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| ID | Type | Description | Link |
|---|---|---|---|
| MED IIS | Other Identifier | Nevro Corp |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | Pulse Dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCS Device Program Setting | Device | A Pulse Dose setting specifies a brief duration of stimulation 'on' and stimulation 'off' durations, applied in a continuously cycled manner |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Patient Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mayank Gupta, MD | Neuroscience Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuroscience Research Center | Overland Park | Kansas | 66210 | United States |
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| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
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The subject will rate their satisfaction with the SCS program on a scale from "Very Satisfied," "Satisfied," "Not Sure," "Dissatisfied," to "Very Dissatisfied."
| 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". | 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. | 3 months |
| Patient Catastrophizing Scale | 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. | 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. | 3 months |
| Daily device recharge duration | 3 months |
| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |