This is a single-center, prospective, non-randomized exploratory study in subjects with chronic, intractable back pain and/or leg pain per the center's routine practice. The primary endpoint is the distribution of responders by 'lowest preferred pulse dose (PD)' setting, where a subject is a responder to the lowest PD setting they preferred prior to entering the Observational period. The study is performed in patients who already have Nevro SCS devices implanted.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
A Pulse Dose setting specifies a brief duration of stimulation 'on' and stimulation 'off' durations, applied in a continuously cycled manner
Neuroscience Research Center
Overland Park, Kansas, United States
Preference for Pulse Dose Setting
Starting from a standardized low pulse dose (PD) setting, subjects will try progressively lower PD settings depending upon their response to each setting, to arrive at the lowest PD setting they prefer. Up to 5 PD settings will be tried by each subject.
Time frame: 3 months
Numerical Rating Scale of Back, Leg, and Overall Pain Intensity
The numerical rating scale ranges from 0 to 10, where 0 = no pain and 10 = worst pain imaginable.
Time frame: 3 months
Patient Satisfaction
The subject will rate their satisfaction with the SCS program on a scale from "Very Satisfied," "Satisfied," "Not Sure," "Dissatisfied," to "Very Dissatisfied."
Time frame: 3 months
Patient Global Impression of Change
This 7-point scale is used to assess the subject's global change in their general state of health for each particular phase of the study. Responses range from "Very Much Worse" to "No Change" to "A Great Deal Better".
Time frame: 3 months
Oswestry Disability Index
The Oswestry Disability Index (ODI) uses 10 questions covering aspects of daily life affected by back pain, such as pain intensity, personal care, lifting, walking, and social activities. Each question is scored on a 0-5 scale, with higher scores indicating greater disability. The total score is calculated as a percentage, with 0% representing no disability and 100% representing complete disability. Outcomes will be categorized as follows: 0-20%: Minimal disability; 21-40%: Moderate disability; 41-60%: Severe disability; 61-80%: Crippled; 81-100%: Bedridden.
Time frame: 3 months
Patient Catastrophizing Scale
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Subjects are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52), along with three subscale scores assessing rumination, magnification and helplessness.
Time frame: 3 months
PROMIS-SF Sleep Disturbance Scale
Each of the 8 items on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Time frame: 3 months
Daily device recharge duration
Time frame: 3 months