Key Findings (as interpreted by Back Builder, Inc.):
Of 38 patients who (1) had a physician's recommendation for lumbar or cervical
surgery, (2) had no medical condition preventing exercise, and (3) were willing to
participate in an approximately 10-week outpatient program, only three required surgery
upon completing the program within 16 months after discharge. These patients were
able to avoid surgery in the short term by engaging in an aggressive treatment consisting
mainly of intensive, specific, progressive resistance exercise of the isolated lumbar or
cervical spine performed to failure.
Can Spinal Surgery Be Prevented by Aggressive Strengthening
Exercises? A Prospective Study of Cervical and Lumbar Patients
Brian W. Nelson, MD, David M. Carpenter, MS, Thomas E. Dreisinger, PhD, Michelle
Mitchell, PTA, Charles E. Kelly, MD, Joseph A. Wegner, MD
Objective: To determine if patients recommended for
spinal surgery can avoid the surgery through an aggressive strengthening program.
Setting: A privately owned clinic, staffed by
physicians and physical therapists, that provides treatment for patients with neck and/or
back pain.
Methods: Over a period of 2-1/2 years, consecutive
patients referred to the clinic for evaluation and treatment were enrolled in the study if
they (1) had a physician's recommendation for lumbar or cervical surgery, (2) had no
medical condition preventing exercise, and (3) were willing to participate in the
approximately 10-week outpatient program. Treatment consisted mainly of intensive,
progressive resistance exercise of the isolated lumbar or cervical spine. Exercise
was continued to failure, and patients were encouraged to work through their pain.
Third-party payors in Minneapolis were surveyed for average costs. Average follow-up
occurred 16 months after discharge.
Results: Forty-six of the 60 participants completed
the program; 38 were available for follow-up and three required surgery after completing
the program.
Discussion/Conclusion: Despite methodologic
limitations, the results are intriguing. A large number of patients who had been
told they needed surgery were able to avoid surgery in the short term by aggressive
strengthening exercise. This study suggests the need to define precisely what
constitutes "adequate conservative care."
It is well known that only a small percentage of patients account for the majority of
medical and compensation costs associated with spinal disorders. The Quebec Task
Force reported that 7.4% of patients account for 76% of costs. In this small but
expensive group, surgical patients are most common. In fact, low back disease ranks
third as a reason for surgical procedures. Despite many less than optimal outcomes,
the number of surgical procedures continues to increase, with significantly more spine
surgeries per capita performed in the United States than in any other industrial nation.
Driven largely by surgical and indemnity expenditures, the average cost per
industrial back injury in the US is now more than $24,000. We have personally seen
cases with surgery that resulted in total costs of more than $500,000. It is clear
that any successful cost containment strategy for spinal disorders must address surgical
costs or it is unlikely to succeed.
Partly because of the limited success and expense of surgery,
noninvasive treatment strategies have emerged. Saal and Saal have published data
showing that significant lumbar and cervical disc syndrome can be treated successfully
with exercise and stabilization training. Mayer and associates have had success
treating long-term chronic low back pain with a multidisciplinary approach, including
aggressive exercise. Manniche's group studied the effects of aggressive
strengthening exercises on chronic low back pain (CLBP) and showed that patients who
engaged in intensive exercise did better than patients who received traditional passive
modalities or less intensive exercise. Manniche also found that the
"dosage" of exercise was important and that CLBP patients treated with higher
dosages did significantly better than similar patients at reduced dosages.
Ruiz-Topinka reported that Rosomoff and his group also found that patients selected for
spine surgery can often avoid such surgery with an aggressive strengthening program, but
Rosomoff's group has not published data to support this position. To date, no study
has investigated the effects of aggressive strengthening exercises on patients who have
been recommended for spinal surgery.
We recently published data detailing the outcomes of 895 CLBP patients
who were treated with aggressive strengthening exercises. Many of these patients
were surgical candidates who were able to avoid surgery. Because of this success,
many more patients have been referred with the hope that surgery can be prevented.
To document the results of these patients a prospective study was
designed. This article reports results on all surgical candidates referred to our
clinic and treated with an aggressive strengthening program over a 2-1/2-year period (May
1993 to December 1995). Program participants were surveyed by telephone an average
of 16 months after they completed the program to document its efficacy. In addition,
three insurance companies were surveyed to determine average costs of spine surgeries.
METHODS
Patients
A total of 651 cervical or lumbar patients were referred to the
program. Eight patients with contraindications to any type of aggressive
strengthening exercises were excluded from the study because of medical conditions such as
significant heart and/or lung disease or inflammatory arthritis. Of the remaining
643 patients, 62 met the inclusion criteria (each had seen one or more physicians who
recommended spinal surgery). All patients were referred either by physicians
familiar with our program, by friends who had been treated at our clinic, or by insurance
companies. None were referred by surgeons. Two patients, after the initial
evaluation, elected not to enter the program. Sixty patients began the program and
46 completed treatment.
The average patient age was 42 years old, and the average duration of
symptoms was 28 months. There were 28 men (60.9%) and 18 women (39.1%). Most
patients (90%) had already tried and failed some type of exercise program. The
average number of visits required to complete the program was 21 (approximately 10 weeks).
According to our clinic's billing department the average total cost of the exercise
rehabiliation program was $1,950. Cost included all physician evaluations, physician
visits, reports, and some home exercise devices. Patients paid for the program with
various insurance types.
At the initial evaluation a comprehensive history and physical
examination was performed. Detailed charts were kept on all patients and any
complications were noted. . . Of the 38 surgical candidates who completed the
program and were located for follow-up, lumbar fusion was recommended for 15, lumbar
decompression for 13, cervical fusion for 3, and cervical decompression for 7.
Exercise Strengthening Program
Exercise rehabilitation and specific isometric strength testing was
performed with equipment that isolates the spinal musculature, including the lumbar
extensors, cervical extensors and rotators, and thoracic rotators. This equipment's
unique feature is its ability to quantify and develop spinal muscle strength through
stabilization systems that isolate specific muscle groups. The efficacy of isometric
testing and dynamic progressive resistance exercise (PRE) using this equipment on the
healthy, asymptomatic, and chronic back pain populations has been well documented. . .
The torso and cervical rotation devices are similar but allow only isolated testing
and exercise of thoracic and cervical rotation, respectively.
Patients were seen twice weekly for approximately 1 hour and were
supervised by physical therapists. The mainstay of the treatment was PRE of the
isolated lumbar or cervical spine, which none of the patients had performed previously.
At each visit patients also performed aerobic exercise and strength training for
other major muscle groups (eg, abdominals, hamstrings, glutei, trapezii, latissiimus
dorsi) even though more than 90% had previously tried similar exercises without success.
Specific details of the training methods have been published. An important
point is that the training was quite vigorous and did not stop because of pain
exacerbation. In such cases patients were seen by the physician, and, provided there
were no clinical evidence of significant deterioration, the patient was reassured and
treatment continued.
Objective measurements included static strength at predetermined points
throughout the range of motion, dynamic endurance, and range of motion in both the
sagittal and rotational (transverse) planes. Dynamic endurance was defined by the
amount of weight and the number of repetitions a patient could perform until volitional
muscular fatigue was reached, with the following muscle groups isolated: lumbar extensors,
cervical extensors, torso rotators, cervical rotators. Weight load was increased
periodically to allow approximately 20 repetitions during each maximum workout.
Weight trainers using Nautilus variable resistance machines commonly use this type of PRE
protocol based on holding repetitions constant and increasing the weight as strength
increases. Objective measurements with this equipment have previously been shown to
be valid and reliable.
Treatment was ended when one or more of the following criteria was met:
1. The patient was pain free or nearly pain free and objective
functional levels were at or near normal. Pain was rated with a 10-point visual
analogue scale; functional levels of isometric muscular torque, dynamic muscular
endurance, and isolated lumbar or cervical sagittal and rotational range of motion were
measured and evaluated weekly.
2. The patient was no longer making objective gains in spinal
function.
3. The patient refused to cooperate or give a good effort, a
response to treatment that we recorded as a poor outcome. Response to treatment was
rated as excellent, good, fair, or poor using a 10-point system previously described in
detail. The ratings were defined as follows: excellent, resolution or near
resolution of spine and/or extremity pain, attained normal or near normal strength values;
good, substantial but not complete pain relief, substantial strength gains; fair,
minimal pain relief, significant strength gains; and poor, minimal pain relief,
minimal or no strength gains.
For this study, however, the most important measure of treatment
efficacy was whether the patient underwent surgery.
After discharge all patients wre instructed in a very specific home
maintenance program that incorporated the principles of progressive resistance training.
Cervical patients were given home exercise devices, included in the price of the
program, and, in addition, the lumbar patients were strongly advised to purchase a 45
degree back extension unit, approximately $165, from a local vendor in order to maintain
lumbar strength. Patients were given permission to be vigorous. They were
taught that "hurt does not necessarily mean harm." Instruction for
self-treatment exacerbations was provided. Education emphasized natural history,
imaging abnormalities seen in the general population, body mechanics, herniated disc
reabsorption, and so forth.
Cost Data
Studies on spinal treatment often lack cost data.
Consequently, the expense associated with spine surgery is often obscured. To
highlight the economic impact, we requested appropriate data from local third-party
payors based on 14 Current Procedural Terminology (CPT) codes representative of the most
common spinal surgeries. Insurance companies are able to process information based
on CPT codes from computer databases, which allows access to large number of cases.
Costs were broken down into medical costs (physician fees, hospitalization, drugs,
postoperative therapy), indemnity (lost wages paid), and permanency costs (lump sum paid
to workers' compensation patients after spine surgery to compensate for the injury).
The sums were then averaged.
Follow-Up
A vigorous attempt was made to contact by telephone all patients,
including those who quit before the program completion and those seen only for the initial
evaluation. Follow-up was completed an average of 16.2 months (range, 12 to 30 mo,
SD 5.2 mo) after the patient was last seen at the clinic. Of the original 46
surgical candidates completing the program, 38 (82.6%) were located for follow-up.
Each patient was asked the following questions: Since you completed the program have you
had surgery on your spine? If yes, what type of surgery did you have?
Statistics
Statistics were compiled using SPSS/Windows. Student's t
test was used to analyze strength increases within the group before and after treatment.
RESULTS
Objective dynamic endurance increased significantly among 46
surgical candidates completing the program. . . All strength gains were
statistically significant (p < .001) and ranged from 62% to 134%. At
follow-up, the clinical outcome was "excellent" in 17 subjects (44%),
"good" in 14 (36.8%), "fair" in 4 subjects (10.5%), and
"poor" in 3 subjects (7.9%).
Of the 46 surgical candidates completing the program we located 38
(82.6%). Only three of the 38 patients needed surgery in the follow-up period; two
had lumbar laminectomies and one had a lumbar fusion. None of the cervical patients
underwent surgery in the follow-up period.
Cost Analysis
To obtain representative costs we surveyed third-party payors in
Minneapolis/St. Paul on 14 CPT codes representative of typical spine surgeries.
Study participants were identified if their case file included one of these codes. .
. In comparison, the average cost of the aggressive strengthening program was
$1,950.
DISCUSSION
The debate about spinal surgery continues in the United States. Critics claim overutilization; supporters claim otherwise. There is no dispute about how costly spinal surgery can be. This study raises several interesting questions. Can we do a better job of defining who needs surgery? Who should first try exercise? What part should an aggressive strengthening program play in treatment plans? What constitutes adequate "conservative care?"
Limitations of the Method
Despite the methodologic shortcomings of this study, the results are
still intriguing. First, the patients were not randomized because of a referral,
private practice clinic, we could not do so practically.
