The primary objective of this study is to prospectively examine outcomes in 12 patients using ziconotide Intrathecal Drug Therapy(IDT) as first-line monotherapy with the use of an algorithm of slow titration for dosing. The use of Prialt has demonstrated fewer and less serious associated adverse effects as compared to IDT morphine, especially when titrated slowly. We will use an average Numerical Rating Scale as our primary outcome and the Oswestry Disability Index(ODI), Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS), Clinical Global Impression of Change Scale including binary satisfaction measures(CGIC), Lawton-Brody Instrumental Activities of Daily Living(IADL) and Short Form-36 as secondary outcome measures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Initial dose at time of the implant will be 1.2 mcg/day with dose increases of no more the .4 mcg/day planned for 3, 6, 8, 9, 10, 12 weeks and 4, 5, 6 and 12 months.
Quantitative sensory testing will be done using different types of sensory stimulation to objectively quantify sensation and pain tolerance. VonFrey fibers of various widths are used to detect sensation, a Neuropen pin prick iutilized to detect pain, along with a tuning fork to measure vibrationand a pressure guage to measure pressure felt on the skin. Cold/hot sensation is tested with Medoc Pathway system to quantitatively measure the temperature felt by patients to be done at baseline, 6 months and 12 months,
Increases in these biomarkers indicate nerve pain as they are released from macrophages in patients with damaged nerves.
Albany Medical College
Albany, New York, United States
Numerical Rating Scale (NRS)
This scale allows the subject to quantify their pain numerically, with 10 being the worst pain imaginable. This scale describe subject reported pain at its worst and best in the week prior to reporting, as well as total pain on average, and at the time of documentation. The mean of these scores will be used as the primary outcome. This scale also includes a question of subject experienced global improvement in which the patient is asked to quantify their overall change in pain with 0 being no change and 10 being completely changed. Using the NRS we will calculate a responder rate, assessing percentage of patients with a 50% response in NRS
Time frame: Baseline, 3, 4, 6, 8, 9, 10, 12 week and 4, 5, 6 and 12 months
Oswestry Disability Index Scale
Comprises 11 sections, this survey asks the patient to indicate the degree to which they have difficulty in daily life relating to pain.
Time frame: Baseline, 12 weeks, 6 month, 12 month
SF (Short Form) - 36
This scale utilizes 36 questions to determine overall quality of life in patients by discussing physical health, emotional health, and social engagement.
Time frame: Baseline, 12 weeks, 6 month
IADL(Instrumental Activities of Daily Living)
Used to assess complex functional activities of daily living, this scale extrapolates on basic activities such as ability to eat or walk, to include cooking shopping, housekeeping.
Time frame: Baseline, 12 weeks, 6 month, 12 month
Beck Depression Inventory
21 question survey pertaining to a patient's severity of depression. Each question is scored for 0 to 3, with 0 indicating no depression and 3 indicating the most severe depression
Time frame: Baseline, 12 weeks, 6 month, 12 month
Pain Catastrophizing Scale
This scale separates three types of catastrophizing: rumination, magnification and helplessness. Catastrophic thinking can contribute to the probability that a pain condition will be persistent over tim.
Time frame: Baseline, 12 weeks, 6 month, 12 month
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