Chronic Low-back Pain Clinical Trial
Official title:
Intermittent Dosing of Spinal Cord Stimulation as Alternate Paradigm to Continuous 10kHz Frequency Therapy (HF10 Therapy)
NCT number | NCT04709757 |
Other study ID # | 20121301 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2021 |
Est. completion date | March 1, 2023 |
Verified date | October 2023 |
Source | Rush University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Spinal cord stimulation (SCS) delivered at 10kHz frequency (HF10 Therapy) has demonstrated superiority to traditional SCS for leg and back pain. Intermittent dosing (ID) refers to the cycling of stimulation, in which there is a designated time period of stimulation being active (ON) and inactive (OFF). Previous studies have demonstrated the safe and effective use of intermittent dosing. However, there still remains a paucity of clinical data on the use of intermittent dosing and which doses (i.e. on/off cycle time periods) are most effective. Furthermore, no previous studies have utilized HF10 therapy when evaluating intermittent dosing. Patients with chronic back and/or leg pain who have undergone permanent spinal cord stimulator implantation delivered by the Nevro Omnia Neurostimulation System and who are reporting decreased efficacy of continuous HF10 therapy will be randomized into one of two treatments: 1) Intermittent Dosing therapy at 30 seconds ON, 90 seconds OFF 2)Intermittent Dosing therapy at 30 seconds ON, 360 seconds OFF. After randomization, each consented subject will present to clinic at which time will first be seen by a team of investigators, sub-investigators, and/or study staff. After evaluation and collection of baseline data, a clinical specialist for the Nevro Omnia Neurostimulation system will program the subject's SCS system according to the treatment group to which they have been randomized, under direct physician supervision Patient's will be seen and evaluated prior to randomization, and thereafter at 2, 4 and 6 weeks. At the 6-week time period, patients will be crossed over to the other study arm and thereafter evaluated at 2, 4 and 6 weeks. As our primary endpoint, we hypothesize that ID HF10 therapy will provide non-inferior pain relief as measured by VAS scores when compared to continuous HF10 therapy. Other endpoints include: charging frequency, EQ-5D scores of wellbeing; PROMIS score for physical function, pain interference, sleep disturbance, and emotional distress; chronic pain acceptance questionnaire 8 (CPAQ-8), patient satisfaction scores, and patient global impression of change
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 1, 2023 |
Est. primary completion date | March 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Age between 18 and 90 - 1-year or more use of continuous HF10 therapy as delivered a permanently implanted Nevro Omnia Neurostimulation System for chronic back and/or leg pain - Some level of decreasing pain relief from their SCS system (see fig. 3) - Willing and able to complete protocol requirements, including: - Complete health questionnaires and pain scales as specified in the protocol - Sign the study-specific informed consent form - Complete follow-ups at the designated time periods Exclusion Criteria: - Previous intermittent dosing usage and/or failure - Cervical SCS system - Other concurrent neuromodulation system in place - Current daily morphine milligram equivalent usage 90mg or higher |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rush University Medical Center |
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | NRS pain scores | Subject's Numeric Rating Scale (NRS) score for pain being treated by spinal cord simulation for up to 3 months of designated treatment on a 22 point scale from 0-10 in 0.5 increments with 0 being no pain to 10 being the worse imaginable pain. | Up to 3 months | |
Secondary | Patient Satisfaction with Treatment Score | At each study visit, subjects will rate their satisfaction with their current spinal cord stimulation therapy over the last 3 days as either:
Completely satisfied, Very satisfied, Slightly Satisfied, Neither satisfied nor dissatisfied, Slightly dissatisfied, Very dissatisfied, Completely dissatisfied |
Up to 3 months | |
Secondary | CPAQ-8 | At each study visit, subjects will complete the Chronic Pain Acceptance Questionnaire (CPAQ-8) which asks subjects to rate the truth of different statements about their chronic pain (i.e. I live a full life even though I have chronic pain) as either:
Never true (0), Very rarely true (1), Seldom true (2), Sometimes true (3), Often true (4), Almost always true (5), Always true (6) |
Up to 3 months | |
Secondary | Current mode of stimulation | Spinal cord stimulator settings as either continuous, intermittent dosing 30 seconds ON/120 seconds OFF, or intermittent dosing 30 seconds ON/360 seconds OFF | Up to 3 months | |
Secondary | Stimulator settings- frequency | Subject's current spinal cord stimulator setting frequency in hertz (Hz) | Up to 3 months | |
Secondary | Stimulator settings- amplitude | Subject's current spinal cord stimulator setting amplitude in milliamps (mA) | Up to 3 months | |
Secondary | Stimulator settings- pulse width | Subject's current spinal cord stimulator setting pulse width in microseconds (µs) | Up to 3 months | |
Secondary | Charging frequency of spinal cord stimulator | Average charging frequency over the last week of patient's spinal cord stimulator in hours/minutes. | Up to 3 months | |
Secondary | PROMIS- Fatigue 8 questionnaire | Fatigue 8 questionnaire outcome at up to 3 months on designated treatment. Subjects will rate statements pertaining to feelings of fatigue (i.e. I feel fatigue...) as not at all (1), a little bit (2), somewhat (3), quite a bit (4), or very much (5).