It also might be argued that the patients in this study were more
motivated to avoid surgery. This may not be true, but how many patients, having seen
a surgeon who recommends surgery, are aware that such an alternative exists? Many
patients might decide to postpone surgery if they knew the success rate of an alternative
program.
The study lacked a control group- a major shortcoming. This
report is submitted to stimulate discussion and provide the rationale for future
randomized, controlled trials assessing aggressive exercise as an alternative.
The clinical results (excellent, good, fair, poor) were not determined
by a blinded observer and can be questioned. Our experience, however, demonstrates
that this rating system is a simple and accurate measure of treatment outcome in a busy
private clinic as well as a good predictor of short-term treatment efficacy.
Additionally, this report is not primarily concerned with clinical results. The
essence of this study is whether or not the patient had surgery in the 16-month period
after discharge, a result that is definitive and not subjected to any bias.
A critical reader might question if the clinical results were
long-lasting. Perhaps patients were avoiding surgery but were miserable in doing so.
Although we do not report here on whether or not the subjective improvement was
lasting, we have done so previously in a similar CLBP population with good or excellent
results from an aggressive strengthening program. In that group of patients, 94%
maintained their improvement with a home program at 1-year follow-up. This suggests
that not only can surgical candidates avoid surgery, they can improve subjectively and
maintain their improvement with a home strengthening program. Manniche reported
similar lasting improvement from intensive exercise and rehabilitation, provided that
patients continued with their exercises, findings similar to those reported by our own
group and those of Risch and colleagues, who published a randomized comparative study
using the same protocols.
Finally, not all patients completed the strengthening program (77%
completion) and not all who completed it were available for follow-up (82.6%). As
was found in our previous study of exercise and chronic low back pain, most of the
patients who dropped out of the program did so early on, completing an average of only
seven visits. In comparison, patients who finished the present program completed an
average of 21 visits. Early attrition is unfortunate because patients undergoing
aggressive strengthening exercises often do not begin to feel better until 3 to 4 weeks
into the program. Also, some patients are unwilling to devote the time and energy
required for aggressive strengthening exercises and elect passive care and/or surgery
instead.
Nevertheless, we believe that the study is valuable because it shows
that a large number of surgical candidates at a private practice clinic can avoid surgery
over an extended period. Further, there were no significant complications or
negative consequences associated with delaying surgery while patients participated in an
aggressive strengthening program. Occasional exacerbations occurred, but these were
self limited and did not prevent rehabilitation from continuing.
The Need for Muscle Isolation and Exercise Intensity
One key factor in the treatment protocol is that the strengthening
program was specific and intense. "Specific" was defined as exercise with
the pelvis (for lumbar injuries) or upper torso (for cervical injuries) immobilized to
isolate the lumbar and cervical musculature, respectively. "Intensive" was
defined as muscular exercise against dynamic resistance to volitional failure, ie,
exercise performed on a strength training device through a full range of motion. The
exercise activity was continued for as many repetitions as possible, as long as the
patient could maintain the range of motion demonstrated during the first repetition.
Few disagree with the position that patients with chronic spine pain
should fail an adequate trial of nonoperative care prior to surgery. But what is an
adequate trial of conservative care? How should it be defined? The patients in
this study had already tried some conservative care, and most had tried several different
treatments. More than 90% had tried a previous exercise program. Why, then,
did the majority of these patients have better outcomes with an aggressive strengthening
program?
We believe there are several reasons. First, most of the surgical
candidates talked about their "degenerative disc" or "ruptured disc"
or "spinal stenosis" or "spondylolisthesis," etc. Reinforced
through extensive exposure within the health care system, they saw themselves as damaged
goods. Few understood that literally millions of people have the same radiologic
diagnoses with few or no symptoms.
Surgical candidates are often considered more "fragile" than
nonsurgical patients and are more often guided toward inactivity to protect the spine.
Many have been told to remain inactive based on MRI scans. They develop a
keen sense of fear when it comes to spinal motion. Spinal pain patients become
expert at substituting pelvic or thoracic movement for lumbar or cervical motion,
respectively. In this way they protect the injured body part from meaningful
exercise.
