Chronic PainNCT03681262
Comparing Long-term Effectiveness of High Frequency and Burst Spinal Cord Stimulation
A study testing High frequency spinal cord stimulation and Burst spinal cord stimulation in people with Chronic Pain, run by Stanford University at 1 site in United States.
Trial summary
Over 100 million Americans suffer from chronic pain resulting in annual cost of roughly $635 billion. Limited treatments are available for this widespread disease. The data supporting these treatments lack generalizability to patients with more serious medical and psychological comorbidities who are often excluded… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- High frequency spinal cord stimulation and Burst spinal cord stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult English-speaking patient 18 years old or above
- Persistent pain in lower back and/or leg for more than six months
- Candidate for spinal cord stimulation (with either high frequency or burst waveforms) based on recommendations from Stanford Pain Management Center Neuromodulation Multidisciplinary Team Conference.
Who cannot join
- Motor weakness in neurological examination in lower body based on the assessment by treating pain physicians
- Previous failed spinal cord stimulation trial with either high frequency or burst waveforms
- Patient refusal
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Pain Management Center
Redwood City, California, 94063
About this study
Official title: Comparing Long-Term Effectiveness of High Frequency and Burst Spinal Cord Stimulation
Over 100 million Americans suffer from chronic pain resulting in annual cost of roughly $635 billion. Limited treatments are available for this widespread disease. The data supporting these treatments lack generalizability to patients with more serious medical and psychological comorbidities who are often excluded from explanatory efficacy trials. This study aims to integrate randomized comparative effectiveness research with patient care. The investigators will randomize the patients and collect data using an open-source learning healthcare system already in use in the department to monitor patients' progress: Collaborative Health Outcomes Information Registry (CHOIR). CHOIR uses the National Institute of Health Patient Reported Outcomes Measurement Information System item banks for comparative metrics through computer adaptive testing. The investigators will leverage the advantage of this novel system to compare effectiveness of high frequency and burst spinal cord stimulation in improving pain and function in patients with chronic back and/or leg pain. Spinal cord stimulation is an effective treatment for chronic pain resulting in >50% pain relief in about half of the patients. Novel waveforms for spinal cord stimulation - high frequency and burst - increased the efficacy of this treatment even further. However, there is lack of data guiding decision making of the clinicians in choosing the best waveform in treating the patients with chronic pain. The proposed study will provide the clinicians with this evidence. Currently, data about safety and efficacy of these two novel waveforms is available for up to 24 months. The proposed research will provide data about effectiveness of these two modalities for at least 36 months. Moreover, this study will evaluate feasibility of integrating randomized comparative effectiveness research with patient care in Stanford Pain Management subspecialty clinic. CHOIR can then be applied for numerous future trials to advance knowledge in perioperative and pain medicine.
Read the detailed description
Specific Aims:
The investigators are proposing to compare the effectiveness of high frequency and burst spinal cord stimulation in patients with chronic back and/or leg pain.
More than one hundred million Americans suffer from chronic pain with estimated annual cost of $635 billion.1 To better characterize these patients, Stanford Pain Management Center has implemented a patient reported registry, Collaborative Health Outcomes Information Registry (CHOIR), since 2012. CHOIR surveys include National Institute of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) item banks, a body map, questions about pain intensity, pain catastrophizing scale, and questions about patients' pain experience and healthcare utilization. This learning healthcare system also has the capability of point-of-care randomization.
Spinal cord stimulation is one of the most effective treatments for patients with intractable trunk and limb pain. Traditional tonic spinal cord stimulation resulted in at least 50% pain reduction in about half of the patients.2,3 Newer waveforms - high frequency and burst - achieve 50% pain reduction in 60-75% of the patients in comparison.4-6 However, more studies are needed to compare effectiveness of these two new waveforms.
The investigators are proposing to use patient reported outcomes to conduct a pragmatic clinical trial that integrates with patients' clinical care; thus, allowing faster recruitment of a larger patient cohort. The patient's provider will use CHOIR point-of-care randomization to randomly assign patients to either receive high frequency or burst spinal cord stimulation. The patients will then complete online CHOIR surveys sent out to them at baseline and then 1, 3, 6, 12, 18, 24 and 36 months after their device implant. These surveys will include PROMIS item banks for pain interference, function, depression and anxiety; questions about pain intensity; and questions about any potential side effects. The investigators will include patients with chronic (pain for at least 6 months) back and/or leg pain refractory to conventional management.
Specific Aim 1: Comparing effectiveness of high frequency and burst spinal cord stimulation in improving pain, function and pain interference in patients with chronic low back and/or leg pain persistent more than 6 months.
The investigators hypothesize that high frequency spinal cord stimulation is more effective than burst spinal cord stimulation in decreasing chronic low back and/or leg pain.
The investigators' primary outcome is change from baseline in pain intensity at 12 months. The investigators will also compare improvement in function and pain interreference at all follow up time points. The investigators will plot the trend of all these measures and study change from baseline at 12 months. The investigators will use repeated measure linear regression to compare these measures between the groups at follow up time points with time as the fixed effect and treatment as random effect.
Specific Aim 2: Comparing effectiveness of high frequency and burst spinal cord stimulation in improving depression and anxiety in patients with chronic low back and/or leg pain persistent more than 6 months.
The investigators hypothesize that high frequency spinal cord stimulation is more effective than burst spinal cord stimulation in decreasing stress and anxiety in patients with chronic low back and/or leg pain.
Burst stimulation modulates medial thalamic pathway, which attributes adverse emotions to pain. The investigators will therefore compare emotional response to these waveforms. The investigators will compare change from baseline of depression and anxiety at 12 months. The investigators will also plot depression and anxiety trend at all follow up time points between two groups using repeated measure linear regression. The investigators will then perform a similar stratified analysis in responders (patients with 50% or more pain reduction at 1 year) and non-responders to these treatments; this analysis is to asses if pain reduction is an effect measure modifier in this relationship.
- Conditions
- Chronic Pain
- Being tested
- High frequency spinal cord stimulation, Burst spinal cord stimulation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High frequency spinal cord stimulationDevice
We will use Senza® (Nevro Corp., Palo Alto, CA) trial and implant systems to deliver high frequency spinal cord stimulation. A trial system includes two trial leads, an external pulse generator, and a remote control. The permanent implant system includes two leads, an internal pulse generator, a remote control, and a charging device for internal pulse generator. We will use our routine process of trial and implant. High frequency waveform will be delivered with following parameters: frequency of 10,000 hertz, pulse width of 20 microseconds, and amplitude of 0-15 milliamperes.
Burst spinal cord stimulationDevice
We will use BusrtDRTM (Abbott Saint Jude Medical, St. Paul, MN) trial and implant systems to deliver burst spinal cord stimulation. A trial system includes two trial leads, an external pulse generator, and a remote control. The permanent implant system includes two leads, an internal pulse generator, a remote control, and a charging device for internal pulse generator. We will use our routine process of trial and implant. The parameters of the stimulation are as below: each burst includes 5 pulses of electrical stimulation at intra-burst frequency of 500 hertz without time for discharge in between pulses. These bursts will be repeated at inter-burst frequency of 40-60 hertz. The amplitude will range between 0 and 15 milliamperes.
| Study group | Role | What they receive |
|---|---|---|
| High frequency spinal cord stimulation | Experimental | Implant of the device that can deliver high frequency waveform to spinal cord Receives: Device: High frequency spinal cord stimulation |
| Burst spinal cord stimulation | Experimental | Implant of the device that can deliver burst waveform to spinal cord Receives: Device: Burst spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With >50% Improvement in Pain Intensity
Change from baseline in pain intensity at 12 months. Baseline pain intensity is measured at last CHOIR completion before trial, and is based on patient reported outcome in CHOIR for average pain in the week prior to completion of questionnaire. Score range: 0-10 (higher scores correspond to more severe pain)
Measured: 12 months
Secondary outcomes (6)
Number of Participants With Score of 4 or Higher on the Patient Global Impression of Change Survey
Patient global impression of change as Likert scale from 1-5 (higher scores corresponds to more improvement)
Measured: 12 months
Pain Intensity Scale Score
Nuremical rating scale of average pain intensity from 0-10 (higher scores corresponds with more severe pain)
Measured: 12 months
PROMIS Physical Function T-Score
NIH (National Institute of health) PROMIS (Patient reported outcomes measure information system) function in t-score with population mean of 50 and standard deviation of 10 (higher scores corresponds with worse function)
Measured: 12 months
PROMIS Pain Interference T-Score
NIH (National Institute of health) PROMIS (Patient reported outcomes measure information system) pain interference in t-score with population mean of 50 and standard deviation of 10 (higher scores corresponds with worse pain interference)
Measured: 12 months
PROMIS Depression T-Score
NIH (National Institute of health) PROMIS (Patient reported outcomes measure information system) depression in t-score with population mean of 50 and standard deviation of 10 (higher scores corresponds with worse depression)
Measured: 12 months
PROMIS Anxiety T-Score
NIH (National Institute of health) PROMIS (Patient reported outcomes measure information system) anxiety in t-score with population mean of 50 and standard deviation of 10 (higher scores corresponds with worse anxiety)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start1 Aug 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized open label parallel group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vafi Salmasi, Stanford University
- Investigators
- Vafi Salmasi, MD., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681262
- Sponsor's protocol ID
- 47965
- Status last verified
- Apr 2026
- First submitted
- 20 Sep 2018
- Last updated
- 13 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Long-Term Effectiveness of High Frequency and Burst Spinal Cord Stimulation
- ClinicalTrials.gov ID
- NCT03681262
- Acronym / sponsor ID
- 47965
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Sep 2018 (actual)
- Results
- Posted 14 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over 100 million Americans suffer from chronic pain resulting in annual cost of roughly $635 billion. Limited treatments are available for this widespread disease. The data supporting these treatments lack generalizability to patients with more serious medical and psychological comorbidities who are often excluded from explanatory efficacy trials. This study aims to integrate randomized comparative effectiveness research with patient care. The investigators will randomize the patients and collect data using an open-source learning healthcare system already in use in the department to monitor patients' progress: Collaborative Health Outcomes Information Registry (CHOIR). CHOIR uses the National Institute of Health Patient Reported Outcomes Measurement Information System item banks for comparative metrics through computer adaptive testing. The investigators will leverage the advantage of this novel system to compare effectiveness of high frequency and burst spinal cord stimulation in improving pain and function in patients with chronic back and/or leg pain. Spinal cord stimulation is an effective treatment for chronic pain resulting in >50% pain relief in about half of the patients. Novel waveforms for spinal cord stimulation - high frequency and burst - increased the efficacy of this treatment even further. However, there is lack of data guiding decision making of the clinicians in choosing the best waveform in treating the patients with chronic pain. The proposed study will provide the clinicians with this evidence. Currently, data about safety and efficacy of these two novel waveforms is available for up to 24 months. The proposed research will provide data about effectiveness of these two modalities for at least 36 months. Moreover, this study will evaluate feasibility of integrating randomized comparative effectiveness research with patient care in Stanford Pain Management subspecialty clinic. CHOIR can then be applied for numerous future trials to advance knowledge in perioperative and pain medicine.
Detailed description
Specific Aims:
The investigators are proposing to compare the effectiveness of high frequency and burst spinal cord stimulation in patients with chronic back and/or leg pain.
More than one hundred million Americans suffer from chronic pain with estimated annual cost of $635 billion.1 To better characterize these patients, Stanford Pain Management Center has implemented a patient reported registry, Collaborative Health Outcomes Information Registry (CHOIR), since 2012. CHOIR surveys include National Institute of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) item banks, a body map, questions about pain intensity, pain catastrophizing scale, and questions about patients' pain experience and healthcare utilization. This learning healthcare system also has the capability of point-of-care randomization.
Spinal cord stimulation is one of the most effective treatments for patients with intractable trunk and limb pain. Traditional tonic spinal cord stimulation resulted in at least 50% pain reduction in about half of the patients.2,3 Newer waveforms - high frequency and burst - achieve 50% pain reduction in 60-75% of the patients in comparison.4-6 However, more studies are needed to compare effectiveness of these two new waveforms.
The investigators are proposing to use patient reported outcomes to conduct a pragmatic clinical trial that integrates with patients' clinical care; thus, allowing faster recruitment of a larger patient cohort. The patient's provider will use CHOIR point-of-care randomization to randomly assign patients to either receive high frequency or burst spinal cord stimulation. The patients will then complete online CHOIR surveys sent out to them at baseline and then 1, 3, 6, 12, 18, 24 and 36 months after their device implant. These surveys will include PROMIS item banks for pain interference, function, depression and anxiety; questions about pain intensity; and questions about any potential side effects. The investigators will include patients with chronic (pain for at least 6 months) back and/or leg pain refractory to conventional management.
Specific Aim 1: Comparing effectiveness of high frequency and burst spinal cord stimulation in improving pain, function and pain interference in patients with chronic low back and/or leg pain persistent more than 6 months.
The investigators hypothesize that high frequency spinal cord stimulation is more effective than burst spinal cord stimulation in decreasing chronic low back and/or leg pain.
The investigators' primary outcome is change from baseline in pain intensity at 12 months. The investigators will also compare improvement in function and pain interreference at all follow up time points. The investigators will plot the trend of all these measures and study change from baseline at 12 months. The investigators will use repeated measure linear regression to compare these measures between the groups at follow up time points with time as the fixed effect and treatment as random effect.
Specific Aim 2: Comparing effectiveness of high frequency and burst spinal cord stimulation in improving depression and anxiety in patients with chronic low back and/or leg pain persistent more than 6 months.
The investigators hypothesize that high frequency spinal cord stimulation is more effective than burst spinal cord stimulation in decreasing stress and anxiety in patients with chronic low back and/or leg pain.
Burst stimulation modulates medial thalamic pathway, which attributes adverse emotions to pain. The investigators will therefore compare emotional response to these waveforms. The investigators will compare change from baseline of depression and anxiety at 12 months. The investigators will also plot depression and anxiety trend at all follow up time points between two groups using repeated measure linear regression. The investigators will then perform a similar stratified analysis in responders (patients with 50% or more pain reduction at 1 year) and non-responders to these treatments; this analysis is to asses if pain reduction is an effect measure modifier in this relationship.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized open label parallel group
| Arm | Type | Receives |
|---|---|---|
| High frequency spinal cord stimulation | Experimental | Device: High frequency spinal cord stimulationImplant of the device that can deliver high frequency waveform to spinal cord |
| Burst spinal cord stimulation | Experimental | Device: Burst spinal cord stimulationImplant of the device that can deliver burst waveform to spinal cord |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult English-speaking patient 18 years old or above
- Persistent pain in lower back and/or leg for more than six months
- Candidate for spinal cord stimulation (with either high frequency or burst waveforms) based on recommendations from Stanford Pain Management Center Neuromodulation Multidisciplinary Team Conference.
Key exclusion criteria (3 listed)
- Motor weakness in neurological examination in lower body based on the assessment by treating pain physicians
- Previous failed spinal cord stimulation trial with either high frequency or burst waveforms
- Patient refusal
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 |
|---|---|---|
| High frequency spinal cord stimulationWe will use Senza® (Nevro Corp., Palo Alto, CA) trial and implant systems to deliver high frequency spinal cord stimulation. A trial system includes two trial leads, an external pulse generator, and a remote control. The permanent implant system includes two leads, an internal pulse generator, a remote control, and a charging device for internal pulse generator. We will use our routine process of trial and implant. High frequency waveform will be delivered with following parameters: frequency of 10,000 hertz, pulse width of 20 microseconds, and amplitude of 0-15 milliamperes. | Device | High frequency spinal cord stimulation |
| Burst spinal cord stimulationWe will use BusrtDRTM (Abbott Saint Jude Medical, St. Paul, MN) trial and implant systems to deliver burst spinal cord stimulation. A trial system includes two trial leads, an external pulse generator, and a remote control. The permanent implant system includes two leads, an internal pulse generator, a remote control, and a charging device for internal pulse generator. We will use our routine process of trial and implant. The parameters of the stimulation are as below: each burst includes 5 pulses of electrical stimulation at intra-burst frequency of 500 hertz without time for discharge in between pulses. These bursts will be repeated at inter-burst frequency of 40-60 hertz. The amplitude will range between 0 and 15 milliamperes. | Device | Burst spinal cord stimulation |
Primary outcome
Number of Participants With >50% Improvement in Pain Intensity
Time frame: 12 months
Change from baseline in pain intensity at 12 months. Baseline pain intensity is measured at last CHOIR completion before trial, and is based on patient reported outcome in CHOIR for average pain in the week prior to completion of questionnaire. Score range: 0-10 (higher scores correspond to more severe pain)
6 secondary outcomes
Number of Participants With Score of 4 or Higher on the Patient Global Impression of Change Survey
Time frame: 12 months
Pain Intensity Scale Score
Time frame: 12 months
PROMIS Physical Function T-Score
Time frame: 12 months
PROMIS Pain Interference T-Score
Time frame: 12 months
PROMIS Depression T-Score
Time frame: 12 months
PROMIS Anxiety T-Score
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Vafi Salmasi, MD. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High frequency spinal cord stimulation and Burst spinal cord stimulation in people with Chronic Pain, run by Stanford University at 1 site in United States.
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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With >50% Improvement in Pain Intensity (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2026.