Lumbar Disc Precision Treatment

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A variety of radiofrequency procedures have been developed for the treatment of discogenic pain. An ongoing limitation is the lack of a gold standard for proving discogenic pain, and the term "precision treatment" refers to treatment of a proven pain generator unlike treating "non-specific low back pain." Provocation discography is generally used in research but this procedure has its issues. Leggett et al in 2015 found mixed evidence for radiofrequency procedures for discogenic pain.[1] Helm et al in 2019 concluded that there was level 1 evidence for the use of biacuplasty, and level 3 evidence for intradiscal electrothermal annuloplasty for the treatment of discogenic pain.[2] The author is not aware of any Musculoskeletal Medicine specialists in New Zealand using radiofrequency procedures for discogenic pain.

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 Surgery

There are no sham controlled studies whatsoever for fusion surgery. There are not even any randomised controlled trials with an active control when disc pain has been proven. RCTs on non specific low back pain with an active control were negative.[3] Therefore the benefit of fusion surgery for proven disc pain is unknown, and such surgery has no basis in any high level evidence.

Radiofrequency Procedures

Cooled Radiofrequency Biacuplasty

Biacuplasty.png

Two cooled RF electrodes are placed on the posterolateral sides of the annulus to coagulate the nociceptors of the neo-innervated tissue. A dumbbell shape is formed between the two RF probes to cover the posterior annulus. This procedure produces internal disc temperatures in excess of 45° C. Kapural et al used a setting of 50° C for 15 minutes, followed by individual monopolar lesions (RF energy transferred via one probe at a time in sequence) to extend the lateral extent of the central lesion set at 60°C for 2.5 minutes. They used intravenous sedation including midazolam, fentanyl, or propofol. But during the active heating portion of biacuplasty, subjects were awake and indicated whether pain was localized to the lesion area or if they had any other symptoms.[4]

Cooled Radiofrequency Biacuplasty RCTs
Study N Arms Selection Criteria Results Comments
Kapural et al 2013[4]

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[5]

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

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[6]

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[7]

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)[8]

13

  1. Intranuclear RF
  2. Sham RF

1 x positive analgesic discography (>50% relief)

❌Negative study at 2 months

Kvarstein et al, 2009 (RCT)[9]

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)[10]

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 evaluted 120 vs 360 seconds at 80 degrees and found no difference.[11]

Mixed Radiofrequency Studies

Mixed Radiofrequency RCTs
Study N Arms Selection Criteria Results Comments
Juch et al 2017[12]

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

Intraosseous Basivertebral Nerve Ablation

This treatment is best thought of as treating endplate pain rather than disc pain, i.e. vertebrogenic pain. It is a more invasive treatment than other ablation procedures as the probe needs to go through bone, and there is a longer burning time. This treatment is very durable as the basivertebral nerve is unmyelinated and does not regenerate. There are no clinicians in New Zealand that offer or have training in this procedure.

Basivertebral Nerve Ablation RCTs
Study N Arms Selection Criteria Results Comments
Fischgrund et al 2019[13][14] 147
  1. Basivertebral nerve thermal ablation
  2. Sham ablation
Modic type 1 or 2 changes ✅Positive study


Responder rates at 3 months

VAS ≥1.5cm in 65.4%


At 2 years

ODI ≥ 10 points in 76.4%

ODI ≥ 20 points in 57.5%

VAS ≥1.5cm in 70.2%


At 5 years

66% had >50% pain reduction

47% had >75% pain reduction

34% had complete resolution

  • Follow up for 5 years
  • Blinding maintained for 12 months
  • Optional cross-over at 12 months

Intradiscal Therapies

A small sham controlled trial found intradiscal PRP to be modestly superior to sham for both pain and function. Controlled follow up was only to 8 weeks and at this point the current pain NRS difference was 0.22 vs 1.65 (5% vs 35% relief), and FRI difference was -0.92 vs -13.48. In uncontrolled follow up the benefits were maintained at one year. The only categorical data presented was the number of people "satisfied" which was 56% vs 18%. Selection criteria was flawed due to lack of pressure measurement and lack of excluding those with positive control discs.[15]

Quiz

1 With regards to lumbar disc innervation, which is true?

Disc innervation is localised to each level and does not cross levels.
The sinuvertebral nerve has no autonomic supply
The lateral aspects of the disc have the greatest nerve endings, a smaller number in the posterior aspect, and the least anteriorly.

