Spinal Cord Stimulation for Chronic Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Toronto Western Hospital, Toronto, Canada
Chronic Pain+3 More
Spinal Cord Stimulation - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether different types of spinal cord stimulation can be used to treat chronic pain.

See full description

Eligible Conditions

  • Chronic Pain
  • Neuropathic Pain

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Spinal Cord Stimulation will improve 3 primary outcomes and 4 secondary outcomes in patients with Chronic Pain. Measurement will happen over the course of Six months after implantation..

Day 12
To correlate data on physical activity as measured by an accelerometer during trials of novel SCS modes with data obtained from validated questionnaires
To correlate data on sleep as measured by an accelerometer during trials of novel SCS modes with data obtained from validated questionnaires
Month 6
Changes in neuronal activity with the novel PF-SCS modes as detected by fMRI and MEG
Changes in sensory threshold with the novel PF-SCS modes as detected by QST
Month 6
To measure long-term outcomes of novel PF-SCS modes including intensity and quality of pain, physical and psychological functioning, and patients' global impression of change
Six months after implantation.
To measure incidence of more than 50% reduction in pain intensity scores in patients with NP syndromes with novel modes of SCS
To measure incidences of analgesic failure (as indicated with less than 50% reduction in pain intensity scores) and adverse effects of PF-SCS

Trial Safety

Side Effects for

Spinal Cord Stimulation
Device stimulation issue
10%
Inadequate analgesia
3%
Back pain
3%
This histogram enumerates side effects from a completed 2019 Phase 4 trial (NCT03284411) in the Spinal Cord Stimulation ARM group. Side effects include: Device stimulation issue with 10%, Inadequate analgesia with 3%, Back pain with 3%.

Trial Design

1 Treatment Group

Spinal Cord Stimulation
1 of 1
Experimental Treatment

This trial requires 90 total participants across 1 different treatment group

This trial involves a single treatment. Spinal Cord Stimulation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Spinal Cord Stimulation
Device
At baseline, the following data will be recorded: standard-of-care questionnaire scores, neuroimaging (fMRI, MEG), psychophysical testing (QST), accelerometer sleep and activity data. The trial will proceed as follows: Day 1-4: Paresthesia-based SCS (PB-SCS) Day 5-8: No SCS (placebo) Day 9-12: PF-SCS Neuroimaging and psychophysical testing will be conducted at the end of the trial, and will be assessed 6-months post-implantation of the SCS device along with adverse effects. A decision to implant the SCS system will be made based on reduction of patient pain intensity by 50% in PB-SCS and/or PF-SCS modes, but not with placebo SCS. Based on the response in the trial, the patient will either not be a candidate for an SCS implant, or they will receive one of the four modes upon implantation (PB-SCS, or one of the three PF-SCS: Burst, High Frequency, High Density).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spinal Cord Stimulation
2014
Completed Phase 4
~70

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 days after the initiation of the scs trial
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 days after the initiation of the scs trial for reporting.

Who is running the study

Principal Investigator
A. B.
Anuj Bhatia, Director, Anesthesia Chronic Pain Clinical Services
University Health Network, Toronto

Closest Location

Toronto Western Hospital - Toronto, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adults, 18 - 80 years of age, with refractory neuropathic pain (as per clinical features and DN4 score > 3/10) in back and or lower limbs for more than 3 months following lumbar spine surgery
Severity of pain > 3/10 on NRS and ODI score for disability >40/100;
Pain refractory to conventional medical management tried for at least 3 months.

Patient Q&A Section

What are the signs of chronic pain?

"Chronic pain includes symptoms which can be grouped into subtypes. The main types are nonspecific dysaesthesia (painful sensations and abnormal sensations including tingling of the nervous system), neuropathic (pain felt due to inflammation of a nerve or a damaged nerve bundle in the body), and psychological (sufferers report that the pain originates in the mind). An additional subtype is that of 'intermittent pain. The treatment plan for chronic pain can be tailored to the patient’s signs and symptoms, but all chronic pain should be treated with non-drug treatments that are tailored to the patient." - Anonymous Online Contributor

Unverified Answer

What are common treatments for chronic pain?

