveness and Cost-Effectiveness of Treatments for


Patients With Chronic Pain
Dennis C. Turk, Ph.D.
University of Washington, Seattle, Washington, U.S.A.

Abstract:
Objective: Chronic pain is a prevalent and costly problem. This review addresses
the question of the clinical effectiveness and cost-effectiveness of the most common
treatments for patients with chronic pain.
Data Sources: Representative published studies that evaluate the clinical effective-
ness of pharmacological treatments, conservative (standard) care, surgery, spinal cord
stimulators, implantable drug delivery systems (IDDSs), and pain rehabilitation pro-
grams (PRPs) are examined and compared. The cost-effectiveness of these treatment
approaches is also considered.
Data Synthesis: Outcome criteria including pain reduction, medication use, health
care consumption, functional activities, and closure of disability compensation cases
are examined. In addition to clinical effectiveness, the cost-effectiveness of PRPs,
conservative care, surgery, spinal cord stimulators, and IDDSs are compared using
costs to return a treated patient to work to illustrate the relative expenses for each of
these treatments.
Conclusions: There are limitations to the success of all the available treatments. The
author urges caution in interpreting the results, particularly in comparisons between
treatments and across studies, because there are broad differences in the pain syn-
dromes and inclusion criteria used, the drug dosages, comparability of treatments, the
definition of “chronic” used, the outcome criteria selected to determine success, and
societal differences. None of the currently available treatments eliminates pain for the
majority of patients. Pain rehabilitation programs provide comparable reduction in pain
to alternative pain treatment modalities, but with significantly better outcomes for
medication use, health care utilization, functional activities, return to work, closure of
disability claims, and with substantially fewer iatrogenic consequences and adverse
events. Surgery, spinal cord stimulators, and IDDSs appear to have substantial benefits
on some outcome criteria for carefully selected patients. These modalities are, how-
ever, expensive. Pain rehabilitation programs are significantly more cost effective than
implantation of spinal cord stimulators, IDDSs, conservative care, and surgery, even
for selected patients. Research is needed to identify which patients are most likely to
benefit from the available treatments and to study combinations of the available treat-
ments since none of them appear capable of eliminating pain or significantly improv-
ing functional outcomes for all treated.
Key Words: Anticonvulsants—Antidepressants—Implantable drug delivery sys-
tems—Opioids—Pain rehabilitation program—Spinal cord stimulation.

Received April 27, 2002; accepted April 27, 2002.


CHRONIC PAIN: NUMBERS OF
Preparation of this article was supported in part by grants from the PEOPLE AFFECTED
National Institute of Arthritis and Musculoskeletal and Skin Diseases
(AR/AI44724, AR47298), and the National Institute of Child Health Surveys in several Western countries confirm that
and Human Development/National Center for Medical Rehabilitation chronic and recurring pain is a significant problem for a
Research (HD33989). Preparation of this article and the special section in
which it appears was supported by an unrestricted educational grant from substantial proportion of the population. Verhaak et al.1
Pfizer to the University of Rochester Office of Professional Education. reviewed 15 epidemiologic studies and noted that in the
Address correspondence and reprint requests to Dennis C. Turk, adult population chronic pain ranges from 2% to 40%,
Ph.D., Department of Anesthesiology, Box 356540, University of
Washington, Seattle, Washington 98195, U.S.A.; e-mail: turkdc@ and they concluded that the median point prevalence
u.washington.edu (reports of pain at the time of survey, therefore not

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356 TURK

dependent on recollection) of 15% of the adult popula- pain actually interfered with their daily activities. In a
tion reported chronic pain. In comparison, epidemiologic primary care cohort in the United States, 13% of head-
studies in lower income countries (i.e., Nepal, India, Ni- ache and 18% of back pain patients asserted that they
geria, China, Indonesia, and the Philippines) indicate were unable to obtain or maintain full-time work over a
comparable point prevalence rates (18.5%), but for back 3-year period because of their pain.10
pain alone.2 Another way to view the data on chronic pain is to
Examination of the largest categories of chronic pain examine health care use. In the United States, 17% of
syndromes shows that the vast majority of persons have patients seen in primary care report persistent pain.11
symptoms that are not related to demonstrable diseases Based on a national survey of pain specialists conducted
such as low back pain and headache.3 In the Netherlands, in 1995, the authors12 estimated that 2.9 million Ameri-
over 10,000 new cases of work-related disability are re- cans (1.1% of the population) are treated annually by
ported annually.4 In the United Kingdom, 12.5% of all health care professionals specializing in chronic pain.
unemployed people cite back pain as the reason.5 An This figure does not, of course, include patients treated
estimated 2.5 million people reported having back pain by primary care physicians or specialists who do not
every day of the year.5 consider themselves pain specialists, nor does it include
Back pain is one of the most common sources of dis- visits to practitioners of complementary and alternative
ability as well as pain. Volinn2 identified seven epide- medicine modalities, or self-medication using over-the-
miologic studies conducted in Britain, Belgium, Ger- counter preparations.
many, and Sweden that reported on the point prevalence The figures cited here attest to the significant numbers
of low back pain. Weighting the percentages by the of people who report that they experience chronic pain
sample size and aggregating across studies reveal that the
and that pain significantly impacts their lives. Chronic
rates of back pain in these countries averages approxi-
pain not only affects the individual sufferer but his or her
mately 34%, almost twice that reported in surveys con-
“significant others.” If we consider spouses, partners,
ducted in the less developed countries noted previously.2
family members, then the absolute numbers of people in
Several epidemiologic studies have been published
the population affected by pain expands geometrically,
since the Verhaak et al.1 and Volinn et al.2 reviews. In a
leaving only a minority of the population untouched.
large-scale telephone survey conducted in Australia, ap-
Few, if any, people will completely avoid an intimate
proximately 17% of male respondents and 20% of fe-
relation with persistent pain symptoms at some time dur-
male respondents reported the presence of some form of
chronic pain.6 In the Welsh Health Survey more than ing their lives.
30% of respondents reported that they experienced back
pain, and 25% of the adults indicated that they had pain COSTS OF CHRONIC PAIN
associated with arthritis.7 In a mail survey conducted in
Sweden, 34.5% of the population indicated the presence Clinicians have an extensive armamentarium available
of persistent pain for at least three months.8 A survey to treat people with chronic pain—pharmacological
conducted in Scotland found that more than 50% of re- preparations (e.g., opioids, nonsteroidals, anticonvul-
spondents reported chronic pain.9 The wide range (20% sants, tricyclic antidepressants, NMDA antagonists, topi-
to 50%) may be due partially to the sampling methods cal preparations), operative procedures, physical modali-
used, the definition of chronicity, the type of measure, ties (e.g., ultrasound, transcutaneous electrical nerve
the focus on specific body locations, the phrasing of the stimulation, diathermy), regional anesthesia, neuroaug-
questions, and the sample size included. Despite the dis- mentation modalities (e.g., spinal column stimulators
crepancies, there seems no question that, when asked, a [SCSs], implantable drug delivery systems [IDDSs]),
significant proportion of the population will indicate that comprehensive pain rehabilitation programs (PRPs)
they experience chronic pain. (e.g., interdisciplinary pain centers, functional restora-
The figures cited must be viewed with some caution tion programs), and complementary and alternative
because response to mail and telephone surveys may lead medicine modalities (e.g., chiropractic, acupuncture).
to inflated estimates of the prevalence of symptoms. It is The direct costs for the totality of various treatment
reasonable to consider the behavioral impact of symp- approaches are astronomical and underscore the ex-
toms for those who report they have chronic pain—in tremes undertaken to avert the human suffering associ-
particular, are those who report chronic pain impaired or ated with chronic pain. Cousins13 suggested that the
disabled by these symptoms. The results of the Australia costs of health care for patients with chronic pain might
survey6 noted that approximately 35% of those who exceed the combined costs of treating patients with coro-
specified that they experienced chronic pain reported that nary artery disease, cancer, and AIDS. In the United

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EFFECTIVENESS OF TREATMENTS 357

Kingdom, back pain alone is estimated to cost society tions also varies by location. Again, in Atlanta, Straus23
$11 billion to $20.6 billion each year14 (note that all cost reported that one frequently prescribed anticonvulsant
estimates used in this article are converted to U.S. dol- medication for neuropathic pain, Neurontin (Parke-
lars). Direct costs associated with migraine in the United Davis, Morris Plains, NJ, U.S.A.), cost $1.19 for each
States are estimated to be in excess of $1 billion (1993 300-mg tablet. Based on the data provided by Straus,
rates).15 De Lissovy et al.16 estimated that, in the United failed back surgery patients would spend almost $1,300
States, the cost of treatment in the first year after failed a year for Neurontin alone. This is a relatively conser-
back surgery for pain was approximately $18,883 (1997 vative figure because patients may be prescribed up to
dollars). Health care expenditures comprise only a rela- four times the dosage stipulated by Straus.
tively small portion of the costs associated with chronic Approximately 317,000 lumbar surgeries are per-
pain. The majority of the costs are associated with dis- formed each year, primarily for pain, at a conservatively
ability compensation, lost productivity, and lost tax rev- estimated cost of $15,000 per operation.24 Using these
enue. Frymoyer and Durett17 projected the costs for back figures, the cost of lumbar surgery in the United States
pain, the most prevalent chronic pain syndrome, to ex- would exceed $4.8 billion each year. There are, of
ceed $33.6 billion for health care, $11 to $43 billion for course, many other forms of surgery to alleviate pain
disability compensation, $4.6 billion for lost productiv- other than lumbar surgery (e.g., carpel tunnel release,
ity, and $5 billion in legal services. Indirect costs asso- cervical neurectomy).
ciated with migraine are anticipated to exceed $13 billion Based on the Marketdata survey cited earlier,12 only
each year in the United States (1993 dollars).15 Again about 176,850 (6% of those treated by pain specialists) of
using United States data, patients with rheumatoid arthri- chronic pain patients are treated at PRPs. Using the av-
tis are projected to incur over $14 billion (year 2000 erage figure of $13,28420 for nonsurgical health care
dollars) in medical expenditures and work loss.18 Pain is expenditures, seven years as the mean duration of pain,
costly not only in the United States. In the state of Vic- and the mean number of surgeries 1.725 at an average
toria [Melbourne], Australia, for example, over $151 cost of $15,000,17 we can estimate the cost of health care
million was paid out in claims for back pain in 1996– alone before treatment of patients at PRPs to be in excess
97.19 of $20 billion. Involvement of multiple disciplines at a
The annual health care costs incurred by a chronic PRP is labor-intensive and costly because each of the
pain patient, excluding costs for surgical procedures, clinicians involved in treatment expects to receive pay-
may range from $500 to as high as $35,400, with the ment for the services provided. Based on the average cost
averages ranging from $12,900 to $18,833 annually of treatment at PRPs ($8,100)12 and the number treated
(1988–1997 dollars).16,20,21 The vast majority of chronic (176,850), the annual cost of treatment at PRPs would
pain patients are managed with medication. Over the past exceed $1.4 billion (1995 dollars).
decade there has been a surge of articles extolling the Over the past quarter century technological advances
virtues of opioids to treat chronic pain that is not asso- have resulted in a number of sophisticated implantable
ciated with cancer and a recognition that the negative devices (i.e., SCS, IDDS) that are used to treat patients
consequences previously feared (e.g., addiction, drug di- with chronic pain. Segal and Stacey26 suggested that, by
version) are not as common as previously thought in this 1996, 10,000 SCSs had been implanted worldwide, with
patient population. In 1999, more than 3 million pre- 7,000 implanted in the United States. Bell et al.21 pro-
scriptions were written for one opioid, Oxycontin (Pur- jected that the five-year costs required for treating and
due Pharma L.P., Norwalk, CT, U.S.A.).22 The costs of maintaining patients with SCSs in the United States
drugs will vary by location. The cost of one 20-mg tablet would equal $76,180. Thus, in the United States by 1996,
of Oxycontin in two locations in Atlanta, Georgia, in more than a half billion dollars had been committed to
2000 ranged from $2.22 to $2.56/tablet.23 Straus noted these devices, related services, and treatment of adverse
that a typical patient with failed back surgery syndrome events.
in two practices in Atlanta might, along with NSAIDS Implantable drug delivery systems are being advo-
and other drugs (e.g., muscle relaxants, antidepressants, cated to treat recalcitrant chronic pain.27 This technology
anxiolytics, anticonvulsants), be prescribed five 20-mg can be expensive. The initial costs for screening and
tablets of Oxycontin a day. The costs for Oxycontin hospital and professional charges can range from
alone would exceed $4,600 per year, not including re- $15,000 to $30,000 (1997 dollars). De Lissovoy et al.16
lated physician visits or laboratory work. suggested that the five-year costs would range from
There has been growing support for the use of anti- $82,893 to $125,102. If the annual costs for medical
convulsants, antidepressants, and topical preparations for management range from $13,000 to $19,000, however,
neuropathic pain syndromes. The cost for these medica- then the treatment with IDDSs would be expected to

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358 TURK

“break even” in from 4 to 10 years. Similar calculations may mask the results of the efficacy of different treat-
for SCSs suggest that the five-year expected costs would ments with different samples.
be $76,180 and thus the break-even point would occur in At a recent consensus meeting of specialists who treat
4 to 6 years. neuropathic pain, tricyclic antidepressants, anticonvul-
What is evident from these figures is that chronic pain sant drugs, and topical preparations were viewed as the
is both prevalent and is, regardless of how it is treated, treatments of choice.32 Seldom, however, do these phar-
exceedingly expensive. Despite the high cost of treating macological agents reduce pain below a rating of 4 on an
chronic pain, relief for many pain sufferers remains elu- 11-point visual analog scale (e.g., 0–10 with 10 being the
sive and total elimination of pain is rare. As we shall see highest level of pain) with 30% to 40% of patients re-
in what follows, although there have been phenomenal porting at least 50% reduction in pain.33,34 A common
advances in the knowledge of sensory physiology, outcome criterion used in drug trials is the “number
anatomy, and biochemistry, along with the development needed to treat” (NNT) to achieve a 50% reduction in
of potent analgesic medications and other innovative pain beyond what would have been achieved with a pla-
medical and surgical interventions, we have not elimi- cebo. Several meta-analyses have reported using this cri-
nated pain and disability as problems for a significant terion for a range of antidepressant and anticonvulsant
portion of the population. medications for different pain syndromes, primarily neu-
A number of criteria have been used to evaluate the ropathic pain. Pooling the data from these trials reveals
effectiveness of different pain treatment approaches and that the NNTs to achieve 50% pain reduction was 2.9.33
modalities. Self-reports of pain and adverse events are That is, for every three people receiving an antidepres-
the most commonly used endpoints. Other criteria exam- sant or anticonvulsant for their pain, one will experience
ined include functional activities, “return to work” at least a 50% pain relief that would not have occurred
(RTW), health care utilization, and, to a lesser extent,
with a placebo. Conversely, two of the three treated pa-
reduction in disability compensation. In the remainder of
tients will have less than a 50% reduction in pain. I will
this article I will examine the clinical effectiveness and
return to the criteria on which to base conclusions about
cost-effectiveness of the most common treatments used
clinical effectiveness later. As is the case for opioids, the
for patients with chronic pain.
duration of trials for antidepressants and anticonvulsants
is relatively brief, usually less than 3 months.
PAIN REDUCTION Obviously, medications do not eradicate all pain for
the majority of patients treated. This does not mean that
The first-line treatment of pain consists of a host of
pharmacological agents. Pain medications are the second these drugs are not beneficial, only that we need to be
most prescribed drugs (after cardiac-renal drugs) during cautious in what outcomes can reasonably be expected.
visits to physicians’ offices and emergency rooms,28 ac- The data also suggest that there is a need to consider
counting for 12% of all medication prescribed during treatment combinations that may potentially improve
ambulatory office visits in the United States.29 Pharma- outcomes since these drugs do not completely eliminate
ceutical industry data indicate that over 312 million pre- the problem of pain.
scriptions for analgesic medications were written in 2000 Persistence of back pain, and, to a lesser extent, other
in the United States, more than one prescription for an- chronic pain syndromes, frequently leads to surgery. A
algesics for every man, woman, and child (Merck, per- number of studies,35–38 however, reveal that significant
sonal communication, November, 2001)! pain may persist after surgery. For example, Lehmann et
Despite their frequent use, currently available medi- al.37 showed that 75% of patients who had spinal fusion
cations do not eliminate pain. For example, the average for back pain continued to report pain after surgery;
pain reduction for patients placed on “long-term opioids” Dvorak et al.35 studied 575 back pain patients who had
is approximately 32%, when effects reported in studies surgery herniated disks and noted that 70% continued to
are weighted by sample size.31 I placed long-term opioid report back pain up to 17 years after surgery; and North
therapy in quotation marks because the duration of the et al.38 noted that 66% of patients who underwent repeat
majority of the published trials ranges from a week to surgery for back pain continued to experience pain five
several months.31 years after surgery.
A word of caution here and throughout this article Several studies of SCSs have reported impressive re-
where I reported on averaged data across studies. Often sults in pain reduction for carefully selected patients with
diverse pain syndromes, medications, surgical proce- pain of long duration. For example, in a well-designed
dures, and studies conducted in different countries are study, North et al.39 reported on a long-term follow-up
included in the aggregation. This combination of factors (mean 7 years) for a consecutive series of patients. They

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EFFECTIVENESS OF TREATMENTS 359

noted that 52% of 171 patients receiving permanent im- 11 of 22 patients achieved at least a 25% reduction in
plants reported at least 50% relief of pain and 60% in- pain.
dicated that they would undergo the procedure again The reduction of pain after treatment at PRPs has been
even though they still continued to have at least some reported to be statistically significant in several meta-
pain. In a systematic review, Turner et al.40 reviewed 39 analyses25,49,50, with one meta-analysis25 reporting the
studies of SCSs for low back pain and concluded that, on mean pain reduction for patients treated at PRPs as 37%.
average, 59% of patients had at least a 50% reduction in The majority of patients continue to experience consid-
pain. erable pain. The rates of reduction in pain across differ-
More recently, however, Van Buyten et al.41 reported ent treatment modalities are displayed in Fig. 1. It is
that, four years after implantation with an SCS, 61% of important to acknowledge once again that none of the
patients continued to report that their pain ranged from available treatments for chronic pain have been demon-
“uncomfortable” to “horrible”; 37% fewer of the patients strated to eliminate all pain for all patients.
rated their pain in this category at follow-up than before Interestingly, the pain reduction achieved at PRPs is
implantation. One caution in interpreting these results: accompanied by a significant decrease (63%) in prescrip-
the follow-up excluded 22 patients who had the stimu- tion pain medication.25 A number of SCS studies report
lators removed, 20 who could not be contacted, and an- significant reductions in consumption of analgesics. For
other 22 who had died (none attributed to the SCS). example, Ohnmeiss et al.51 reported that, two years after
Burchiel et al.42 presented one-year follow-up data and implantation, 84% of patients decreased or eliminated
reported that 40% of implanted patients indicated at least opioids. North et al.39 reported that 58% of patients
a 50% reduction in pain. The absolute percentage of treated with SCSs demonstrated a reduction in, or elimi-
average change in pain severity, as reported on a visual nation of, analgesic medication consumption, and in a
analog scale (range 0–10), was only 18.6%, decreasing retrospective study, Kumar et al.52 reported that 40% of
from 7.31 to 5.95. These data raise a question regarding patients no longer used prescription analgesics. In con-
the meaning of categorical ratings of percent pain reduc- trast, however, a prospective study by Burchiel et al.42
tion. The reduction in pain of 18.6% would not reach the found that only 7% of patient reported elimination of
criterion of clinical significance—a 33% reduction.43 opioid use one year after the implant. In one recent study,
Moreover, the data indicate that patients still continued SCSs have been reported to reduce consumption of opi-
to experience substantial pain severity after receiving the oids by 35%.41 One study53 noted a 76.7% decrease in
implant. oral pain medication after implantation of an intraspinal
Significant reductions of pain have also been reported infusion system. The medication-sparing effects for im-
for IDDSs for both chronic pain associated with cancer plantable therapies and PRPs can provide significant sav-
and other pain syndromes (e.g., back pain). Good to ex- ings, in costs for medication and health care.
cellent results have been reported in most published stud-
ies. For example, Hassenbusch et al.44 and Paice et al.45 IATROGENIC COMPLICATIONS AND
both reported a mean pain reduction of approximately ADVERSE EVENTS
60% after epidural infusions in mixed samples of pa-
tients with different pain syndromes. In a small study (n At least as important as reduction in pain severity
⳱ 16), Kumar et al.46 reported a mean 57.5% reduction is the potential for iatrogenic complications and ad-
in pain at a follow-up of over two years, with 44% (n ⳱ verse events to result from treatment. Selection of any
7) patients reporting greater than 50% reduction in pain.
These results are particularly impressive since the pa-
tients who were included had had inadequate pain con-
trol after conservative approaches, long-term use of opi-
oids, and implantation of an SCS.
It is important to be alert to the mixed diagnosis of
patients treated across and within studies using the same
treatment, since some syndromes may be more or less
responsive to the treatment. For example, in contrast to
the Hassenbusch et al.44 and Paice et al.45 studies, Has-
senbusch et al.47 found that pain reduction was only 39%
for a sample of patients with neuropathic pain who were
implanted, and, in a mixed sample of predominantly neu- FIG. 1. Mean percentage of pain reduction after treatments for
ropathic pain, Anderson and Burchiel48 found that only chronic pain.

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360 TURK

intervention must balance the positive outcomes with sant medication.59–62 Similarly, outcomes studies for re-
potential negative consequences. Each of the treatments gional anesthesia ignore RTW as an outcome. Only 1 of
for chronic pain patients, perhaps with the exception of 14 studies examining the efficacy of regional blockage
PRPs, has the potential for undesirable consequences. for complex regional pain syndrome included functional
Long-term use of medication raises concerns about measures as outcomes.63
tolerance, tolerability, drug diversion (i.e., opioids), and Similar to the pharmacological studies, outcomes re-
side effects including neurotoxicity (e.g., 33,54). There are search for IDDSs rarely attends to the impact of treat-
always contraindications based on the patient’s medical ment on functioning. In the 18 studies described in a
condition, age, childbearing status, co-occurring medical recent review of intrathecal morphine,64 only 4 included
conditions, and other medications prescribed. outcomes related to functional activities. When func-
Studies have reported that a significant percentage of tional outcomes are reported, the results are not particu-
chronic pain patients treated with surgery report that larly impressive. For example, Paice et al.45 noted that
their pain is worse after surgery.36–38 Malter et al.55 re- only 22.8% of a mixed sample of cancer and noncancer
ported complication rates of 18% and 7% for back pain patients with pain treated with IDDS reported “great”
patients having lumbar surgery involving fusion and with increases in activities of daily living; however, 24.6%
laminectomy or discectomy alone, respectively. Reop- reported no change, and 3.8% indicated a decrease in
eration rates were 18% and 15% for fusion and nonfu- functional activities.
sion patients. Up to 33% of back surgeries are repeated In contrast to pharmacological, regional anesthesia,
because of problems associated with previous surgery.56 and IDDS studies, investigators evaluating the effective-
Subsequent operations do not guarantee resolution of ness of SCSs, surgery, and PRPs have, more frequently,
pain, with some studies acknowledging the poor results considered changes in functional outcomes along with
achieved for reoperations.38,57 Bell et al.21 suggested that pain severity. For example, in a retrospective study of
there is a 10% probability of a repeat surgery in every SCSs, Van Buyten et al.41 noted a 26.6% improvement in
succeeding year after lumbar surgery. daily activities at follow-up. Kumar et al.46 found a
In a systematic review of 13 outcome studies for 37.5% reduction in the number of patients reporting re-
SCSs, Turner et al.40 reported that on average, 42% of strictions in their activities after implantation of an
patients experienced complications requiring interven- IDDS. Interestingly, Gallon65 noted that 58% of back
tions related to the procedure itself or malfunctions of the pain patients who had surgery described themselves as
device. Although many of the complications are minor, worse on a measure of physical functioning, compared
some require substantial medical or surgical intervention with 30% of patients who indicated they were more dis-
and, consequently, cost. abled after standard care. In their meta-analysis, Flor et
al.25 reported a 43% increase in physical activities after
treatment in PRPs.
PHYSICAL FUNCTIONING
Many studies reporting on changes in physical activi-
Outcomes regarding changes in pain severity are de- ties have relied on patients’ self-reports. A more objec-
pendent on patients’ self-reports. Many factors can bias tive measure of function is RTW. There are caveats that
patients’ responses. Moreover, the relation between pain need to be taken into consideration, however, when con-
reports and functional behavior is modest. As a conse- sidering RTW rates. The actual return to work may have
quence, evaluation of the effectiveness of pain treatment little to do with the readiness of a person to resume
approaches should consider functional outcomes such as job-related activities.66 For example, the mean duration
improvement in physical activity and, when appropriate, of pain for patients treated at PRPs is 7 years,25 and
RTW, along with reductions in pain severity. someone who has been away from work for such a long
Inspection of the pharmacological studies for pain re- period may not have a job to return to and may find skills
veals a striking lack of attention to functional outcomes. outdated, making return to the previous job difficult.
For example, in one systematic review of antidepressants Economic factors (e.g., the job market) will also influ-
for neuropathic pain,34 only 1 of 20 studies included any ence whether someone returns to gainful employment
indication of improvements in physical functioning after after treatment. Finally, administrative decisions regard-
initiation of treatment. The emphasis in the pharmaco- ing appropriateness of RTW may be primary, with little
logical literature is almost exclusively on pain relief and consideration given to the presence of the patients’
adverse events. There are no data demonstrating that sig- symptoms or physical capacities. These limitations, how-
nificant numbers of patients return to work and minimal ever, apply equally to all treatments, so even though
data on improvement in functioning after long-term opi- there are significant limitations, RTW rates can be used
oids,58 tricyclic antidepressants,33,35,59–61 or anticonvul- to compare different pain treatments.

