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Long-Term Outcomes of Restorative Neurostimulation in Patients With Refractory Chronic Low Back Pain Secondary to Multifidus Dysfunction: Two-Year Results of the ReActiv8-B Pivotal Trial.

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Journal Neuromodulation : journal of the International Neuromodulation Society
Year 2023
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BACKGROUND: Impaired neuromuscular control and degeneration of the multifidus muscle have been linked to the development of refractory chronic low back pain (CLBP). An implantable restorative-neurostimulator system can override the underlying multifidus inhibition by eliciting episodic, isolated contractions. The ReActiv8-B randomized, active-sham-controlled trial provided effectiveness and safety evidence for this system, and all participants received therapeutic stimulation from four months onward. OBJECTIVE: This study aimed to evaluate the two-year effectiveness of this restorative neurostimulator in patients with disabling CLBP secondary to multifidus muscle dysfunction and no indications for spine surgery. MATERIALS AND METHODS: Open-label follow-up of 204 participants implanted with a restorative neurostimulation system (ReActiv8, Mainstay Medical, Dublin, Ireland) was performed. Pain intensity (visual analog scale [VAS]), disability (Oswestry disability index [ODI]), quality-of-life (EQ-5D-5L), and opioid intake were assessed at baseline, six months, one year, and two years after activation. RESULTS: At two years (n = 156), the proportion of participants with ≥50% CLBP relief was 71%, and 65% reported CLBP resolution (VAS ≤ 2.5 cm); 61% had a reduction in ODI of ≥20 points, 76% had improvements of ≥50% in VAS and/or ≥20 points in ODI, and 56% had these substantial improvements in both VAS and ODI. A total of 87% of participants had continued device use during the second year for a median of 43% of the maximum duration, and 60% (34 of 57) had voluntarily discontinued (39%) or reduced (21%) opioid intake. CONCLUSIONS: At two years, 76% of participants experienced substantial, clinically meaningful improvements in pain, disability, or both. These results provide evidence of long-term effectiveness and durability of restorative neurostimulation in patients with disabling CLBP, secondary to multifidus muscle dysfunction. CLINICAL TRIAL REGISTRATION: The study is registered on clinicaltrials.gov with identifier NCT02577354.

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Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results.

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Journal Regional anesthesia and pain medicine
Year 2021
Links Pubmed DOI PubMed Central

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INTRODUCTION: Vertebral endplates, innervated by the basivertebral nerve (BVN), are a source of chronic low back pain correlated with Modic changes. A randomized trial comparing BVN ablation to standard care (SC) recently reported results of an interim analysis. Here, we report the results of the full randomized trial, including the 3-month and 6-month between-arm comparisons, 12-month treatment arm results, and 6-month outcomes of BVN ablation in the former SC arm. METHODS: Prospective, open label, 1:1 randomized controlled trial of BVN ablation versus SC in 23 US sites with follow-up at 6 weeks, 3, 6, 9, and 12 months. SC patients were re-baselined and followed up for 6 months post BVN ablation. The primary endpoint was the between-arm comparison of mean Oswestry Disability Index (ODI) change from baseline. Secondary endpoints were Visual Analog Scale (VAS), Short Form (SF-36), EuroQual Group 5 Dimension 5-Level Quality of Life (EQ-5D-5L), responder rates, and rates of continued opioid use. RESULTS: 140 were randomized. Results from BVN ablation (n=66) were superior to SC (n=74) at 3 months for the primary endpoint (mean ODI reduction, difference between arms of -20.3 (CI -25.9 to -14.7 points; p<0.001)), VAS pain improvement (difference of -2.5 cm between arms (CI -3.37 to -1.64, p<0.001)) and quality of life outcomes. At 12 months, basivertebral ablation demonstrated a 25.7±18.5 point reduction in mean ODI (p<0.001), and a 3.8±2.7 cm VAS reduction (p<0.001) from baseline, with 64% demonstrating ≥50% reduction and 29% pain free. Similarly, the former SC patients who elected BVN ablation (92%) demonstrated a 25.9±15.5 point mean ODI reduction (p<0.001) from baseline. The proportion of opioid use did not change in either group (p=0.56). DISCUSSION/CONCLUSION: BVN ablation demonstrates significant improvements in pain and function over SC, with treatment results sustained through 12 months in patients with chronic low back pain of vertebrogenic origin.

