Dataset Information

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.

ABSTRACT: 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. CONCLUSIONS:Electrical stimulation to elicit episodic lumbar multifidus contraction is a new treatment option for CMLBP. Results demonstrate clinically important, statistically significant, and lasting improvement in pain, disability, and QoL.

SUBMITTER: Deckers K

PROVIDER: S-EPMC5814827 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

Deckers Kristiaan K De Smedt Kris K Mitchell Bruce B Vivian David D Russo Marc M Georgius Peter P Green Matthew M Vieceli John J Eldabe Sam S Gulve Ashish A van Buyten Jean-Pierre JP Smet Iris I Mehta Vivek V Ramaswamy Shankar S Baranidharan Ganesan G Sullivan Richard R Gassin Robert R Rathmell James J Gilligan Chris C

Neuromodulation : journal of the International Neuromodulation Society 20171215 1

<h4>Objectives</h4>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).<h4>Materials and methods</h4>Fifty-three subjects were implanted with a neurostimulator (ReActiv8, Mainstay Medical Limit ...[more]

PMID: 29244235

Similar Datasets

Project description:ObjectivesThe 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 methodsReActiv8-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.ResultsAt 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.ConclusionsIn 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.

Project description:BackgroundLumbar multifidus (LM) is regarded as the major stabilizing muscle of the spine. The effects of exercise therapy in low back pain (LBP) are attributed to this muscle. A current literature review is warranted, however, given the complexity of LM morphology and the inconsistency of anatomical descriptions in the literature.MethodsScoping review of studies on LM morphology including major anatomy atlases. All relevant studies were searched in PubMed (Medline) and EMBASE until June 2019. Anatomy atlases were retrieved from multiple university libraries and online. All studies and atlases were screened for the following LM parameters: location, imaging methods, spine levels, muscle trajectory, muscle thickness, cross-sectional area, and diameter. The quality of the studies and atlases was also assessed using a five-item evaluation system.ResultsIn all, 303 studies and 19 anatomy atlases were included in this review. In most studies, LM morphology was determined by MRI, ultrasound imaging, or drawings - particularly for levels L4-S1. In 153 studies, LM is described as a superficial muscle only, in 72 studies as a deep muscle only, and in 35 studies as both superficial and deep. Anatomy atlases predominantly depict LM as a deep muscle covered by the erector spinae and thoracolumbar fascia. About 42% of the studies had high quality scores, with 39% having moderate scores and 19% having low scores. The quality of figures in anatomy atlases was ranked as high in one atlas, moderate in 15 atlases, and low in 3 atlases.DiscussionAnatomical studies of LM exhibit inconsistent findings, describing its location as superficial (50%), deep (25%), or both (12%). This is in sharp contrast to anatomy atlases, which depict LM predominantly as deep muscle. Within the limitations of the self-developed quality-assessment tool, high-quality scores were identified in a majority of studies (42%), but in only one anatomy atlas.ConclusionsWe identified a lack of standardization in the depiction and description of LM morphology. This could affect the precise understanding of its role in background and therapy in LBP patients. Standardization of research methodology on LM morphology is recommended. Anatomy atlases should be updated on LM morphology.

