OUTCOMES OFACUTE ANDCHRONICPATIENTSWITHMAGNETIC
OUTCOMES OFACUTE ANDCHRONICPATIENTSWITHMAGNETIC
ABSTRACT
Objective: The purposes of this study were to evaluate patients with low-back pain (LBP) and leg pain due to
magnetic resonance imaging–confirmed disc herniation who are treated with high-velocity, low-amplitude spinal
manipulation in terms of their short-, medium-, and long-term outcomes of self-reported global impression of change
and pain levels at various time points up to 1 year and to determine if outcomes differ between acute and chronic
patients using a prospective, cohort design.
Methods: This prospective cohort outcomes study includes 148 patients (between ages of 18 and 65 years) with LBP,
leg pain, and physical examination abnormalities with concordant lumbar disc herniations. Baseline numerical rating
scale (NRS) data for LBP, leg pain, and the Oswestry questionnaire were obtained. The specific lumbar spinal
manipulation was dependent upon whether the disc herniation was intraforaminal or paramedian as seen on the
magnetic resonance images and was performed by a doctor of chiropractic. Outcomes included the patient’s global
impression of change scale for overall improvement, the NRS for LBP, leg pain, and the Oswestry questionnaire at 2
weeks, 1, 3, and 6 months, and 1 year after the first treatment. The proportion of patients reporting “improvement” on
the patient’s global impression of change scale was calculated for all patients and acute vs chronic patients.
Pretreatment and posttreatment NRS scores were compared using the paired t test. Baseline and follow-up Oswestry
scores were compared using the Wilcoxon test. Numerical rating scale and Oswestry scores for acute vs chronic
patients were compared using the unpaired t test for NRS scores and the Mann-Whitney U test for Oswestry scores.
Logistic regression analysis compared baseline variables with “improvement.”
Results: Significant improvement for all outcomes at all time points was reported (P b .0001). At 3 months, 90.5% of
patients were “improved” with 88.0% “improved” at 1 year. Although acute patients improved faster by 3 months, 81.8% of
chronic patients reported “improvement” with 89.2% “improved” at 1 year. There were no adverse events reported.
Conclusions: A large percentage of acute and importantly chronic lumbar disc herniation patients treated with chiropractic
spinal manipulation reported clinically relevant improvement. (J Manipulative Physiol Ther 2014;37:155-163)
Key Indexing Terms: Intervertebral Disc Displacement; Lumbar Vertebrae Manipulation, Spinal; Chiropractic
a
Private practice, Zürich, Switzerland. nurse, DC, MEd. Department of Chiropractic Medicine, Orthopaedic
b
Professor, Chiropractic Medicine and Radiology departments, University Hospital Balgrist, Forchstrasse 340, 8008 Zürich, Switzer-
Orthopaedic University Hospital Balgrist, University of Zürich, land. (e-mail: [email protected] [email protected]).
Zürich, Switzerland. Paper submitted October 14, 2013; in revised form December
c
Professor and Chairperson, Chiropractic Medicine Depart- 20, 2013; accepted December 25, 2013.
ment, Faculty of Medicine, Orthopaedic University Hospital 0161-4754
Balgrist, University of Zürich, Zürich, Switzerland. Copyright © 2014 by National University of Health Sciences.
Submit requests for reprints to: Cynthia K. Peterson, registered Open access under CC BY-NC-ND license.
http://dx.doi.org/10.1016/j.jmpt.2013.12.011
155
156 Leemann et al Journal of Manipulative and Physiological Therapeutics
Disc Herniations Treated With Manipulation March/April 2014
pproximately 70% of the population will have back self-reported global impression of change and pain levels at
Statistical Methods
Patients responding “better” or “much better” were
categorized as “improved,” and all other patients as “not Fig 3. Flowchart showing patient numbers at the various data
improved.” “Improved” was the primary outcome measure. collection time points. N, number of patients.
“Slightly improved” was not considered clinically relevant
improvement. The proportion (%) of patients “improved” or deviation [SD]) was also calculated. IBM SPSS version 20
“worse” was calculated for each time point. In addition to (Chicago, IL) was used for all data analyses.
descriptive statistics, the NRS scores at pretreatment and
posttreatment were compared using the paired Student t
test. The OPDQ baseline and posttreatment scores were
compared using the Wilcoxon test for matched pairs.
RESULTS
Comparisons were made at each time point with the There were 148 patients with baseline and 1 year data
baseline scores. Change scores for the NRS and Oswestry (110 males). Figure 3 shows the number of patients for each
questionnaire at all data collection time points were also data collection time point and the reasons for missing data
calculated. Subgroup analysis was carried out on chronicity between baseline and 1 year. The main reason for the
of complaint comparing only acute (symptoms, b 4 weeks) smaller sample sizes at the various time points is due to
with chronic (symptoms, N 12 weeks) patients. The NRS missed telephone calls during the time window agreed for
mean and change scores and the OPDQ change scores for each call. However, unless 3 consecutive telephone calls
acute vs chronic patients were compared at the various time were missed, the patient remained in the study. To obtain
points using the unpaired t test. Baseline demographic 148 patients with 1 year data, 171 patients with baseline
factors were compared between acute and chronic patients data were enrolled.
using the χ 2 test for categorical variables. In addition, Table 1 shows the proportion of patients within the
logistic regression analysis was done comparing the various various categories of the baseline variables. There was no
baseline factors with the primary outcome of “improve- significant age difference between the sexes nor was there a
ment” for all of the data collection time points in a significant difference between the sexes for baseline NRS
univariate model for all patients. The mean number of LBP or leg pain scores, duration of complaint, or baseline
chiropractic treatments during the first month (+ standard Oswestry scores. Of the 148 patients, 79 had symptoms of
Journal of Manipulative and Physiological Therapeutics Leemann et al 159
Volume 37, Number 3 Disc Herniations Treated With Manipulation
Table 2. Baseline and Outcome Data for All Patients at the Various Time Points
Baseline Data
(148 pts) 2 Wks (123 pts) 1 Mo (142 pts) 3 Mos (137 pts) 6 Mos (142 pts) 1 Y (148 pts)
PGIC 69.9%, Much 79.6%, Much 90.5%, Much 88.7%, Much 88.0%, Much
better or better better or better better or better better or better better or better
1.6%, Slightly 1.4%, Slightly 2.1%, Slightly 2.8%, Slightly 2.8%, Worse
worse worse worse or worse worse
NRS back (mean) 5.67 (2.98) 2.94 a (2.28) 2.12 a (1.80) 1.67 a (1.71) 1.50 a (1.78) 1.42 a (1.73)
Change (SD) 2.73 (3.00) 3.59 (2.83) 4.07 (2.98) 4.28 (3.14) 4.35 (3.28)
NRS leg (mean [SD]) 5.68 (3.12) 3.00 a (2.50) 2.08 a (2.16) 0.91 a (1.48) 0.94 a (1.58) 0.91 a (1.67)
Change (SD) 2.68 (2.93) 3.20 (2.87) 4.50 (3.23) 4.51 (3.23) 4.87 (3.47)
Oswestry (mean [SD]) 18.75 (10.24) 12.86 a (6.63) 10.13 a (6.73) 6.19 a (5.08) 5.25 a (5.54) 4.82 a (5.12)
Change (SD) 5.82 (8.87) 8.29 (9.26) 12.23 (10.76) 13.53 (11.69) 13.92 (11.83)
NRS, numerical rating system; PGIC, patient’s global impression of change; pts, patients.
a
P b .0001 compared with baseline score.
less than 4 weeks and were labeled as “acute,” whereas 37 for any of the categorical demographic factors, including
had symptoms of 3 months or longer and were labeled as number of previous episodes.
“chronic.” Subacute patients (n = 31) were not included in
the subgroup analysis. There was no significant age
Prognostic Variables. Direct logistic regression analysis of
difference between the acute and chronic patients.
potential predictors at baseline for improvement at 2 weeks
Table 2 shows the baseline data and outcomes data for
is shown in Table 4. The only factors linked with
all patients (acute, subacute, and chronic) at all data
“improvement” at this first data collection time point were
collection time points. At 2 weeks after the start of
“duration of complaint category” and “NRS leg pain.”
treatment, a large proportion of patients reported substantial
Acute patients were 73% more likely to “improve” at 2
“improvement,” with the percentage reporting “improve-
weeks. For every 1 point increase in leg pain at baseline, the
ment” increasing at 1 (79.6%) and 3 (90.5%) months. This
odds of the patient improving decreased by a factor of .644.
then stabilized at the 6-month and 1-year data collection
There were no significant predictors at baseline for
time points. There was statistically significant improvement
“improvement” at 1 month. At both 3 and 6 months, the
(P b .0001) in NRS and OPDQ scores at each time point
only predictor of “improvement” was the baseline OPDQ
compared with baseline scores. A very small percentage of
score (Table 4). The higher the baseline OPDQ score, the
patients reported that they were “worse,” and 3 went to
more likely the patient was to “improve.” For every 1 point
surgery, although they had all reported “improvement” on
increase in the baseline OPDQ score, the odds of the patient
their PGIC scores at 1 month. One patient had an epidural
improving increased by a factor of 1.17 at 3 months and a
injection, and 11 patients reported a recurrence of
factor of 1.20 at 6 months (Table 4). “Improved” patients
symptoms between the 6-month and 1-year data collection
had a baseline to 3-month OPDQ change score of 14.25
points. No cases of cauda equina syndrome or other adverse
(SD, 11.72) compared with 3.33 (SD, 5.91) for patients
events were reported, and no patients were excluded based
not improved. Similarly, at 6 months, the OPDQ change
on the type of disc herniation visualized on their MRI scans.
score was 15.21 (SD, 11.11) for “improved” patients, and
The mean number of SMT treatments up to the 1-month
only 0.96 (SD, 8.21) for patients who were not improved.
data collection period was 11.20 (SD, 3.61).
There were no significant baseline factors that were
A comparison of outcomes for acute and chronic patients
predictors of “improvement” at 1 year. With so few
is shown in Table 3. The mean duration of complaint for the
factors associated with “improvement,” no further
chronic patients was 450.97 (SD, 624.82) days. The
detailed analyses were performed.
proportion of patients reporting “improvement” continued
to increase up to the 3-month time point for acute patients.
This then stabilized or slightly reduced for acute patients.
However, the chronic patients continued to report higher DISCUSSION
percentages of “improvement” at both 6 months (88.6%) The purpose of this study was to document outcomes
and 1 year (89.2%). The pain and disability scores continued of patients with confirmed, symptomatic lumbar disc
to decrease substantially for both groups up to 3 months after herniations and sciatica who were specifically treated with
the first treatment and then basically stabilized at the 6- side posture high-velocity, low-amplitude, spinal manip-
month and 1-year time points. These changes were faster ulation to the level of the disc herniation. It is important to
and more dramatic for the acute patients. There were no emphasize that all patients in this study had clear
significant differences between acute and chronic patients abnormal physical examination findings of radiculopathy,
160 Leemann et al Journal of Manipulative and Physiological Therapeutics
Disc Herniations Treated With Manipulation March/April 2014
Table 3. Comparison of Disc Herniation Patients With Symptoms 4 Weeks or Less With Those Having Symptoms 3 Months or Longer
(Acute vs Chronic)
Baseline 2 Wks 1 Mo 3 Mos 6 Mos 1Y
NRS back
Acute (n = 80) (n = 66) (n = 76) (n = 74) (n = 76) (n = 80)
Mean (SD) 6.23 (2.90) 2.61 (2.19) 2.21 (1.91) 1.49 (1.56) 1.33 (1.69) 1.27 (1.73)
Change (SD) 3.54 a (2.91) 4.05 (2.87) 4.60 (2.90) 4.87 (2.99) 4.99 (3.43)
Chronic (n = 37) (n = 30) (n = 34) (n = 33) (n = 35) (n = 37)
Mean (SD) 5.78 (2.49) 3.68 a (2.23) 2.68 (1.90) 2.08 (1.84) 1.90 (2.15) 1.99 (1.86)
Change (SD) 2.05 a (2.88) 3.24 (2.47) 4.05 (2.99) 3.85 (3.15) 3.79 (2.67)
NRS leg
Acute
Mean 5.89 (3.26) 2.93 (2.46) 2.07 (2.30) 0.78 (1.33) 0.75 (1.49) 0.81 (1.62)
Change 4.56 a (3.08) 3.11 a (2.89) 3.76 a (3.08) 5.10 a (3.36) 5.04 (2.27) 5.14 a (3.49)
Chronic
Mean 3.36 (2.70) 2.35 (2.07) 0.88 (1.19) 0.85 (1.36) 1.24 (2.01)
Change 1.39 a (2.48) 2.03 a (2.21) 3.67 a (2.78) 3.96 (3.07) 3.27 a (3.59)
Oswestry
Acute
Mean 21.25 (11.04) 12.50 (6.60) 9.93 (6.78) 5.55 (5.31) 4.69 (5.87) 4.51 (5.00)
Change 15.41 (7.03) a 8.24 a (9.86) 10.98 a (10.13) 14.93 a (11.65) 16.45 a (12.69) 16.74 a (12.78)
Chronic
Mean 12.57 (5.16) 10.48 (5.81) 7.26 (4.60) a 6.34 (4.95) a 5.93 (5.79)
Change 3.51 a (5.62) 4.65 a (6.54) 8.42 a (5.62) 9.31 a (7.32) 9.48 a (7.99)
PGIC
Acute 80.6%, Much 84.6%, Much 94.5%, Much 90.9%, Much 86.3%, Much
better or better better or better better or better better or better better or better
(1.5% worse) (1.3% worse) (1.4% worse) (1.3% worse) (3.8% worse)
Chronic 46.7%, Much 70.6%, Much 81.8%, Much 88.6%, Much 89.2%, Much
better or better better or better better or better better or better better or better
(3.3% sl. worse) (0% worse) (0% worse) (2.9% slightly worse) (2.7% worse)
NRS, numerical rating system; PGIC, patient’s global impression of change; sl, slightly.
