Chronic Low-back PainNCT04709757
Comparison of Continuous and Burst High Frequency Spinal Cord Stimulation Paradigms
A study testing Intermittent Dosing HF10 30/90 and Intermittent Dosing HF10 30/360 in people with Chronic Low-back Pain and CRPS, run by Rush University Medical Center.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Low-back Pain, CRPS, Peripheral Neuropathy
- What is being tested?
- Intermittent Dosing HF10 30/90 and Intermittent Dosing HF10 30/360
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2021to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Intermittent Dosing of Spinal Cord Stimulation as Alternate Paradigm to Continuous 10kHz Frequency Therapy (HF10 Therapy)
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.
Read more
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
Read the detailed description
Spinal cord stimulation (SCS) delivered at 10kHz frequency (HF10 Therapy) has demonstrated superiority to traditional SCS for leg and back pain. This mode of stimulation entails delivery of a greater charge per second compared to traditional tonic spinal cord stimulation and corresponding implications for battery usage. Although not yet studied in novel modes of SCS such as HF10 and Burst3 due to their relative infancy, the possibility of decreased pain relief over time very much exists. This has been well-documented with the use of tonic spinal cord stimulation. Furthermore, the most common cause of spinal cord stimulator explant remains the lack or loss of efficacy. In order to mitigate the potential for waning pain relief over time and downstream consequences of increased charge burden, other paradigms of stimulation within the framework of HF10 therapy must be evaluated.
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. In 2020, Deer et al. reported the efficacy of intermittent dosing of Burst stimulation with settings ranging from 30 seconds ON and 90 seconds OFF, to 30 seconds ON and 360 seconds OFF. In this 50 subject study, 45.8% of patients preferred stimulation with 30 seconds ON and 360 seconds OFF. 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.
This study seeks to prospectively compare continuous HF10 therapy versus two intermittent dosing HF10 (ID HF10) therapies - 1) 30 seconds ON and 120 seconds OFF; 2) 30 seconds ON and 360 seconds OFF - in patients endorsing decreasing efficacy of continuous HF10 therapy.
We hypothesize that ID HF10 therapy will provide non-inferior pain relief as measured by NRS scores when compared to continuous HF10 therapy. The primary outcome for this study will be NRS pain scores (0 to 10 where 0 = no pain and 10 = worst pain ever in 0.5 increments). Secondary endpoints include: charging frequency, EQ-5D scores of wellbeing, PROMIS scores 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.
Patients with chronic back and/or leg pain who have undergone permanent spinal cord stimulator implantation delivered by the Nevro Omnia Neurostimulation System, have had the system in place for at least 1 year, utilizing continuous HF10 therapy, and now endorsing decreasing efficacy of continuous HF10 therapy will be randomized to 2 groups, in a single-blinded, 1:1 fashion:
- ID HF10 therapy at 30 seconds ON, 90 seconds OFF
- ID HF10 therapy at 30 seconds ON, 360 seconds OFF
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.
Randomization will be performed using a computer-generated random sequence generator with equal selection probabilities to all groups. Subjects will be blinded to their randomization.
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 will be subsequently seen at 2, 4 and 6-weeks in a clinic setting. At each interval, the patient will be seen by a team of investigators, sub-investigators, and/or study staff to administer questionnaires and collect data. .
Patient specific data to be collected will include:
- Age
- Height
- Weight
- BMI
- Gender
- Primary diagnosis
- Current daily morphine milligram equivalent usage
Data to be collected at baseline and at 6 and 12 weeks of stimulation:
- Patient Health Questionnaire (PHQ-8)
- PROMIS Health questionnaires
- Global Health 10 item questionnaire
- Physical Function 8b questionnaire
- Emotional Distress-8a Anxiety questionnaire
- Sleep Disturbance 4a questionnaire
- Fatigue 8 item questionnaire
- CPAQ-8 score (Chronic Pain Acceptance Questionnaire 8)
- Average charging frequency over last week
- Patient Global Impression of Change
- Patient Satisfaction Score
Data to be collected at each study visit:
- NRS pain scores (22-point scale, 0-10 in 0.5 increments)
- Current dorsal root ganglion stimulation parameters (i.e. mode of stimulation-continuous vs. ID, frequency, amplitude, pulse width)
- Average charging frequency over last week (see fig. 1)
Data will be collected and entered on Redcap with data access limited to research personnel. Data will be exported from RedCap™ into an Excel sheets and stored for analysis on the Department of Anesthesiology shared network folder on the Rush domain. Access to this shared resource is limited to research personnel and access is controlled using the users Rush login. The data will be analyzed on an investigators workstation that is password protected.
- Conditions
- Chronic Low-back Pain, CRPS, Peripheral Neuropathy
- Being tested
- Intermittent Dosing HF10 30/90, Intermittent Dosing HF10 30/360
- Keywords
- Chronic pain, Spinal cord stimulation, CRPS
- Medical subject headings
- Peripheral Nervous System Diseases, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Dosing HF10 30/90Device
10kHz frequency spinal cord stimulation delivered at 30 seconds ON and 120 seconds OFF
Intermittent Dosing HF10 30/360Device
10kHz frequency spinal cord stimulation delivered at 30 seconds ON and 360 seconds OFF
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Dosing HF10 30/90 | Active comparator | Stimulation delivered at 30 seconds ON and 120 seconds OFF through patient's existing spinal cord stimulator. Receives: Device: Intermittent Dosing HF10 30/90 |
| Intermittent Dosing HF10 30/360 | Active comparator | Stimulation delivered at 30 seconds ON and 360 seconds OFF through patient's existing spinal cord stimulator. Receives: Device: Intermittent Dosing HF10 30/360 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months
Secondary outcomes (15)
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
Measured: Up to 3 months
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)
Measured: Up to 3 months
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
Measured: Up to 3 months
Stimulator settings- frequency
Subject's current spinal cord stimulator setting frequency in hertz (Hz)
Measured: Up to 3 months
Stimulator settings- amplitude
Subject's current spinal cord stimulator setting amplitude in milliamps (mA)
Measured: Up to 3 months
Stimulator settings- pulse width
Subject's current spinal cord stimulator setting pulse width in microseconds (μs)
Measured: Up to 3 months
Charging frequency of spinal cord stimulator
Average charging frequency over the last week of patient's spinal cord stimulator in hours/minutes.
Measured: Up to 3 months
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).
Measured: Up to 3 months
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).
Measured: Up to 3 months
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).
Measured: Up to 3 months
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).
Measured: Up to 3 months
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).
Measured: Up to 3 months
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).
Measured: Up to 3 months
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
Measured: Up to 3 months
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
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study startAug 2021 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Why it stopped: Intermittent paradigm replaced with change in frequency and amplitude. The updated protocol is NCT04909138
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized to receive 1) Intermittent Dosing Therapy 30 seconds ON 90 seconds OFF or 2) Intermittent Dosing Therapy 30 seconds ON and 360 seconds OFF Patients 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Lubenow, Rush University Medical Center
- Investigators
- Robert J McCarthy, PharmD, Study director, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709757
- Sponsor's protocol ID
- 20121301
- Status last verified
- Oct 2023
- First submitted
- 6 Jan 2021
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Available upon reasonable request from principal investigator.
Publications
Kapural L, Yu C, Doust MW, Gliner BE, Vallejo R, Sitzman BT, Amirdelfan K, Morgan DM, Brown LL, Yearwood TL, Bundschu R, Burton AW, Yang T, Benyamin R, Burgher AH. Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial. Anesthesiology. 2015 Oct;123(4):851-60. doi: 10.1097/ALN.0000000000000774.
PubMed 26218762Miller JP, Eldabe S, Buchser E, Johanek LM, Guan Y, Linderoth B. Parameters of Spinal Cord Stimulation and Their Role in Electrical Charge Delivery: A Review. Neuromodulation. 2016 Jun;19(4):373-84. doi: 10.1111/ner.12438. Epub 2016 May 6.
PubMed 27150431Deer T, Slavin KV, Amirdelfan K, North RB, Burton AW, Yearwood TL, Tavel E, Staats P, Falowski S, Pope J, Justiz R, Fabi AY, Taghva A, Paicius R, Houden T, Wilson D. Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Neuromodulation. 2018 Jan;21(1):56-66. doi: 10.1111/ner.12698. Epub 2017 Sep 29.
PubMed 28961366Alo KM, Redko V, Charnov J. Four Year Follow-up of Dual Electrode Spinal Cord Stimulation for Chronic Pain. Neuromodulation. 2002 Apr;5(2):79-88. doi: 10.1046/j.1525-1403.2002.02017.x.
PubMed 22151846Turner JA, Loeser JD, Deyo RA, Sanders SB. Spinal cord stimulation for patients with failed back surgery syndrome or complex regional pain syndrome: a systematic review of effectiveness and complications. Pain. 2004 Mar;108(1-2):137-47. doi: 10.1016/j.pain.2003.12.016.
PubMed 15109517Hayek SM, Veizi E, Hanes M. Treatment-Limiting Complications of Percutaneous Spinal Cord Stimulator Implants: A Review of Eight Years of Experience From an Academic Center Database. Neuromodulation. 2015 Oct;18(7):603-8; discussion 608-9. doi: 10.1111/ner.12312. Epub 2015 Jun 5.
PubMed 26053499Pope JE, Deer TR, Falowski S, Provenzano D, Hanes M, Hayek SM, Amrani J, Carlson J, Skaribas I, Parchuri K, McRoberts WP, Bolash R, Haider N, Hamza M, Amirdelfan K, Graham S, Hunter C, Lee E, Li S, Yang M, Campos L, Costandi S, Levy R, Mekhail N. Multicenter Retrospective Study of Neurostimulation With Exit of Therapy by Explant. Neuromodulation. 2017 Aug;20(6):543-552. doi: 10.1111/ner.12634. Epub 2017 Jul 17.
PubMed 28714533Van Buyten JP, Wille F, Smet I, Wensing C, Breel J, Karst E, Devos M, Poggel-Kramer K, Vesper J. Therapy-Related Explants After Spinal Cord Stimulation: Results of an International Retrospective Chart Review Study. Neuromodulation. 2017 Oct;20(7):642-649. doi: 10.1111/ner.12642. Epub 2017 Aug 18.
PubMed 28834092Vesper J, Slotty P, Schu S, Poeggel-Kraemer K, Littges H, Van Looy P, Agnesi F, Venkatesan L, Van Havenbergh T. Burst SCS Microdosing Is as Efficacious as Standard Burst SCS in Treating Chronic Back and Leg Pain: Results From a Randomized Controlled Trial. Neuromodulation. 2019 Feb;22(2):190-193. doi: 10.1111/ner.12883. Epub 2018 Nov 19.
PubMed 30456795Deer TR, Patterson DG, Baksh J, Pope JE, Mehta P, Raza A, Agnesi F, Chakravarthy KV. Novel Intermittent Dosing Burst Paradigm in Spinal Cord Stimulation. Neuromodulation. 2021 Apr;24(3):566-573. doi: 10.1111/ner.13143. Epub 2020 Mar 23.
PubMed 32202044
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Dosing of Spinal Cord Stimulation as Alternate Paradigm to Continuous 10kHz Frequency Therapy (HF10 Therapy)
- ClinicalTrials.gov ID
- NCT04709757
- Acronym / sponsor ID
- 20121301
- Conditions
- Chronic Low-back Pain, CRPS, Peripheral Neuropathy
- Keywords
- Chronic pain, Spinal cord stimulation, CRPS
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Intermittent paradigm replaced with change in frequency and amplitude. The updated protocol is NCT04909138
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Spinal cord stimulation (SCS) delivered at 10kHz frequency (HF10 Therapy) has demonstrated superiority to traditional SCS for leg and back pain. This mode of stimulation entails delivery of a greater charge per second compared to traditional tonic spinal cord stimulation and corresponding implications for battery usage. Although not yet studied in novel modes of SCS such as HF10 and Burst3 due to their relative infancy, the possibility of decreased pain relief over time very much exists. This has been well-documented with the use of tonic spinal cord stimulation. Furthermore, the most common cause of spinal cord stimulator explant remains the lack or loss of efficacy. In order to mitigate the potential for waning pain relief over time and downstream consequences of increased charge burden, other paradigms of stimulation within the framework of HF10 therapy must be evaluated.
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. In 2020, Deer et al. reported the efficacy of intermittent dosing of Burst stimulation with settings ranging from 30 seconds ON and 90 seconds OFF, to 30 seconds ON and 360 seconds OFF. In this 50 subject study, 45.8% of patients preferred stimulation with 30 seconds ON and 360 seconds OFF. 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.
This study seeks to prospectively compare continuous HF10 therapy versus two intermittent dosing HF10 (ID HF10) therapies - 1) 30 seconds ON and 120 seconds OFF; 2) 30 seconds ON and 360 seconds OFF - in patients endorsing decreasing efficacy of continuous HF10 therapy.
We hypothesize that ID HF10 therapy will provide non-inferior pain relief as measured by NRS scores when compared to continuous HF10 therapy. The primary outcome for this study will be NRS pain scores (0 to 10 where 0 = no pain and 10 = worst pain ever in 0.5 increments). Secondary endpoints include: charging frequency, EQ-5D scores of wellbeing, PROMIS scores 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.
