Natural History and Treatment for Sciatica Wilco C. Peul MD, PhD & Bart W. Koes, PhD for the
Leiden–The Hague
Spine Intervention Prognostic Study Group (SIPS) Leiden University Medical Center Medical Center The Hague
Absenteeism from Work
Hernia Chirurgie is geen Remedie voor Rugpijn
PDN
Discus Prothese
Gouden Standaard ???
Richtlijn Specifieke Lage Rugpijn
• • • • • •
Onvoldoende bewijs Rol Discografie Steeds meer ingrepen Start Outcome Registratie Quasi Randomized Trial Druk media
Krause 1908
Mixter WJ and Barr J 1934
Indicatie
Techniques since 1934 • • • • • • • • • •
Laminectomie and Discectomie Laminotomie and Discotomie Chemonucleolysis Microdiscectmie Sequestrectomie Percutane Nucleotomie Laser Discectomie Nucleoplasty Discectomie with PDN Micro-Endoscopische Discectomie
Chemonucleolysis
Microdiscectomie
Advantages • Minimal invasive • Outpatient • Less Backpain?
Techniek PLDD
(Micro)-endoscopic Discectomy
Modern Technology
The Sciatica Mast-Trial A Randomized Controlled Trial investigating the cost-effectiveness of minimal invasive surgical treatment for the lumbosacral radicular syndrome (LSRS)
Weber 1983 A controlled prospective study with ten years of observation. Spine 1983; 8:131-140
• Surgery vs “Wait and See” • RCT • Equivalence ? • Methodological flaws • Indication ?
Saal and Saal 1989 Natural history and non-operative treatment of lumbar disc herniation. Spine 1996; Suppl. 24 S: 2S-9S.
Spine surgeons/million persons
EBM in Wervelkolom Chirurgie
Dutch Health Council 1999 Gezondheidsraad 1999/18. Diagnostiek en behandeling van het LSRS
• Bedrest not effective • Physiotherapist guidance ? (Research) • Information and Counselling ? (Research) • Timing and complications of surgery ? (Research) • Surgical Techniques ? (Research) • Patient and Physician preferences ? (Research)
Research Question • Surgery after 6-12 weeks sciatica
compared to
• Prolonged conservative care with delayed surgery
Treatment strategies • Unilateral Microdiscectomy –
Minimal or no bone removal
–
Removal of degenerated disc tissue
• Wait-and-See strategy ● ● ●
Adequate analgetics Guidance by family physician or neurologist Surgery when necessary
Patients 6-12 weeks severe sciatica MRI correlating unilateral disc herniation Unequivocal agreement surgeon and neurologist No stenosis
Outcomes • Roland Disability Questionnaire • VAS pain leg/back • Perceived recovery EuroQol
Analysis Area under the curve primary outcomes • Mixed model repeated measurement analysis Time to Complete Recovery • Unadjusted Cox proportional hazard model According to Baseline Characteristics • Adjusted Cox proportional hazard model
Copyright ©2008 BMJ Publishing
Facts • 141 Early Surgery – 125 surgery (Median 1.8 week)
• 142 Prolonged Conservative Treatment – 55 surgery (Median 15 weeks)
Kaplan Meier - time to surgery Prolonged Conservative Care
Early surgery
16
Mean difference of Roland AUC’s (CI)
42.5 (-12.4—97.4) *
12
ROLAND
AUC conservative 316.3 ± 18.8
8
4
AUC surgery=273.9 ± 20.7
-4
0
4
8
12
16
20
weeks
24
28
32
36
40
44
48
52
Mean difference of VAS leg pain AUC’s (CI)
341.7 (163.8—519.6) *
60
LEG PAIN
40
AUC conservative 977.0 ± 68.3
20
AUC surgery 635.3 ± 58.6
0
4
8
12
16
20
24
28
weeks
32
36
40
44
48
52
Mean difference of VAS back pain AUC’s (CI)
163.7 (-52.5—379.9) *
BACK PAIN
60
40
AUC conservative 1047.9 ± 77.6
20
AUC surgery 884.2 ± 77.6
0 0
4
8
12
16
20
24
28
weeks
32
36
40
44
48
52
1,0
0, 9
0, 8
Cumulative Probabilty of Recovery
E a r ly S u r g e ry 0, 7
0, 6
C o n se rva t ive T re a tm e n t
0, 5
0, 4
0, 3
0, 2
C o x P r op o r ti o n a l H a za r d R a ti o ( 9 5 % C I ) ‡
1 . 9 7 ( 1 .7 2 -2 . 2 2 )
p < 0 .0 0 1
0, 1
0, 0 0
4
8
12
16
20
24
28
weeks
32
36
40
44
48
52
Subgroup Overall Age * < 40 years ≥ 40 years Intellectual job non-intellectual intellectual Physically demanding work non-physically demanding physically demanding Sex male female Start Sciatica acute severe slowly increasing Influence intra-abdominal pressure provocation sciatica no provocation Lasègue's sign * ‡ straight leg raising > 60 ° straight leg raising ≤ 60 ° Crossed straight leg raising negative positive VAS leg pain intensity * ‡ > 70 ≤ 70 Sciatica provocation by sitting † no provocation provocation Tingling/numbness pain area no sensation sensation McGill affective scores * low score < 3 high score MRI Sequester ‡ contained disc herniation sequester MRI Gadolinium ‡ no enhancement enhancement MRI level disc herniation L5S1 L4L5 or L3L4 Preference for surgery ‡ strong preference for surgery some or no preference
Proportion %
Hazard Ratio
P Value
100 0,12 41 59 0,83 36 64 0,61 61 39 0,64 66 34 0,91 61 39 0,45 73 27 0,88 25 75 0,17 41 59 0,98
Interaction
54 46
0,07 24 76 0,66 10 90 0,60 49 51 0,81 59 41 0,60 34 66 0,75 61 39 0,73 39 61 0 Conservative better
1
2
3
Surgery better
4
5
6
1 ,0 0,9
Cumulative Probability of Recovery
0,8
Early surgery 0,7
Conservative treatment
0,6
0,5 0,4
No provocation by sitting
0,3
0,2
Cox Proportional Hazard Ratio (95 % CI) 1.29 (0.76-2.17) p=0.35
0,1
0,0 0
4
8
12
16
20
24
28
32
w eeks
36
40
44
48
52
1 ,0
0,9
Cumulative Probability of Recovery
0,8
Early surgery
0,7
0,6
Conservative treatment
0,5
0,4
Provocation by sitting
0,3
Cox Proportional Hazard Ratio (95 % CI) 2.16 (1.61-2.92) p<0.001
0,2
0,1
0,0 0
4
8
12
16
20
24
28
32
weeks
36
40
44
48
52
EQ5D Utiliteit (NL)
1,0 0,8 0,6 0,4
Vroege operatie
0,2
Afwachtend 0,0 0
13
26
39
Weken sinds randomisatie
52
QALY difference over 1 year • 0.044 QALY
• $ 2,015/QALY (95% CI; $ 915 to $ 3,116)
Costs • Societal perspective $-13 (95%CI $-4,475 to $4,449)/QALY
• Health care perspective $46,000 (95%CI $15,000 to $478,000) /QALY
Unsatisfactory Outcome
Unsatisfactory Outcome 1 year 13 % 2 year 20 % • Univariate Cox Hazard Ratio model • Univariate logistic regression • Multivariate logistic regression • Which variables ?
Logistic regression (Unsatisfactory Outcome) • Univariate –
Gender
–
Bragard
–
Smoking
–
Housewife
3.29 (CI 1.72-6.28) 1.81 (CI 0.96-3.41)
• Multivariate –
Gender
2.81 (CI 1.38-5.74)
–
Smoking
2.01 (CI 0.99-4.1)
–
Surgery
0.49 (CI 0.24-1.00)
Advise • Prolonged wait and see • Intention early surgery……..? – Provocation legpain by sitting – Production loss – Wait for nature “impossible” • Decision based on ……… – Personal choices – No interaction classic neurology
Patient tailored strategy • Timing surgery at 16 – 20 weeks ? • Earlier surgery if patient is well informed about altenative strategy…. –
possible favourable natural course
–
low risk chronicity
HTA Science, politics and society What should we advise to our patients and public?