Project description:ObjectiveTo compare postoperative imaging results, clinical outcomes and complications between the multifidus muscle bundle (MMB) approach and the conventional open (CO) approach in one-level posterior lumbar interbody fusion (PLIF).MethodsBased on the inclusion and exclusion criteria, 201 of 351 patients in our hospital were enrolled in this prospective study and underwent MMB-PLIF or CO-PLIF randomly: 111 patients in the MMB-PLIF group and 90 patients in the CO-PLIF group. A total of 100 patients failed to be followed up in the following 7-9 years. Therefore, in this study, 52 patients of the MMB group and 49 patients of the CO group were included. We evaluated the differences in terms of multifidus atrophy rate, intervertebral disc height and segmental lordosis restoration of the operation segment, lumbar lordosis restoration, fusion rate, visual analogue scale (VAS) for back and leg pain, Oswestry disability index (ODI), complication rates, and patient satisfaction rates between the two groups. Correlation between multifidus muscle degeneration and the incidence of complications was investigated, and we compared the multifidus muscle degeneration rate between patients with or without intractable back pain or adjacent segment degeneration.ResultsThere were no significant differences in age, sex, body mass index (BMI), diagnosis, segments distribution, and mean follow-up time between the MMB-PLIF group and the CO-PLIF group. In addition, no differences regarding sex, age, or BMI were found between the lost follow-up group and the successful follow-up group. In regard to imaging and clinical evaluation, at the final follow-up, there were significant differences in multifidus atrophy rates (27.0% ± 6.8% vs 38.7% ± 10.9%), lumbar lordosis restoration (4.6° ± 2.5° vs 3.0° ± 1.9°), postoperative VAS for back pain (1.1 ± 0.9 vs 1.8 ± 1.2), ODI (7.7 ± 5.0 vs 12.4 ± 6.7), and patient satisfaction rates (86.5% vs 61.2%) between MMB-PLIF and CO-PLIF groups. However, there were no significant differences in segmental lordosis, intervertebral height restoration, postoperative VAS for leg pain or fusion rate between the two groups. In regards to complications, there were significant differences in the incidence of adjacent segment degeneration (3.8% vs 14.3%), intractable back pain (3.8% vs 22.4%), and residual neurological symptoms (5.8% vs 20.4%) between the two groups (P < 0.05) at the final follow-up. In addition, patients with adjacent segment degeneration and intractable back pain were observed with more significant multifidus muscle atrophy than those without these two complications (31.9% ± 1.1% vs 39.6% ± 2.1% and 30.9% ± 1.1% vs 42.8% ± 2.1%).ConclusionCompared with CO-PLIF, MMB-PLIF had advantages in relation to protection of the multifidus muscle, better maintenance of lumbar lordosis, reduced lower back pain and ODI score, fewer complications, and a higher patient satisfaction rate. Protection of the multifidus muscle in lumbar surgery is an important aspect of minimally invasive surgery.

Project description:IntroductionLumbar multifidus muscle (LMM) dysfunction is thought to be related to pain and/or disability in people with chronic low back pain (CLBP). Although psychosocial factors play a major role in pain/disability, they are seldom considered as confounders in analyzing the association between LMM and CLBP.ObjectivesThis study aimed to determine: (1) differences in psychological factors, insomnia, and LMM characteristics between people with and without CLBP; (2) associations between psychological factors, insomnia, or LMM characteristics and low back pain (LBP) intensity or LBP-related disability in people with CLBP; and (3) whether LMM characteristics are related to LBP symptoms in people with CLBP after considering confounders.MethodsSeventy-eight volunteers with CLBP and 73 without CLBP provided sociodemographic information, filled the 11-point numeric pain rating scale and Roland-Morris disability questionnaire (RMDQ). They completed the Hospital Anxiety and Depression Scale (HADS), Pain Catastrophizing Scale (PCS), Fear Avoidance Belief Questionnaire (FAB), and Insomnia Severity Index Scale (ISI). Resting and contracted thickness of LMM at L4-S1 levels were measured from brightness-mode ultrasound images. Percent thickness changes of LMM at L4-S1 levels during contraction were calculated. Resting LMM stiffness at L4-S1 was measured by shear wave elastography. Associations among LMM, psychosocial or insomnia parameters and clinical outcomes were analyzed by univariate and multivariate analyses.ResultsPeople with CLBP demonstrated significantly higher LBP-intensity, RMDQ, HADS, FAB, PCS, and ISI scores than asymptomatic controls (p < 0.05). The former also had significantly smaller percent thickness changes of LMM at L4/L5 during contraction. LBP-intensity was positively related to scores of PCS-total, PCS-helplessness, FAB-total, FAB-work, and ISI in people with CLBP (p < 0.05). RMDQ scores were positively associated with the scores of HADS-total, HADS-depression, PCS-total, FAB-total, FAB-physical activity, PCS-helplessness, and ISI in people with CLBP (p < 0.05). FAB-work and ISI scores together explained 24% of LBP-intensity. FAB-total scores alone explained 34% of variance of LBP-related disability in people with CLBP.ConclusionMore fear-avoidance belief or insomnia is related to greater LBP-intensity and/or LBP-related disability in people with CLBP. Although people with CLBP were thought to have aberrant LMM morphometry/function, no LMM characteristics were related to LBP-intensity or LBP-related disability after considering other confounders.

Dataset Information

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.

Publications

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.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets