Burst Spinal Cord Stimulation as Compared With L2 Dorsal Root Ganglion Stimulation in Pain Relief for Nonoperated Discogenic Low Back Pain: Analysis of Two Prospective Studies.

INTRODUCTION: Chronic discogenic low back pain (CD-LBP) is caused by degenerated disks marked by neural and vascular ingrowth. Spinal cord stimulation (SCS) has been shown to be effective for pain relief in patients who are not responsive to conventional treatments. Previously, the pain-relieving effect of two variations of SCS has been evaluated in CD-LBP: Burst SCS and L2 dorsal root ganglion stimulation (DRGS). The aim of this study is to compare the effectivity in pain relief and pain experience of Burst SCS with that of conventional L2 DRGS in patients with CD-LBP. MATERIALS AND METHODS: Subjects were implanted with either Burst SCS (n = 14) or L2 DRGS with conventional stimulation (n = 15). Patients completed the numeric pain rating score (NRS) for back pain and Oswestry disability index (ODI) and EuroQoL 5D (EQ-5D) questionnaires at baseline, and at three, six, and 12 months after implantation. Data were compared between time points and between groups. RESULTS: Both Burst SCS and L2 DRGS significantly decreased NRS, ODI, and EQ-5D scores as compared with baseline. L2 DRGS resulted in significantly lower NRS scores at 12 months and significantly increased EQ-5D scores at six and 12 months. CONCLUSIONS: Both L2 DRGS and Burst SCS resulted in reduction of pain and disability, and increased quality of life in patients with CD-LBP. L2 DRGS provided significantly increased pain relief and improvement in quality of life when compared with Burst SCS. CLINICAL TRIAL REGISTRATION: The clinical trial registration numbers for the study are NCT03958604 and NL54405.091.15.

A prospective study of BurstDR™ spinal cord stimulation for non-operated discogenic low back pain.

INTRODUCTION: Chronic discogenic low back pain (CD-LBP) is caused by degeneration of the disc due to trauma to the annulus or by unprovoked degeneration, resulting in chronic pain. Spinal cord stimulation (SCS) employing the BurstDR™ waveform has been shown to be an effective treatment in a variety of chronic pain conditions. The aim of this prospective case study was to determine the effect of BurstDR™ SCS on pain relief, disability, and patient satisfaction in a population with CD-LBP. METHODS: Seventeen subjects with CD-LBP received a SCS trial with BurstDR™ stimulation. Patients with >50% pain relief after a trial period of 2 weeks were permanently implanted (n = 15). Patients then rated LBP and leg pain using the numeric rating scale (NRS), Oswestry disability index (ODI), patient global impression of change (PGIC), EQ-5D quality of life, and painDETECT for neuropathic pain at baseline following trial, 3, 6, and 12 months after permanent implantation. RESULTS: Treatment with BurstDR™ SCS resulted in significant reduction of LBP as the NRS was reduced from 71.7 ± 7.3 at baseline to 42.5 ± 18.1 at 12 months. Average pain relief at 12 months was 42.5%. In patients with leg pain (n = 8), pain was significantly reduced from 66.9 ± 8.2 to 11.7 ± 10.4 at 12 months. PainDETECT scores for neuropathic pain significantly reduced from 18.9 ± 4.8 at baseline, and 14.8 ± 3.2 at 12 months. Baseline ODI score significantly reduced from 41.2 ± 12.8 to 25.8 ± 8.6 at 12 months. PGIC scores remained low from 2.6 ± 1.6 at 3 months, 2.5 ± 1.0 at 6 months, and 2.5 ± 1.3 at 12 months. EQ-5D-5L rates remained constant from baseline 56.10 ± 23.9 to 68.6 ± 12.9 at 12 months. CONCLUSION: BurstDR™ SCS resulted in significant reduction of back pain, leg pain, and quality of life in patients with CD-LBP and decreased the level of disability and generated positive patient satisfaction scores.

Dutch Consensus Paper: A Consensus View on the Place of Neurostimulation Within the Treatment Arsenal of Five Reimbursed Indications for Neurostimulation in The Netherlands.

INTRODUCTION: After an interpretation trajectory, the Dutch Quality of Healthcare Institute recommended that for five indications, spinal cord stimulation, dorsal root ganglion stimulation, or occipital nerve stimulation, together referred to as neurostimulation, can be considered effective and be reimbursed in the Netherlands. These five indications are the well and largely studied, accepted neurostimulation indications in scientific literature. As an extension of this, all the scientific societies involved in the Netherlands were required to reach a consensus about the diagnosis and treatment of these five formulated indications to describe the place of neurostimulation within the treatment algorithm. This article describes the development process and content of the consensus paper. MATERIALS AND METHODS: A scientific committee, consisting of three anesthesiologists/pain physicians (one of whom acted as the working group's chair), a neurosurgeon, a neurologist, a rehabilitation physician, and three nurse practitioners, participated. A quality advisor of the Knowledge Institute of the Dutch Federation of Medical Specialists supported the committee. The committee participated on behalf of their various scientific and professional societies. Three sessions were organized during which the place of neurostimulation in the treatment algorithm of the five relevant indications was discussed extensively. A narrative literature review and experts' opinions formed the basis of decision-making in the process. RESULTS: For all five diagnoses, general and diagnosis-specific treatment requirements, conservative treatments, and minimally invasive treatments are listed. These treatments should be considered in the chronic pain management algorithm before eventually proceeding to neurostimulation. DISCUSSION/CONCLUSION: The content of this consensus view was discussed and compared with other literature on cost-effectiveness and the place in the algorithm of treating chronic pain. This Dutch consensus paper could ultimately contribute to the maintenance or expansion of neurostimulation and the reimbursement.

No Transfer of Pressure to Adjacent Discs During Human Low-Pressure Controlled Discography: A Prospective Clinical Study.

Background: A substantial part of low back pain (LBP) originates from degeneration of the intervertebral disc. To confirm the diagnosis of discogenic pain, provocation discography seems the best available tool. However, provocation discography is also considered to be a controversial and subjective test because the patient's personal pain response is the most crucial for the result of the test. Recently, an in vivo porcine study and a study in nine human subjects showed passing of pressure to the adjacent discs during discography. This could mean that the concordant pain the patient describes originates from an adjacent disc. The object of this study is to assess if during human lumbar pressure-controlled provocation discography there is pressure transmission to adjacent discs. Methods: Consecutive patients between age 18 and 65 years with intractable low back pain and at least 50% preserved height of the suspected painful disc were included. Exclusion criteria were prior lumbar surgery of the suspected level, use of anticoagulants, pregnancy, local infection, and iodine allergy. An arterial blood pressure monitoring system simultaneously assessed the pressure in the adjacent discs while low-speed flow, pressure-controlled discography was performed. Results: In 50 patients with a positive discography, the average intradiscal peak pressure was 15.1 psi (SD = 11.1). In 48 procedures, no pressure rise in the adjacent discs was found. A small pressure rise (1.1 psi) in the adjacent disc during discography was recorded in two patients. Conclusions: Pressure rise in adjacent discs does not seem to occur during low-speed flow pressure-controlled lumbar provocation discography. False-positive pain reactions caused by potentially painful adjacent discs are therefore unlikely during pressure-controlled discography.

Comparison of cooled versus conventional radiofrequency treatment of the genicular nerves for chronic knee pain: a multicenter non-inferiority randomized pilot trial (COCOGEN trial).

BACKGROUND: Radiofrequency (RF) treatment of the genicular nerves has the potential to reduce chronic knee pain due to osteoarthritis or persistent postsurgical pain, however, a direct comparison between the two main modalities used, conventional and cooled, is lacking. METHODS: This double blind, non-inferiority, pilot, randomized controlled trial compared the effects of cooled and conventional RF in chronic knee pain patients suffering from osteoarthritis or persistent postsurgical pain after total knee arthroplasty. Patients were randomized following a 1:1 rate. The primary outcome was the proportion of patients with ≥50% pain reduction at 3 months postintervention. Other outcomes were knee pain, functionality, quality of life, emotional health, and adverse events up to 6 months postintervention. Conventional RF treatment was tested for non-inferiority to cooled in reducing knee pain at 3 months follow-up. RESULTS: Forty-nine of 70 patients were included, of which 47 completed a 3-month follow-up. The primary outcome was achieved in 4 of 23 patients treated with conventional RF (17%) vs in 8 of 24 with cooled (33%) (p=0,21). Results from the non-inferiority comparison were inconclusive in relation to the non-inferiority margin. There was no statistically significant difference between secondary outcomes. There were no serious adverse events. CONCLUSIONS: Both conventional and cooled RF treatment reduced pain in the osteoarthritis and persistent postsurgical pain population. This pilot study did not demonstrate statistically significant differences in the proportion of patients experiencing ≥50% pain reduction between techniques. The non-inferiority analysis was inconclusive. These results warrant further research. TRIAL REGISTRATION NUMBER: NCT03865849.

A multicenter randomized controlled trial on the efficacy of intradiscal methylene blue injection for chronic discogenic low back pain: the IMBI study.

A study published in PAIN in 2010 showed remarkable effects of intradiscal methylene blue (MB) injections compared with placebo on pain intensity in patients with chronic discogenic low back pain (CD-LBP). Both groups received lidocaine hydrochloride injections for pain associated with the procedure. We replicated the design of the previously published study and performed a multicenter, double-blind, randomized, placebo-controlled trial to assess whether the extraordinary effects of MB on pain intensity could be confirmed. The primary outcomes were treatment success defined as at least 30% reduction in pain intensity and the Patients' Global Impression of Change 6 months after the intervention. We included 84 patients with CD-LBP of which 14 (35%) in the MB plus lidocaine group showed treatment success compared with 11 (26.8%) in the control group who received placebo plus lidocaine (P = 0.426). Twenty-seven percent of all participants treated with MB stated that their overall health improved much or very much (Patients' Global Impression of Change), vs 25.6% in the placebo group (P = 0.958). We were unable to confirm that intradiscal MB injections are better capable of significantly reducing pain in patients with CD-LBP 6 months after treatment compared with placebo. We observed that over one-quarter of patients receiving only lidocaine injections reported treatment success, which is in contrast with the previously published study. Our results do not support the recommendation of using intradiscal MB injections for patients with CD-LBP.