Nonoperative care versus surgery in lumbar disc herniation with radiculopathy. what is the evidence?
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This is a brief review of the current state of evidence for nonoperative versus operative care for lumbar disc herniation with radiculopathy. The current NASS guidelines are summarized.
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Nonoperative care versus surgery in lumbar disc herniation with radiculopathy. what is the evidence?
- 1. Dr. Kshitij Chaudhary, MS, DNB Consultant Spine Surgeon Sir HN Reliance Foundation Hospital, Mumbai N O N O P E R A T I V E V E R S U S S U R G I C A L M A N A G E M E N T L U M B A R D I S C H E R N I A T I O N W H A T I S T H E E V I D E N C E ?
- 2. Levels of Evidence Level 1 High quality RCT Level 2 Prospective comparative Low quality RCT Level 3 Retrospective comparative Level 4 Case series Level 5 Expert opinion
- 3. The Evidence RCTs 5 Prospective comparative 4 Retrospective comparative 1 Surgery versus Nonop treatment
- 4. RCT 126 patients Discectomy or Physical therapy Outcome measures - Unvalidated measure (Poor, Fair, Good, Ex) 10 year FU 1 year - Surgery better 4 year - Surgery equivalent to PT
- 5. RCT 100 patients failed noninvasive therapy for 6 weeks Discectomy or ESI Outcome measures - ODI, VAS, Pt satisfaction 2-3 years FU Discectomy did better (short term) No statistical advantage for surgery at the end Buttermann et al, JBJS Am 2004
- 6. RCT 56 patients with radicular pain for 6-8 wks Discectomy or Physical therapy Outcome measures - ODI and VAS 2 years FU Discectomy short term benefit At 2 years → no difference
- 7. RCT 208 patients Discectomy or Nonoperative Rx Outcome measures - ODI and VAS 2 years FU Discectomy better at 6 months At 1 and 2 years → no difference Puel et al, BMJ 2008
- 8. RCT (multicenter) 501 patients Discectomy (245) or Nonoperative Rx (256) Outcome measures - SF36, ODI, Self reported outcome, work status and satisfaction 2 and 4 years FU No clinically or statistically significant difference between discectomy and non-operative treatment.
- 9. f multiple RCTs over last 2 decades are showing no difference Then why do discectomy at all ?
- 10. Patients with radiculopathy (100) Surgery (50) Conservative Rx (50)Randomized Ideally, at End of Study
- 11. Patients with radiculopathy (100) Surgery (30) Conservative Rx (30)Randomized In real life Intent to Treat Cross over
- 12. At best these RCT studies are Level 2
- 13. Prospective cohort Level 2 Summary Follow up Spengler et. al. 77% good result with surgery Minimum 1 year Atlas et. al. (MAINE STUDY) Surgical group did better up to 10 years 1, 5 and 10 years Weinstein et. al. (SPORT) Significantly better outcomes for surgery at 3mo, 1, 2 and 4 years 2 and 4 years Guilfoyle et. al. Significant improvement in SF-36 and RM scores at 2 years 2 years
- 14. Retrospective cohort study Out of 58 patient in conservative group 90% had good results However, 347 patients were enrolled and only 58 were followed What happened to the remaining 289 patients? Saal and Saal, Spine 1989
- 15. Current Recommendation Discectomy is suggested to provide more effective symptom relief than medical/interventional care for patients with lumbar disc herniation with radiculopathy whose symptoms warrant surgical intervention. In patients with less severe symptoms, surgery or medical/interventional care appear to be effective for both short- and long-term relief. NASS Guidelines 2014 Grade of Recommendation: B
- 16. What about patients with motor deficit ? Is surgery better ?
- 17. Neurological deficit Complete motor recovery Weber (1983) 96% non operative cohort 94% operative cohort Hekelius (1970) 77% non operative cohort 76% operative cohort Can you really apply this to severe deficits?
- 18. Natural history severe deficits MRC<3 Buttermann (2004) 100% recovery with surgery 0% with nonoperative treatment Dubourg (2002) 25% recovery with surgery 32% with nonoperative treatment 0 - 32% recovery for severe deficits
- 19. Systematic Review 7 studies with 354 patients Grade 3 or worse Surgery - 38% recovery (at least MRC 4 in 52%) Nonoperative treatment - 32% recovery Timing - inconclusive Only 6% difference
- 21. Guidelines
- 22. Grades of Recommendation Grade A 2 or more consistent Level 1 studies Grade B Two or more consistent Level 2 or 3 studies Grade C Two or more consistent Level 4 studies Grade I Single study or multiple studies with inconsistent findings
- 23. Pharmacological treatment Grade I Insufficient evidence (Gabapentin, Steroids, Amytriptyline, NSAIDS) Physical therapy Grade I Expert consensus - limited course of structured exercise for mild to moderate symptoms Traction Grade I Insufficient evidence for or against
- 24. TFESI (short term) Grade A TFESI provide short term pain relief (2-4 weeks) TFESI (long term) Insufficient evidence Insufficient evidence for or against 12 month efficacy of TFESI Interlaminar ESI Grade C Interlaminar ESI may be considered
- 25. Nucleoplasty Grade I Insufficient evidence for or against Plasma disc decompression Grade I Insufficient evidence for or against Percutaneous Electrothermal disc decompression Grade I Insufficient evidence for or against
- 26. Intradiscal Ozone Grade I Insufficient evidence for or against Automated percutanous discectomy (versus open discectomy) Grade I Insufficient evidence for or against Endoscopic percutaneous discectomy (versus open discectomy) Grade B Endoscopic discectomy suggested in carefully selected patients (lesser early post pain compared to open)
Editor's Notes
- Weber from Norway, At one year surgery better but at 4 year both equivalent (surgery and PT)
- Study from minnesota Similar result - short term surgery better, but no advantage of surgery in the end
- Study from Finland Another RCT and again similar outcome
- From Netherlands the Hague Spine study group Another one - similar result
- SPORT, Winstein. Large multicenter study. NIH funded One of the largest trials. But again similar result.
- If one does a randomized controlled study, in an ideal situation you would want all the participants to stick to the same group.
- But that does not happen in real life. Many patients while waiting for surgery, changed their mind (may because they got better) and switched to the conservative group. Similarly many patients while on conservative treatment switched to surgery group (may be they had more pain and were fed up with non operative care). However to avoid bias (confounding variables) an RCT is always analyzed with Intent to treat analysis. That means that patients who switched from surgery to non operative group are still considered in surgery group for statistical analysis. Problem is that when there is a very high rate of crossover between the groups (almost 30 to 40% in SPORT) the results don’t make much sense. When SPORT analyzed the data with “as treated analysis” (that means all patients with surgery compared to all patient to had non operative treatment) then the surgery group did better. However, when as treated analysis is done there is a potential for bias to creep in as the patients who opted for surgery even after assigned the nonoperative group might have more severe baseline pain than the patients who stuck to non operative group. Interestingly, even if this is true (more pain preop for surgery group) in as treated analysis they ended up doing better than nonoperative group.
- Due to the high rate of cross over there RCT’s are at best Level 2 studies.
- These are the 4 non-randomized prospective cohort studies. All studies (for similar reasons) show better outcomes for surgery.
- We often quote to patients that 90% for sciatica episodes are going to do well with nonoperative care. This number comes from this study by Saal and Saal. This is a retrospective comparative study. 58 patients in conservative group. But they started out with 347 patients. What happened to the rest? Selection bias?
- From all these studies NASS has recommended the following guideline for discectomy for lumbar disc herniation. This Grade of recommendation is B (two for more consistent level 2 or level 3 studies)
- These studied are often cited when claiming that irrespective of surgery or no surgery, stable neurological deficits recover in similar rates. However, can one really say this about severe neurological deficits.
- When only severe neurological deficits are considered (Grade <3) what do the studies have to say. Buttermann study says 0% with non operative care and 100% recovery with surgery In contrast Dubourg study says the recovery rate is kind of similar in both operative and non operative treatment. Hence controversial.
- Systematic review 2014 from Stanmore England found that with surgery there was 38% recovery and nonoperative treatment 32% recovery of severe deficits. Only 6% difference. Hence current studies do not support the notion that surgery has any better rate of recovery for severe deficit compared to nonoperative care.
- Systematic review 2014 from Stanmore England Hence current studies do not support the notion that surgery has any better rate of recovery for severe deficit compared to nonoperative care.
- Here is the summary of the guidelines (NASS) for diagnosis and treatment of Lumbar disc herniation with radiculopathy.