Patients with chronic back and/or leg pain who have undergone permanent spinal cord stimulator implantation delivered by the Nevro Omnia Neurostimulation System, have had the system in place for at least 1 year, utilizing continuous HF10 therapy, and now endorsing decreasing efficacy of continuous HF10 therapy will be randomized to 2 groups, in a single-blinded, 1:1 fashion:
- ID HF10 therapy at 30 seconds ON, 90 seconds OFF
- ID HF10 therapy at 30 seconds ON, 360 seconds OFF
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.
Randomization will be performed using a computer-generated random sequence generator with equal selection probabilities to all groups. Subjects will be blinded to their randomization.
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 will be subsequently seen at 2, 4 and 6-weeks in a clinic setting. At each interval, the patient will be seen by a team of investigators, sub-investigators, and/or study staff to administer questionnaires and collect data. .
Patient specific data to be collected will include:
- Age
- Height
- Weight
- BMI
- Gender
- Primary diagnosis
- Current daily morphine milligram equivalent usage
Data to be collected at baseline and at 6 and 12 weeks of stimulation:
- Patient Health Questionnaire (PHQ-8)
- PROMIS Health questionnaires
- Global Health 10 item questionnaire
- Physical Function 8b questionnaire
- Emotional Distress-8a Anxiety questionnaire
- Sleep Disturbance 4a questionnaire
- Fatigue 8 item questionnaire
- CPAQ-8 score (Chronic Pain Acceptance Questionnaire 8)
- Average charging frequency over last week
- Patient Global Impression of Change
- Patient Satisfaction Score
Data to be collected at each study visit:
- NRS pain scores (22-point scale, 0-10 in 0.5 increments)
- Current dorsal root ganglion stimulation parameters (i.e. mode of stimulation-continuous vs. ID, frequency, amplitude, pulse width)
- Average charging frequency over last week (see fig. 1)
Data will be collected and entered on Redcap with data access limited to research personnel. Data will be exported from RedCap™ into an Excel sheets and stored for analysis on the Department of Anesthesiology shared network folder on the Rush domain. Access to this shared resource is limited to research personnel and access is controlled using the users Rush login. The data will be analyzed on an investigators workstation that is password protected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive 1) Intermittent Dosing Therapy 30 seconds ON 90 seconds OFF or 2) Intermittent Dosing Therapy 30 seconds ON and 360 seconds OFF Patients 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.
| Arm | Type | Receives |
|---|---|---|
| Intermittent Dosing HF10 30/90 | Active comparator | Device: Intermittent Dosing HF10 30/90Stimulation delivered at 30 seconds ON and 120 seconds OFF through patient's existing spinal cord stimulator. |
| Intermittent Dosing HF10 30/360 | Active comparator | Device: Intermittent Dosing HF10 30/360Stimulation delivered at 30 seconds ON and 360 seconds OFF through patient's existing spinal cord stimulator. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent Dosing HF10 30/9010kHz frequency spinal cord stimulation delivered at 30 seconds ON and 120 seconds OFF | Device | Intermittent Dosing HF10 30/90 |
| Intermittent Dosing HF10 30/36010kHz frequency spinal cord stimulation delivered at 30 seconds ON and 360 seconds OFF | Device | Intermittent Dosing HF10 30/360 |
Primary outcome
NRS pain scores
Time frame: Up to 3 months
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.
15 secondary outcomes
Patient Satisfaction with Treatment Score
Time frame: Up to 3 months
CPAQ-8
Time frame: Up to 3 months
Current mode of stimulation
Time frame: Up to 3 months
Stimulator settings- frequency
Time frame: Up to 3 months
Stimulator settings- amplitude
Time frame: Up to 3 months
Stimulator settings- pulse width
Time frame: Up to 3 months
Charging frequency of spinal cord stimulator
Time frame: Up to 3 months
PROMIS- Fatigue 8 questionnaire
Time frame: Up to 3 months
PROMIS- Sleep Disturbance 4a questionnaire
Time frame: Up to 3 months
PROMIS- Emotional Distress- 8a Anxiety questionnaire
Time frame: Up to 3 months
PROMIS- Physical Function 8b questionnaire
Time frame: Up to 3 months
PROMIS- Pain Interference 6b questionnaire
Time frame: Up to 3 months
PROMIS- Global Health 10 item questionnaire
Time frame: Up to 3 months
PHQ-8
Time frame: Up to 3 months
Patient Global Impression of Change
Time frame: Up to 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Background: PubMed 26218762Kapural L, Yu C, Doust MW, Gliner BE, Vallejo R, Sitzman BT, Amirdelfan K, Morgan DM, Brown LL, Yearwood TL, Bundschu R, Burton AW, Yang T, Benyamin R, Burgher AH. Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial. Anesthesiology. 2015 Oct;123(4):851-60. doi: 10.1097/ALN.0000000000000774.
