title: Auto-Targeted Neurostimulation Is Not Superior to Placebo in Chronic Low Back Pain: A Fourfold Blind Randomized Clinical Trial.
abstract: Myofascial trigger points (MTrPs) are common in people with musculoskeletal pain and may play a role in chronic nonspecific low back pain (CLBP). One of the potential treatments of MTrPs is the Nervomatrix Soleve® auto-targeted neurostimulation device, providing targeted transcutaneous electrical nerve stimulation (TENS) to MTrPs in the lower back muscles. To date, no controlled studies have evaluated the effectiveness of this device for the pain management of this population.
  
  
  
  To examine whether the Nervomatrix Soleve® auto-targeted neurostimulation device is superior over placebo for the treatment of CLBP.
  
  
  
  A fourfold-blind randomized controlled trial was conducted.
  
  
  
  Brussels University Hospital, health care centers and pharmacies around Belgium.
  
  
  
  Participants with CLBP for at least 3 months were randomly assigned to the experimental (the Nervomatrix Soleve® auto-targeted neurostimulation device providing TENS-stimulation and mechanical pressure) or placebo group (the Nervomatrix Soleve® auto-targeted neurostimulation device providing mechanical pressure alone without current). The treatment protocol in both groups consisted of 6 treatment sessions per patient. Participants were evaluated at baseline prior to the intervention, immediately following treatment, and at one month follow-up. Pain and pain behavior (steps climbed) were assessed as primary outcome measures. Secondary outcome measures were pain functioning, health beliefs, symptoms of central sensitization, pain catastrophizing, and kinesiophobia.
  
  
  
  In total, 39 participants were included in the study. Participants in both groups improved significantly for pain and functioning, but no significant differences were observed between groups. These improvements were not clinically meaningful for any of the reported measures. The health beliefs changed significantly in both groups (P < 0.05), with superior results at follow-up in the placebo group.
  
  
  
  The follow-up period is limited to one month.
  
  
  
  Treatment of MTrPs with the Nervomatrix Soleve® auto-targeted neurostimulation device in patients with CLBP does not result in a better outcome than placebo-treatment in terms of pain, pain behavior, functioning, central sensitization, pain catastrophizing, and health beliefs.
authors.affiliation: Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Belgium; Department of Physical Therapy, University of Granada, Spain.
authors.forename: Maria Encarnación
authors.initials: ME
authors.lastname: Aguilar Ferrándiz
authors.affiliation: Pain in Motion Research Group (www.paininmotion.be); Department of Human Physiology and Physiotherapy, Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium; Department of Physical Medicine and Physiotherapy, University Hospital Brussels, Brussels, Belgium.
authors.forename: Jo
authors.initials: J
authors.lastname: Nijs
authors.forename: Yori
authors.initials: Y
authors.lastname: Gidron
authors.forename: Nathalie
authors.initials: N
authors.lastname: Roussel
authors.affiliation: Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
authors.forename: Rob
authors.initials: R
authors.lastname: Vanderstraeten
authors.affiliation: Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
authors.forename: Dries
authors.initials: D
authors.lastname: Van Dyck
authors.affiliation: Pain in Motion International Research Group; Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Belgium.
authors.forename: Eva
authors.initials: E
authors.lastname: Huysmans
authors.affiliation: Pain in Motion Research Group (www.paininmotion.be); Department of Human Physiology and Physiotherapy, Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium; Department of Physical Medicine and Physiotherapy, University Hospital Brussels, Brussels, Belgium; Department of Neurology, Faculty of Medicine, University of Antwerp, Antwerp, Belgium.
authors.forename: Margot
authors.initials: M
authors.lastname: De Kooning
mesh_terms: D000328:Adult; D059350:Chronic Pain / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010919:Placebos; D004561:Transcutaneous Electric Nerve Stimulation / Q000295:instrumentation* / Q000379:methods; D016896:Treatment Outcome
chemical_list: D010919:Placebos