Substitution protects the lumbar or cervical spine from normal
movement. Without motion the disc deteriorates, disc pH decreases, and muscles
become deconditioned. Recent evidence suggests that a damaged disc becomes more
acidic and that reduced pH is a mediator of spinal pain. The adult disc is an
avascular structure that depends on diffusion for its nutrition. Diffusion is
facilitated by a pumping action through spinal motion. Lack of motion, however,
hinders diffusion. In the aggressive strengthening program in this study, patients
were not allowed to substitute. The cervical and/or lumbar spine was isolated in
such a way that substitution was impossible. Exercise therefore facilitated fluid
exchange in the disc, which may account for the subjective improvement even though most
patients (90%) had tried and failed other strengthening programs that did not provide
isolated, intensive exercise. Graves and associates showed that attempts to
strengthen the lumbar spine using traditional exercise equipment are completely
ineffective. These and similar devices are capable of strengthening the pelvic
extensors but not the lumbar extensors. The data from Graves and from our study
suggest that to be effective, exercise must both isolate and intensely work the target
muscles and joints.
Another essential component of the rehabilitation program used in this
study is exercise intensity. Patients were directed to perform PRE to volitional
muscle fatigue within 20 repetitions. Weight loads were increased periodically to
maintain exercise intensity. Rather than using pain as a barometer to guide physical
activity, patients were educated and encouraged and ultimately became self motivated to
exercise beyond their pain threshold. For most patients, symptoms dissipated as
functional status improved. For example, surgical candidates increased the amount of
weight lifted to volitional muscle fatigue by 72% to 87% for the lumbar extensors and 60%
to 95% for the thoracic rotators. Eighty percent of these patients reported a good
or excellent response to treatment. These findings are consistent with those of
previous studies that used intensive exercise to improve spinal musculoskeletal function
in CLBP patients. Further, aggressive exercise complies with recent guidelines for
spinal rehabilitation that emphasize treatment directed toward improved activity tolerance
rather than toward symptom relief. Visual feedback of improving performance,
provided by specific lumbar or cervical testing, encourages patients to continue
exercising even in the face of initial discomfort. As patients improve spinal
function, pain and fear decrease while confidence and ability to perform activities of
daily living increase.
Surgical Costs
This study documents the high cost of surgery. The higher the
cost, the more attractive nonsurgical alternatives become. The average cost of the
exercise rehabilitation program in this study was $1,950. In contrast, an average
worker's compensation lumbar fusion costs $168,000, 86 times more expensive.
Additionally, the cost data implicitly assume that surgically treated
patients have a successful outcome. Considering the minimum 15% failure rate
estimated for spinal surgery, the predicted surgical costs presented in the current study
are likely understated. Whether the results are representative of all or most
surgical candidates is not known, but the obvious morbidity and cost benefits suggest that
further study is warranted.
CONCLUSION
Although this study has methodologic limitations, it
nonetheless represents actual practice in a private clinic. Because of the sheer
volume, most spinal patients will necessarily be treated in private clinics, and
practical, yet efficacious, treatment strategies must be developed with cost containment
in mind.
The significance of this study is that many patients were spared
surgery during the study period even though surgery had been recommended. The
findings show that a percentage of spinal patients can avoid surgery by competing an
aggressive strengthening program and that even patients recommended for spinal surgery can
tolerate intensive, specific exercise. Also, this study documents the amount of
physical treatment each patient received, thus enabling comparisons with other types of
physical treatment programs. Moreover, these findings suggest that substantial cost
savings are possible by first attempting aggressive strengthening exercises. To be
effective, such exercises must be specific and intensive. In the absence of
deteriorating physical condition, patients should be encouraged to exercise beyond their
intial pain to achieve the functional improvements, symptom relief, and cost savings this
program can offer. Finally, the spinal treatment community needs a concensus
definition of "adequate conservative care." At present it is defined
however a physician wishes it to be defined.
All references excluded in this transcript are available in the original published journal or upon request.