This is an independent prospective, noninterventional, observational post-market data collection of the patient-reported effectiveness, ongoing safety and satisfaction outcomes for patients treated with the Intracept Procedure at a single study site.
The Investigator Sponsor will initially approach patients planning to undergo the Intracept Procedure to discuss their interest in learning more about the study. With patient permission, contact information will be forwarded to a third-party research organization which will contact the patient to explain more about the study and to gather Verbal Informed Consent. Study data will be collected by the University of Utah research staff via 4 telephone study visits under the direction of the Sponsor Investigator. The study research staff will enter the study data directly into a study database and issue the subject stipend after the completion of each study visit. Data will be analyzed by a statistician under the direction of the Sponsor Investigator for this single-site study.
Study Type
OBSERVATIONAL
Enrollment
150
Radiofrequency ablation of the basivertebral nerve for the relief of chronic vertebrogenic low back pain
University of Utah Farmington Health Center
Farmington, Utah, United States
University of Utah Orthopaedic Center
Salt Lake City, Utah, United States
University of Utah South Jordan Health Center
South Jordan, Utah, United States
Oswestry Disability Index (ODI) Change
Validated questionnaire of low back pain related disability. Comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). Comparison of mean ODI baseline to 3 months.
Time frame: 3 months
Oswestry Disability Index (ODI) Change
Mean Improvement in ODI scores from baseline (scale 0 to 100): Validated questionnaire of low back pain related disability. Comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). Comparison of mean ODI baseline to 3 months.
Time frame: 12 months
Oswestry Disability Index (ODI) Change
Mean improvement in ODI scores from baseline (scale 0 to 100): Validated questionnaire of low back pain related disability. Comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). Comparison of mean ODI baseline to 3 months.
Time frame: 24 months
Numeric Pain Rating Scale (NPRS)
Mean change in patient-reported low back pain from baseline. The scale is from 0 (no pain) to 10 (worst pain imaginable).
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Numeric Pain Rating Scale (NPRS)
Mean change in patient-reported low back pain from baseline. The scale is from 0 (no pain) to 10 (worst pain imaginable).
Time frame: 12 months
Numeric Pain Rating Scale (NPRS)
Mean change in patient-reported low back pain from baseline. The scale is from 0 (no pain) to 10 (worst pain imaginable).
Time frame: 24 months
Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPRS ≥ 2)
Percent of responders meeting both thresholds
Time frame: 3 months
Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPRS ≥ 2)
Percent of responders meeting both thresholds
Time frame: 12 months
Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPRS ≥ 2)
Percent of responders meeting both thresholds
Time frame: 24 months
PROMIS 29 Change
Mean change in PROMIS-29 from baseline. (PROMIS-29 includes Numeric Rating Score (NRS) and Seven Health Domains. \[NRS 0-10 zero being none and 10 the worst. Seven health domains scaled 1-5: physical function (1 unable to do to 5 without any difficulty), fatigue (1 not at all and 5 very much), pain interference (1 not at all and 5 very much), depressive symptoms (1 never and 5 always), anxiety (1 never and 5 always), ability to participate in social roles and activities (1 never and 5 always), and sleep disturbance(1 not at all and 5 very much)\])
Time frame: 3 months
PROMIS 29 Change
Mean change in PROMIS-29 from baseline. (PROMIS-29 includes Numeric Rating Score (NRS) and Seven Health Domains. \[NRS 0-10 zero being none and 10 the worst. Seven health domains scaled 1-5: physical function (1 unable to do to 5 without any difficulty), fatigue (1 not at all and 5 very much), pain interference (1 not at all and 5 very much), depressive symptoms (1 never and 5 always), anxiety (1 never and 5 always), ability to participate in social roles and activities (1 never and 5 always), and sleep disturbance(1 not at all and 5 very much)\])
Time frame: 12 months
PROMIS 29 Change
Mean change in PROMIS-29 from baseline. (PROMIS-29 includes Numeric Rating Score (NRS) and Seven Health Domains. \[NRS 0-10 zero being none and 10 the worst. Seven health domains scaled 1-5: physical function (1 unable to do to 5 without any difficulty), fatigue (1 not at all and 5 very much), pain interference (1 not at all and 5 very much), depressive symptoms (1 never and 5 always), anxiety (1 never and 5 always), ability to participate in social roles and activities (1 never and 5 always), and sleep disturbance(1 not at all and 5 very much)\])
Time frame: 24 months
Quadrants of % reduction in low back pain from baseline to each follow-up period.
Review of the % of low back pain reduction in participants
Time frame: 3 months
Quadrants of % reduction in low back pain from baseline to each follow-up period.
Review of the % of low back pain reduction in participants
Time frame: 12 months
Quadrants of % reduction in low back pain from baseline to each follow-up period.