A strategy of early surgery seems cost-effective,
but….
The art of medicine consists in comforting the patient for a few months while nature cures the sciatica.
Adapted to Voltaire
Who did have delayed surgery ? • • • • •
Basal demographics Neurological Examination Pain en disability Preferences MRI (Sequester vs contained; Gado enhancement)
Logistic Regression
Role of Neuroradiology in Nature or Surgery? I see, I see what a surgeon does not see. Prognosis by MRI Parallel MRI study
To conclude • Early surgery is effective for fast recovery • Delayed surgery prevents 56 % of interventions, risking prolonged suffering • Both strategies are safe • Intense sciatic neuralgia and inability to sit are good arguments for early surgery
•
Peul WC, van Houwelingen HC, van den Hout WB, Brand R, Eekhof JA, Tans JT,Thomeer RT, Koes BW Surgery versus prolonged conservative treatment for sciatica.
N Engl J Med. 2007 May 31;356(22):224531;356(22):2245-56. 56. •
Koes BW, van Tulder MW, Peul WC.Diagnosis and treatment of sciatica.
BMJ. 2007 Jun 23;334(7607):131323;334(7607):1313-7 •
Peul WC, Brand R, Thomeer RT, Koes BW.Improving prediction of "inevitable" surgery during non-surgical treatment of sciatica.
Pain. 2008 September 2008 •
Peul WC, Brand R, Thomeer RT, Koes BW.Influence of gender and other prognostic factors on outcome of sciatica.
Pain 15 august 2008 •
Peul WC, Van den Hout WB, Brand R, Thomeer RT, Koes BW; Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: two year results of a randomised controlled trial
BMJ. 2008 May 23 •
Van den Hout WB, Peul WC, Koes BW, Brand R, Kievit J, Thomeer RT;.Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: cost utility analysis alongside a randomised controlled trial.
BMJ, 2008 May 23 •
Peul WC, Arts MP, Brand R, Koes BW Timing of Surgery for
Eur Spine J 9 January 2009
AandachtspuntenDiscussie
• Wat zijn de indicaties voor operatie?
• Wat is de effectiviteit van verschillende behandelvormen bij een LSRS?
AandachtspuntenDiscussie
• Wat zijn de voor- en nadelen van vroege operatieve behandeling richting zwaar lichamelijk werk?
• Wat is de meerwaarde van fysiotherapie ten opzichte van de NHG standaard of NVAB?
Door patiënten aangegeven herstel (EUR studie) 100 (Luijsterburg ; Peul; Koes et al) Percentage 80 60 40
Fysiotherapie
20
Geen fysiotherapie 0 0
6
12
18
24
30
36
42
48
54
Weken
Door patiënten aangegeven pijn 10
Gemiddelde pijn score
Fysiotherapie
8
Geen fysiotherapie 6 4 2 0 0
6
12
18
24
30
36
42
48 Weken
54
Door patiënten aangegeven functioneren Gemiddelde functie score
24
Fysiotherapie
20
Geen fysiotherapie
16 12 8 4 0 0
6
12
18
24
30
36
42
48 54 Weken
Resultaat: Kosten •
•
Elke meer herstelde patiënt met fysiotherapie kost: –
€ 837,00 zonder ziekteverzuim
–
€ 6.224,00 met ziekteverzuim
Fysiotherapie duurder
AandachtspuntenDiscussie
• Wat zijn de lange termijn effecten van de verschillende behandelvormen?
• Wat zijn de prognostische factoren voor een ongunstig natuurlijk beloop bij LSRS?
AandachtspuntenDiscussie
• Wat zijn de voorspellende factoren voor een onvermijdbare operatie bij een in aanvang conservatief behandelde HNP? • Zijn er indicaties voor een eventuele verwijzing door de bedrijfsarts of verzekeringsarts en waaraan moet deze verwijzing voldoen?
Spine Intervention Prognostic Study Group –Leiden University Medical Center-Medical Center The HagueWilco C. Peul, M.D, PhD Neurosurgeon and Epidemiologist
