Spine (Phila Pa 1976). 2012 (May 15); 37 (11): E668677
Gore, Mugdha PhD, BPharm, Sadosky, Alesia PhD, Stacey, Brett R. MD,
Tai, Kei-Sing MS, and Leslie, Douglas PhD
Avalon Health Solutions, Inc.,
Philadelphia, PA 19102, USA.
STUDY DESIGN: Retrospective analysis of an insurance claims database.
OBJECTIVE: To examine the comorbidities, treatment patterns, health care resource utilization, and direct medical costs of patients with chronic low back pain (CLBP) in clinical practice.
SUMMARY OF BACKGROUND DATA: Although the socioeconomic impact of CLBP is substantial, characterization of comorbidities, pain-related pharmacotherapy, and health care resource use/costs of patients with CLBP relative to non-CLBP controls have been infrequently documented.
METHODS: Using the LifeLink Health Plan Claims Database (IMS Health Inc., Watertown, MA), patients with CLBP, defined using the International Classification of Diseases, Ninth Revision, Clinical Modification, were identified and matched (age, sex, and region) with non-CLBP individuals. Comorbidities, pain-related pharmacotherapy, and health care service use/costs (pharmacy, outpatient, inpatient, total) were compared for the 2 groups during 2008.
RESULTS: A total of 101,294 patients with CLBP and controls were identified (55% women; mean age was 47.2 ± 11.6 years). Relative to controls, patients with CLBP had a greater comorbidity burden including a significantly higher (P < 0.0001) frequency of musculoskeletal and neuropathic pain conditions and common sequelae of pain such as depression (13.0% vs. 6.1%), anxiety (8.0% vs. 3.4%), and sleep disorders (10.0% vs. 3.4%). Pain-related pharmacotherapy was significantly greater (P < 0.0001) among patients with CLBP including opioids (37.0% vs. 14.8%; P < 0.0001), nonsteroidal anti-inflammatory drugs (26.2% vs. 9.6%; P < 0.0001), and tramadol (8.2% vs. 1.2%; P < 0.0001). Prescribing of "adjunctive" medications for treating conditions associated with pain (i.e., depression, anxiety, and insomnia) was also significantly greater (P < 0.0001) among patients with CLBP; 36.3% of patients received combination therapy. Health care costs were significantly higher in the CLBP cohort (P < 0.0001), reflecting greater resource utilization. Total direct medical costs were estimated at $8386 ± $17,507 in the CLBP group and $3607 ± $10,845 in the control group; P < 0.0001).
CONCLUSION: Patients with CLBP are characterized by greater comorbidity and economic burdens compared with those without CLBP. This economic burden can be attributed to greater prescribing of pain-related medications and increased health resource utilization.
From the FULL TEXT Article:
Low back pain (LBP) is one of the most prevalent and
costly musculoskeletal conditions. [1, 2] An epidemiologic review reported that more than a quarter of adults in the United States have had LBP in the past 3 months, increasing to 55% when the duration of report was extended to the past year.  LBP is equally common among men and women
and has a substantial impact on functioning. 
Recent estimates of the economic burden of LBP in the
United States, encompassing both direct and indirect costs,
range from $84.1 billion to $624.8 billion.  Lost work productivity is the primary driver of this economic burden, resulting in indirect costs of $7.4 billion to $28 billion.  However, LBP also results in substantial direct medical costs associated with the use of health care resources, including physician visits; LBP is the second most common reason for visits to physicians in the United States. [4, 5] In addition, pharmacologic, nonpharmacologic, and invasive therapies contributed to the $26 billion in incremental health care expenditures that were attributable to LBP for the year 1998, the most recent year for which comprehensive data are available. 
Although most cases of LBP resolve within 8 to 12 weeks,
it may become chronic (≥3 months) in up to 15% of patients,
resulting in periods of intense pain, significant physical limitations, and activity impairment.  Despite the low proportion of cases, chronic LBP (CLBP) accounts for a majority of the disability and costs associated with LBP. [7, 11, 12]
Recommendations for CLBP management include a multidisciplinary approach that may consist of patient education,
pharmacotherapy, psychosocial interventions, physical therapy, massage therapy, acupuncture, spinal manipulation, and
alternative treatments; surgical interventions are generally
reserved for subsets of patients (e.g., those with progressive neurological deficit).  Among pharmacotherapeutic
options, acetaminophen, nonsteroidal anti-inflammatory
drugs (NSAIDs), opioids, tramadol, and antidepressants are
used, although no 1 drug has been identified as conveying an
advantage, and suboptimal efficacy or side effects complicate
their use.  Opioids have limited long-term data to support
their use, present issues of tolerability, and are associated
with potential misuse/abuse.  There are inadequate data
supporting the analgesic effects of acetaminophen, particularly in severe pain.  Although NSAIDs also have limited efficacy in severe pain, their cardiovascular, renal, and gastrointestinal side effects are of significant concern, especially in the elderly.  Nevertheless, a recent review of pharmacologic recommendations reinforces acetaminophen and NSAIDs as first-line options regardless of symptom duration, and skeletal muscle relaxants and benzodiazepines are suggested as adjunctive medications with the caveat that these drugs have
a high incidence of sedation. 
The burden of CLBP is diffuse and has not been fully
characterized. Burden of illness studies has explored the
socioeconomic impact of CLBP (reviewed by Dagenais et a ),
yet the characterization of comorbidities compared with nonCLBP individuals has been infrequently documented. [27, 28] Although a series of studies has evaluated psychiatric comorbidity in patients with chronic disabling occupational spinal disorders,  it is not clear how this broader category of disabilities/disorders overlaps with CLBP, nor is the proportion of patients with CLBP reported in the observed populations. In addition, to our knowledge, comparisons of patients with CLBP with non-CLBP individuals has not been combined with an evaluation of pain-related pharmacotherapy and
other health resource utilization in clinical practice. Therefore, the purpose of this study was to determine the comorbidity prevalence in patients with CLBP and to evaluate painrelated treatment patterns and costs among these patients in
usual care settings relative to individuals without CLBP.
MATERIALS AND METHODS
Data for the study were obtained from the LifeLink Health
Plan Claims Database (IMS Health Inc., Watertown, MA).
The LifeLink database comprises adjudicated medical and
pharmaceutical claims data from a systematic sample of more
than 98 commercially managed care health plans throughout the United States (Midwest 34%, Northeast 22%, South
29%, West 15%), covering more than 62 million individuals and more than 4 billion claims. The data are nationally
representative, quality controlled, and HIPAA (Health Insurance Portability and Accountability Act of 1996) compliant.
The database includes patient demographic and enrollment
information, inpatient and outpatient diagnoses, surgeries,
procedures, and retail and mail order prescription records.
All records for each patient can be linked with a unique
encrypted patient identifier to create a longitudinal record
of the individuals medical and pharmacy claims during the
period of evaluation.
All patients with 2 or more health care encounters with an
associated diagnosis of CLBP (International Classification of
Diseases, Ninth Revision, Clinical Modification codes 720,
720.1, 720.2, 721.3, 721.42, 722.1, 722.32, 722.5, 722.73,
722.83, 722.93, 724, 724.02, 724.2, 724.3, 724.4, 724.5,
724.6, 724.7, 724.71, 724.79, 738.4, 739.3, 739.4, 756.11,
756.12, 805.4, 805.6, 846, 846.1, 846.2, 846.3, 846.8,
846.9, 847.2, 847.3, 847.4) during each of calendar years
(CY) 2007 and 2008, with the 2 diagnoses records being at
least 90 days apart, in each of the 2 years, were identified.
Patients with CLBP who were continuously enrolled during
CY 2008 were then selected. Patients were excluded if they
were younger than 18 years, had missing data for age or sex,
or were 65 years or older and not enrolled in a Medicare risk
plan, because claims histories of these patients may be incomplete. An age-, sex-, and region-matched comparison group of
persons with no diagnosis of CLBP during their entire tenure
in the database was also identified. All other sample inclusion and exclusion criteria (continuous enrollment during CY
2008, 18 years or older, no missing data for age and sex, and
65 years or older and not enrolled in a Medicare risk plan)
were also applied to the control group.
Measures and Analyses
Demographic and Clinical Characteristics
Demographic and clinical characteristics of patients with
CLBP and controls were examined, including age, sex and
coprevalence of selected musculoskeletal pain conditions,
neuropathic pain conditions, and common sequelae of pain
including depression, anxiety, and sleep disorders. The prevalence of comorbidities was determined on the basis of the
presence of 1 or more health care encounters with an associated diagnosis code (see the Appendix, Supplemental Digital Content 1) for the specific comorbidity during the study period.
Pain-Related Treatment Patterns
Pain-related medication exposure was determined in terms
of proportions of subjects who received 1 or more prescriptions for the various medication classes and the average
number of prescriptions for each of the medication classes
used to treat CLBP and sequelae of chronic pain, such as
anxiety/depression and sleep disorders. The medication
classes examined in this study included opioids, nonselective NSAIDs, cyclooxygenase-2 (COX-2) inhibitors, salicylates, tramadol, acetaminophen, muscle relaxants, selective
serotonin reuptake inhibitors, serotonin-norepinephrine
reuptake inhibitors, tricyclic antidepressants, tetracyclic and
miscellaneous antidepressants, benzodiazepines, sedatives
and hypnotics, antiepileptics, miscellaneous agents, topical
agents, and intramuscular onabotulinumtoxinA (Botox).
Health Care Resource Utilization and Direct Medical Costs
Use of health care resources and direct medical costs were
examined for the CLBP and control groups, including
CLBP-related surgeries (lumbar and sacral laminectomy and
discectomy, and lumbar fusion) and procedures (epidural,
transforaminal, or intravertebral injections), physician office
visits by specialty type, emergency department (ED) visits,
hospitalizations, and use of other outpatient services ( e.g.,
labs, radiology, imaging). Direct costs included amounts reimbursed by payers as well as patient co-pays.
Descriptive statistics (numbers and percentages for categorical
variables; means with standard deviations and medians with
interquartile ranges [IQR] for continuous variables) were used
to evaluate the different variables as appropriate. Conditional
logistic regression models conditioning for matching group
were used to evaluate the differences between patients with
CLBP and controls in the prevalence of comorbidities and percentage of exposure to pain-related medications. Proportional
odds models adjusting for correlated observations within
matching group (using GEE, or generalized estimating equations) were used to examine the association between CLBP/
control group membership and quartiles of prescription medications and health care resource use ( e.g., physician
office visits, ED visits, hospitalization) variables. Age, sex, and region were used as covariates in the models. Odds ratios with 95% confidence intervals (CIs) provided an estimate of effect size. Because cost data are highly skewed, the nonparametric Wilcoxon signed-rank test (which does not assume a normal population) was used to compare cost differences between the CLBP and control groups. P < 0.05 was considered statistically significant. All analyses were performed using the SAS software system, PC version 8.0 (SAS Institute Inc., Cary, NC).
Demographic and Clinical Characteristics
A total of 101,294 patients with CLBP satisfied the study
entry criteria and were included in the analyses. The control
group comprised a 1:1 age, sex, and region match of the
CLBP group. Both cohorts comprised 54.8% women, with a
mean age of 47.2 ± 11.6 years.
The prevalence of all examined comorbidities was significantly higher ( P < 0.0001 for all comorbidities except phantom limb pain) for patients with CLBP than for controls (Table 1). Back pain and neck pain other than LBP, musculoskeletal (43.1%), as well as neuropathic (34.2%), were the most prevalent pain conditions in the CLBP group. Nearly a third (30.6%) of patients with CLBP also had neuropathic LBP, pain radiating into the buttock and leg and considered to result from sciatica or disc herniation. The prevalence rates of common sequelae of chronic pain including depression (13.0%), anxiety (8.0%), and sleep disorders (10.0%) were 2.3, 2.5, and 3.2fold higher, respectively, among patients with CLBP than among controls.