"Treatment in chronic pain is highly variable among primary care specialists, with variable adherence to guidelines. The majority of treatment for chronic pain is related to acute pain management, but this should not replace the development of reliable and effective pain management plans for long-term management and treatment." - Anonymous Online Contributor

Unverified Answer

Can chronic pain be cured?

"Chronic pain cannot be cured. Neither can chronic pain be cured within a week. However, chronic pain can be treated in many ways to make people function better than they otherwise might be while suffering." - Anonymous Online Contributor

Unverified Answer

What causes chronic pain?

"Factors beyond the biological process of pain, such as the severity of the underlying disease, the level of functional impairment, and the patient's psychological state, can significantly affect pain perception. This may relate to the increased focus of pain research on the biological mechanisms of pain, as well as the social and behavioral factors in the treatment of pain." - Anonymous Online Contributor

Unverified Answer

How many people get chronic pain a year in the United States?

"The American Cancer Society estimates that 11.1 million Americans have chronic pain at any point in time. As a group, people with chronic pain have worse health-related quality of life and the use of many health services than people in the general population. The prevalence and severity of chronic pain are not improving over the last several years. This report outlines the magnitude of chronic pain in the US and describes what is already being done to better understand the burden of the disease and to better address the needs of a population that needs access to effective treatment. The goal of this database will be to provide a national screening program for chronic pain and to help better understand the factors that impact treatment." - Anonymous Online Contributor

Unverified Answer

What is chronic pain?

"Chronic pain is a long-term pain that presents with either continuous or ongoing pain at rest. It can be caused by many diseases or physical conditions, can be either acute or chronic, and can be intermittent, or sustained. Topics discussed include causes, risk factors, assessment and management, and specific cases of chronic pain." - Anonymous Online Contributor

Unverified Answer

Is spinal cord stimulation safe for people?

"A significant complication, requiring spinal cord decompression, occurred during and after the procedure in 12.6% of patients. These patients underwent decompressive operation which led to the death of one in five patients. Thus, the risk of spinal cord damage by spinal cord stimulator implantation must be kept in mind, particularly in young patients with pre-existing diseases and high risk to spinal cord injuries." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of spinal cord stimulation?

"The adverse events reported with spinal cord stimulation were uncommon. Most of the patients who participated in this study experienced no side effects. The most common side effects reported by patients who have already used implantable spinal cord stimulators are pain at the implanted site and occasional numbness/tingling or weakness. The patients who do not have these side effects tend to have a longer functioning stimulator and a better prognosis for treatment outcome." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating chronic pain?

"While there have been many new discoveries for chronic pain, current research remains largely ineffective for those with chronic pain. Patients and their doctors need to continue collaborating to make the biggest impact on decreasing the number of adults and adolescents suffering from chronic pain." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of chronic pain?

"There may be many underlying triggers that cause people to develop chronic pain such as psychological and physical trauma and illnesses. The cause of any chronic pain cannot be clearly determined yet. It is most likely that the cause is multilevel and may include nerve, joint and muscle dysfunction.\n" - Anonymous Online Contributor

Unverified Answer

What is spinal cord stimulation?

"Patients who were satisfied evaluated SSC as a helpful therapy; the main problem faced was long treatment times. No patients reported that SSC alleviated all of their pain complaints. Those patients who have other comorbidities usually report a little or no pain relief. No serious adverse reactions were reported. The cost of the device is also very low." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets chronic pain?

"This is a large study of a cohort of patients seeking treatment for CP/TMD, a condition with a wide spectrum of pain and disability, yet with few diagnostic criteria. The mean age of onset of CP/TMD is 27." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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