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Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results.

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Journal North American Spine Society journal
Year 2021
Links Pubmed DOI PubMed Central

This article is included in 1 Systematic review Systematic reviews (1 reference)

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BACKGROUND: Vertebral endplates, innervated by the basivertebral nerve, can be a source of vertebrogenic low back pain when damaged with inflammation, visible as types 1 or 2 Modic changes. A randomized controlled trial (RCT) compared basivertebral nerve ablation (BVNA) to standard care (SC) showed significant differences between arms at 3 and 6-months. At 12-months, significant improvements were sustained for BVNA. We report results of the BVNA arm at 24-months. METHODS: Prospective, open label, single-arm follow-up of the BVNA treatment arm of a RCT in 20 US sites with visits at 6-weeks, and 3, 6, 9, 12 and 24-months. Paired comparisons to baseline were made for the BVNA arm at each timepoint for Oswestry Disability Index (ODI), Visual Analog Scale (VAS), Short Form Health Survey (SF-36), EQ-5D-5L, and responder rates. RESULTS: 140 patients were randomized, 66 to BVNA. In the 58 BVNA patients completing a 24-month visit, 67% had back pain for >5 years, 36% were actively taking opioids at baseline, 50% had prior epidural steroid injections, and 12% had prior low back surgery. Improvements in ODI, VAS, SF-36 PCS, and EQ-5D-5L were statistically significant at all timepoints through 2 years. At 24 months, ODI and VAS improved 28.5±16.2 points (from baseline 44.5; p < 0.001) and 4.1±2.7 cm (from baseline 6.6; p < 0.001), respectively. A combined responder rate of ODI≥15 and VAS≥2 was 73.7%. A ≥50% reduction in pain was reported in 72.4% of patients and 31.0% were pain-free at 2 years. At 24 months, only 3(5%) of patients had BVNA-level steroid injections, and 62% fewer patients were actively taking opioids. There were no serious device or device-procedure related adverse events reported through 24 months. CONCLUSION: Intraosseous BVNA demonstrates an excellent safety profile and significant improvements in pain, function, and quality of life that are sustained through 24 months in patients with chronic vertebrogenic low back pain.

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Durability of the Therapeutic Effect of Restorative Neurostimulation for Refractory Chronic Low Back Pain.

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Journal Neuromodulation : journal of the International Neuromodulation Society
Year 2021
Links Pubmed DOI PubMed Central

This article is included in 1 Systematic review Systematic reviews (1 reference)

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OBJECTIVES: The purpose of the ongoing follow-up of ReActiv8-A clinical trial is to document the longitudinal benefits of episodic stimulation of the dorsal ramus medial branch and consequent contraction of the lumbar multifidus in patients with refractory mechanical chronic low back pain (CLBP). We report the four-year outcomes of this trial. MATERIALS AND METHODS: ReActiv8-A is a prospective, single-arm trial performed at nine sites in the United Kingdom, Belgium, and Australia. Eligible patients had disabling CLBP (low back pain Numeric Rating Scale [NRS] ≥6; Oswestry Disability Index [ODI] ≥25), no indications for spine surgery or spinal cord stimulation, and failed conventional management including at least physical therapy and medications for low back pain. Fourteen days postimplantation, stimulation parameters were programmed to elicit strong, smooth contractions of the multifidus, and participants were given instructions to activate the device for 30-min stimulation-sessions twice daily. Annual follow-up through four years included collection of NRS, ODI, and European Quality of Life Score on Five Dimensions (EQ-5D). Background on mechanisms, trial design, and one-year outcomes were previously described. RESULTS: At baseline (N = 53) (mean ± SD) age was 44 ± 10 years; duration of back pain was 14 ± 11 years, NRS was 6.8 ± 0.8, ODI 44.9 ± 10.1, and EQ-5D 0.434 ± 0.185. Mean improvements from baseline were statistically significant (p < 0.001) and clinically meaningful for all follow-ups. Patients completing year 4 follow-up, reported mean (±standard error of the mean) NRS: 3.2 ± 0.4, ODI: 23.0 ± 3.2, and EQ-5D: 0.721 ± 0.035. Moreover, 73% of participants had a clinically meaningful improvement of ≥2 points on NRS, 76% of ≥10 points on ODI, and 62.5% had a clinically meaningful improvement in both NRS and ODI and 97% were (very) satisfied with treatment. CONCLUSIONS: In participants with disabling intractable CLBP who receive long-term restorative neurostimulation, treatment satisfaction remains high and improvements in pain, disability, and quality-of-life are clinically meaningful and durable through four years.

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Allogeneic mesenchymal precursor cells treatment for chronic low back pain associated with degenerative disc disease: a prospective randomized, placebo-controlled 36-month study of safety and efficacy.

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Journal The spine journal : official journal of the North American Spine Society
Year 2021
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This article is included in 1 Systematic review Systematic reviews (1 reference)

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BACKGROUND CONTEXT PURPOSE: Evaluate the safety and efficacy of a single intradiscal injection of STRO-3+ adult allogeneic mesenchymal precursor cells (MPCs) combined with hyaluronic acid (HA) in subjects with chronic low back pain (CLBP) associated with degenerative disc disease (DDD) through 36-month follow-up. STUDY DESIGN/SETTING: A multicenter, randomized, controlled study conducted at 13 clinical sites (12 in the United States and 1 in Australia). SUBJECT SAMPLE: A total of 100 subjects with chronic low back pain associated with moderate DDD (modified Pfirrmann score of 3-6) at one level from L1 to S1 for at least 6 months and failing 3 months of conservative treatment, including physical therapy were randomized in a 3:3:2:2 ratio to receive 6 million MPCs with HA, 18 million MPCs with HA, HA vehicle control, or saline control (placebo) treatment. OUTCOME MEASURES: Subjects were clinically and radiographically evaluated at 1, 3, 6, 12, 24, and 36 months postinjection. Subject-reported outcomes including adverse events, LBP on a Visual Analog Scale (VAS), Oswestry Disability Index (ODI), SF-36 and Work Productivity and Activity Index were collected. METHODS: Clinical and radiographic measures were collected at each visit. All randomized subjects were included in the safety assessments and analyzed based on the treatment received. Safety assessments included assessments of AEs, physical and radiographic examinations and laboratory testing. Efficacy assessments evaluated changes in VAS, ODI, and modified Pfirrmann (MP) scores between all active and control groups, respectively. Assessments included least squares mean (Mean), LS mean change from baseline (Mean Change) and responder analyses in order to assess the clinical significance of observed changes from baseline. The population for efficacy assessments was adjusted for the confounding effects of post-treatment interventions (PTIs). This study was conducted under an FDA Investigational New Drug application sponsored and funded by Mesoblast. RESULTS: There were significant differences between the control and MPC groups for improvement in VAS and ODI. The PTI-corrected VAS and ODI Means and Mean Change analyses; the proportion of subjects with VAS ≥30% and ≥50% improvement from baseline; absolute VAS score ≤20; and ODI reduction ≥10 and ≥15 points from baseline showed MPC therapy superior to controls at various time points through 36 months. Additionally, the proportion of subjects achieving the minimally important change and clinically significant change composite endpoints for the MPC groups was also superior compared with controls at various time points from baseline to 36 months. There were no significant differences in change in MP score from baseline across the groups. There were also no statistically significant differences in change in modified MP score at the level above or below the level treated between study arms. Both the procedure and treatment were well tolerated and there were no clinical symptoms of immune reaction to allogeneic MPCs. There was a low rate of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events, and the rates of these events in the MPC groups were not significantly different from the control groups. One TEAE of severe back pain was possibly related to study agent and one TEAE of implantation site infection was considered to be related to the study procedure. CONCLUSIONS: Results provide evidence that intradiscal injection of MPCs could be a safe, effective, durable, and minimally invasive therapy for subjects who have CLBP associated with moderate DDD.

Primary study

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Endoscopic rhizotomy for chronic lumbar zygapophysial joint pain.

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Authors Xue Y , Ding T , Wang D , Zhao J , Yang H , Gu X , Feng D , Zhang Y , Liu H , Tang F , Wang W , Lu M , Wu C
Journal Journal of orthopaedic surgery and research
Year 2020
Links Pubmed DOI PubMed Central

This article is included in 1 Systematic review Systematic reviews (1 reference)

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BACKGROUND: Chronic lumbar zygapophysial joint pain is a common cause of chronic low back pain. Percutaneous radiofrequency ablation (RFA) is one of the effective management options; however, the results from the traditional RFA need to be improved in certain cases. The aim of this study is to investigate the effect of percutaneous radiofrequency ablation under endoscopic guidance (ERFA) for chronic low back pain secondary to facet joint arthritis. METHODS: This is a prospective study enrolled 60 patients. The cases were randomized into two groups: 30 patients in the control group underwent traditional percutaneous radiofrequency ablation, others underwent ERFA. The lumbar visual analog scale (VAS), MacNab score, and postoperative complications were used to evaluate the outcomes. All outcome assessments were performed at postoperative 1 day, 1 month, 3 months, 6 months, and 12 months. RESULTS: There was no difference between the two groups in preoperative VAS (P > 0.05). VAS scores, except the postoperative first day, in all other postoperative time points were significantly lower than preoperative values each in both groups (P < 0.05). There was no significant difference between the two groups in VAS at 1 day, 1 month, and 3 months after surgery (P > 0.05). However, the EFRA demonstrated significant benefits at the time points of 3 months and 6 months (P > 0.05). The MacNab scores of 1-year follow-up in the ERFA group were higher than that in the control group (P < 0.05). The incidence of complications in the ERFA group was significantly less than that in the control group (P < 0.05). CONCLUSIONS: ERFA may achieve more accurate and definite denervation on the nerves, which leads to longer lasting pain relief.

Primary study

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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

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Journal International journal of spine surgery
Year 2019
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Background: The purpose of the present study is to report the 2-year clinical outcomes for chronic low back pain (CLBP) patients treated with radiofrequency (RF) ablation of the basivertebral nerve (BVN) in a randomized controlled trial that previously reported 1-year follow up. Methods: A total of 147 patients were treated with RF ablation of the BVN in a randomized controlled trial designed to demonstrate safety and efficacy as part of a Food and Drug Administration-Investigational Device Exemption trial. Evaluations, including patient self-assessments, physical and neurological examinations, and safety assessments, were performed at 2 and 6 weeks, and 3, 6, 12, 18, and 24 months postoperatively. Participants randomized to the sham control arm were allowed to cross to RF ablation at 12 months. Due to a high rate of crossover, RF ablation treated participants acted as their own control in a comparison to baseline for the 24-month outcomes. Results: Clinical improvements in the Oswestry Disability Index (ODI), Visual Analog Scale (VAS), and the Medical Outcomes Trust Short-Form Health Survey Physical Component Summary were statistically significant compared to baseline at all follow-up time points through 2 years. The mean percent improvements in ODI and VAS compared to baseline at 2 years were 53.7 and 52.9%, respectively. Responder rates for ODI and VAS were also maintained through 2 years with patients showing clinically meaningful improvements in both: ODI ≥ 10-point improvement in 76.4% of patients and ODI ≥ 20-point improvement in 57.5%; VAS ≥ 1.5 cm improvement in 70.2% of patients. Conclusions: Patients treated with RF ablation of the BVN for CLBP exhibited sustained clinical benefits in ODI and VAS and maintained high responder rates at 2 years following treatment. Basivertebral nerve ablation appears to be a durable, minimally invasive treatment for the relief of CLBP. Lumbar Spine.

Primary study

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Randomized prospective trial of cooled versus traditional radiofrequency ablation of the medial branch nerves for the treatment of lumbar facet joint pain.

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Journal Regional anesthesia and pain medicine
Year 2019
Links Pubmed DOI PubMed Central

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BACKGROUND AND OBJECTIVES: No previous study has assessed the outcomes of cooled radiofrequency ablation (C-RFA) of the medial branch nerves (MBN) for the treatment of lumbar facet joint pain nor compared its effectiveness with traditional RFA (T-RFA). This study evaluated 6-month outcomes for pain, function, psychometrics, and medication usage in patients who underwent MBN C-RFA versus T-RFA for lumbar Z-joint pain. METHODS: In this blinded, prospective trial, patients with positive diagnostic MBN blocks (>75% relief) were randomized to MBN C-RFA or T-RFA. The primary outcome was the proportion of 'responders' (≥50% Numeric Rating Scale (NRS) reduction) at 6 months. Secondary outcomes included NRS, Oswestry Disability Index (ODI), and Patient Global Impression of Change. RESULTS: Forty-three participants were randomized to MBN C-RFA (n=21) or T-RFA (n=22). There were no significant differences in demographic variables (p>0.05). A ≥50% NRS reduction was observed in 52% (95% CI 31% to 74%) and 44% (95% CI 22% to 69%) of participants in the C-RFA and T-RFA groups, respectively (p=0.75). A ≥15-point or ≥30% reduction in ODI score was observed in 62% (95% CI 38% to 82%) and 44% (95% CI 22% to 69%) of participants in the C-RFA and T-RFA groups, respectively (p=0.21). CONCLUSIONS: When using a single diagnostic block paradigm with a threshold of >75% pain reduction, both treatment with both C-RFA and T-RFA resulted in a success rate of approximately 50% when defined by both improvement in pain and physical function at 6-month follow-up. While the success rate was higher in the C-RFA group, this difference was not statistically significant. TRIAL REGISTRATION NUMBER: NCT02478437.

Primary study

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New Therapy for Refractory Chronic Mechanical Low Back Pain-Restorative Neurostimulation to Activate the Lumbar Multifidus: One Year Results of a Prospective Multicenter Clinical Trial

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Journal NEUROMODULATION
Year 2018
Links Pubmed DOI PubMed Central

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Objectives: The purpose of the international multicenter prospective single arm clinical trial was to evaluate restorative neurostimulation eliciting episodic contraction of the lumbar multifidus for treatment of chronic mechanical low back pain (CMLBP) in patients who have failed conventional therapy and are not candidates for surgery or spinal cord stimulation (SCS). Materials and Methods: Fifty-three subjects were implanted with a neurostimulator (ReActiv8, Mainstay Medical Limited, Dublin, Ireland). Leads were positioned bilaterally with electrodes close to the medial branch of the L2 dorsal ramus nerve. The primary outcome measure was low back pain evaluated on a 10-Point Numerical Rating Scale (NRS). Responders were defined as subjects with an improvement of at least the Minimal Clinically Important Difference (MCID) of >= 2-point in low back pain NRS without a clinically meaningful increase in LBP medications at 90 days. Secondary outcome measures included Oswestry Disability Index (ODI) and Quality of Life (QoL; EQ-5D). Results: For 53 subjects with an average duration of CLBP of 14 years and average NRS of 7 and for whom no other therapies had provided satisfactory pain relief, the responder rate was 58%. The percentage of subjects at 90 days, six months, and one year with >= MCID improvement in single day NRS was 63%, 61%, and 57%, respectively. Percentage of subjects with >= MCID improvement in ODI was 52%, 57%, and 60% while those with >= MCID improvement in EQ-5D was 88%, 82%, and 81%. There were no unanticipated adverse events (AEs) or serious AEs related to the device, procedure, or therapy. The initial surgical approach led to a risk of lead fracture, which was mitigated by a modification to the surgical approach.