Spinal Cord Stimulation for Chronic Pain
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Minnesota
Disqualifiers: Pacemakers, Pregnant, Prisoners, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?Spinal cord stimulation modulates the nervous system to effectively block pain signals originating from the back and legs. Spinal cord stimulation has been shown to improve chronic pain, improve quality of life, and reduce disability. Unfortunately, spinal cord stimulation has a high trial failure rate and a high long-term failure rate. This study consists of a prospective cohort of patients clinically scheduled to undergo spinal cord stimulation for the treatment of chronic back pain or radiculopathy. Participants will undergo a structured optimization evaluating existing types of stimulation (tonic, burst, and multistim). Each participant will try out all types of available stimulation but be blinded to the type. Over the course of four months, each participant will evaluate each type of stimulation by reporting daily pain scores. Thompson sampling will be used to identify which setting produces the biggest improvement in pain and recommend it for future use. Participants will follow up routinely to collect laboratory, behavioral, and survey responses to test for the feasibility of obtaining data explaining pain phenotype.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of this treatment for chronic pain?
Research shows that spinal cord stimulation (SCS) is effective for managing chronic pain, especially in conditions like failed back surgery syndrome and complex regional pain syndrome. Studies highlight that SCS is a safe, reversible treatment that can improve quality of life without addictive issues or systemic side effects.
12345Is spinal cord stimulation generally safe for humans?
Spinal cord stimulation (SCS) is generally considered safe for treating chronic pain, with long-term safety data available from real-world evaluations. However, complications can occur, and the risk of spinal cord injury, although not well quantified, is a concern during electrode implantation.
56789How is spinal cord stimulation different from other treatments for chronic pain?
Spinal cord stimulation (SCS) is unique because it uses electrical impulses to modulate pain perception in the spinal cord, offering a non-drug approach to pain relief. Unlike traditional methods that may cause a tingling sensation (paresthesia), newer SCS patterns like DTM and FAST provide pain relief without this sensation, making them more comfortable for some patients.
1011121314Eligibility Criteria
This trial is for English-speaking adults aged 22 or older with chronic back pain or radiculopathy, who are scheduled to undergo spinal cord stimulation and have a baseline pain rating of 6 or higher. It excludes those getting permanent implants without a trial, people with pacemakers/neurostimulators, pregnant individuals, those unable to consent, employees/students of the principal investigator (PI), prisoners, and anyone unable to read/use a smartphone.Inclusion Criteria
I am 22 years old or older.
My pain level is 6 or higher on a scale of 0-10.
English speaker
+1 more
Exclusion Criteria
I am scheduled for a permanent implant without a trial period.
Employees or students of PI
Pregnant
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo spinal cord stimulation with different types of stimulation (tonic, burst, and multistim) over four months, reporting daily pain scores.
16 weeks
Follow-up
Participants are monitored routinely to collect laboratory, behavioral, and survey responses to test for the feasibility of obtaining data explaining pain phenotype.
3 years
Participant Groups
The study tests different patterns of spinal cord stimulation (tonic, burst, multistim) in patients with chronic pain. Participants will be blinded to the type they receive and report daily pain scores over four months. The most effective setting for reducing pain will be identified using Thompson sampling and recommended for future use.
1Treatment groups
Experimental Treatment
Group I: Experimental groupExperimental Treatment1 Intervention
Prospective cohort of patients clinically scheduled to undergo spinal cord stimulation for the treatment of chronic back pain or radiculopathy.
Various Stimulation Patterns is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Spinal Cord Stimulation for:
- Chronic back pain
- Radicular pain
- Failed back surgery syndrome
- Neuropathic pain
- Complex regional pain syndrome
- Peripheral vascular disease
- Diabetic neuropathy
🇪🇺 Approved in European Union as Spinal Cord Stimulation for:
- Chronic back pain
- Radicular pain
- Failed back surgery syndrome
- Neuropathic pain
- Complex regional pain syndrome
- Peripheral vascular disease
- Diabetic neuropathy
- Visceral abdominal pain
- Perineal pain
🇨🇦 Approved in Canada as Spinal Cord Stimulation for:
- Chronic back pain
- Radicular pain
- Failed back surgery syndrome
- Neuropathic pain
- Complex regional pain syndrome
- Peripheral vascular disease
- Diabetic neuropathy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MinnesotaMinneapolis, MN
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Who Is Running the Clinical Trial?
University of MinnesotaLead Sponsor
References
Spinal cord stimulation for failed back surgery syndrome and other disorders. [2019]Chronic pain is a complex condition that requires a multi-disciplinary approach to management. Spinal cord stimulation (SCS) has evolved into a relatively easily implemented, reversible technique with low morbidity for the management of chronic, intractable pain in selected patients. Percutaneous placement of electrode arrays, under local anaesthesia. supported by programmable, implanted electronics has been a major technical advance. Multicenter prospective studies were conducted and demonstrated that SCS. as a neuromodulation procedure, is indeed a superior method for treatment of chronic pain if the patients are selected with caution and a proper strategy. Future development of innovative electrodes and pulse generation systems will continue to improve this therapy.
Current and future trends in spinal cord stimulation for chronic pain. [2022]Spinal cord stimulation (SCS) is a reversible treatment for chronic pain that is gaining favor as a first-line therapy for many disease states. Because there are no addictive issues and no side effects systemically, the treatment is moving up the treatment continuum ladder. First used clinically in 1967, the procedure was used exclusively for failed back surgery syndrome. Over the past 30 years selection criteria, psychologic screening, and technology have improved. These advances have broadened the treatment options for many patients in pain. This review focuses on the selection, indications, techniques, new advances, complications, and outcomes involved with SCS. A review is provided for the treatment of radiculitis, failed back surgery syndrome, complex regional pain syndrome, peripheral neuropathies, pelvic pain, occipital neuralgia, angina, ischemic extremity pain, and spasticity. Technologic advances such as multi-lead and multi-electrode arrays are also discussed in regard to the impact these developments have on the clinical application of the therapy.
International neuromodulation society critical assessment: guideline review of implantable neurostimulation devices. [2022]Spinal cord stimulation (SCS) is well accepted for the treatment of chronic pain since its beginning in 1967. As its use continues to enter into the chronic pain treatment algorithm earlier, conscience patient selection and durability of the therapy are clearly clinically relevant. To improve treatment efficacy, consensus statements and guidelines were developed.
Factors associated with the success of trial spinal cord stimulation in patients with chronic pain from failed back surgery syndrome. [2021]Spinal cord stimulation (SCS) is an effective means of treatment of chronic neuropathic pain from failed back surgery syndrome (FBSS). Because the success of trial stimulation is an essential part of SCS, we investigated factors associated with success of trial stimulation.
Prospective Evaluation of Patient Usage of Above and Below Threshold Waveforms With Traditional Spinal Cord Stimulation Devices. [2022]Spinal cord stimulation (SCS) is an efficacious therapy used to treat chronic pain. The type of SCS programming is important in improving patients' quality of life and overall satisfaction. In this study, 19 patients who underwent SCS with traditional devices were given between 4 and 6 programs including programs with stimulation below sensory threshold and above sensory threshold. Usage patterns and preferences were assessed.
Spinal cord stimulation for chronic refractory pain: Long-term effectiveness and safety data from a multicentre registry. [2019]Spinal cord stimulation (SCS) is an established therapy for refractory neuropathic pain. To ascertain the balance between treatment benefits and risks, the French National Authority for Health requested a post-market registry for real-world evaluation of the long-term effectiveness and safety of the therapy.
Techniques for Safe Removal of Spinal Cord Stimulation Paddle Leads. [2022]Spinal cord stimulation (SCS) is a safe neuromodulatory treatment used to treat failed back surgery syndrome, chronic neuropathic pain, and complex regional pain syndrome. Despite its efficacy, some patients fail to achieve pain relief and elect to undergo removal of SCS paddle leads. The safety and best practices of these procedures have not been defined.
Is spinal cord stimulation safe? A review of 13 years of implantations and complications. [2022]The aim of this review was to evaluate the complications of spinal cord stimulation (SCS) for chronic pain.
The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. [2022]Spinal cord stimulation (SCS) has been proven effective for multiple chronic pain syndromes. Over the past 40 years of use, the complication rates of SCS have been well defined in the literature; however, the incidence of one of the most devastating complications, spinal cord injury (SCI), remains largely unknown. The goal of the study was to quantify the incidence of SCI in both percutaneous and paddle electrode implantation.
Efficacy of the latest new stimulation patterns of spinal cord stimulation for intractable neuropathic pain compared to conventional stimulation: study protocol for a clinical trial. [2023]Spinal cord stimulation (SCS) is one of the neuromodulation therapies for chronic neuropathic pain. The conventional paresthesia-based SCS involves the application of tonic stimulation that induces a sense of paresthesia. Recently, new SCS stimulation patterns without paresthesia have been developed. Differential target multiplexed (DTM) stimulation and fast-acting subperception therapy (FAST) stimulation are the latest paresthesia-free SCS patterns.
[Spinal cord stimulation in 62 patients: Retrospective evaluation]. [2018]Spinal cord stimulation (SCS) is used for various indications such as Failed Back Surgey Syndrome, peripheral causalgia, neuropathic pain, complex regional pain syndrome, reflex sympathetic dystrophy, peripheral vascular disease, ischemic heart disease and cancer pain.
Tonic, Burst, High-Density, and 10-kHz High-Frequency Spinal Cord Stimulation: Efficiency and Patients' Preferences in a Failed Back Surgery Syndrome Predominant Population. Review of Literature. [2021]Spinal cord stimulation (SCS) is a neuromodulation process to treat neuropathic pain, initially developed on tonic paresthesia-based stimulation. In the last decade, 3 major paresthesia-free SCSs have emerged. Several studies show their superiority over tonic stimulation.
Spinal cord stimulation for FBSS and CRPS: A review of 80 cases with on-table trial of stimulation. [2018]Spinal cord stimulation (SCS) is used for the treatment of chronic neuropathic pain, a notoriously difficult condition to treat. Failed Back Surgery Syndrome (FBSS) and Complex Regional Pain syndrome (CRPS) remain the strongest indications. Funding remains a difficult issue and the use of trial of stimulation is the traditional method of ensuring best outcomes from implantation.
[Minimally invasive implantation technique of a system for spinal cord stimulation]. [2021]Spinal cord stimulation (SCS) targets structures of the dorsal column and dorsal horn of the spinal cord with electrical impulses, thereby, modulating pain perception. For chronic pain patients, e.g., in failed back surgery syndrome (FBSS), the aim is to achieve pain relief and enable patients to improve their quality of life.