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ORlGINAL CONTRlBUTION
Surgical vs Nonoperative Treatment for Lumbar Disk Herniation The Spine Patient Outcomes Research Trial (SPORT): A Randomized Trial
James N. Weinstein, DO, MSe
Tor D. Tosteson, ScD
Jon D. Lurie, MD, MS
Anna N. A. ScD
Brett Hanscom, MS
Jonathan S.
William A. Abdu,
Man S. MD
Scott D. Boden, MD
Richard A. MD, MPH
PhD
MS
L UMBAR DI5KECTOMY 15 THE MOST
common surgical procedure performed in the United States
for patients having back and leg
symptoms; the vast majority of the pro- cedures are elective. However, lumbal' disk herniation is often seen on imag- ing studies in the absence of symp- toms1.2 and can regress over time vvith-
out surgery.3 Up to 15- fold variation in regional diskectomyrates in the United States4 and lower rates internationaHy
mise questions regarding the appropri-
ateness of some of these surgeries.5,6
Several studies have compared sur- gical and nonoperative treatment of pa- tients wirh herniated but base-
line differences between treatment groups, small or lack of validated outcome measures these
studies limit conclu- sions
Context Lumbar diskectomy ia the most common surgical procedure performed for back and leg symptoms in US patients, but the efficacy of the procedure relative to nonoperative care remains controversiaL
Objective To assess the efficacy of surgery for lumbar intervertebral disk herniation.
Design, Setting, and Patients The Spine Patient Outcomes Research Trial, a ran- domized dinical trial enrolling patients between March 2000 and November 2004 from 13 multidisdplinary spine dinks in 11 US states. Patients were 501 surgical candidates (mean age, 42 years; 42 % women) with imaging-confirmed lumbar intervertebral disk
hemiation and persistent signs and symptoms of radiculopathy for at least 6 weeks.
Interventions Standard open diskectomy vs nonoperative treatment individualized to the patient.
Main Outcome Measures Primary outcomes were changes rrom baseline for the Medical Outcomes Study 36-item Short-Form Health Survey bodily paln and physical runction scales and the modified Oswestry Disability Index (American Academy of Or- thopaedic Surgeons MODEMS version) at 6 weeks, 3 months, 6 months, and 1 and 2
years from enrollment. Secondary outcomes included sciatica severity as measured by the Sciatica Bothersomeness Index, satisfaction with symptoms, se!f-reported improve- ment, and employment status.
Results Adherence to assigned treatment was limited: 50% of patients assigned to
surgery received surgery within 3 months of enrollment, while 30% of those assigned to nonoperative treatment received surgery in the same period. IntenHo-treat analy- ses dernonstrated substantial improvements for all primary and secondary outcomes in both treatment groups. Between-group differences in improvements were consis- tently in favor of surgery for all periods but were small and not statistically significant for the primary outcomes.
Conclusions Patients in both the surgery and the nonoperatíve treatment groups improved substantially over a 2-year period. Because of the large numbers of patients who crossed over in both directions, conclusions about the superiority or equivalence of the treatments are not warranted based on the intent-to-treat analysis.
Trial Registration ciinicaltrials.gov Identifier: NCT00000410 JAMA. 2006;296:2441-2450 www.jama.com
2000 to compare the outcomes of sur.
SURGlCAL VS NONOPERATlVE TREATMENT FOR LUMBAR DISK HERNIATlON
oVln treatment but othenvise met all the
other criteria for indusion and who agreed to undergo follow-up accord- ing to the same protocol. This article
reports intent-to-treat results through 2 years for the randomized cohort.
Flgure 1. Flow Diagram of the SPORT Randomized Controlled Trial of Dlsk Herniation: Exdusion, Enrollment, Randomization, and Follow-up
i 2720 Pallenta Screened for Efiglbilìty
Assigned 10 Reoeive Surgery
6-wk Foltow-up
Had Date Availabla
40 M1ssad Visit 2 Wlthdrew' o Dlad'
74 Underwaf\t Surgery (32%)'t
198 Had Dala Available
45 Mlssad Vislt .2 Wrthdraw o Dled
115 UndelWen! Surgery (50%)
6-mo Follow-up
200 Had Date Availabla
37 Mlssad Vialt
ß Withdrew o Dlad
132 Underwent Surgery (57%)
1-y Follow-up
202 Had Data Avaltable
29 Missed Visll 14 WithdrèW
o Ciad
Underwent Surgery (59%)
FoIlow-up
186 Had Date. Avaiiabie
32 MIssad \!ïstl
23 Withdrew o Died 4 2-'1 Fcltcw-up Not Completed
729 Candldates
Noooperatlva
Raceive
219 Had Date Avaiiabte
37 Missed Vi.!t o Wlthdrew' o Dled'
211 Had 44 Mlsaed \tls~
1 Wlthdrew o Diad
71
6-ma Fcllow-up
210 Had Data Avallabie 4 i Mlssed VlslI
, 5 Wlthdraw
I 0 Died
~ Underwent Surgary (39%)
1-y Follow-up
213 Had Dats Avaiiabla
27 Missed Vlalt
15 Wlthdrew 1 Died
i 03 Underwant Surgef/ (43%)
187 Had Data Avaiiable
31 Missed Vlsit
27 Wllhdrew
2 Dled 9
1^^ ur
für surgery;
METHODS Study Design SPORT was conducted at 13 multidis- dplinary spine practices in 11 US states
(Califomia, Georgia, Illinois, Maine, Michigan, Missouri, Nebraska, New York, New Hampshire, Ohio, Pennsyl-
vania). The human subjects commit- tee of each participating institution ap- proved a standardized protocoL All patients provided written informed con-
sent. An independent data and safety
monitoring board monitored the study
at 6-month intervals.13
Patient Population
Patients were considered for inclu- sion iE theywere 18 years and olderand diagnosed by participating physidans
during the study enrollment period as
having intervertebral disk herniation and persistent symptoms despite some
nonoperative treatment for at least 6
weeks. The content of preenrollment non operative care was not prespeci- fied in the protocol but included edu-
cation/counseling (71%), physical therapy (67%), epidural injections
(42%), chiropractìc therapy(32%), anti-
inflammatorymedications (61%), and opioid analgesics (40%).
Specific inclusion criteria at enroll-
ment were rarucular pain (below the knee for lower lumbar herniations, into the an- tedor thigh for upper lumb ar hernia- tions) and evidence oE nerve-raot irrita-
tion with a positive nerve-root tension sign (straight leg be- tween 300 and 700 or femoral
ora
sensation in
showíng disk hemiation (protrusion, ex- trusion, or sequestered fragment)!4 at a
level and side corresponding to the clini- cal symptoms. Patients with multiple hemiations were inc1uded if only one of
the hemiations was considered symp- tomatic (ie, if only one was planned to
be opera ted on). Exclusion criteria included prior lum-
bar surgery, cauda equina syndrome,
scoliosis greater than 150, segmental in- stability(> 100 angular motion or >4-mm lIanslation), vertebral fractures, spine in- feetion or tumor, inflammatory spondy- loarthropathy, pregnancy, comorbid eon- ditions conlIaindicating surgery, or inability/umvillingness to have surgery
wíthin 6 months.
Study Interventions
The surgery was a standard open dis- kectomy wíth examination of the in- volved nerve roOt.15.l6 The proeedure agreed on by all participating centers
was performed under general or loeal anesthesia, wíth patients in the prone or knee-ehest position. Surgeons were encouraged to use loupe magnifica-
tion or a microseope. Using a midline incision reflecting the paraspinous muscles, the interlaminar space was en- tered as described by Delamarter and McCuUough.15 In some cases the me- dial border of the superior facet was re- moved to provide a dear view of the in- volved nerve root. Using a small annular incision, the fragment of disk was re-
moved as described by Spengler. 16 The
canal was inspected and the foramen probed for residual disk 01' bony pa- thology. The nerve root was decom- pressed, leaving it freely mobile.
The non operative treatment group received "usual care," with the study protocol recommending that the mini- mum nonsurgical treatment include
at least active physical therapy, educa- wíth home exercise in-
nonsteroidal
SURGICAL VS NON OPERATIVE TREATMENT FOR LUMBAR DlSK HERNIATlON
Table 1. Patient Baseline Demographie Characteristics, Comorbid Condítions, Clinícal Findings, and Health Status Measures*
Patlents, No, (%)
43
93
status
Pein with reise
SF-36
Scietlca indices, moon
SURGìCAL VS
Table 2. Treatments
GliniciansiserJÍces Educatlcn/oounseling 299
52 119 36
195
MedicaUens NSAiDs GOX-2 inhibitors Gral steroids
NarceUos MlJscla relaJamts
Gther Devicas
Brece Gelset
142 13
180 102
193 101
15 147 66
172
18 (6) 9(3)
12 (4) 38(12) 25(8) 12 (4) 27 (8)
None 216 (68)
Abbreviatioos: COX.2, cyclooxygenase 2; NS?JDS, non. staroidal anti-lnnammalory drJgs; TENS. transcutane- aus elootñcaJ nerve stimulaton.
*Patients wI10 had used ciinlclans. treatments. medioa- tlens, and d6'Aoos withln 1
year foliowing enrollment Of
untlllhe time 01 SUfgery; 323 patlents eil her had no BUf-
gerv 10 Ihe (jffit y'OOl' 01 enrollmenl or had at least 1 regu- lariÝsd'eduredIDlk:w.up vlsitprior tosurgery al wrJch non- operaWe treatment Informatioo c.ould be assessed.
Study Measures The primary measures were the Medi- cal Outcomes Study 36-Item Short- Form Health Survey (SF- 36) bodily pain
and physícal functìon scales18-21 and the Americall Academy of Orthopaedìc Sur- geons MODEMS version of the Oswe- stry Disability Index (ODI)Y As specí-
fied in the trial protocol, the primary outcomes were changes from baseline in these scales at 6 weeks, 3 months, 6
mOllths, alld land 2 years from enrollment.
Secondary measures included pa- tient improvemcm, work status, and satisfaction with eunent
care. Symptom se-
DISK HERNIATION
eligibility. For recruitment and in- formed consent, evidence-based vid- eotapes described the surgícal aud non- operative treatments and the expected
benefits, risks, and uncertainties.26,27 Particípants were offered enrollment in either the randomized trial or a con- current observational cohon, the re- sults of whích are reported in a com- panion article.
Enrollment began in March 2000 and
ended in November 2004. Baseline vari- ables were collected prior to random- ization. Patients self-reported race and ethnicity using Nationallnstitutes of Health categories.
Computer-genera ted random treat-
ment assignment based on permuted blocks (randomly genera ted blocks of 6, 8, 10, and 12)28 within sites oc- curred immediately after enrollment via
an automated system at each site, en- suring proper allocation concealment. Study measures were collected at base-
Une and at regularly scheduled fol- low-upvisits. Short-term follow-upvis-
its occurred at 6 wecks and 3 months. If surgery was delayed beyond 6 weeks, additional follow-up da ta were ob- tained 6 weeks and 3 months pos top- eratively. Longer-term follow-up vis- its occurred at 6 months, 1 year from enrollment, and annually thereafter.
Statistical Analyses
We originally determined a sampIe size
of 250 patients in each treatment group to be suffícient (wÜh a 2-sided signífí-
canee level of .05 and 85% power) to
deteet a lO-point difference in the SF-36 bodily pain and physical functioning
scales or a similar effect size in the ODI. This difference corresponded to pa- tients' reports ofbeing "a lÜde better"
in the Maine Lumbar (MLSS).29 The sampIe size caIculation allowed for up to 20% data but did not aecount any levels oE
2 years. To adjust for the possible effect
of missing da ta on the study results, the analysis of mcan changes for continu- ous outcomes was performed using
maximum likelihoad estimation for longitudinal mixed-effects models un- der "missing at random" assumptions and including a term for treatment cen- ter. Comparative analyses were per- formed using the single
methods of baseline value carried for-
ward and last value earried forward, as wen as a longitudinal mixed model con- trolling for covariates associated with missed visits.30
For binary secondary outcomes, lon- gitudinal logistic regression models were fitted using generalized estimat- ing equatians31 as implemented in the
PROC GENMOD program of SAS ver- sion 9.1 (SAS Institute lne, Cary, NC). Treatment effects were estimated as dif- fe rene es in the estimated proportions in the 2 treatment groups.
P<'05 (2-sided) was used to es tab- lish statistical significanee. For the pri- mary outeomcs, 95% eonfidenee inter- vals (CIs) for mean treatment effects
were calculated at each designated time point. Global tests of the joint hypoth- esis of no treatment effect at any of the designated periods were performed us- ing Wald tests32 as implemented in SAS.
These tests aceount for the intraindi- vidual correlation due to repeated mea- surements aver time.32
N onadherence to randomly as- signed treatment may mean that the intention-to-treat analysis under- estimates the real beneHt of the treat- ment.33,34 As a preplanned sensítívÜy
analysis, we also estimated an "as- treated" longitudinal analysis based on comparisons of those actually treated
and Re- peated measures of outcomes were used as the variables, and treat- ment received was included a time-
eovariate.
included to adjust for possible con- founding.
RESUL TS
SPORT achieved full enrollment, with 501 (25%) ofl991 eligible patients en- rolled in the randomized trial. A total of 472 participants (94%) completed at
least 1 follow-up visit and were in- cluded in the analysis. Data were avail- able for between 86% and 73% of pa- tients at each of the designated follow-up times (FIGURE 1).