Pain-Related Treatment Patterns
Exposure to pain-related treatments among patients with
CLBP and controls is described in Table 2. Relative to controls, except for intramuscular onabotulinumtoxinA ( P =
NS), a significantly higher proportion of patients with CLBP
( P < 0.0001) received all the evaluated pain-related medications, including any opioids (37.0% vs. 14.8%), any NSAIDs
(26.2% vs. 9.6%), tramadol (8.2% vs. 1.1%), muscle relaxants (21.2% vs. 2.6%), and antiepileptics (9.7% vs. 2.3%).
In addition, many patients with CLBP were prescribed
adjunctive medications often used to treat conditions associated with pain such as depression, anxiety, and insomnia.
Combination therapy was consistently higher in the CLBP
group than in the controls ( P < 0.05), with more than a third
(36.3%) of patients in the CLBP group receiving combinations of drugs, compared with only 10.5% of individuals in
the control group. The most frequent combinations in the
CLBP group were NSAIDS + opioids and opioids + muscle
relaxants, with 16.3% of patients with CLBP receiving each
of these combinations.
Except for intramuscular onabotulinumtoxinA, patients
with CLBP also received a significantly higher ( P < 0.0001)
number of prescriptions (median [IQR]) for a majority of the
evaluated medications during the study period than controls
including (Table 3) any opioids (3.0 [1.010.0] vs. 1.0 [1.0
2.0]); any NSAIDs (2.0 [1.04.0] vs. 1.0 [1.02.0]); tramadol
(2.0 [1.04.0] vs. 1.0 [1.03.0]); muscle relaxants (2.0 [1.0
4.0] vs. 1.0 [1.02.0]); benzodiazepines (3.0 [1.08.0] vs. 2.0
[1.06.0]); and sedatives and hypnotics (3.0 [1.08.0] vs. 3.0
Health Care Resource Utilization and Direct Medical Costs
Less than 10% of patients with CLBP received epidural,
transforaminal, or intravertebral injections during the study
period; 1.5% underwent lumbar or sacral laminectomy/discectomy; 0.7% had lumbar fusion; and 1.6% received acupuncture. The use of epidural injections and acupuncture was significantly higher (P < 0.0001) in the CLBP group than in the controls, and as would be expected, no patients in the control group had any surgeries for LBP. Among patients with CLBP who received acupuncture during the study period, the average number of sessions, mean 6.5 ± 6.6 and median 4.0 (IQR, 2.09.0), was not significantly different relative to controls, mean 7.2 ± 6.5 and median 6.0 (IQR, 2.010.0). However, the number of epidural injections during the study period was significantly higher among patients with CLBP (mean 2.0 ± 1.2, median 2.0 [IQR, 1.03.0]) than among controls (1.1 ± 0.2, median 1.0 [IQR, 1.01.0]; P < 0.0001).
Health care resource utilization is described in Table 4
and direct medical costs are described in Table 5. Both the
proportions of patients with CLBP who used health care
services (P < 0.0001) and the magnitude of service use
among users (P < 0.0001) were significantly higher in the
CLBP group than in the controls. For example, all patients
in the CLBP group versus 85.4% of controls had at least
1 outpatient visit and 9.2% of patients with CLBP versus
4.9% of controls had at least 1 hospitalization during the
study period. Among the users of these services, the number of physician office visits during the study period among
patients with CLBP were median 10.0 (IQR, 6.017.0) compared with median 3.0 (IQR, 2.06.0) among controls and the number of hospitalizations among patients with CLBP were median 3.0 (IQR, 2.05.0) compared with median 2.0 (IQR, 1.04.0) among controls.
