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Comparing Long-term Effectiveness of High Frequency and Burst Spinal Cord Stimulation

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ClinicalTrials.gov Identifier: NCT03681262
Recruitment Status : Not yet recruiting
First Posted : September 24, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Vafi Salmasi, Stanford University

Brief 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 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Device: High frequency spinal cord stimulation Device: Burst spinal cord stimulation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized open label parallel group
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Comparing Long-Term Effectiveness of High Frequency and Burst Spinal Cord Stimulation
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: High frequency spinal cord stimulation
Implant of the device that can deliver high frequency waveform to spinal cord
Device: High frequency spinal cord stimulation
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.

Experimental: Burst spinal cord stimulation
Implant of the device that can deliver burst waveform to spinal cord
Device: Burst spinal cord stimulation
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.




Primary Outcome Measures :
  1. Change 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.


Secondary Outcome Measures :
  1. Patient global impression of change [ Time Frame: 12, 24 and 36 months ]
    Patient global impression of change as likert scale from 1-5

  2. Pain Intensity [ Time Frame: 12, 24 and 36 months ]
    Nuremical rating scale of average pain intensity from 0-10

  3. Function [ Time Frame: 12, 24 and 36 months ]
    NIH (National Institute of health) PROMIS (Patient reported outcomes measure information system) function in percentile

  4. Pain Interference [ Time Frame: 12, 24 and 36 months ]
    NIH (National Institute of health) PROMIS (Patient reported outcomes measure information system) pain interference in percentile

  5. Depression [ Time Frame: 12, 24 and 36 months ]
    NIH (National Institute of health) PROMIS (Patient reported outcomes measure information system) depression in percentile

  6. Anxiety [ Time Frame: 12, 24 and 36 months ]
    NIH (National Institute of health) PROMIS (Patient reported outcomes measure information system) anxiety in percentile



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03681262


Contacts
Contact: Vafi Salmasi, MD. 6507250246 vsalmasi@stanford.edu

Locations
United States, California
Stanford Pain Management Center
Redwood City, California, United States, 94063
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Vafi Salmasi, MD. Stanford University

Responsible Party: Vafi Salmasi, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT03681262     History of Changes
Other Study ID Numbers: 47965
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms