Chronic Low Back Pain: Restoration of Dynamic Stability

Deckers, Kristiaan; Smedt, K. De; Buyten, Jean‐Pierre Van; Smet, Iris; Eldabe, Sam; Gulve, Ashish; Baranidharan, Ganesan; Andrés, José De; Gilligan, Christopher; Jaax, Kristen N.; Heemels, Jan Pieter; Crosby, P. A.

doi:10.1111/ner.12275

Cited by 30 publications

(14 citation statements)

References 45 publications

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“…Subjects were asked to perform two 30‐min sessions daily—ideally at the same time in the morning and evening. The duration of 60 min per day was chosen based on the results of the Feasibility Study 28 which used 40 min per day and was increased to 60 min following recommendations from investigators. Furthermore, 60 min per day is consistent with physical therapy practice for muscle rehabilitation.…”

Section: Methodsmentioning

confidence: 99%

“…Dysfunction of the lumbar multifidus can allow the vertebral segments to move outside their pain‐free zone 24, increasing the risk of being reinjured, resulting in potential further motor control impairment, and arthrogenic muscle inhibition, leading to a chronic pain state 26. A detailed review of role of the lumbar multifidus in CMLBP is presented in a companion paper in this issue of Neuromodulation 27.…”

Section: Introductionmentioning

confidence: 99%

“…Upon completion of preclinical testing, a feasibility study was conducted in 26 patients to test the hypothesis (28). The results of this feasibility study demonstrated significant and clinically important improvements in low back pain, disability, and QoL at 90-days post activation.…”

Section: Introductionmentioning

confidence: 99%

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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

Deckers

Smedt

Mitchell³

et al. 2018

Neuromodulation: Technology at the Neural Interface

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ObjectivesThe 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 MethodsFifty‐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).ResultsFor 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.ConclusionsElectrical 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.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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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

Deckers

Smedt

Mitchell³

et al. 2018

Neuromodulation: Technology at the Neural Interface

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“…A feasibility study to explore this concept using "off the shelf" neurostimulation hardware showed encouraging results (131). Based on the results of this study, a custom implantable neurostimulator was developed and subjected to a single arm clinical trial, which subsequently led to CE Mark approval of the device (see https:// clinicaltrials.gov/ct2/show/NCT01985230).…”

Section: Restorative Neurostimulation For Clbpmentioning

confidence: 99%

Muscle Control and Non-specific Chronic Low Back Pain

Russo¹,

Deckers

Eldabe

et al. 2018

Neuromodulation: Technology at the Neural Interface

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146

129

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ObjectivesChronic low back pain (CLBP) is the most prevalent of the painful musculoskeletal conditions. CLBP is a heterogeneous condition with many causes and diagnoses, but there are few established therapies with strong evidence of effectiveness (or cost effectiveness). CLBP for which it is not possible to identify any specific cause is often referred to as non‐specific chronic LBP (NSCLBP). One type of NSCLBP is continuing and recurrent primarily nociceptive CLBP due to vertebral joint overload subsequent to functional instability of the lumbar spine. This condition may occur due to disruption of the motor control system to the key stabilizing muscles in the lumbar spine, particularly the lumbar multifidus muscle (MF).MethodsThis review presents the evidence for MF involvement in CLBP, mechanisms of action of disruption of control of the MF, and options for restoring control of the MF as a treatment for NSCLBP.ResultsImaging assessment of motor control dysfunction of the MF in individual patients is fraught with difficulty. MRI or ultrasound imaging techniques, while reliable, have limited diagnostic or predictive utility. For some patients, restoration of motor control to the MF with specific exercises can be effective, but population results are not persuasive since most patients are unable to voluntarily contract the MF and may be inhibited from doing so due to arthrogenic muscle inhibition.ConclusionsTargeting MF control with restorative neurostimulation promises a new treatment option.

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“…Because of the cross‐sectional design of these studies, no conclusions regarding whether lumbar muscle characteristics predict or modify future back pain or function can be drawn. Whether lumbar muscle properties are risk factors for back pain or result from back pain is of great clinical interest, as lumbar muscles are easily identified on common cross‐sectional imaging protocols with magnetic resonance imaging (MRI) or computed tomography (CT) and could be a target for clinical intervention [13].…”

Section: Introductionmentioning

confidence: 99%