All mean results are statistically significant compared with the baseline figures at P b .0001.
a
P b .05 comparing the acute with the chronic patients.
as described in the methods section, corresponding to their the start of treatment. By 3 months, this figure was up to
MRI abnormalities. Although previous studies have 90.5% and then stabilized at 6 months and 1 year. One may
identified the presence of “leg pain” in addition to LBP argue that most of the treatment effect is explained by
as a negative prognostic factor for improvement with natural history. This might contribute significantly to the
chiropractic treatment compared with patients with LBP outcomes in the acute patient subgroup. However, for the
only, a recent, large, prospective outcome study found that chronic patients, any positive effect due to natural history
the presence of radiculopathy was not a negative predictor should already have occurred. The natural history of
of improvement in LBP patients being treated with sciatica in acute disc herniation patients is normally quite
chiropractic therapy. 14,17,18 favorable, with 36% reporting major improvement after 2
The proportion of patients reporting clinically relevant weeks and up to 73% having resolution of their leg pain by
improvement in this current study is surprisingly good, with 12 weeks. 19,20 The acute patients in this current study
nearly 70% of patients improved as early as 2 weeks after reported more substantial improvement and improved more
quickly than the chronic patients, with more than 80%
Table 4. Significant Predictors of “Improvement” From Logistic reporting clinically relevant improvement as early as 2
Regression Analysis at the Various Time Points weeks and 94.5% improved at 3 months. These results are
Predictor Variable/Data
better than the natural history figures cited above. 19,20
Collection Time Point Unadjusted OR (95% CI) P Even the chronic patients in this study, with the mean
duration of their symptoms being over 450 days, reported
Duration category: 2 wks 0.73 (0.21-2.58) .004
NRS leg: 2 wks 0.64 (0.50-0.83) .001 significant improvement, although this takes slightly
Pre-OPDQ total: 3 mos 1.17 (1.01-1.36) .033 longer. More than 81% reported being “improved” at 3
Pre-OPDQ total: 6 mos 1.20 (1.06-1.36) .006 months, and the proportion reporting “improvement” at 1
CI, confidence intervals; NRS, numeric rating system; OPDQ, Oswestry year (89.2%) was slightly higher than the percentage for
pain and disability questionnaire; OR, odds ratio. acute patients. This was due to the higher number of acute
Journal of Manipulative and Physiological Therapeutics Leemann et al 161
Volume 37, Number 3 Disc Herniations Treated With Manipulation
patients reporting a recurrence. In addition, the LBP NRS result. However, it does not explain why the OPDQ was not
levels for chronic patients significantly dropped from a prognostic until later in the course of the condition. Not
baseline mean of 5.78 to 2.08 at 3 months, and their leg pain until it was placed into the logistic regression model,
decreased from 4.56 at baseline to 0.88 at 3 months. This controlling for other factors, did it became predictive.
cannot be explained by natural history as a previous study The major criticism of this study may be that it is not an
found that duration of symptoms more than 30 days was RCT using a control group which had no treatment.
predictive of an unfavorable outcome, at 3 months after start Although RCTs are traditionally the criterion standard for
of treatment. 20 The results from this current study are better determining effective treatments, there has been recent
than the 60% of chronic patients who benefited from side criticism of this research methodology pointing out that
posture SMT at 12 weeks reported by McMorland et al, 10 their strict inclusion and exclusion criteria may result in
better than the 50% of chronic patients reporting improve- study populations that do not represent real-world condi-
ment in an article by Cassidy et al, 21 and better than the tions, and thus, the results may be of limited use to
59% of subacute and chronic patients reporting success clinicians and not generalizable to the intended
after manipulation by Petersen et al 22 The results in this population. 25,26 However, pragmatic RCTs, which use a
current study are encouraging when considering that it is broader selection criteria and observational studies, as in
chronic LBP patients who are a large economic burden with this prospective outcomes study, can include large and
greater use of prescription medications and increased use of diverse populations and are more likely to reflect the
other health care resources. 23 patients routinely seen in clinical practice. The inclusion/
Unfortunately, recurrences cannot be avoided complete- exclusion criteria (and therefore the participants) in this
ly because the genesis of this condition is multifactorial. In study are no different from those that would be recruited in
the acute patient group, 11 patients reported a recurrence an RCT to address the same study hypotheses.
between the 6-month and 1-year data collection periods. No Treatment in this current study was standardized to 1 of
chronic patients reported a recurrence however. A small the 2 possible manipulative procedures, based on the
proportion of patients reported being “worse” after the start location of the disc herniation as seen on the MRI scans.
of treatment with 2.1% of 137 patients reporting that they Furthermore, patients whose herniations had penetrated
were “slightly worse” or “worse” at 3 months and 2.8% of through the peripheral annular fibers, the posterior
patients reporting that they were “slightly worse” at 1 year. longitudinal ligament or were sequestered were not
No patient reported being “much worse.” One topic that excluded from being treated with SMT as was done in the
needs to be addressed is the often stated fear that SMT RCT by Santilli et al 7 However, no studies have been
applied to patients with disc herniation often causes cauda conducted to determine whether there is a difference in
equina syndrome. 6,24 No cases of cauda equina syndrome outcome based on the choice of the specific manipulative
or other serious adverse events were reported in this current procedure or the type and location of disc herniation.
study. Three patients did choose to have surgery, however, The hypothetical rationale behind selecting one SMT
although they had reported significant improvement at 1 procedure over the other based on the MRI and clinical
month, and one patient elected to have an epidural injection findings is based on the mechanics of each lesion. First, by
of anesthetic and corticosteroid. combined flexion and lateral bending, the side on which the
It was not surprising that there were few predictors of patient lies is determined because it is not desired to treat
“improvement” identified from the baseline variables as into the pain. For foraminal hernias, it is preferred to gap the
previous studies have also struggled to find reliable foramen on the affected side thereby inducing more normal
predictors of improvement in LBP patients. 14,18 However, movement patterns, decreasing the pressure on the disc and
chronicity of complaint was a predictor for early improve- nerve, releasing adhesions, allowing efflux of chemical
ment with acute patients having better outcomes at 2 weeks, irritants, and stimulating the receptors in the surrounding
most likely due to the natural history of this condition as tissues. For paramedian hernias, it is the unaffected side but
previously mentioned. Although patients reporting higher with the same therapeutic goals in mind. The opening of the
levels of leg pain at baseline were less likely to improve at 2 foramen seems to be of lesser importance for these disc
weeks, this factor was no longer predictive at all follow-up herniations. Of course, this is all hypothetical and needs to
time points. This information is useful for patients as well as be investigated further.
the clinicians treating these patients. Surprisingly, the
baseline OPDQ total score was not prognostic for
improvement until the 3- and 6-month time points with
higher baseline scores associated with an increased LIMITATIONS
likelihood of improvement. Certainly, acute patients have As this is a cohort outcomes study rather than an RCT
higher baseline disability and pain scores compared with means that the outcomes cannot be directly attributed to the
chronic patients and improve more quickly than chronic SMT treatment. Additional research comparing SMT with
patients as noted above, so this may be one reason for this other treatments, for example, therapeutic nerve root
162 Leemann et al Journal of Manipulative and Physiological Therapeutics
Disc Herniations Treated With Manipulation March/April 2014
infiltrations needs to be done. All patients were examined Data collection/processing (responsible for experiments,
and treated in a single chiropractic practice in Zürich, patient management, organization, or reporting data):
Switzerland using a standardized treatment approach. SL, CS, BA, CP.
Therefore, the results obtained may not be representative Analysis/interpretation (responsible for statistical analy-
of other chiropractic practices. The relatively small sample sis, evaluation, and presentation of the results): CP.
size for the subgroup of disc herniation patients whose
symptoms were “chronic” (37 patients) is another limitation. Literature search (performed the literature search):
CP, SL.
Writing (responsible for writing a substantive part of the
CONCLUSIONS manuscript): CP, SL, CS.
Critical review (revised manuscript for intellectual
A large percentage of acute and importantly chronic
content, this does not relate to spelling and grammar
lumbar disc herniation patients treated with high-velocity,
checking): SL, KH, CP, CS, BA.
low-amplitude side posture SMT reported clinically
relevant “improvement” with no serious adverse events.
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