Lumbar Disc Precision Treatment

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Introduction

Leggett et al in 2015 found mixed evidence for radiofrequency procedures for discogenic pain. Helm et al in 2019 concluded that there was level 1 evidence for the use of biacuplasty for the treatment of discogenic pain.[1]

Lumbar Disc Innervation

Disc innervation.jpg

Sinuvertebral nerves, formed by a somatic root from ventral ramus and an autonomic root from grey ramus communicans. An ascending branch passes as far as the above vertebral disc. A descending branch supplies the disc at the level of entry

Fusion

There are no sham controlled studies. There are not even any randomised controlled trials with active controls when disc pain has been proven. RCTs on non specific low back pain were negative.[2] Therefore the benefit of fusion surgery for proven disc pain is unknown.

Radiofrequency Procedures

Intradiscal Electrothermal Annuloplasty

in IDET a resistive coil is placed between the annulus and nucleus and along the posterior annulus. It is heated to 90 degrees, Putatively seals the fissure and denatures the annulus.

Intradiscal Electrothermal Annuloplasty RCTs
Study N Arms Selection Criteria Results Comments
Freeman 2005[3]

57

  1. IDET
  2. Sham IDET

Provocation CT discography with discrete annular tear or global degeneration

❌Negative study up to 6 months

  • More disabled population than Pauza.
  • Not clear if treating doctor was blinded.
  • Used cefazolin 100mg ?caused irritation.
  • Included patients with positive Waddell’s signs, workers comp, and pain up to 20 years.
  • No response in either group, so questions about metholodology (i.e. no placebo effect)
Pauza 2004[4]

64

  1. IDET
  2. Sham IDET

CT Provocation discography with posterior annular tear only

❓ “Positive” study, but modest improvements only

  • IDET: VAS 6.6 -> 4.2, 40% success for >50% pain relief.
  • Sham: VAS 6.5 -> 5.4. 33% success for >50% pain relief.
  • Statistical benefit but really very modest.
  • Using comparison of mean, many did not benefit at all.
  • Did not control for multilevel disease.
  • Highly selected population.

Lumbar Disc IN, discTRODE, Ramus Communicans RF

  • DiscTRODE™ (radio-frequency electrode) is positioned within the posterior annulus
  • The RF electrode is positioned in the middle of the nucleus. Temperature achieved may not be sufficient to denervate posterior annulus when the heat source is inside the nucleus
Lumbar Disc IN, discTRODE, Ramus Communicans RF RCTs
Study N Arms Selection Criteria Results
Barendse et al, 2001 (RCT)[5]

13

  1. Intranuclear RF
  2. Sham RF

1 x positive analgesic discography (>50% relief)

❌Negative study at 2 months

Kvarstein et al, 2009 (RCT)[6]

10

  1. discTRODE RF
  2. Sham RF

1 x positive concordant provocation discography (pain >7/10 at 1/3 levels)

❌ Negative study up to 12 months

Van Tilburg 2017, (RCT)[7]

60

  1. Ramus communicans RF
  2. Sham RF

1 x positive block at ramus communicans (decrease NRS 2 or more, placement confirmed with sensory and motor stimulation)

❌Negative study at 3 months


Also Ercelen. Evaluated 120s vs 360 seconds at 80 degrees. Active control No difference. Erçelen O, Bulutçu E, Oktenoglu T, et al. Radiofrequency lesioning using two different time modalities for the treatment of lumbar discogenic pain: a randomized trial. Spine (Phila Pa 1976). 2003;28(17):1922-1927. doi:10.1097/01.BRS.0000083326.39944.73


Also Finch 2005, prospective controlled but not randomised. Positive study. Finch PM, Price LM, Drummond PD. Radiofrequency heating of painful annular disruptions: one-year outcomes. J Spinal Disord Tech. 2005;18(1):6-13. doi:10.1097/01.bsd.0000143312.08303.5d

RF procedure different to block procedure. So unclear if the block is predictive, and how many false negatives there would be.

Cooled Radiofrequency Biacuplasty

Cooled Radiofrequency Biacuplasty RCTs
Study N Arms Selection Criteria Results Comments
Kapural et al 2013[8]

59

  1. Biacuplasty RF
  2. Sham RF

Positive provocative discography and negative control.

✅Positive study

6 months: Mean NRS decrease 2.78 vs 1.32, mean SF-36 increase 15. no significant improvement in ODI (except in post hoc <40 yo patients)

Success: 29.6% vs 3.3% (15 point increase in SF-36 and 2 reduction in NRS

  • Extensive exclusion criteria (1894 screened), mainly due to BMI >30 and smoking.
  • The sham procedure was slightly different (probes not placed in disc)
  • Latter 16 had additional monopolar lesions
  • Highest success in younger patients with single level disease
  • Modest benefits only
Desai et al 2016[9]

63

  1. Biacuplasty RF + Medical Mx
  2. Medical Mx

Provocation discography

✅Positive study

6 months: Mean NRS decrease -2.4 vs -0.56, Treatment response 50% vs 18%

12 months: Mean NRS decrease -2.2, Treatment response 50% SF36 + 64% ODI

  • Not placebo controlled

Mixed Radiofrequency Studies

Mixed Radiofrequency RCTs
Study N Arms Selection Criteria Results Comments
Juch et al 2017[10]

202

  1. Combinations of heterogenous facet RF, SIJ RF, and for disc: Intradiscal Electrothermal Therapy or Biacuplasty
  2. Standardised exercise program

Positive provocative discography and negative control.

❌Negative study

  • This study is too heterogenous to made any sense of.
  • Randomised before blocks because it would otherwise be “unethical”.
  • MINT trials were hugely controversial

Bottom Line

References

  1. ↑ Helm Ii S, Simopoulos TT, Stojanovic M, Abdi S, El Terany MA. Effectiveness of Thermal Annular Procedures in Treating Discogenic Low Back Pain. Pain Physician. 2017;20(6):447-470…. and my opinion for Ramus communicans RF.
  2. ↑ Harris IA, Traeger A, Stanford R, Maher CG, Buchbinder R. Lumbar spine fusion: what is the evidence?. Intern Med J. 2018;48(12):1430-1434. doi:10.1111/imj.14120
  3. ↑ Freeman BJ. IDET: a critical appraisal of the evidence. Eur Spine J. 2006;15 Suppl 3(Suppl 3):S448-S457. doi:10.1007/s00586-006-0156-2
  4. ↑ Pauza KJ, Howell S, Dreyfuss P, Peloza JH, Dawson K, Bogduk N. A randomized, placebo-controlled trial of intradiscal electrothermal therapy for the treatment of discogenic low back pain. Spine J. 2004;4(1):27-35. doi:10.1016/j.spinee.2003.07.001
  5. ↑ Barendse GA, van Den Berg SG, Kessels AH, et al. Randomized controlled trial of percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic back pain: Lack of effect from a 90-second 70 C lesion. Spine 2001;26:287-92.
  6. ↑ Kvarstein G, Mawe L, Indahl A, et al. A randomized double-blind controlled trial of intra-annular radiofrequency thermal disc therapy – a 12-month follow-up. Pain 2009;145:279-86
  7. ↑ van Tilburg CW, Stronks DL, Groeneweg JG, Huygen FJ. Randomized sham-controlled, double-blind, multicenter clinical trial on the effect of percutaneous radiofrequency at the ramus communicans for lumbar disc pain. Eur J Pain. 2017;21(3):520-529. doi:10.1002/ejp.945
  8. ↑ Kapural L, Vrooman B, Sarwar S, et al. A randomized, placebo-controlled trial of transdiscal radiofrequency, biacuplasty for treatment of discogenic lower back pain. Pain Med. 2013;14(3):362-373. doi:10.1111/pme.12023
  9. ↑ Desai MJ, Kapural L, Petersohn JD, et al. A Prospective, Randomized, Multicenter, Open-label Clinical Trial Comparing Intradiscal Biacuplasty to Conventional Medical Management for Discogenic Lumbar Back Pain. Spine (Phila Pa 1976). 2016;41(13):1065-1074. doi:10.1097/BRS.0000000000001412
  10. ↑ Juch JNS, Maas ET, Ostelo RWJG, et al. Effect of Radiofrequency Denervation on Pain Intensity Among Patients With Chronic Low Back Pain: The Mint Randomized Clinical Trials [published correction appears in JAMA. 2017 Sep 26;318(12 ):1188]. JAMA. 2017;318(1):68-81. doi:10.1001/jama.2017.7918
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