Spinal versus local anaesthesia for CL-SCS implantation and its influence on the ECAP
- Conditions
- Failed back surgery syndrome
- Registration Number
- NL-OMON20564
- Lead Sponsor
- none
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
•Subject has been diagnosed with chronic, intractable leg and/or back pain (NPRS = 6), which has been refractory to conservative therapy for at least 6 months;
•Subject has been approved by the Investigator to undergo a trial of spinal cord stimulation;
•Subject is an appropriate candidate for the surgical procedures required for SCS based on the clinical judgment of the implanting physician;
•Subject is on a stable dose (no new, discontinued, or changes in dose) of all prescribed pain medication for at least 30 days prior to baseline evaluation;
•Subject is willing and capable of giving written informed consent;
•Subject is willing and able to comply with study-related requirements, procedures, and visits.
•Subject has a medical condition or pain in area(s) that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator;
•Subject is not an SCS candidate due to anatomical or structural findings and/or changes which would benefit from surgical intervention as determined by investigator;
•Subject has evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance with intervention and/or ability to evaluate treatment outcomes as determined by the Investigator;
•Subject has had another neuromodulation system;
•Subject has a condition currently requiring or likely to require the use of MRI or diathermy;
•Subject is not a good surgical candidate (e.g., has an uncontrolled coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, uncontrolled diabetes mellitus, or cannot come off anticoagulant therapy for procedure);
•Subject is concomitantly participating in another clinical study unless pre-approved by the Principal Investigator;
•Subject is involved in a process (e.g., involved in an injury claim under current litigation) in which pain relief may be considered detrimental (i.e., secondary gains).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •To evaluate patient pain and comfort level under spinal or local anaesthesia during SCS trial lead implantation.
- Secondary Outcome Measures
Name Time Method •To evaluate the difference in amount of propofol anaesthesia and additional pain medication required by patients when implanting SCS leads, during SCS trial lead implantation under spinal or local anaesthesia. <br>•To evaluate the degree of pain relief achieved during the SCS trial period.<br>•To evaluate patient and physician satisfaction with the trial lead implantation procedure. <br>•To evaluate the effect of spinal or local anaesthesia on ECAPs elicited by SCS during SCS lead implantation.<br>•To evaluate the effect of spinal, local and general anaesthesia on nerve conduction velocity.<br>•To evaluate differences in sensitivity to stimulation during and post-washout of spinal or local anaesthesia.<br>•To evaluate differences in ECAP recordings from different postures.