Updates and Recent Controversy in Treatment of Lower Back Pain Benjamin Bonte, MD Interventional Pain Fellow Hudson Spine & Pain Medicine 8/30/2017

Joint disorders and disc pain Lumbar Facet arthropathy SIJ pain Discogenic pain Controversial Dutch Neurotomy Study (Juch et al) Study published in July JAMA has caused a stir among interventionalists. As this article focused on 3 targets/pain generators for back pain, this is a brief review of these 3 causes.

Joint disorders and disc pain Lumbar Facet arthropathy SIJ pain Discogenic pain Controversial Dutch Neurotomy Study

Lumbar facet arthropathy Facet joints are synovial joints that sustain progressively increasing loads down the spine, reaching 12-25% body weight in the lumbar region. As disc height decreases (age, trauma), progressive load is placed on facet joint Lumbar facet hypertrophy can lead to central canal and lateral recess/foraminal stenosis i.e. radiculopathy can coexist with this pathology

Pain worse with oblique movements and extension Facet arthropathy Pain worse with oblique movements and extension Referred pain pattern can be seen Pure facet pain should not have neurologic abnormalities Imaging – XR, CT, MRI *there’s actually no evidence for this- no hx or PE finding have been shown to predict lumbar facet joint pain; only the actual injections have evidence for confirming this. 107.M. Kaplan, P. Dreyfuss, B. Halbrook, et al.: The ability of lumbar medial branch blocks to anesthetize the zygapophysial joint. A physiologic challenge. Spine (Phila Pa 1976). 23 (17):1847-1852 1998 9762741 MRI – may show capsule hypertrophy Image – Distribution of referred pain from the lumbar zygapophyseal joints and dorsal rami. Hypertonic saline injected at multiple levels reliably reproduced symptoms in a referral pain pattern. Fukui S, Ohseto K, Shiotani M, Ohno K, Karasawa H, Naganuma Y. Clin J Pain. 1997 Dec;13(4):303-7. PMID: 9430810

Treatment Rest, pain control (NSAIDs, muscle relaxants) PT – flexion based or neutral postures, proper body mechanics Injections, RFA

Treatment Z-Joint Injection Medial Branch Block Mostly for therapeutic purposes As anesthetic can easily spread to nerve root, may not allow to distinguish between facet<>radicular pain Performed for diagnostic reasons to confirm pain generator. Precursor for RFA No reported complications Z-joint injections – not in vogue right now; not reliable in terms of diagnostics, and RFA has higher quality evidence for relief. Z-joint injection complications are very rare – abscess, discitis, radiculopathy, septic arthritis of z-joint MBB – no case reports of complications

Lumbar Radiofrequency Ablation (RFA) Radiofrequency current used to create heat. 85 degrees C, 90 seconds Lesion is produced along the length of the noninsulated tip, so needle placement parallel to nerve is ideal Painful, thus conscious sedation is typical Stimulation used to rule out placement near the nerve root/DRG Complications are rare Local pain or neuritic pain lasting >2 weeks is 0.5% P. Lau, S. Mercer, J. Govind, et al.: The surgical anatomy of lumbar medial branch neurotomy (facet denervation). Pain Med. 5 (3):289-298 2004 15367308