Total medication costs for the CLBP group ($1572 ± $4451,
median $323; IQR, $13$1506) were significantly higher
( P < 0.0001) than for the control group ($909 ± $4171, median
$104, IQR $0$733). The direct costs of physician office visits
($1110 ± $1216 vs. $453 ± $696), ED visits ($331 ± 1414
vs. $78 ± $376), hospitalizations ($1892 ± $11,559 vs. $870
± $6911), and total direct medical costs ($8386 ± $17,507 vs.
$3607 ± $10,845) were each significantly higher ( P < 0.0001)
in the CLBP group than in the controls. Among patients with CLBP who had low back surgical procedures, the costs were lumbar and sacral laminectomy/discectomy ($28,286 ± $28,798, median $19,590; IQR, $10,250$36,491) and lumbar fusion ($47,205 ± $39,212,
median $37,417; IQR, $27,653$55,102).
This study, using data from a large and geographically diverse
US population, demonstrates that patients with CLBP have
a significantly higher prevalence of comorbid conditions and
are characterized by a substantial medication burden compared with matched controls. As expected, comorbid musculoskeletal pain conditions were significantly more prevalent among patients with CLBP than among controls. However, the magnitude of the prevalence of conditions, such as arthritis and other arthropathies (34%) and rheumatism excluding the back (40%), was surprising considering the young demographic of this population (mean age, 47.2 ± 11.6 yr; 97.3% <65 yr).
Although the cause-and-effect relationship between CLBP
and comorbidities is unclear, it has been suggested that LBP
may be part of an overall health pattern characterized by
disease clusters in certain individuals. Despite the uncertain
causality, the prevalence of conditions associated with chronic
pain, including depression and anxiety, was higher among
patients with CLBP, and increased sleep disturbances were
also more likely in patients with CLBP. The higher prevalence
of such conditions may derive in part from a reciprocal relationship between these outcomes and pain. 
The presence of any comorbidity in patients with CLBP
may be associated with a significantly longer duration of
work disability, [38, 39] and it has also been reported that health care costs for other conditions, especially those prescribed psychiatric medications, are higher after LBP onset.  In this regard, as previously noted, the likelihood of depression or anxiety was higher in patients with CLBP, odds ratios of 2.3 and 2.5, respectively, than in controls.
Regardless of causality, the increased presence of comorbid conditions among patients with CLBP increases the
complexity of management, as manifested by the overall
significantly higher medication burden observed among
patients with CLBP. Importantly, there was substantial
polypharmacy, including concomitant use of different pain
medication classes, and pain medications combined with
adjunctive medications for the treatment of insomnia and
mood. It should be noted that the total medication burden is likely to be underestimated because our estimates
included only prescription pain-related medications; we did
not consider medications for many of the comorbidities
Furthermore, because the database provides information
only on prescription medications, we could not evaluate
the potential utilization of over-the-counter medications for
CLBP or other pain-related conditions.
Opioids and opioid combinations were most frequently
prescribed, exceeding NSAIDs in proportion of patients and
number of prescriptions. Because of the limited evidence for
efficacy and the potential for side effects, opioids are recommended for the treatment of CLBP in patients who have severe, disabling pain that is not controlled with acetaminophen and NSAIDs. [14, 16, 26] Although acetaminophen and NSAIDs are generally considered first-line, we could not ascertain whether opioids were prescribed as first-line, as a result of prior treatment failure, or as rescue medication. Thus, we cannot be certain to what extent current recommendations for pharmacologic therapy were followed.
Short-acting opioids are frequently used as rescue mediation or on an as needed basis, and the high prescribing
of these medications (36.5%) may support this type of use.
Although the frequency of use of long-acting opioids was low
(3.8%), the median (7.0) number of prescriptions were higher
than for any other medication. A similarly high rate of opioid prescribing (37.7%) for CLBP was previously reported,  but these rates are substantially lower than the 60% recently suggested on the basis of patient self-report for a population of patients with CLBP in a regional study.  Although
Ritzwoller et al  observed an overall lower rate of opioid use (28.5%), they reported that use increased with increasing number of LBP episodes, an observation we could not confirm because of database limitations. Opioids continue to be recommended and used, despite evidence of a negative association with outcomes in CLBP, including function and productivity, [21, 43, 44] and an increased likelihood of substance use disorders. 
Prescribing of pain-related medications in the CLBP
cohort was paralleled by mean costs for these medications that were nearly twice that of controls and median
costs that were slightly more than 3fold higher. We also
observed significantly greater resource utilization compared
with controls across all other resource categories, resulting
in costs approximately 2 to 3fold higher across categories and total costs more than 2fold higher among patients
with CLBP. The primary cost driver was outpatient visits,
accounting for 59% of total medical costs. This high utilization of outpatient services may be indicative of less than
optimal efficacy of therapeutic regimens, because there was
still a substantial need for these services despite prescribing of pain-related medications. However, it could not be
determined to what extent these services were specifi cally
for CLBP, and the possibility exists that at least some of
these visits were related to comorbidities.
Although acupuncture and chiropractic services are among
the nonpharmacologic therapies that are recommended, [14, 46]
they are often not reimbursed by health insurance plans, and
the extent to which these services were covered in the study
database is not known. Therefore, it is likely that our assessment of these resources represents an underestimate.
Limitations associated with such retrospective database
analyses include errors in coding and recording, which could
potentially result in misdiagnosis in a proportion of patients.
Because we required at least 2 claims in each of 2 consecutive years (at least 4 claims during a 2yr period) with a diagnosis code for CLBP to select patients in the CLBP cohort,
we do not think that coding errors could have affected our
identifi cation of patients with CLBP. However, the comorbidity burden might be overestimated in our study, because
the presence of comorbidities was identified on the basis
of 1 or more claims for each comorbidity during the study
period. Although this might be a potential limitation, any
overestimation is likely to be random and unlikely to differentially affect either group, thus maintaining the validity of the reported differences in the comorbidity profiles between
the 2 groups.
Another limitation of claims databases is an inability to
link the condition of interest, CLBP, with the prescribing of
a particular pain or adjunctive medication. This limitation
may be especially relevant to populations characterized by
multiple comorbidities, including those with neuropathic
involvement for which many of the same medications are
also recommended.  Nevertheless, the data indicate that regardless of the reasons, patients with CLBP were prescribed significantly more pain-related medications than controls. A similar limitation is that such a database precludes ascertainment of patient compliance, with the corollary that prescribing particular medications does not necessarily imply that the patient filled the prescriptions or used the medications. Finally, because information on pain severity is not available in the database, we recognize that it is not possible to know the basis for medication prescribing, nor the effect on painrelated outcomes.
Despite the limitations, this study extends our knowledge
of the CLBP burden by characterizing this population with
respect to comorbidities and resource utilization. These analyses demonstrate the presence of significantly greater comorbid conditions and emphasize increased use of analgesic and
adjunctive medications as well as overall resource utilization
in patients with CLBP relative to non-CLBP individuals. Such
data may help inform clinical decisions regarding appropriate
management strategies for patients with CLBP. Although a
comparison of the burden of CLBP with other musculoskeletal disorders was not a goal of this study, such comparisons
are warranted, and the results reported here can provide a
useful baseline for further research.
Relative to controls, patients with CLBP had a significantly higher ( P < 0.0001) prevalence of musculoskeletal and neuropathic pain conditions and common
sequelae of pain including depression, anxiety, and
Pain-related pharmacotherapy was significantly greater ( P < 0.0001) among patients with CLBP
Prescribing of adjunctive medications (for depression, anxiety, and insomnia) was also significantly
greater ( P < 0.0001) among patients with CLBP.
Health care costs were significantly higher ( P < 0.0001) in the CLBP cohort, reflecting the greater
resource utilization among these individuals.
Total direct medical costs were estimated at $8386 ± $17,507 in the CLBP group and $3607 ± $10,845 in the control group; P < 0.0001.
The authors thank E. Jay Bienen for editorial assistance in the
preparation of the manuscript.
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