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EFFECTIVENESS OF TREATMENTS 361

Rates of RTW after lumbar surgery have been re- Health care utilization
ported to be as low as 20%.38 One recent study reported One way to consider cost-effectiveness is to evaluate
a 50% RTW rate after radiofrequency facet joint dener- reduction in health care utilization. The results of the
vation in the treatment of low back pain.67 At first this meta-analysis by Flor et al.25 indicate that, after treat-
outcome seems quite impressive; however, the group of ment at PRPs, patients required one third the number of
patients treated with sham therapy showed the same rate surgical interventions and hospitalizations compared
of RTW. These sobering results underscore the necessity with patients treated by alternative medical and surgical
of developing and using appropriate placebo treatments. care. Beyond the professional costs and facility charges
Studies of patients who have been implanted with for medical and surgical treatments, an additional factor
SCSs suggest that from 5% to 31% eventually return to contributing to the comparative cost benefits for PRPs, in
work.38,39,46,68 One of the few studies on the results of contrast with neuroaugmentative modalities and long-
IDDSs on the RTW criterion indicates that none of the term opioid therapy, is that minimal medical monitoring
patients (n ⳱ 16) returned to gainful employment.46 of patients treated at PRPs is required.
These outcomes can be compared with the RTW rates Simmons et al.20 reported a 62% reduction of medical
reported for patients treated at PRPs that range from 48% costs after treatment at a PRP. If we extrapolate the sav-
to 65%.25 The outcomes after treatment at PRPs are quite ings reported by Simmons et al. to the 2,318 patients
impressive given the long pain duration (mean ⳱ 7 successfully treated in PRPs reported in the meta-
years) for treated patients. analysis by Flor et al.,25 factoring the cost of treatment at
the PRP, a savings of over $18 million in medical ex-
CLOSURE OF DISABILITY CLAIMS penses would accrue during the first year after treatment.
These figures are for the first year’s medical expenses
Disability payments may exceed medical costs for per-
only and do not reflect savings in reduced disability pay-
sons with chronic pain by a factor of five. An important
ments, gains in productivity, and gains in revenue from
outcome, at least from a societal perspective, is closure
taxes paid by the successfully treated patients.
of disability claims. Once again, I need to invoke a cau-
Of course, reduction in medication is not a goal of
tion. As in the case for RTW, closure of disability claims
pharmacological treatments. Rather the intent is to have
may depend on administrative decisions and not on pain
patients take appropriate and adequate doses of medica-
per se. Only outcomes studies for PRPs and one for
tion to reduce their pain and thereby improve the quality
SCS42 have reported on changes in disability claims after
of their lives.
treatment. Flor et al.25 note an approximately 50% reduc-
Using the figure of 176,000 patients treated at PRPs12
tion in rates of disability after treatment at PRPs. This rate
and the figures for health care expenditures described
can be compared with the study of SCSs conducted in the
above, I estimate that the medical cost savings during the
United States42 that reported a 20% reduction (not statisti-
first year after treatment at PRPs at more than $1.87
cally significant) in disability status one year after implant.
billion. Bell et al.21 suggest that the annual medical costs
Recently, Thomsen et al.69 used social records instead
for failed back syndrome patients is $12,900 (including
of self-reports to evaluate the efficacy of a PRP, obtain-
hospitalization, physician visits, medications, alternative
ing data on disability and welfare costs for a period of 6
therapies, diagnostic procedures, rehabilitation, and other
months before entry to a 4-month waiting list and at a
therapies). Using the figure of 68% reduction in health
9-month follow-up after termination. The authors identified
care expenses in the year after treatment at a PRP re-
significant reductions in social transfers (welfare benefits,
ported by Simmons et al.,20 I estimate that the cost sav-
sickness benefit, and pensions). These investigators noted a
ing for health care expenditures in years subsequent to
63% decline in benefits during the follow-up period.
the first year after treatment at $8,772 per treated patient
per year. The average age of patients treated at PRPs is
COST BENEFITS AND COST-EFFECTIVENESS
44,25 and, assuming a mean life expectancy of 75 years,
At a time when resources for health care are limited we can estimate $45 billion in savings in health care
there is a growing concern about not only the clinical expenditures (without correcting for inflation rates dur-
effectiveness of treatment but also the cost-effectiveness. ing those 30 years). Stieg and Turk 70 calculated
As the data presented earlier attest, there is no question $350,000 (corrected for inflation to 1999 dollars) as the
that chronic pain syndromes are exceedingly costly. The cost for each compensation-covered male subject with a
expenditures for chronic pain, in addition to actual health back injury on the job lost to permanent disability. Sys-
care, include welfare and disability payments, lost tax tematic comparisons of the cost-effectiveness across dif-
revenue, lost productivity, and expenses required to train ferent modalities need a common metric. Cost effective-
replacement workers. ness can be viewed as:

