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CHAPTER 13/ THE ROLE OF OUTCOMES AND HOW TO INTEGRATE THEM INTO YOUR PRACTICE / 143
TABLE 13-5. Parsimonious routine care
Patient outcomes
1. During the past week, how bothersome have each of the following symptoms been? (circle one number in
each row)
a. Low back pain 1 2 3 4 5
b. Leg pain 1 2 3 4 5
(sciatica)
2. During the past week, how much did pain interfere with your normal work (including both work outside the
home and housework)?
3. If you had to spend the rest of your life with the symptoms you have right now, how would you feel about it?
4. During the past 4 weeks, about how many days did you cut down on the things you usually do for more than
half the day because of back pain or leg pain (sciatica)? _____ Number of days
5. During the past 4 weeks, how many days did low back pain or leg pain (sciatica) keep you from going to work
or school? _____ Number of days
6. Over the course of treatment for your low back pain or leg pain (sciatica), how satisfied were you with your
overall medical care?
a
Note: most of these items are included in the AAOS Lumbar Cluster, the Low Back Pain TyPE, and
the NASS low back outcome instrument.
From Deyo RA, Battie M, Beurskens AJ, et al. Outcome measures for low back pain research.A pro-
posal for standardized use. Spine 1998;23:2003–2013, with permission.
Not at all Slightly Moderately Very Extremely
bothersome bothersome bothersome bothersome bothersome
Not at all A little bit Moderately Quite a bit Extremely
Very Somewhat Neither satisfied Somewhat Very
dissatisfied dissatisfied nor dissatisfied satisfied satisfied
Very Somewhat Neither satisfied Somewhat Very
dissatisfied dissatisfied nor dissatisfied satisfied satisfied
a
demonstrated in diagnosis coding for reimbursement suggests that this is a real concern.
Aside from quality improvement, some practices have
adopted routine measurement of health outcomes for helping to inform clinical care. Thus, for example, some practices have routinely had patients complete the SF-36 or the
Oswestry Disability Questionnaire, and made the results
available to clinicians as they see the patients. In many
cases, these have been academic practices where extramural resources, including grants, could help to support
these activities. Nonetheless, some private practitioners
have also adopted the strategy and f ind the information
useful to inform their own care of individual patients.
OUTCOME MEASUREMENT FOR RESEARCH
PURPOSES
Aside from their use in quality improvement, outcome
measures might be used for comparing the effectiveness of
different clinical approaches to a particular problem. In
some circumstances, this might be done in the form of a randomized controlled trial. However, randomized trials are
probably less common in routine practice settings than
observational studies, such as cohort studies. In cohort studies, patients may receive different treatments for the same
condition, but with the treatments determined by the course
of usual care rather than the dictates of a randomization
schedule. Although such studies do not yield information as
definitive as randomized trials with regard to treatment efficacy, outcome studies using cohort designs have sometimes
added greatly to our understanding of patient experience of
various outcomes, unexpected consequences of therapy , and
important gaps in clinical knowledge.
An example of such work can be found in the MLSS,
where we followed patients with either herniated lumbar
discs or lumbar spinal stenosis with pretreatment measures, and follow-up data collected at 3 months, 6
months, 1 year, and annually thereafter. Table 13-6 provides selected data from that study , using se v eral state-ofthe art outcome questionnaires (19).
The MLSS collected data from the offices of orthopedic surgeons, neurosurgeons, and occupational medicine
physicians. The study provided much greater detail
regarding patient outcomes than was previously available
from the one randomized trial of surgical versus nonsurgical treatment for sciatica (20). Like that study, the
MLSS suggested that surgery offered an advantage in
outcomes for several years, although the differences in
outcome between surgical and nonsurgical treatment
gradually narrowed over several years. The MLSS also
found that return to work after 1 year and 3 years was virtually the same with or without surgery (6).
144 /SECTION I/BASIC SCIENCE
TABLE 13-6. Outcomes data for patients with sciatica, comparing surgical and nonsurgical therapy in a cohort study
Treatment group
Outcome variable
Symptoms
Low back pain compared to baseline
Better 75.0 54.5
Same 16.8 29.9
Worse 8.2 15.6
Leg pain compared to baseline
Better 81.3 55.8
Same 13.4 33.3
Worse 5.3 10.9
Change in predominant symptom
Completely gone 30.6 11.4
Much better 40.2 31.7
Better 9.1 13.2
About the same or a little better 14.3 29.9
A little worse to much worse 5.8 13.8
Sciatica Frequency Index, mean change −11.2 −3.4 <0.001
Functional status
Roland score, mean change (1-yr baseline) −11.1 −4.7 <0.001
SF-36 score, mean change (1-yr baseline)
Physical function 40.3 17.5 <0.001
Bodily pain 44.0 20.4 <0.001
Disability days in past month, mean changes
In bed −10.1 −3.3 <0.001
Decreased activity −16.0 −12.5 0.04
Absent from work −10.2 −8.0 0.06
Quality of life, ≥ moderate improvement 79.7 57.6 <0.001
Patient satisfaction
Overall results of treatment, ≥ very good 61.1 46.0 0.005
Spend rest of life like now, satisfied 60.1 39.6 <0.001
If surgery, still choose back operation, yes 86.5
Employment and WC status
If receiving WC at entry (n = 60) (n = 63)
Unemployed at 1-yr evaluation 30.5 44.1 0.13
Receiving WC at 1-yr evaluation 45.6 55.2 0.30
If employed at entry (n = 113) (n = 78)
Unemployed at 1-yr evaluation 5.4 6.9 0.68
Receiving WC at 1-yr evaluation 4.6 7.1 0.47
SF-36, Short Form 36; WC, workers’ compensation.
a
All variables expressed in percentages, except where noted.
b
Symptom severity was reported to be “better” if the response was “better” to “completely gone,” the
same if the response was “about the same” or “a little better,” and worse if the response was “a little
worse” or “much worse.”
c
Predominant symptom, either leg or back pain, at entry.
d
Comparing difference of two distributions using the Kolmogorow-Smirnov statistic.
From Atlas SJ, Deyo RA, Kellar RB, et al.The Maine Lumbar Spine Study, Part II.
One year outcomes of surgical and non-surgical management of sciatica. Spine 1996;21:1777–1786,
with permission.
a
b
b
c
d
Surgical Nonsurgical
(n = 219) (n = 170) P value
<0.001
<0.001
<0.001
An example of a randomized trial using similar outcome
measures is the Spine Outcome Research Trial (SPORT)
currently underway in the United States. This study is randomizing patients to surgical or nonsurgical treatment for
herniated discs, spinal stenosis, or degenerative spondylolisthesis. The trial in v olv es data collected from numerous
clinical practices around the country. In this trial, patients
usually complete questionnaires using electronic “tablets,”
allowing instant data entry and analysis. Outcome measures in this study include the Oswestry Disability Questionnaire, the SF-36, and symptom measures, as well as a
measure of patient satisfaction (21). For projects such as
these, which enjoy extramural research funding, it is feasible to use a larger set of questionnaires than the simple
measures proposed for quality improvement purposes
RECOMMENDED QUESTIONNAIRES FOR
STUDYING OUTCOMES OF LUMBAR SPINE
DISORDERS
As a result of an international low back pain forum, and
a subsequent focus workshop on outcome research, a core
CHAPTER 13/ THE ROLE OF OUTCOMES AND HOW TO INTEGRATE THEM INTO YOUR PRACTICE / 145
TABLE 13-7. A proposed set of patient-based outcome measures for use in spinal disorders
No. of items Score
Domain Instrument options) worse) complete Dimensions
Back specific Roland-Morris 24 (yes/no) 0–24 5 min Physical activities, housework,
function mobility, dressing, getting
or Oswestry 10 (6 levels) 0–100 5 min Pain intensity, personal care,
Generic health SF-36 version 2.0 36 (variable) 8 dimensions: 10 min Eight dimensions: physical
status 100–0 each or function, role physical, bodily
Pain Bodily pain scale 2 (variable) 100–0 or norm- 2 min Pain intensity, pain interference
of SF-36 based: mean: with wor k and housework
(optional) Chronic 7 (11-point NRS) 5 min Current, worse, and average
pain grade + no. of days pain, disability days,
Work disability
a
Work status 10 categories Nominal scale 1 min Employed at usual job, on light
Days off work and No. of days 2 min
days of reduced
b
work
Time to return to No. of days 2 min
work
Satisfaction: back Satisfaction with 17 (5 levels) Information, caring, effective-
specific care: Patient ness of treatment, and others
Satisfaction
Scale
Satisfaction with 1 (7 levels) 1–7 1 min Extremely, very, somewhat
treatment satisfied, mixed, somewhat,
outcome: Global very, extremely dissatisfied
question
NRS, Numerical Rating Scale.
a
The SF-36 physical and mental role scales refer to all roles (work as well as house w ork).The reader
specifically interested in work-related disability would need to modify these scales to refer to work roles
only.
b
The U.S. National Health Interview Survey asks about days off work and reduced activity both from
usual work and other role activities. The reader specifically interested in work-relatedness would need
to modify these questions to refer to work roles only.
From Bombardier C. Outcome assessments in the evaluation in the treatment of spinal disorders;
summary and general recommendations. Spine 2000;25:3100–3103, with permission.
(response (best to Time to
help, appetite, irritability, pain
lifting, walking, sitting,
standing, sleeping, sex life,
social life, traveling
norm-based: pain, general health, vitality,
mean: 50; SD: social function, role
10 emotional, and mental health
Can be aggregated into two
components: Physical and
mental health
50; SD: 10
in pain interference with usual
activities, recreational, social
and family activities, and
work (including housework)
duty, or some restricted work
assignment, paid leave/sick
leave, unpaid leave, unemployed because of health
problems, unemployed
because of other reason,
student, keeping house/
homemaker, retired, on
disability
146 /SECTION I/BASIC SCIENCE
set of patient-based outcome measures for research purposes has been proposed (9,10). As shown in Table 13-7,
these include measures of back-specific functioning,
generic health status, pain, work disability, and patient satisfaction. Each of the instruments in Table 13-7 has been
well v alidated, and the characteristics of the questionnaires
are indicated in the table. This set of measurement instruments corresponds closely to the lumbar spine cluster proposed by the AA OS and to the North American Spine Society (NASS) spine questionnaires. The special focus issue
of Spine contains a summary of the data relating to these
questionnaires, including information about their reliability, reproducibility, and responsiveness to changes over
time (10,22,23). For key elements of this recommended
set, such as the Roland and Morris disability questionnaires and the SF-36, well-validated versions are available
in many languages, especially European languages.
This set of instruments was intended to be a core set
that might be used by most investigators studying low
back problems, to help improve comparability among
studies and also to facilitate formal meta-analysis of multiple studies. However, the intent was to make this core
set sufficiently brief so that investigators could add additional instruments for purposes specific to the conditions
and treatments they are studying. Thus, investigators may
wish to add more psychological measures or disease-specific modules such as measures for spinal stenosis or scoliosis.
This is certainly not an exhaustive list of validated
instruments for studying low back pain. However, it does
represent a set that appears to be well validated, widely
used, and at least equivalent in performance characteristics to other available instruments.
HAZARDS IN OUTCOME MEASUREMENT
The difficulties in making fair comparisons among
physicians or hospitals have previously been addressed.
In general, valid comparisons of outcomes would require
at least adjustment for disease severity, comorbid conditions, baseline health status, and several important demographic variables. Even with such adjustment, comparisons should be made with caution, because we do not yet
know all the relevant variables for predicting patient
prognosis or outcome.
Those who assess spine outcomes must be aware that
many factors other than medical care can affect the
results of a particular disease. Patients with multiple
comorbid diseases (e.g., heart disease or diabetes) are
likely to have worse outcomes than patients without
comorbid illnesses. Low income or homeless patients are
likely to have worse outcomes than more affluent
patients. Patient compliance, genetic endowment, psychological characteristics, and environmental factors
(such as workplace characteristics) ma y also ha v e a major
influence on patient outcomes. Thus, in comparing qual-
ity of care between providers or in comparing the effectiveness of different treatments, caution is warranted if
outcomes are used. In most situations, random allocation
to alternative treatments is the best way to assure that one
is truly comparing equivalent groups, but this is rarely
feasible in comparing health care providers or workplaces.
The optimal timing and duration of follow-up for outcome assessment may vary according to the condition or
treatment under study. For example, studies of spinal
manipulation have suggested that any benefits occur
within a few days or weeks of treatment, and do not have
long-lasting effects. In contrast, surgical intervention
may result in a temporary decline in patient functioning
during the postoperative recovery period, with benefits
only becoming apparent in long-term follow-up. Similarly, the timing of outcome measures may vary according to whether one is studying patients with acute pain or
chronic pain.
Patients’ literacy and language fluency are additional
potential barriers to the use of questionnaire measures
such as those presented here, though these barriers can
sometimes be overcome (24). Standards for developing
equivalent questionnaires in different languages have
been proposed (25), and oral interviews can sometimes
replace self-administration.
An important caveat is that financial incentives may
affect a patient’s self-report. If f inancial gain may result
from high levels of disability (e.g., disability compensation), patients may report worse functioning on standardized questionnaires. This is not being dishonest as much
as it is a natural tendency to maximize symptoms and
dysfunction under such circumstances. Conversely, some
patients have reported fear of losing their insurance coverage if they admit to any functional problems that might
be seen as “preexisting conditions” in any new insurance
application. Such patients would perceive a financial
incentive to report excellent functioning and no symptoms, skewing results in the opposite direction. The magnitude of such effects has not been well-quantified or
studied, although it seems clear that outcomes are generally worse among patients who receive disability compensation than among those who do not, even with apparently similar lev els of anatomic or ph ysiologic disruption.
Such incentives may also influence performance on standardized physical tasks.
FUTURE DEVELOPMENTS
Item response theory has been well known among
those who do psychological testing for man y years, but its
application to health status measures is relatively recent.
Item response theory allows one to rate the “difficulty” of
a question in comparison to other similar questions. Thus,
for example, “walking one block” would be rated easier
than “walking one mile”. Although the ranking of these
CHAPTER 13/ THE ROLE OF OUTCOMES AND HOW TO INTEGRATE THEM INTO YOUR PRACTICE / 147
two items is obvious, the relative rankings of other functional items may be less clear. Item response theory
allows a diverse range of items to be ranked by their difficulty. Such techniques can allow the construction of a
large bank of individual questions that measure the same
underlying construct (such as physical function or emotional function) and calibration of every item within that
bank (26).
With computer technolo gy, adaptive testing would then
become possible. The idea is that if a patient indicates he
or she is able to walk a mile, then questions about less
demanding activities would be avoided. Instead, a series
of more difficult questions would be posed, allowing the
investigator to reach a very precise estimate of a patient’s
physical functional ability with just a few items. Thus,
after the first question, the computer selects each subsequent item from the pool of calibrated items according to
the subject’s responses to the initial and each subsequent
item. The goal is to achieve a high level of accuracy with
as few items as possible.
Item response theory models have been used for some
scale validation, and the Quebec Back Pain Disability
Scale was developed using this technique (27). An effort
to calibrate all the items found in major scales for back
pain should be encouraged, because this could lead to
construction of a relevant item bank, and in turn toward
computerized adaptive testing (26).
Adaptive testing aside, the Internet offers enticing
prospects for the future of studying patient outcomes. If
Internet access was widely available in patients’ homes,
patients would be able to complete questionnaires and
transmit data to a central database without using pencil and
paper, stamps, or envelopes. In settings where computer
access is widely available, this may already be feasible.
CONCLUSION
Variations in care and rising health care costs hav e led to
growing calls for accountability by those who pay the bills.