Evidence supporting lumbar RFA Evidence is variable due to two important considerations: Patient Selection Studies that set the bar low for RFA have less success. Single blocks, or low % relief from block VanKleef - Patients fare worse, 50% pain relief in 46% of RFA group vs 12% controls Some studies show no benefit When strict inclusion criteria are used, results are better. Dreyfuss et al – 60% of patients had +90% pain relief. 87% of patients had +60% relief. Nath et al – 40 patients (20/20) inclusion = 3 diagnostic blocks. RFA –statistically significant improvement in pain, QOL Technique Larger probes with longer active tips are more likely to denervate the medial branch. Dreyfuss – 16g, 5-mm tip (2 contiguous lesions with goal of 10mm lesion) Nath - 22g, 5-mm tip (2 contiguous lesions with goal of 10mm lesion), made at 3 different locations for each medial branch M. van Kleef, G.A. Barendse, A. Kessels, et al.: Randomized trial of radiofrequency lumbar facet denervation for chronic low back pain. Spine (Phila Pa 1976). 24 (18):1937-1942 1999 10515020 P. Dreyfuss, B. Halbrook, K. Pauza, et al.: Efficacy and validity of radiofrequency neurotomy for chronic lumbar zygapophysial joint pain. Spine (Phila Pa 1976). 25 (10):1270-1277 2000 10806505 (Electromyography of the multifidus muscle was performed before and after surgery to ensure accuracy of the neurotomy.) S. Nath, C.A. Nath, K. Pettersson: Percutaneous lumbar zygapophysial (facet) joint neurotomy using radiofrequency current, in the management of chronic low back pain: a randomized double-blind trial. Spine (Phila Pa 1976). 33 (12):1291-1297 2008 discussion 1298 18496338

Joint disorders and disc pain Lumbar Facet arthropathy SIJ pain Discogenic pain Controversial Dutch Neurotomy Study

Joint disorders and disc pain Lumbar Facet arthropathy SIJ pain Discogenic pain Controversial Dutch Neurotomy Study

SI Joint Pain Synovial joint anteriorly and syndesmosis posteriorly. L5 dorsal ramus and lateral S1-S3 dorsal rami Typically 6 provocation tests are used in academic literature (distraction, compression, thigh thrust, gaenslen’s, FABER, Sacral thrust) If none are positive, SIJ can be ruled out. If 3+ are positive, then PPV of SIJ pain is 77% Still, the only accepted method of diagnosing this pain is with a diagnostic injection. Thigh thrust – posterior shear on SIJ Sacral thrust – what it sounds like – anteriorly directed force on sacrum while patient is prone.

treatment Trial of noninterventional care (PT, medications) Utility of a corticosteroid injection is debatable except in cases of sacroiliitis. Generally a diagnostic procedure.

evidence Multiple RCTs show benefit from intraarticular steroids in sacroiliitis. No conclusive evidence for other reasons of SIJ pain. Optimal RFA results occur when there is very stringent selection criteria. Cohen + Abdi 18 subjects with 80% relief with SIJ block. 9 had 50% relief from L4MBB, L5DR, and S1-S3 LBB. All underwent RFA 8 of 9 had >50% relief for duration of 9 months. Technical success maximized with parallel needle placement, larger gauge needle, and multiple lesion technique. S.P. Cohen, S. Abdi: Lateral branch blocks as a treatment for sacroiliac joint pain: a pilot study. Reg Anesth Pain Med. 28 (2):113-119 2003 12677621

Joint disorders and disc pain Lumbar Facet arthropathy SIJ pain Discogenic pain Controversial Dutch Neurotomy Study

Discogenic pain irritation of the annulus and PLL, with innervation from sinuvertebral nerve and/or somatic afferent nerves Worse with lumbar flexion as this increases intradiscal pressure Seated leg press is a completely nonphysiologic movement where lumbar spine is forced into gradual flexion and you are pushing a load up an incline while seated, eliminating need for core stability. (contrast to squat)

Diagnosis and Evidence for treatment Provocation discography with balloon tipped intradiscal catheters, followed by anesthetic injection to the disc with 50%+ reduction in pain has better response to interbody fusion surgery than use of standard contrast studies. Intradiskal electrothermal therapy (IDET), radiofrequency therapy are procedures that require further study, with some studies showing benefit/decreased cost as compared to surgery. Pain Pract. 2017 Sep 12. doi: 10.1111/papr.12641. [Epub ahead of print] A Cost-Effectiveness Analysis of Intradiscal Electrothermal Therapy (IDET) Compared with Circumferential Lumbar Fusion. Stamuli E1, Kesornsak W2, Grevitt MP2, Posnett J3, Claxton K4.

