Effectiveness of high dose spinal cord stimulation for non‐surgical intractable lumbar radiculopathy ‐ HIDENS Study

Mehta, Vivek; Poply, Kavita; Ahmad, Alia; Lascelles, Joanne; Elyas, Amin; Sharma, Sonal; Ganeshan, Balaji; Ellamushi, Habib; Nikolic, Serge

doi:10.1111/papr.13087

Cited by 11 publications

(9 citation statements)

References 42 publications

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“…Disability as measured with the ODI decreased significantly from baseline and was maintained over the 12‐month period. Our baseline ODI was consistent with similar non‐surgical LBP cohorts, 29,31 falling on the cusp of severe disability. Our patients demonstrated a 39% improvement in ODI, moving from severe to moderate disability, these improvements in pain and function are reflected in the consistent satisfaction seen in their PGIC scoring.…”

Section: Discussionsupporting

confidence: 81%

“…Results from studies with heterogeneous LBP populations, such as the SUNBURST study indicate that pain relief after BurstDR™ SCS in patients with LBP was superior to conventional SCS. 15 A recent systematic review by Vallejo et al 30 compared the effect on pain relief of various SCS waveforms in LBP patients, which included the SUNBURST trial. 15 Based on this review, evidence for BurstDR™ SCS for use in LBP was rated as 'fair' to 'limited' based on the data by Deer et al 15 This study provides further support for the application of BurstDR™ SCS as a viable option for patients with CD-LBP.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2022

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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.

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Section: Discussionsupporting

confidence: 81%

Section: Discussionmentioning

confidence: 99%

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

et al. 2022

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“…Figure 1 depicts the PRISMA flow chart of the study selection and inclusion process. A total of 36 studies met the inclusion criteria and were included for the qualitative analysis 22 40–74 Table 1. describes the characteristics of the included studies.…”

Section: Resultsmentioning

confidence: 99%

“…describes the characteristics of the included studies. There were 7 included RCTs,22 40 50 55 61 63 69 17 prospective studies,41–44 46 47 51 56 59 60 62 64 65 68 70–72 11 retrospective studies,45 48 49 52–54 57 58 66 67 73 and 1 ambispective observational study 74. Thirteen studies were conducted in multiple centers 41–43 46 51 55 56 61 63 68 69 72–74.…”

Section: Resultsmentioning

confidence: 99%

Physical functioning following spinal cord stimulation: a systematic review and meta-analysis

ElSaban

Kleppel

Kubrova

et al. 2023

Reg Anesth Pain Med

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BackgroundSpinal cord stimulation (SCS) has emerged as an important treatment for chronic pain disorders. While there is evidence supporting improvement in pain intensity with SCS therapy, efforts to synthesize the evidence on physical functioning are lacking.ObjectiveThe primary objective of this meta-analysis was to assess long-term physical function following 12 months of SCS for chronic back pain.Evidence reviewPubMed, EMBASE, Scopus, and CENTRAL databases were searched for original peer-reviewed publications investigating physical function following SCS. The primary outcome was physical function at 12 months following SCS therapy for chronic back pain compared with baseline. A random effects model with an inverse variable method was used. The Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) framework was used to determine the certainty of evidence.FindingsA total of 518 studies were screened, of which 36 were included. Twenty-two studies were pooled in the meta-analysis. There was a significant reduction in Oswestry Disability Index (ODI) scores at all time frames up to 24 months following implantation. Pooled results revealed significant improvement in ODI scores at 12 months with a mean difference of −17.00% (95% CI −23.07 to −10.94, p<0.001). There was a very low certainty of evidence in this finding as per the GRADE framework. There was no significant difference in subgroup analyses based on study design (randomised controlled trials (RCTs) vs non-RCTs), study funding, or stimulation type.ConclusionThis meta-analysis highlights significant improvements in physical function after SCS therapy. However, this finding was limited by a very low GRADE certainty of evidence and high heterogeneity.

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“…Among the investigated neuromodulatory techniques, spinal cord stimulation (SCS) constitutes a well-established method, which has demonstrated potential effectiveness in the treatment of numerous diseases such as peripheral diabetic neuropathy, failed back surgery syndrome, irritable bowel syndrome, painful radiculopathy, complex regional pain syndrome and postherpetic neuralgia [ 179 , 182 , 183 , 184 , 185 , 186 ]. Moreover, the cost-effectiveness of this method compared with conventional treatment modalities has been demonstrated [ 201 ].…”

Section: Treatment Strategies For Neuropathic Painmentioning

confidence: 99%

Diagnosis and Management of Neuropathic Pain in Spine Diseases

Bielewicz

Kamieniak

Szymoniuk

et al. 2023

JCM

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Neuropathic pain is generally defined as a non-physiological pain experience caused by damage to the nervous system. It can occur spontaneously, as a reaction to a given stimulus, or independently of its action, leading to unusual pain sensations usually referred to as firing, burning or throbbing. In the course of spine disorders, pain symptoms commonly occur. According to available epidemiological studies, a neuropathic component of pain is often present in patients with spinal diseases, with a frequency ranging from 36% to 55% of patients. Distinguishing between chronic nociceptive pain and neuropathic pain very often remains a challenge. Consequently, neuropathic pain is often underdiagnosed in patients with spinal diseases. In reference to current guidelines for the treatment of neuropathic pain, gabapentin, serotonin and norepinephrine reuptake inhibitors and tricyclic antidepressants constitute first-line therapeutic agents. However, long-term pharmacologic treatment often leads to developing tolerance and resistance to used medications. Therefore, in recent years, a plethora of therapeutic methods for neuropathic pain have been developed and investigated to improve clinical outcomes. In this review, we briefly summarized current knowledge about the pathophysiology and diagnosis of neuropathic pain. Moreover, we described the most effective treatment approaches for neuropathic pain and discussed their relevance in the treatment of spinal pain.

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Effectiveness of high dose spinal cord stimulation for non‐surgical intractable lumbar radiculopathy ‐ HIDENS Study

Cited by 11 publications

References 42 publications

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

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

Physical functioning following spinal cord stimulation: a systematic review and meta-analysis

Diagnosis and Management of Neuropathic Pain in Spine Diseases

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