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

NCT03681262 | Active Not Recruiting Results FDA Device

• 1 other identifier: 47965
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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)

  12 months

Secondary Outcomes (6)

• Number of Participants With Score of 4 or Higher on the Patient Global Impression of Change Survey

  12 months

• Pain Intensity Scale Score

  12 months

• PROMIS Physical Function T-Score

  12 months

• PROMIS Pain Interference T-Score

  12 months

• PROMIS Depression T-Score

  12 months

Study Arms (2)

High frequency spinal cord stimulation

EXPERIMENTAL

Implant of the device that can deliver high frequency waveform to spinal cord

Device: High frequency spinal cord stimulation

Burst spinal cord stimulation

EXPERIMENTAL

Implant of the device that can deliver burst waveform to spinal cord

Device: Burst spinal cord stimulation

Interventions

High frequency spinal cord stimulation DEVICE

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.

High frequency spinal cord stimulation

Burst spinal cord stimulation DEVICE

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.

Burst spinal cord stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Pain Management Center

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Emerging technology halted recruitment, leading to a small number of participants analyzed

Results Point of Contact

• Title: Vafi Salmasi, MD. MS.
• Organization: Stanford University

vsalmasi@stanford.edu

6507250246

Study Officials

• Vafi Salmasi, MD.

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized open label parallel group

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 24, 2018
• Study Start: August 1, 2019
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 4, 2025
• Results First Posted: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)