Joint disorders and disc pain Lumbar Facet arthropathy SIJ pain Discogenic pain Controversial Dutch Neurotomy Study

Controversial Dutch Neurotomy Study SIS refers to this as the significantly flawed dutch neurotomy study The article brands itself as the “Mint” study, which is a study of Minimally interventional treatment for chronic back pain. Dutch study Anesthesia, Epidiemiology, General Practice

Objective To evaluate the effectiveness of RF denervation added to a standardized exercise program for patients with chronic low back pain

Importance of the study Low back pain is the #1 leading cause of disability with tremendous effects on quality of life and healthcare spending Estimated costs in the US have been estimated at $87b over 17 years (1996-2013) Mechanical low back pain (facet joints, SI joints, intervertebral discs) is frequently treated with RF; low to moderate quality evidence has been demonstrated in the past to show effectiveness

Study design 3 randomized clinical trials with 681 participants Chronic low back pain originating from Facet joints SI joints Combination – combination of facet, SI, or intervertebral disc (Intervertebral disc alone - terminated due to lack of eligible participants) conservative treatment – not defined

Inclusion criteria Pain related to facet, SI, or intervertebral disc Source – determined by clinical examination Facet – clinical examination + facet block; included in randomization if this was positive. SI – positive in at least 3 of 6 provocation tests qualified for a block, then included if this was positive. Compression test, distraction test, FABER, Gaenslen, thigh thrust, Gillett Mixed – (facet, SI, or intervertebral disc) – 1 block; included if positive, 2nd block if first negative, 3rd block if 2nd negative. Positive = 50% pain reduction within 30-90 minutes after the block, after injecting the areas with 2% lidocaine (0.5ml). For disc, pressure controlled discography and 1 negative control level. Age 18-70 No improvement in symptoms after conservative treatment Gillett – stand on one leg. Contralateral leg raised to 90 degrees. PSIS on contralateral leg should rotate down. If not, abnormal motion implies SIJ involvement

Exclusion criteria Pregnancy Severe psychological problems Involvement in work-related conflicts/claims BMI >35 Age >70 On anticoagulant therapy or with coagulopathy

Other interventions All received a physical therapy program Randomized participants received radiofrequency denervation with 22g needle (full technical details not included in main article – next slide) Cointerventions were not allowed Surgery, manual therapy, chiropractic therapy, new medications. OTC meds allowed Radiofrequency denervation was allowed after 3 months. Psychological care was not considered a co-intervention

RFA technique The lumbar medial branch radiofrequency neurotomy technique employed in the Juch study used a small gauge (22G) electrode with positioning inconsistent with the “parallel technique” as described in the SIS Guidelines, wherein large gauge radiofrequency electrodes have been established as effective in providing pain relief for patients with lumbar facet joint pain. The small lesions employed in the Dutch study most likely missed many of the targeted nerves and would not be expected to relieve pain from the lumbar facet joints

Outcome measurements Primary outcome Secondary outcomes Pain from 0-10 (NRS) 3 months after the intervention Clinically important difference was 2 points or more. Secondary outcomes Perceived recovery, patient satisfaction, functional status, QOL Data collection at 3,6,9,12 month follow-up intervals, through web-based questionnaires.

Results – facet joint trial 251 patients ultimately included in facet joint trial 123 in the intervention group, 126 in the control group Similar group composition however first episode of LBP was 12 years prior compared to 8 years prior in control group. No significant differences between groups were found when success was defined as more than 30% or 2 point reduction in pain at 3 months. Mean age 52.2 years. 61.8% female Mean baseline pain intensity of 7.1

Results – sij trial 228 patients included in the SIJ trial 116in the intervention group / 112 in the control group First episode of LBP was 97 months compared with 65 months on control group No significant differences in outcome found when success was defined as more than 30% or 2 points reduction or more in pain at 3 months.

Results – combination trial 202 patients in the combination trial 103 in the intervention group / 99 in the control group Statistically significant difference in outcome found when success was defined as more than 30% or 2 points reduction or more in pain at 3 months.

DIscussion Radiofrequency denervation is not recommended and patients with chronic LBP with no improvement in symptoms after conservative treatment have no clear alternative therapies. Strengths Sample size, good randomization, outcome measures, followup duration of 12m Some Key Limitations Different SIJ RFA techniques were used (cooled RF, palisade, simplicity III) Not blinded Threshold value for a “positive block” Exclusion of patients with psychological problems may affect how generalizable results are

Points of controversy

Inherent Bias this unblinded study was funded in part by grant money received from Dutch health insurance companies Because this unblinded study was funded in part by grant money received from Dutch health insurance companies, SIS is concerned about the potential risk of bias arising from this possible conflict of interest.

Inadequate Diagnostic Assessment many patients treated with RFN likely did not have facet joint or sacroiliac joint pain, and would not have been expected to experience pain relief or functional improvement. Inclusion criteria (from prior slide) Source – determined by clinical examination Facet – clinical examination + facet block; included in randomization if this was positive. SI – positive in at least 3 of 6 provocation tests qualified for a block, then included if this was positive. Compression test, distraction test, FABER, Gaenslen, thigh thrust, Gillett Mixed – (facet, SI, or intervertebral disc) – 1 block; included if positive, 2nd block if first negative, 3rd block if 2nd negative. Positive = 50% pain reduction within 30-90 minutes after the block, after injecting the areas with 2% lidocaine (0.5ml). For disc, pressure controlled discography and 1 negative control level. The study selected patients for radiofrequency neurotomy (RFN) based on inadequate diagnostic assessment. For that reason, many patients treated with RFN likely did not have facet joint or sacroiliac joint pain, and would not have been expected to experience pain relief or functional improvement.

(again) Evidence supporting lumbar RFA Evidence is variable due to two important considerations: Patient Selection Studies that set the bar low for RFA have less success. Single blocks, or low % relief from block VanKleef - Patients fare worse, 50% pain relief in 46% of RFA group vs 12% controls Some studies show no benefit When strict inclusion criteria are used, results are better. Dreyfuss et al – 60% of patients had +90% pain relief. 87% of patients had +60% relief. Nath et al – 40 patients (20/20) inclusion = 3 diagnostic blocks. RFA –statistically significant improvement in pain, QOL Technique Larger probes with longer active tips are more likely to denervate the medial branch. Dreyfuss – 16g, 5-mm tip (2 contiguous lesions with goal of 10mm lesion) Nath - 22g, 5-mm tip (2 contiguous lesions with goal of 10mm lesion), made at 3 different locations for each medial branch M. van Kleef, G.A. Barendse, A. Kessels, et al.: Randomized trial of radiofrequency lumbar facet denervation for chronic low back pain. Spine (Phila Pa 1976). 24 (18):1937-1942 1999 10515020 P. Dreyfuss, B. Halbrook, K. Pauza, et al.: Efficacy and validity of radiofrequency neurotomy for chronic lumbar zygapophysial joint pain. Spine (Phila Pa 1976). 25 (10):1270-1277 2000 10806505 (Electromyography of the multifidus muscle was performed before and after surgery to ensure accuracy of the neurotomy.) S. Nath, C.A. Nath, K. Pettersson: Percutaneous lumbar zygapophysial (facet) joint neurotomy using radiofrequency current, in the management of chronic low back pain: a randomized double-blind trial. Spine (Phila Pa 1976). 33 (12):1291-1297 2008 discussion 1298 18496338

Ineffective Technique Selection Small lesions with 22g needle most likely missed many targeted nerves and would not be expected to relieve pain from the lumbar facet joints. The lumbar medial branch radiofrequency neurotomy technique employed in the Juch study used a small gauge (22G) electrode with positioning inconsistent with the “parallel technique” as described in the SIS Guidelines, wherein large gauge radiofrequency electrodes have been established as effective in providing pain relief for patients with lumbar facet joint pain. The small lesions employed in the Dutch study most likely missed many of the targeted nerves and would not be expected to relieve pain from the lumbar facet joints.

Thank you!

Procedure for intradiscal rfa