In many cases, studying patient outcomes in a rigorous
fashion is likely to be the best way to identify effective
treatments and to assess the quality of care. For low back
disorders, traditional measures such as death, cure, and
physiologic outcomes have only limited applicability. In
many cases, patients’symptoms, function, and work status
are the most important outcomes to measure. While these
are subjective, modern instruments can assess these
dimensions of outcome with demonstrable reliability and
validity. A standard battery of instr uments can be recommended for measuring several dimensions of patient outcome, generally obviating any need to “reinvent the
wheel.” However, improvements in such measures will
inevitably be developed, and comparisons among potential
outcome measures should be encouraged. Such comparisons should quantify the construct validity, reproducibility, and responsiveness of these instruments.
When comparing providers with regard to quality of
care, or when comparing treatment effecti veness, e xtreme
care is warranted to assure that the comparisons are fair,
considering potential baseline differences in disease
severity, health status, and demographic characteristics. A
variety of logistic barriers must be o v ercome before these
instruments are widely used in routine practice, including
the resource requirements for collection, automation,
analysis, and reporting of the data. Nonetheless, such
efforts offer the promise of substantial improvements in
quality of care and in the effectiveness of treatment
approaches.
ACKNOWLEDGMENTS
Supported in part by grant no. 1 P60 AR 48093 from
the National Institute of Arthritis, Musculoskeletal and
Skin Diseases.
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446–452.
18. Zucherman J, Hsu K, Piccetti G, et al. Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. Spine 1992;17:834–837.
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Part II. One year outcomes of surgical and non-sur gical management of
sciatica. Spine 1996;21:1777–1786.
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23. Ware JE. SF-36 Health Survey update. Spine 2000;25:3130–3139.
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SECTION II
Alternatives to Traditional
Nonoperative Treatment
CHAPTER 14
Manual Therapy in Patients with Low Back Pain
Jiri Dvorak, Scott Haldeman, and Wolfgang Gilliar
The hands are one of the oldest tools available to clinicians for healing. References to manual treatment methods can be found in the writings of virtually all ancient
and modern civilizations. This discipline, in its broadest
definition and as it relates to low back pain, includes all
procedures where practitioners apply their hands for
diagnostic and therapeutic purposes in the hope of relieving symptoms and restoring function. Since the 1950s,
and in particular since the 1970s, manual medicine has
experienced unprecedented growth and acceptance, not
only by the general population, but also by traditionally
orthodox branches of medicine. This growing interest is
due to a number of social and political forces. One of the
strongest of these forces has been the failure of traditional
medicine practitioners to develop treatment methods that
control low back pain to the satisfaction of patients.
Despite the marked increase in diagnostic technology
and improvements in both medications and surgical procedures, there is no evidence that the amount of suffering
and related disability due to back pain has improved, and
if anything, it appears to be increasing. There has also
been a marked resurgence in interest by the public in socalled alternative and complementary medicine, or CAM
approaches to health care. This ma y, in part, be a response
to the more aggressive use of medications, injection therapies, and surgery along with the growing realization that
these procedures rarely cure back pain, at least in the long
term, and have significant complication rates and expenses. A recent series of publications has shown that
more patients use CAM therapies to treat their low back
pain than conventional medical therapies, and that satisfaction with CAM providers is markedly higher than for
traditional medical providers. The most popular CAM
treatment for low back pain is spinal manipulation and
massage, both of which fall into the category of manual
therapies, although particularly in Europe, manual medicine is integrated within the classic education of physicians. In several countries (e.g., Switzerland, Germany,
Czech Republic, France) a subspecialization in manual
medicine has been established within the normal medical
associations.
The initial response by the mainstream medical community to the popularity of manual therapy through the first 75
years of the 20th century was an attempt to ostracize practitioners, especially chiropractors and osteopathic physicians, and to isolate those medical practitioners who
recommended and taught manual therapy. There was, however, a small group of pioneering allopathic physicians
such as James Cyriax, Robert Maigne, Karl Lewit, and
John Mennell, particularly in Europe, and later within
North America and the rest of the world, who maintained
an interest in the manual therapies throughout the 20th century. The “modern” era of manual therapy has often been
attributed to the Swiss physician O. Nägeli (1843–1922),
who described a series of “handgriffe” (hand applications)
for cervical manipulations in 1894. It was during the same
period, at the end of the 19th century and early 20th century, that Andrew Taylor Still, M.D., formulated the concepts of osteopathy and chiropractics was established as a
practice devoted to spinal manipulation by Daniel David
Palmer. There was a parallel growth of the three groups of
practitioners of manual therapy (medical physicians, chiropractors, and osteopaths) through the 20th century that
gradually resulted in communication of ideas and the
teaching of techniques between these different groups of
practitioners. At the same time massage and manual mobilization, which have always been part of rehabilitation and
the practice of physical therapy, became more for malized
within this medical profession. There is a growing body of
academic physical therapists that have become very active
in research in the manual therapies and are responsible for
the publication of a number of clinical trials on the topic.
Components of the manual medicine armamentarium are
increasingly being adopted and integrated in general medical practice and are being included within the teachings of
many medical specialties including neurology, orthopedics,
physical medicine, rehabilitation, and rheumatology (1). In
some settings the manual therapies are practiced by a med-
151
152 /SECTION II/ALTERNATIVES TO TRADITIONAL NONOPERATIVE TREATMENT
ical physician but in many interdisciplinary centers these
therapies are performed by chiropractors, osteopathic
physicians, and sometimes by physical therapists.
DEFINITIONS
Terminology used by practitioners can be difficult to
understand for many physicians who do not have formal
training in the manual medicine field. The German term
“manuelle medizin”, or manual medicine has become the
standard term used for the manipulative therapies practiced by medical physicians in most of Europe. On the
other hand, in North America 90% of the manipulative
treatments are performed by chiropractors who use the
term “chiropractic adjustment” to describe their procedures. Osteopathic physicians refer to specific “osteopathic manipulative therapy (OMT).” Many of the mobilization and massage techniques are generally offered by
physical therapists and a growing number of massage
therapists. Each of these professions, in turn, has numerous techniques or named methods of providing their form
of manual therapy.
It is possible to divide the manual therapies into three
major subdivisions with a fourth category representing a
combination of some of the techniques. The most common procedure, and that which also requires the greatest
amount of skill and training, is the classic “thrust technique.” The thrust technique is also described as “mobilization-with-impulse” technique, or “high velocity, low
amplitude (HVLA) thrust” (Fig. 14-1). The second gen-
eral treatment category is represented by the nonthrust
mobilization techniques, which are also known as “mobilization-without-impulse” techniques. They are easier to
perform and do not take the joint beyond the normal
range of motion. The third cate gory includes the so-called
soft tissue techniques, consisting of various methods of
mobilization and massage applied to the soft tissues of
the spine without movement of a joint.
The fourth manual technique, the “neuromuscular
therapy (NMT)” is a hybrid of the classic manual techniques and includes treatment procedures that attempt to
mobilize and stretch the muscles by engaging specific
muscle action or invoking associated neuromuscular
reflex mechanisms. These techniques rely on direct muscle force (NMT 1) in order to move the spine and stretch
muscles or they include a postisometric relaxation phase
(NMT 2) (Fig. 14-2). Another variation attempts to take
advantage of the reciprocal innervation for inhibition of
specific muscle g roups (NMT 3). This form of manual
therapy is based, in part, on the observation that rotation
of the spine to one side is caused by the contralateral
transversospinal muscular system but may be typically
limited by shortened ipsilateral transversospinal muscles.
Rotational motion of the superior partner of the vertebral
spinal segment is initiated to one side by the rotator and
multifidi muscles on the contralateral side. Thus, the
right rotator and multifidi muscles function as agonists
for rotation to the left side (Fig. 14-3). When the rotatores
and multifidi muscles are shor tened in the same spinal
segment it is assumed that they diminish rotation to the
FIG. 14-1. Manipulation of lumbar spine in side position (mobilization with impulse). (From Dv orak J , Dv orak V, Schneider W, et al. Musculoskeletal medicine
(manual therapy), 3rd English ed.Stuttgart/New York:
G. Thieme Verlag, 2004, with permission.)