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
- Conditions
- Failed Back Surgery SyndromeAnaesthesiology - Pain managementNeurological - Other neurological disorders
- Registration Number
- ACTRN12618000721202
- Lead Sponsor
- Vincent Galan, MD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effectiveness with equal to or greater than 50% pain relief.<br><br>To demonstrate an improvement in average overall pain [as measured by the diary-reported Numeric Pain Rating Scale (NPRS)] from baseline to the end of trial in subjects programmed with two different waveforms. In the event of equal decrease in the overall pain, the subject will decide which system they prefer and why.[Evaluation of First Programming Trial (Day 5)<br>Evaluation of Second Programming Trial (Day 10).<br><br>At end of trial the effectiveness (equal or greater than 50& pain relief) will be determined with both systems. The one with the higher effectiveness will be recommended to be implanted.<br>]
- Secondary Outcome Measures
Name Time Method