A Novel Image-Guided, Automatic, High-Intensity Neurostimulation Device for the Treatment of Nonspecific Low Back Pain

Table 1

Eligibility criteria.

Inclusion criteria	Exclusion criteria
(i) Age 18 years to 70 years	(i) Sciatica
(ii) Nonspecific low back pain that persisted at least 1 month and no longer than 12 months before the study.	(ii) Diagnosed spinal stenosis
(iii) Patients must have a baseline score ≥40 mm on the VAS pain scale.	(iii) Back pain potentially attributable to specific underlying diseases or conditions (e.g., pregnancy, metastatic cancer, spondylolisthesis, fractured bones, dislocated joints, disc eruption).
(iv) If taking analgesics, patients must agree to maintain a steady regimen for the duration of the study.	(iv) Unstable medical or severe psychiatric conditions or dementia
(v) Able to provide written and verbal informed consent.	(v) Previous back surgery
	(vi) Physically unable to undergo treatment; (vii) Patients receiving worker’s compensation or those involved in litigation; (viii) History of pacemaker, implantable devices, or of cardiac arrhythmias; (ix) Allergy or intolerance to adhesive materials; (x) Clinical evidence of cardiovascular, pulmonary, renal, hepatic, neurological, hematological, or endocrine abnormalities.

(European guidelines for the management of chronic nonspecific low back pain, European Commission COST B13 Management Committee; 2004).