- Background: PubMed 27150431Miller JP, Eldabe S, Buchser E, Johanek LM, Guan Y, Linderoth B. Parameters of Spinal Cord Stimulation and Their Role in Electrical Charge Delivery: A Review. Neuromodulation. 2016 Jun;19(4):373-84. doi: 10.1111/ner.12438. Epub 2016 May 6.
- Background: PubMed 28961366Deer T, Slavin KV, Amirdelfan K, North RB, Burton AW, Yearwood TL, Tavel E, Staats P, Falowski S, Pope J, Justiz R, Fabi AY, Taghva A, Paicius R, Houden T, Wilson D. Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Neuromodulation. 2018 Jan;21(1):56-66. doi: 10.1111/ner.12698. Epub 2017 Sep 29.
- Background: PubMed 22151846Alo KM, Redko V, Charnov J. Four Year Follow-up of Dual Electrode Spinal Cord Stimulation for Chronic Pain. Neuromodulation. 2002 Apr;5(2):79-88. doi: 10.1046/j.1525-1403.2002.02017.x.
- Background: PubMed 15109517Turner JA, Loeser JD, Deyo RA, Sanders SB. Spinal cord stimulation for patients with failed back surgery syndrome or complex regional pain syndrome: a systematic review of effectiveness and complications. Pain. 2004 Mar;108(1-2):137-47. doi: 10.1016/j.pain.2003.12.016.
- Background: PubMed 26053499Hayek SM, Veizi E, Hanes M. Treatment-Limiting Complications of Percutaneous Spinal Cord Stimulator Implants: A Review of Eight Years of Experience From an Academic Center Database. Neuromodulation. 2015 Oct;18(7):603-8; discussion 608-9. doi: 10.1111/ner.12312. Epub 2015 Jun 5.
- Background: PubMed 28714533Pope JE, Deer TR, Falowski S, Provenzano D, Hanes M, Hayek SM, Amrani J, Carlson J, Skaribas I, Parchuri K, McRoberts WP, Bolash R, Haider N, Hamza M, Amirdelfan K, Graham S, Hunter C, Lee E, Li S, Yang M, Campos L, Costandi S, Levy R, Mekhail N. Multicenter Retrospective Study of Neurostimulation With Exit of Therapy by Explant. Neuromodulation. 2017 Aug;20(6):543-552. doi: 10.1111/ner.12634. Epub 2017 Jul 17.
- Background: PubMed 28834092Van Buyten JP, Wille F, Smet I, Wensing C, Breel J, Karst E, Devos M, Poggel-Kramer K, Vesper J. Therapy-Related Explants After Spinal Cord Stimulation: Results of an International Retrospective Chart Review Study. Neuromodulation. 2017 Oct;20(7):642-649. doi: 10.1111/ner.12642. Epub 2017 Aug 18.
- Background: PubMed 30456795Vesper J, Slotty P, Schu S, Poeggel-Kraemer K, Littges H, Van Looy P, Agnesi F, Venkatesan L, Van Havenbergh T. Burst SCS Microdosing Is as Efficacious as Standard Burst SCS in Treating Chronic Back and Leg Pain: Results From a Randomized Controlled Trial. Neuromodulation. 2019 Feb;22(2):190-193. doi: 10.1111/ner.12883. Epub 2018 Nov 19.
- Background: PubMed 32202044Deer TR, Patterson DG, Baksh J, Pope JE, Mehta P, Raza A, Agnesi F, Chakravarthy KV. Novel Intermittent Dosing Burst Paradigm in Spinal Cord Stimulation. Neuromodulation. 2021 Apr;24(3):566-573. doi: 10.1111/ner.13143. Epub 2020 Mar 23.
- Individual participant dataSharing planned: No. Available upon reasonable request from principal investigator.
Related trials for Chronic Low-back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J McCarthy, PharmD study director
Rush University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Dosing HF10 30/90 and Intermittent Dosing HF10 30/360 in people with Chronic Low-back Pain and CRPS, run by Rush University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS pain scores (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04709757, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.