Review of the % of low back pain reduction in participants
Time frame: 24 months
Responder rates for Oswestry Disability Index (ODI)
The proportion of subjects who achieve ≥ 15-point reduction in ODI from baseline to each follow-up period. This would indicate a reduction in how much lower back pain is affecting participants' daily activities following the procedure. The Oswestry Disability Index (ODI) is a validated questionnaire of low back pain related disability comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). Comparison of mean ODI baseline to 3 months.
Time frame: 3 months
Responder rates for Oswestry Disability Index (ODI)
The proportion of subjects who achieve ≥ 15-point reduction in ODI from baseline to each follow-up period. This would indicate a reduction in how much lower back pain is affecting participants' daily activities following the procedure. The Oswestry Disability Index (ODI) is a validated questionnaire of low back pain related disability comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). Comparison of mean ODI baseline to 12 months.
Time frame: 12 months
Responder rates for Oswestry Disability Index (ODI)
The proportion of subjects who achieve ≥ 15-point reduction in ODI from baseline to each follow-up period. This would indicate a reduction in how much lower back pain is affecting participants' daily activities following the procedure. The Oswestry Disability Index (ODI) is a validated questionnaire of low back pain related disability comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). Comparison of mean ODI baseline to 24 months.
Time frame: 24 months
Responder rates for the Numeric Pain Rating Scale (NPRS)
The proportion of subjects who achieve a ≥ 2-point reduction in the NPRS from baseline to each follow-up period. The scale is from 0 (no pain) to 10 (worst pain imaginable).
Time frame: 3 Months
Responder rates the Numeric Pain Score
the proportion of subjects who achieve a ≥ 2-point reduction in numeric pain score from baseline to each follow-up period. The scale is from 0 (no pain) to 10 (worst pain imaginable).
Time frame: 12 Months
Responder rates for the Numeric Pain Score
the proportion of subjects who achieve a ≥ 2-point reduction in numeric pain score from baseline to each follow-up period. The scale is from 0 (no pain) to 10 (worst pain imaginable).
Time frame: 24 Months
Narcotic use
The proportion of patients actively utilizing narcotics for low back pain at each follow-up period.
Time frame: 3 Months
Narcotic use
The proportion of patients actively utilizing narcotics for low back pain at each follow-up period.
Time frame: 12 Months
Narcotic use
The proportion of patients actively utilizing narcotics for low back pain at each follow-up period.
Time frame: 24 Months
Low back pain injections
The proportion of patients utilizing injections for low back pain of the same treatment region at each follow-up period.
Time frame: 3 Months
Low back pain injections
The proportion of patients utilizing injections for low back pain of the same treatment region at each follow-up period.
Time frame: 12 Months
Low back pain injections
The proportion of patients utilizing injections for low back pain of the same treatment region at each follow-up period.
Time frame: 24 Months
Low back pain interventions or surgery
The proportion of patients with pain interventions or surgery for low back pain of the same treatment region at each follow-up period
Time frame: 3 Months
Low back pain interventions or surgery
The proportion of patients with pain interventions or surgery for low back pain of the same treatment region at each follow-up period
Time frame: 12 Months
Low back pain interventions or surgery
The proportion of patients with pain interventions or surgery for low back pain of the same treatment region at each follow-up period
Time frame: 24 Months
Work Impact
Patient work status at 12 months indicated by subject using this scale: No impact to my ability to work; Working with restrictions; Had to get a different job due to low back pain; Unable to work at all/disabled by my low back pain (e.g. retired, unemployed); Not currently working unrelated to low back pain; Other. If a subject is working with restrictions, they are asked to specify: Reduced hours; Slower pace; Less heavy work; Not regular job. Subjects are also asked the question: How many workdays have you missed due to low back pain?
Time frame: 12 Months
Patient Global Impression of Change (PGIC)
PGIC at each follow-up period. The subject is asked to rate their low back pain progress with the scale: Very Much Improved; Much Improved; Minimally Improved; No Change; Minimally worse; Much Worse; Very Much Worse.
Time frame: 3 Months
Patient Global Impression of Change (PGIC)
PGIC at each follow-up period. The subject is asked to rate their low back pain progress with the scale: Very Much Improved; Much Improved; Minimally Improved; No Change; Minimally worse; Much Worse; Very Much Worse.
Time frame: 12 Months
Patient Global Impression of Change (PGIC)
PGIC at each follow-up period. The subject is asked to rate their low back pain progress with the scale: Very Much Improved; Much Improved; Minimally Improved; No Change; Minimally worse; Much Worse; Very Much Worse.
Time frame: 24 Months
Patient-reported procedure-related adverse events
Patient-reported procedure-related adverse events including new LBP and/or leg pain at each follow-up period
Time frame: 3 Months
Patient-reported procedure-related adverse events
Patient-reported procedure-related adverse events including new LBP and/or leg pain at each follow-up period
Time frame: 12 Months
Patient-reported procedure-related adverse events
Patient-reported procedure-related adverse events including new LBP and/or leg pain at each follow-up period
Time frame: 24 Months