To evaluate the effectiveness of two (2) different waveforms of Spinal Cord Stimulation in a population of patients with back and leg pain due to failed back surgery syndrome

Vincent Galan, MD0 个研究点目标入组 20 人开始时间: 2018年5月2日最近更新: 2019年7月15日

适应症

试验速览

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•Inclusion Criteria:
•1. Candidate for SCS system (trial and implant) per labeled indication (back and leg pain)
•2. Baseline diary-reported average NPRS is equal or greater than 5 for both trunk and limbs pain.
•3. Willing and able to provide a signed and dated informed consent
•4. At least 18 years old at the time of informed consent
•5. Willing and able to attend visits and comply with the study protocol
•6. Capable of using the patient programmer and recharging the neurostimulator
•7. Willing to not increase pain medications from baseline through the end of trial Visit
•8. Baseline diary completed for a minimum of 3 days

•Exclusion Criteria:
•1. Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound study results.
•2. Based on the medical opinion of the Principal Investigator, Sub- Investigator, Psychologist and/or Psychiatrist, the subject has other psychological conditions (e.g., psychosis, suicidal ideation, borderline personality disorder, somatization, narcissism), or other health conditions (e.g., substance abuse, another chronic condition requiring the regular use of significant pain medications) that would preclude his/her enrollment in the study or potentially confound the results of the study
•3. Trialed or implanted with SCS, subcutaneous stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system which utilizes tonic (paresthesia) stimulation.
•4. Unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the investigator

发起方

Vincent Galan, MD