A prospective, randomised, double-arm, open label exploratory trial to investigate patient and physician experiences of spinal or local anaesthesia and its influence on ECAPs during SCS trial lead implantation.
- Conditions
- Chronic pain as a result of FBSSchronic nerve painfailed back surgery syndrome
- Registration Number
- NL-OMON54096
- Lead Sponsor
- Elisabeth-Tweesteden ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
• Subject has been diagnosed with chronic, intractable leg and/or back pain
(NPRS >= 6), FBSS, which has been refractory to conservative therapy for at
least 6 months.
• Subject has been approved by the Investigator to undergo a trial of SCS
implantation.
• 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 is at least 18 years of age
• 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
the 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 who 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 <p>• Subject experience will be evaluated using a numerical pain rating scale<br /><br>(NPRS) to assess the degree of pain/discomfort during the lead implantation<br /><br>procedure. A clinically meaningful difference in NPRS is set at two points on<br /><br>the NPRS scale (0-10)</p><br>
- Secondary Outcome Measures
Name Time Method