Subjects will also rate statements pertaining to frequency of fatigue (i.e. How often did you have push yourself to get things done because of your fatigue) as either never (1), rarely (2), sometimes (3), often (4), or always (5). |
Up to 3 months | |
Secondary | PROMIS- Sleep Disturbance 4a questionnaire | Sleep Disturbance 4a questionnaire outcome at up to 3 months on designated treatment. Subjects will rate statements pertaining to quality of sleep (i.e. My sleep was refreshing) as either very much (1), quite a bit (2), somewhat (3), a little bit (4), or not at all (5).
They will also rate their sleep quality as very poor (5), poor (4), fair (3), good (2), or very good (1). |
Up to 3 months | |
Secondary | PROMIS- Emotional Distress- 8a Anxiety questionnaire | Emotional Distress- 8a Anxiety questionnaire outcome at up to 3 months on designated treatment. Subjects will rate statements pertaining to feelings of anxiety (i.e. I felt fearful) as either never (1), rarely (2), sometimes (3), often (4), or always (5). | Up to 3 months | |
Secondary | PROMIS- Physical Function 8b questionnaire | Physical Function 8b questionnaire outcome at up to 3 months on designated treatment. Subjects will rate statements pertaining to ability to do physical tasks (i.e. Are you able to run errands and shop) as either unable to do (1), with much difficulty (2), with some difficulty(3), with a little difficulty (4), or without any difficulty (5).
They will also rate statements pertaining to any health limitations on physical functions (i.e. Does your health now limit you in lifting or carrying groceries) as not at all (5), very little (4), somewhat (3), quite a lot (2), or cannot do (1). |
Up to 3 months | |
Secondary | PROMIS- Pain Interference 6b questionnaire | Pain Interference 6b questionnaire outcome at up to 3 months on designated treatment. Subjects will rate statements pertaining the extent that pain interferes with their life (i.e. How much did pain interfere with your enjoyment of life) as either not at all (1), a little bit (2), somewhat (3), quite a bit (4), or very much (5).
They will answer how much pain kept them from socializing with others in the past 7 days as either never (5), rarely (4), sometimes (3), often (2), or always (1). |
Up to 3 months | |
Secondary | PROMIS- Global Health 10 item questionnaire | Global Health 10 item questionnaire outcome at up to 3 months on designated treatment. Subjects will rate statements pertaining to their overall health (i.e. In general, would you say your quality of life is) as either poor (1), fair(2), good (3), very good (4), or excellent (5). | Up to 3 months | |
Secondary | PHQ-8 | At each study visit, subjects will complete the Patient Health Questionnaire (PHQ-8) which asks subjects to rate over the past 2 weeks how often they feel a particular emotion (i.e. feeling tired or having little energy) as either
Not at all, Several days, More than half the days, Nearly every day If any problems were checked off, subjects will rate how difficult these problems made it to do work, take care of things at home, or get along with others as either: Not difficult at all, Somewhat difficult, Very difficult, Extremely difficult |
Up to 3 months | |
Secondary | Patient Global Impression of Change | At each study visit, subjects will be asked to rate their progress with the current spinal cord stimulator therapy over the last 3 days compared to their paresthesia SCS therapy as either:
Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse |
Up to 3 months |
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