2 With regards to lumbar disc RF, Which technique has the most evidence to support its use?

Intranuclear radiofrequency ablation
Intradiscal electrothermal therapy
discTRODE
Biacuplasty


Bottom Line

See Also

References

Literature Review

  1. Leggett et al.. Radiofrequency ablation for chronic low back pain: a systematic review of randomized controlled trials. Pain research & management 2014. 19:e146-53. PMID: 25068973. DOI. Full Text.
  2. Helm Ii et al.. Effectiveness of Thermal Annular Procedures in Treating Discogenic Low Back Pain. Pain physician 2017. 20:447-470. PMID: 28934777.
  3. Harris et al.. Lumbar spine fusion: what is the evidence?. Internal medicine journal 2018. 48:1430-1434. PMID: 30517997. DOI.
  4. 4.0 4.1 Kapural et al.. A randomized, placebo-controlled trial of transdiscal radiofrequency, biacuplasty for treatment of discogenic lower back pain. Pain medicine (Malden, Mass.) 2013. 14:362-73. PMID: 23279658. DOI.
  5. Desai et al.. A Prospective, Randomized, Multicenter, Open-label Clinical Trial Comparing Intradiscal Biacuplasty to Conventional Medical Management for Discogenic Lumbar Back Pain. Spine 2016. 41:1065-74. PMID: 26689579. DOI.
  6. Jacobs et al.. The evidence on surgical interventions for low back disorders, an overview of systematic reviews. European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society 2013. 22:1936-49. PMID: 23681497. DOI. Full Text.
  7. Pauza et al.. A randomized, placebo-controlled trial of intradiscal electrothermal therapy for the treatment of discogenic low back pain. The spine journal : official journal of the North American Spine Society 2004. 4:27-35. PMID: 14749191. DOI.
  8. Barendse 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. PMID: 11224865. DOI.
  9. Kvarstein 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. PMID: 19647940. DOI.
  10. van Tilburg et al.. Randomized sham-controlled, double-blind, multicenter clinical trial on the effect of percutaneous radiofrequency at the ramus communicans for lumbar disc pain. European journal of pain (London, England) 2017. 21:520-529. PMID: 27734550. DOI. Full Text.
  11. Erçelen et al.. Radiofrequency lesioning using two different time modalities for the treatment of lumbar discogenic pain: a randomized trial. Spine 2003. 28:1922-7. PMID: 12973135. DOI.
  12. Juch et al.. Effect of Radiofrequency Denervation on Pain Intensity Among Patients With Chronic Low Back Pain: The Mint Randomized Clinical Trials. JAMA 2017. 318:68-81. PMID: 28672319. DOI. Full Text.
  13. Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2-Year Results From a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study. Int J Spine Surg. 2019;13(2):110-119. Published 2019 Apr 30. doi:10.14444/6015
  14. Fischgrund JS, Rhyne A, Macadaeg K, Moore G, Kamrava E, Yeung C, Truumees E, Schaufele M, Yuan P, DePalma M, Anderson DG, Buxton D, Reynolds J, Sikorsky M. Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. 2020 Aug;29(8):1925-1934. doi: 10.1007/s00586-020-06448-x. Epub 2020 May 25. PMID: 32451777.
  15. Tuakli-Wosornu YA, Terry A, Boachie-Adjei K, Harrison JR, Gribbin CK, LaSalle EE, Nguyen JT, Solomon JL, Lutz GE. Lumbar Intradiskal Platelet-Rich Plasma (PRP) Injections: A Prospective, Double-Blind, Randomized Controlled Study. PM R. 2016 Jan;8(1):1-10; quiz 10. doi: 10.1016/j.pmrj.2015.08.010. Epub 2015 Aug 24. PMID: 26314234.