Comparing Long-term Effectiveness of High Frequency and Burst Spinal Cord Stimulation
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Chronic Pain, Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | May 1, 2019 |
| End Date: | December 31, 2024 |
| Contact: | Vafi Salmasi, MD. |
| Email: | vsalmasi@stanford.edu |
| Phone: | 6507250246 |
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.
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.
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.
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.
Inclusion Criteria:
1. Adult English-speaking patient 18 years old or above
2. Persistent pain in lower back and/or leg for more than six months
3. Candidate for spinal cord stimulation (with either high frequency or burst waveforms)
based on recommendations from Stanford Pain Management Center Neuromodulation
Multidisciplinary Team Conference.
Exclusion Criteria:
1. Motor weakness in neurological examination in lower body based on the assessment by
treating pain physicians
2. Previous failed spinal cord stimulation trial with either high frequency or burst
waveforms
3. Patient refusal
We found this trial at
1
site
Click here to add this to my saved trials
