Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Michigan
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?Recently a new form of spinal cord stimulation therapy called burst spinal cord stimulation (Burst-SCS) is available to treat chronic pain. The goal of this study is to learn more about how Burst-SCS works to reduce chronic pain. The study will examine chronic pain patients who have been deemed candidates for Burst-SCS therapy, and who have already been selected to receive a temporary externalized trial of Burst-SCS from their own doctors as part of their standard clinical care for chronic pain management. During the study, participants will be asked to complete a variety of evaluations at certain time points. In addition, there will be a randomized, double blind, crossover phase, where the particular effects of Burst-SCS and sham SCS will be evaluated. The device used to deliver Burst-SCS and sham SCS is the St. Jude Medical Invisible Trial System.
How is Burst-SCS treatment different from other treatments for chronic pain?
Burst-SCS is unique because it uses a cluster of five pulses at a fixed rate, which modulates different pain pathways compared to conventional spinal cord stimulation. It provides better pain relief with minimal sensation of paresthesia (tingling or prickling) and targets both the emotional and motivational aspects of pain, unlike traditional methods.
13579Is Burst-SCS safe for humans?
Research studies, including the SUNBURST trial, have evaluated Burst-SCS for chronic pain and found it generally safe for humans. Burst-SCS is a type of spinal cord stimulation that can reduce pain without causing the tingling sensation (paresthesia) often associated with traditional methods.
12478Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study coordinator or your doctor.
What data supports the effectiveness of the treatment Burst-SCS for chronic pain?
Research shows that Burst-SCS, a type of spinal cord stimulation, can effectively reduce chronic pain in the trunk and limbs, and may also help decrease the need for opioid pain medications. It has been found to provide good pain relief without causing the tingling sensation (paresthesia) that traditional methods might cause.
14678Eligibility Criteria
This trial is for men and women with chronic pain due to back issues or failed surgery, who are recommended Burst-SCS treatment. Participants must speak English and not be pregnant. They should be able to complete the study without any conditions that could interfere, as judged by the coordinator.Participant Groups
The study tests a new therapy called Burst-SCS against a sham (fake) procedure in people with chronic pain. It involves evaluations over time and uses a device from St. Jude Medical during a randomized, double-blind crossover phase to compare effects.
2Treatment groups
Experimental Treatment
Group I: Sham SCS/Burst-SCSExperimental Treatment2 Interventions
First, participants will receive sham (no) SCS. Study evaluations will be completed prior to and after this sham. Then, participants will have their stimulation adjusted to receive clinically-effective Burst-SCS per their standard of care. Study evaluations will be completed prior to and after stimulation.
Group II: Burst-SCS/sham SCSExperimental Treatment2 Interventions
First, participants will receive clinically-effective Burst-SCS per their standard of care. Study evaluations will be completed prior to and after stimulation. Then, participants will have their stimulation adjusted to receive sham (no) SCS. Study evaluations will be completed prior to and after this sham.
Burst-SCS is already approved in United States for the following indications:
🇺🇸 Approved in United States as BurstDR for:
- Chronic back pain
- Failed back surgery syndrome
- Diabetic peripheral neuropathy
- Non-surgical back pain
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of MichiganAnn Arbor, MI
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Who is running the clinical trial?
University of MichiganLead Sponsor
National Institutes of Health (NIH)Collaborator
References
Burst spinal cord stimulation evaluated in patients with failed back surgery syndrome and painful diabetic neuropathy. [2022]Spinal cord stimulation (SCS) is used for treating intractable neuropathic pain. Generally, it induces paresthesia in the area covered by SCS. Burst SCS was introduced as a new stimulation paradigm with good pain relief without causing paresthesia. Good results have been obtained in patients who were naive to SCS. In this study we assess the effectiveness of burst stimulation in three groups of chronic pain patients who are already familiar with SCS and the accompanying paresthesia.
Burst Spinal Cord Stimulation in a Patient with Complex Regional Pain Syndrome: A 2-year Follow-Up. [2019]Spinal cord stimulation (SCS) is an effective therapy to treat most patients with complex regional pain syndrome (CRPS); however, the effect is not always maintained over time. We present a case report of a patient successfully treated with burst SCS after a diminishing effect of conventional tonic stimulation. Burst stimulation is a novel method of SCS consisting of delivering 5 spikes at 500 Hz, 40 times/s (pulse width 1 mseconds). The current output is set to a subthreshold level for paresthesia in the supine position.
Burst or High-Frequency (10 kHz) Spinal Cord Stimulation in Failed Back Surgery Syndrome Patients With Predominant Back Pain: One Year Comparative Data. [2022]Burst and 10 kHz spinal cord stimulation (SCS) demonstrated improvement for failed back surgery syndrome (FBSS) with predominant, refractory back pain. Here, we report the long-term follow-up of a previously published study comparing the safety and efficacy of burst vs. 10 kHz SCS for predominant back pain (70% of global pain) of FBSS patients.
Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. [2022]The purpose of the multicenter, randomized, unblinded, crossover Success Using Neuromodulation with BURST (SUNBURST) study was to determine the safety and efficacy of a device delivering both traditional tonic stimulation and burst stimulation to patients with chronic pain of the trunk and/or limbs.
Comparison of Neural Activity in Chronic Pain Patients During Tonic and Burst Spinal Cord Stimulation Using Fluorodeoxyglucose Positron Emission Tomography. [2022]Burst spinal cord stimulation (SCS) is a novel stimulation paradigm that seems to provide better pain relief compared to the classic tonic SCS with minimal paresthesia sensation. Based on source localized electroencephalography and clinical data, it has been proposed that burst stimulation as defined by Dirk De Ridder exerts this greater effect by not only modulating the lateral and the descending pain-inhibitory pathways (similar to tonic SCS) but also modulating the medial pain pathway, which encodes the affective, motivational aspects of pain.
Burst Spinal Cord Stimulation: A Clinical Review. [2020]Clinical review on outcomes using burst spinal cord stimulation (SCS) in the treatment of chronic, intractable pain.
The Efficacy of BurstDR Spinal Cord Stimulation for Chronic Abdominal Pain: A Clinical Series. [2020]Chronic abdominal pain is a debilitating condition known for its multifactorial nature. Outcomes with spinal cord stimulation (SCS) for abdominal pain syndromes are noticeably absent in the literature. To date, there have been no published reports of novel waveforms of SCS for management of chronic abdominal pain. We assessed the efficacy and durability of BurstDR SCS in reducing abdominal pain and analgesic consumption.
Neuromodulation With Burst and Tonic Stimulation Decreases Opioid Consumption: A Post Hoc Analysis of the Success Using Neuromodulation With BURST (SUNBURST) Randomized Controlled Trial. [2022]The SUNBURST study was a prospective, multicenter, randomized crossover trial of a single device delivering burst and tonic spinal cord stimulation (SCS) for chronic trunk and/or limb pain. We performed a post hoc analysis of opioid consumption at baseline and after device implantation.
Using evoked compound action potentials to quantify differential neural activation with burst and conventional, 40 Hz spinal cord stimulation in ovines. [2022]Unlike conventional dorsal spinal cord stimulation (SCS)-which uses single pulses at a fixed rate-burst SCS uses a fixed-rate, five-pulse stimuli cluster as a treatment for chronic pain; mechanistic explanations suggest burst SCS differentially modulate the medial and lateral pain pathways vs conventional SCS. Neural activation differences between burst and conventional SCS are quantifiable with the spinal-evoked compound action potential (ECAP), an electrical measure of synchronous neural activation.