The Clinical Journal of Pain, Vol. 18, No. 6, 2002


362 TURK

Cost-Effectiveness = aggregated across 65 studies reported by Flor et al.25 as


Cost of treatment representative, the mean age of treated patients would be
Percentage Who Achieve Outcome 44 years. To consider accrued cost saving, I will use 19
years, since this allows us to follow patients until the
This formula can be used to examine any outcome of treated patients reaches age 65. Based on the figures
interests (e.g., pain reduction, improvement in quality of reported by Thomsen et al., the anticipated average an-
life, patient satisfaction). When costs are not involved it nual savings in health care would be $972 per patient.
is referred to as the cost benefit rather than cost- Since the cost of the treatment reported was very low,
effectiveness. To illustrate the use of this formula I will $99 (substantially lower than reported in the United
compare the cost-effectiveness of several treatments in States), the “break-even point” would be achieved in
returning people to work, making use of the data pro- about six weeks. Multiplying the annual rate by 19 years,
vided in several publications (i.e., 23,25,38). the expected savings in health care expenditures for each
I graphically presented the cost of SCSs, standard patient would be $18,468. The number of patients avail-
care, surgery, and PRPs in returning one treated patient able at the follow-up was 122. Again, using the 19-year
to work. Examination of the data presented in Fig. 2 figure, the estimated health care savings for patients
reveals that treatment of patients at PRPs would be 6.29, treated at the PRP would be in excess of $2.25 million.
15, and 25 times more cost effective than surgery, con- Of course, we must subtract the cost of the treatment of
servative care, or implantation of SCSs, respectively. the 131 patients—$99/patient × 131 treated patients ⳱
These estimates, moreover, do not take into consider- $12,969—but even after subtracting the costs of the
ation the costs incurred for iatrogenic problems that may treatment at the PRP, the health care savings would ex-
follow surgery or SCSs. Iatrogenic problems can be ceed $2.16 million. We can consider the reductions in
prevalent and costly. For example, as noted previously in social transfer for 19 years as well. Working through the
their review of studies of SCSs for back pain, Turner et arithmetic, the total reduction would amount to $58,892
al.40 concluded that 42% of patients who had an SCS per patient treated. Using the number of patients avail-
implanted experienced at least one complication, with able at follow-up (122), the figure totals more than $7
the costs in some cases exceeding $19,000. Moreover, million.
these relative cost ratios do not take into consideration Combining the savings in health care and social trans-
routine follow-up care and monitoring after treatment. fers reported by Thomsen et al.69 indicates that the av-
In the Thomsen et al.69 study cited previously, the erage savings per patient treated at this PRP over a period
authors evaluated the clinical and cost-effectiveness of a of 19 years would be equivalent to $77,360, and for the
PRP in Denmark. This study is particularly noteworthy 122 (and factoring the cost of treatment of 131 patients)
because the authors had access to social records and the calculation would lead to substantial savings, in ex-
could evaluate health care costs and disability without cess of $9 million.
depending on patient self-reports. The authors found that
in the 6 months before treatment at a PRP the average
patient spent $263 per month for health care. In the 9 CONCLUSIONS
months after treatment the patients averaged $182 per Pain is not a monolithic entity such as a fracture or
month (a difference of $81 per month from the before- deficiency of some essential nutrient. Pain is, rather, a
treatment cost). This reflects a 31.1% decrease in health concept used to focus and label a group of sensations,
care consumption after treatment. thoughts, emotions, and behaviors. Since there are many
Thomsen et al.69 did not report on the age of the pa- facets to pain, it should be obvious that no single out-
tients included in their study, but if we accepted the data come measure captures all of the relevant issues. For this
reason, outcomes assessment must look at a variety of
criteria to adequately describe the effects of any
treatment.
Concerns about the cost of health care and, conse-
quently, the cost-effectiveness ratios of treatments, have
become almost as important as clinical effectiveness.
Simply asking whether any treatment is effective is not
the appropriate question. Rather, it is important to focus
on the results for a set of outcomes and to compare these
results with alternative treatments. The need for multiple
FIG. 2. Cost to return one treatment patient to work. criteria to evaluate treatment outcome is underscored by

The Clinical Journal of Pain, Vol. 18, No. 6, 2002


EFFECTIVENESS OF TREATMENTS 363

the reports that success in one area may not necessarily TABLE 1. Differences between patients with chronic pain
be related to success in others. For example, some pa- treated in the community and by pain specialists*
tients may report significant pain reduction but not their Patients treated by pain specialists demonstrate:
return to work. Patients and third-party payers may in- Higher prevalence of work-related injuries
Higher levels of emotional distress
terpret these results quite differently. Greater health care utilization
I need to reiterate an issue that I raised earlier. Inter- More constant pain
preting results by aggregating outcomes across and More negative attitudes about the future
Higher prevalence of opioid intake
within studies, including different pain syndromes, treat- Higher prevalence of past surgery
ments, dosages of medications, criteria of success, coun- Greater functional impairment
tries, follow-up periods, and criteria used to determine
*Adapted from Crook et al.73,74
success, should be undertaken with due caution.
The available data do suggest that PRPs improve over-
all functioning of chronic pain sufferers. These improve- the results for the pain treatments reviewed, especially
ments are not just evident on self-report measures; they those provided by pain specialists, are quite remarkable.
are shown on objective criteria, such as employment sta- Despite the skepticism and criticisms raised by third-
tus, medication use, utilization of the health care system, party payers, the body of literature available provides
and closure of disability cases. Careful selection of pa- substantial evidence that currently available treatments
tients treated with SCSs also appears to lead to improve- can significantly reduce the severity of pain experienced
ments of pain and functioning, although there is a cost of by a large number of people. Functional outcomes,
health care consumption, and reduction in disability also
iatrogenesis. The results for RTW, keeping in mind the
can be favorably affected. This is especially evident in
caution noted in regard to this outcome, are less impres-
the results reported for PRPs. None of the available treat-
sive. The PRPs appear to provide the best outcome on
ments on its own, however, seems capable of eliminating
rates of RTW and disability, with almost 50% of treated
all pain for all pain sufferers. As a consequence we must
patients returning to gainful employment.25 Moreover, a
be realistic in the message that we convey to patients
substantial proportion of patients have closure of disabil-
about the most likely outcomes regarding pain.
ity claims after treatment.25 The PRPs have the potential
There is a trade off between pain reduction and iatro-
to save substantial sums in both health care expenditures
genic complications and adverse events. With the ex-
and disability payments. Unfortunately, studies of the ception of PRPs, all of the other commonly used treat-
most common treatments, medication, rarely consider ments for chronic pain have some risk associated with
outcomes other than improvements in pain severity and them. Health care providers must carefully balance the
prevalence of adverse events and complications associ- risk against the potential benefits of each treatment
ated with the procedures. when selecting from among available treatment options.
The characteristics of patients treated by pain special- The prudent health care provider will be cautious in se-
ists differ in important ways from patients treated in lecting patients for treatments based on potential for
primary care facilities. Typically, populations treated by positive outcomes and adverse events and iatrogenic
specialists demonstrate a high prevalence of depression, complications.
with averages approximately 50%.71 In contrast, in a Currently, few data are available that are consistent in
survey of pain patients treated in a health maintenance identifying the characteristics of patients who would
organization, Von Korff et al.72 reported that the preva- most likely benefit from any of the pain treatment meth-
lence of major depression ranges from 6% to 10% de- ods available. Studies are needed that answer the ques-
pending on the type of pain. In epidemiologic surveys tion: what treatments delivered in what ways are most
conducted by Crook et al.,73,74 chronic pain patients re- effective for patients with what set of characteristics with
ferred to pain specialists were compared with persistent the least iatrogenic complications and adverse events?
pain patients in the community who were not referred to Successful answers to this question will permit more
specialty pain treatment facilities. Examination of differ- clinically effective and cost-effective ways to treat the
ences identified (Table 1) led Weir et al.75 to conclude difficult population of patients with chronic pain.
that “the picture that emerges is one of a pain clinic
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