Patient Charaderistics
Baseline patient characteristics are
shown in T ABLE 1. Overall, the study population had a mean age of 42 years,
with majorities being male, white, em- ployed, and having attended at least
some college; 16% were receiving dis- ability compensation. All patients had
radicular leg pain, 97% in a classic der-
matomal distribution. Most of the her-
niations were at L5-S1, posterolateral,
and were extrusions by imaging crite-
ria.14 The 2 randomized groups were similar at baseline.
Nonoperative Treatments A variety of nonoperative treatments
were used during the study (TABLE 2). Most patients received educationl counseling (93%) and anti-inflamma-
tory medications (61%) (nonsteroidal
anti-inflammatory drugs, cydooxyge-
nase 2 inhibitors, or oral steroids); 46%
received opiates; more than 50% re- ceived injections (eg, epidural ste- raids); and 29% were prescribed activ- ity restriction. Fony-four per cent received active physícal therapy dur- ing the trial; however, 67% had re- ceived it prior to enrollment.
Surgical Treatment and Complications
TABLE 3 the characteristícs oE SUI-
rreatmentand The
SURGICAL vs NONOPERATIVE TREATMENT FOR LUMBAR DISK HERNIA nON
plications of childbirth 11 months af-
ter enrollment. The most common inrraoperative complication was dural
tear (4%). There were na postopera- tive complications in 95% of patients.
Reoperation occurred in 4% of pa- tients within 1 year of the initial sur-
gery; more than 50% of the reopera- tions were for recurrent herniations at the same level.
Nonadherence
Nonadherence to treatment assign- ment affected both groups, ie, some pa- tients in the surgery group chose to de- lay 01' decline surgery, and same in the nonoperative treatment gr01.1p crossed
over to receive surgery CFigure 1). The
characteristics of crassover patients that
were statistically different from pa- tients who did not cross over are shown in TABLE 4. Those more likely to cross
over to receive surgery tended to have
lower incomes, worse baseline symp- toms, more haseline disability on the
om, and were more likely to rate their
symptoms as gettíng worse at enroll-
ment than the other patients receiving
nonoperative treatment. Those more likely to cross over to receive nonop- erative care were older, had higher in-
comes, were more likely to have an 1.1p-
per lumbar disk hemiation, less likely to have a positive straight leg-raising
test result, had less pain, better physi-
cal function, less disability on the om, and were more likely to ra te their symp- toms as getting better at enrollment than the other surgery patients.
Missing Data The rates of missing data were equiva-
lent between the. groups at each time point, with no evidence of differential
dropout to assigned treat-
ment. Characteristics of with missed visits were very similar ta those
of the rest oE the cohort that
with data were
Table 3. Operative Treatments, and Events
level
L4.5 L5-S1
Operation time, mean min Blood mean Blood Length
Same da'1 1 Night 2:2 Nlghts
IntraoperatIve compiicatlonst Dural tearíspinal fluid leak Vascuiar injury Other None
9 89
145 79.1 64.7
4
65 137 37
10 1 2
230
superficial 4 9
226 Other
None Postsurgical reoperatlon,
No. (rate)~ 1 y
Additional surgery Recurrent hernlation Complicatlon or other New conditlon
2'1 Additional surgery Recurrent hemlaUon Complication 01' other
New condition
9(4) 5(2) 4(2)
o
13 (5) 8(3) 4(2)
o
*Data on surglcallevel, blood loss, loogtl1 of etay, and oorn. plloaUons were not avallable for 7 aurgioal patients. Oe. talled surglcaJ information was available for 243 of 247 patlents who had surgery,
tNone cf Ihe followlog ware reported: aspiration, opera- tion at wrang level,
tAny reported complications up to 8 weeks postoperatioo.
None af the following were reported: blood transfusion, cerebrospinal fluid leak, deep wound infectlon, nerve- root inJury, paralysis. cauda equina inJury, wound dehia- oenee, wound hemafoma.
9Rates ere Kaplan-Meier estlmate,s.
Intent-to- Treat Analyses
TABLE 5 shows estimated mean changes
from baseline and the treatment ef- feets (differences in ehanges from base-
line between treatment groups) for 3
months, 1 year, and 2 years. For each
measure and at each point, the treat-
ment effect favors surgery. The treat-
ment effects for the primary outCOIDes
were small and not statístícally
cant at any of the As shown in
FIGURE 2, treatment
SURGICAL VS NONOPERATlVE HERNIA TlON
..
Table 4. Statistlcally Significant Baseline Demdgraphic Characteristics, Comorbid Conditions, Clinical Findings, and Health Status Measures,
by Adherence With Treatment Assignment !..
Assigned to Surgery
No.(%)
Assigned to Nonoperative Treatment
No.(%)
No No
Herniatlon level:j: .45
1 were not symptoms, Range,
severe symptoms, Range tor Oswestrý Disability Index, 0-100; tor soiatica indices, 0-24, tHigher :j:Lower score
Table 5. Treatment Effects for Primar)' and Secondary Outcomes Based on Intent-to-Treat Analyses*
3 Months 1 Year 2 Years
Surgery Nonoperative (n = 198) (n = 211)
Effeot (95%01)
Surgery Nonoperative Treatment Surgery Nonoperative
(n = 202) (n = 213) Effeot (95% CI) (n = 186) (n = 187) Effect
(95% CI)
Prlmary outcomes SF-36 score, mean (SE)t
Bodlly pain
Physicai
Oswestry
signifieant. This test aeeounts for in-
traindividual eorrela tions as de- scribed in the "Methods" seetion.
For the seeondary outcome of scí-
atìca bothersameness, Table 5 and
FIGURE 3 show that there were greater
improvements in thc Scíatica Bother-
someness Index in the surgery graup
at an designated follow-up times: 3
months (treatment effect, -2.1; 95% CI,
-3.4 to -0.9),1 ycar (treatment effect,
-1.6; CI, -2.9 to -0.4), anel 2 years
(treatment effect, -1.6; 95% CI, -2.9 to
-0.3), with resülts of the global hy-
po thesis test being statistically signifi-
cant (P= .003). Patient satisfaction v"ith
symptoms and treatment showed small
effects in favor of surgery while em- plo))"ment status showed small effects
in favor of nonoperative care, but none
of these changes was statistically sig-
nificant. Self-rateel progress showed a
small statistically significant advan-
tage far surgery (P= .04).
As-treated analyses based on treat-
ment receiveel were perfonneel with ael-
justments for the time of surgery and
factors affecting treatment crossover
and missing data. These yieldeel far dif-
ferent results than the intenHo-treat analysis, with strong, statistically sig-
niHcant advantages seen for surgery at
all follow-up times through 2 years. For example, at 1 year the estimated treat-
ment eHeets for the SF-36 bodily pain
SURGICAL VS TREATMENT FüR LUMBAR DlSK HERNIATlON
anel physieal function scales, the ODI,
and the sciatica mcasures were 15.0
CI, 10.910 19.2), 11.5 Cl,
13.6 to 21.5), -15.0 (95% CI, -18.3 to
-l1.ï), and -3.2 CI, -4.3 to -2.1), respeetivdy.
Sensitivity analysis was performed
for 4 different analytic methods of
dealing with the missing data, One
method was based on simple mean ehanges far an patients with data at a
given time point with no special
adjustment for missing data. Two methods useel single imputation methoels-baseline value carried for-
ward and last value earrieel forward.J!
The latter method used the same
mixed-models approach for estimat-
ing mean changes as given in Iable 5
but also adjusted for faetors aHecting
the likelihood of missing data. Treat-
ment effect estimates at 1 year ranged
from 1.6 to 2.9 for the SF-36 bodily
pain seale, 0.74 to 1.4 for thc physical
function scale, -2.2 to -3.3 for the
001, and -1.1 to -1.6 for the scìatiea
measures. Given these ranges, there
appear to be no substantial differences
between any of these methods.
COMMENT Both operateel and nonoperateel pa-
tients with intervertebral disk hernia-
tion improved substantially over a
2-year peliocl. The intent-to-treat analy-
sis in this trial showeel no statistically
significant treatment effects for the pri-
mary outcomes; thc seconclary mea-
sures of sciatica severity and self-
reporteel progress did show statistically
significant aelvantages for surgery,
These results must be vieweel in the
eontext of the substantial rates of non-
aelherenee to assigned treatment. The
pattern of nonadherence is striking be-
cause, unlike many surgical studies,
both the surgical anel non operative
treatment groups were affecteel,35 The
most eomparable previous tria18 had
26% erossover into surgcry at 1 year,
but only 2% erossover out of surgery.
The mixing of treatments elue to cross-
over can be expected to ereate a bias to-
ward the nulp4 The large effects seen
in the as-treated analysis and the char-
acteristics of the crossover patients sug-
gest that the intent-to-treat analysis un- derestimates the true effeet of surgery.
SPORT findings are consistent with
clinical experience in that relief of leg
pain was the most strildng and consis-
tent i.mprovement with surgery. Im- portantly, all patients in this trial had
leg pain with physical examination and imaging Hndings that confirmed a disk
hemiation. There was litde evidenee of
harm from eìther treatment. No pa- tients in either group developed cauda
equina syndrome; 95% of surgical pa-
tients hael no intraoperative complica-
Figure 2. Mean Scores Over Time for SF-36 Bodlly Pain and Physical Function Scales and Oswestry Disability Index
Bodily Paln
1"9.13::3<3" t~on:n=81
Physioal Funotlon Oswestry Dìsability Index
Gi Surgery
A Nonoperative Care
for
SURGICAL VS NONOPERATIVE TREATMENT FOR LUMBAR DlSK HERNIATlON
tions. The most common complica- tion, dural tear, occurred in 4% of patients, sinÜlar to the 20Ic, to 7% noted
in the meta-analysis Hoffman et aV 2.2% seen in the MLSS, and 4% in the
recent series from Stanford.
Oue limitatiou is the potential lack of representativeness of patients agreeing
to be randomized to surgelY or nonop- erative care; however, the characterís- ties of patients agreeing to participate in SPORT were simílar to those in other studies. The mean age of 42
years was similar to the mean ages in the
MLSS,29 the series of Spangfort, 37 and the
randomized trial by Weber, and only slightly older than iliose in the recent se-
ries from Stanford (37.5 years).3Ô The
proportion of patients receiving work- ers' compensation in SPORT (16%) was
similar to the proportion in the Stan-
ford population (19%) but lower than
that in the MLSS population (35%), which specifically oversampled pa- tients receiving compensation. Base-
hne functional status was also similar,
with a mean baselíne om of 46.9 in SPORT vs 47.2 in ilie Stanford series, and
a mean baseline SF-36 physical func-
tíon score of 39 in SPORT vs 37 in the
MLSS.
The strict eligibílity criteria, how- ever, may limit the generalizability of these results. Patients unable to toler-
ate symptoms for 6 weeks and demand- ing earlier surgical intervention were
not included, nor were patients with-
out dear signs and symptoms of nt- diculopathy with confi.nnatory im ag-
ing. We can draw no conclusions regarding ilie efficacy of surgeryin iliese
other groups. However, our entry cri-
tería followed published guidelines for
patient selection for elective diskec-
tomy, and our results should apply to the majority of patients facing a surgi- cal clecision.38,39
To fuHy understand the treatment effect of surgelY compared \v"Íth non- operative treatment, it is worth noting
how each group fared. The improve- ments with surgery in SPORT were símilar to those of prior series at 1 year: for the 001, 31 points vs 34 points in the Stanford series; for the bodily pain
40 points vs 44 in the MLSS; and for sciatica bothersomeness, 10 points
vs 11 in the MLSS. Similarly, Weber8 reported 66% "good" results in the SUf-
gery group, compared with the 76% re- porting "major improvement" and 65%
satisfied with their symptoms in SPORT.
Figure 3. Measures Over Time for Scìatica Bothersomeness Index, Employment Status, Satisfaction With Symptoms, Satisfaction With (are, and Self-rated ImproVèrnent
Sciatlca Bothersomeness SaUsfaction Wlth Symptoms
~ o
()) c !!J
:::;
lj;
,[ ::i'
Global p~ ,003
6 12
Months From Baselíne
SatÎsfactlon Wlth Gare
Work Status
CJ>
C :g o S ?f!.
Months From Baseline
Self-rated Improvement
V) E .8 ~ JJ
~ S 1:J '" "" .SQ 1iJ
rf) ?f!.
24 24
Months From ßaseline
The observed improvements with nonoperative treatment in SPORT were greater than those in the MLSS, result-
ing in the small estimateel treatment effect. The nonoperative improve- ment of 35, anel 9 points in bodily
physícal function, anel sciatica
bothersomeness, respectively, were
much greater than thc improvements of 20,18, and 3 points reported in the
MLSS. The greater improvement with nonoperative treatment in SPORT may be rdated to the large proportion of pa-
tients (43%) who underwent surgery in this group.
The major limitation ofSPORT is the
degree of nonadherence with random-
ized treatment. Given this degree of
crossovcr, it is unlikely that the intent-
to-treat analysis can form thc basis of a valid estimate of the true treatment effect of surgery. The "as-treated" analy-
sis with adjustments for possible con- founders showed much larger effects in favor of surgical treatment. However, this approach does not have the strong
protection against confounding that is
afforded by randomization. We can-
not exclude the possibility that base-
line differences between the as- treated groups, or the selective choke
of some but not other patients to cross
over into surgery, may have affected
these results, even after controlling for
important covariates. Due to practical
and ethical constraints, this srudy was
not masked through the use of sham
procedures. Therefore, any improve-
ments seen with surgery may include
some degree oE "placebo effect."
Another potential limitation is that
the choice of nonoperative treatments
was at Ù1e discretion of the treating phy-
sidan anel patient. However, given the
limited evidence regarding efficacy for
most treatments for lum-
bal' disk herniation and individnal vari- a
SURGICAL VS NüNüPERATIVE TREATMENT FüR LUMBAR orSK HERNIATlüN
transcutaneous electrical nerve stimu-
lation, and braces and corsets, and lÜgher rates of epidural steroid injec-
tions anel use of narcotic analgesics.
This flexible nonoperative protocol had
the advantages of individualizatiol1 that cOl1sidered patient preferences in the
choke of nonoperative treatment and oE reflecting current practice among multidisciplinary spine practices. How-
ever, we cannot make any conclusion regarding the effect of surgery vs any specific nonoperative treatment. Simi- larly, we cannot adequately assess the
relative efficacy of any differences in surgical technique.
CONCLUSION
Patients in both the surgery and non- operative treatment groups improved
substantially over the first 2 years.
Between-group differences in improvements were consistently in favor of surgery for an outcomes and
at an time perioels but were small and
not statistically significant except for
the secondary measures oE sciatica severity and self-rated improvement.
Because of the high numbers of patients who crossed over in both
directions, conclusions about the
superiority or equivalence of the treat-
ments are not warranted based on the
intent-to-treat analysis alane.
Author Contrlbutlons: Dr Weinstein had full access
to all of the data In the study and takes responslbillty
for the integrity of the data and the accuracy of the data analvsis.
Study concept and design: Weinstein, T, Tosteson, Lurle, A. Tosteson, Acquisition of data: Weinstein, T. Tosteson, tude, Abdu, Hillbrand, Boden. Analysis and interpretation of data: Weinstein,
T, Tosteson, Lune, A. Tosteson, Hanscom, Skinner,
Abdu, Hillbrand, Deyo. Drafting of the manuscript: Weinstein, T. Tosteson,
Lurle. Critical revision of the manuscript for important in. telledual content: \Neinstein, T. A. Tosteson, Hanscom, Skinner, Abdu,
Boden, Deyo.
cal Dedsian Making, proceeds to the Department of Or. thopaedics, Dartmouth, Dr Lurie reports that he Fe.
ceives grant support Irom St Francl. Medlcai Technologles and Amerlcan Board 01 Orthopaedic Sur.
gery; has served on advlsory boards for Ortho. MacNeíl Pharmaceutlcals, the Robert Graham Center
of the American Academy of Famííy Practlce, and Cen. toeor; and as a consultant for Myexpertdoctor.com, Pa. elfic Business Group on Health, and the FOíJndation for
Inforrned Medical Decìslon Maklng, Dr A. T csteson re. ports recelvlng funding Irom St Frands Medlcal Tech. nologies. Mr Hanscom reports worklng for the Na- tional Spine Network and recelving funding from Medtronlc. Dr Boden reports seNlng as a consultantfor
Medtronlc. Dr Deyo reports recelvlng research pro.
gram benefits as a gift to the University cf Washington
Irom Synthes, a manufacturer of stJfgical appllances, from which he receives no personal benefits, No other dis.
closures were reDorted. FundingISupport: This was funded by the Na-
tionallnstitute of Arthritis and Musculoskeletal and
Skin Diseases (NIAMS) (U01-AR45444.01 A 1) and the
Office of Research on Women', Health, National in. stltutes of Health; and by the National Institute of Oc- cupatlonal Safety and Heaith, US Centers lor Disease
Controi and Preventlon. The Multldiscìplinary Cllni- cal Research Center in Musouioskeletal Diseases Is
funded by NIAMS (P60.AR048094.01A1), Dr Lurie
Is supported bya Research Career Award from NIAMS (1 K23 AR 048138-01). Role oftne Sponsors: The funding sources had no role in design or conductofthe study; the collectlon, man. agement, analysis, 0, interpretation of the data; orthe preparation, review, or approval of the manuscript.
project Coordlnator, Princlpallnvestlgators, Partici- patlng institutions, and Nurse Coordlnators (in order
by enrol1ment); Judl L. Forman, MPH (Project Coordl. nator), Wiíliam A. Abdu, MD, MS, Barbara Butler- Schmidt, RN, MSN, J. J. Hebb, RN, BSN (Dartmouth- Hitchcock Medical Center); Hany Herkowitz, MD, Gloria
Bradley, BSN, Melissa Lwie, RN (Wiliiam Beaumont Hos. pital); Todd Aibert, MD, Alan Hilibrand, MD, Caroie Si-
mon, RN, MS (Rothman institute atThomas Jefferson
Hospital); Frank Cammisa, MD, Brenda Green, RN, BSN
(Hospital for Special Surgery); Michael Longley, MD, Nancy Fullmer, RN, Ann Marie Fredericks, RN, MSN, CPNP (Nebraska Foundatlon forSpinal Research); Scott
Boden, MD, 5a1iy Lashley, BSN, MSA (Emory University-
The Emory Clinic); Lawrence Lenke, MD, Georgia Sto- bbs, RN, BA (Washington Unlversity); Sanford Emery,
MD, Chrls Furey, MD, Kathy Hlgglns, RN, PhD, CNS
(Unlversity Hospitals of Cleveiand/Case Western Re- seNe); Thomas Errìco, MD, Alex Lee, RN, BSN (Hos. pltal for Joint Dlseases); Harley Goldberg, DO, Pat Ma- lone, RN, MSN, ANP (Kaiser Permanente); Serena Hu,
MD, Pat Malone, RN, MSN, ANP (University of Call.
fornia-San Francìsco); Gunnar Andersson, MD, PhD,
Howard An, MD, Margaret Hlckey, RN, MS (Rush-
Presbyterian-St Luke's Medical Center); Robert Keller,
MD (Mai ne Spine and Rehabilitation).
Enrolllng Physicíans: Wllliam Abdu <Dartmouth- Hltchcock Medlcal Center); David Montgomery, Harry Herkowitz (Wii!iam Beaumont Hospital); Ted Conliffe,
Alan Hilibrand (Rothman Institute at Thomas Jefferson Frank Cammisa (Hos-
Univer;ity-
Foun-
SURGICAL VS NONOPERATlVE TREATMENT FOR LUMBAR DlSK HERNIATlON
nente); Lawrence Kurz (Beaumont); Joseph Dryer (Hos- pital for Joint Diseases); Sanford Emery (University Hospitals of Cleveland/Case Western Reserve); Susan
Dreyer, Howard Levy (Emory); Patrick Bowman (Ne- braska Foundation for Spinal Research); Thomas Errìça
Lee Thibodeau, MD (Maìne Spine and Jeffrey Fischgrund (Beau- mont); Mark Splaine (Darlmouth); John Bendo (Hos- pital for Joint Diseases); Taylor Smith (University of Cali- fomia-San Fmndsco); Enc Phillips (Nebraska Foundation
Research); Dilip Sengupta (Dartmouth); David (Emory); Henry Schmidek (Dartmouth); Har-
iey Go!dberg (Kaiser); Robert Rose (Dartmouth); Slg Ber-
yen (University of Californìa-San Francisco); Frank Phi!- lips, Howard An (Rush-Presbyterian-St Luke's Medical Center); Colleen Olson (Dartmouth); Anthony Margh- erita, John Metzler ('lVashingfon Universìty); Jeffrey Go!d- stein (Hospital for Joint Diseases); Phaedra Mcdonough (Dartmouth); James Farmer (Hospital for Special Sur- gerý); Marsoiais (Case Western); Gwmar Andersson (Rush-Presbyterian-St Luke's); Hilda Magnadottir, Jlm Weinstein, Jon Lurie (Darúnouth); J. X. Yoo (Case West- em); John HeUer (Emory); Jeffrey Spivak (Hospital for Joint Diseases); Roland Hazard (Dartmouth); Michael Schaufele (Emory); Jeffrey Florman (Maine Spine and Rehabilitation); Phìlip Bernini (Dartmouth); Eerie Tr- uurnees (Beaumont); I<. Daniel Riew (Washingfon Uni- verslty); Timothy Burd (Nebraska Foundation for Spl- nai Research); John Rhee (Emory); Henry Sohlman (Case Western); Richard Perry (Hospital for Joint Diseases); Ed- ward Goldberg (Rush-Presbyterian-St luke's); Christo- pher Furey (Case Western). Acknowledgment We thank Tamara S. Morgan, MA, Department of Orthopaedic Surgery, Dartmauth Medi- cal Schaol, for graphie design and produetion, jour- nal Interfacing, and shepherdingthe SPORT study from its original submission and Into the foreseeable fu- ture. Ms Margan Is funded through the department and partially by SPORT. This study Is dedlcated to the memory of Brleanna Weinstein.
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