Spinal Cord Stimulation for Chronic Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how spinal cord stimulation affects the brain in people with chronic pain. Researchers will use special brain scans (rs-fNIRS/EEG) to observe any changes in brain activity or structure. The trial seeks U.S. veterans with chronic neuropathic pain who are already using or considering spinal cord stimulation at the Cleveland VA Medical Center. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that spinal cord stimulation is safe for treating chronic pain?
Research has shown that spinal cord stimulation (SCS) is generally safe for treating chronic pain. A large study found that SCS is safe for long-term use, though some side effects were reported. Most side effects were serious, and a few were very serious. Despite these risks, many people use SCS without major problems. The treatment uses mild electrical signals to help relieve pain. It has been used for some time and is approved by the FDA for other conditions, suggesting it is considered safe.12345
Why are researchers excited about this trial?
Spinal Cord Stimulation (SCS) is unique because it offers a new way to manage chronic pain by directly targeting the nervous system. Unlike traditional pain medications that primarily work by blocking pain signals or reducing inflammation, SCS involves implanting a device that sends electrical impulses to the spinal cord, altering how pain signals travel to the brain. Researchers are excited about this treatment because it has the potential to provide significant pain relief without the side effects associated with long-term medication use, offering a promising alternative for chronic pain sufferers.
What evidence suggests that spinal cord stimulation is effective for chronic pain?
Research has shown that spinal cord stimulation (SCS) can help treat chronic pain. In one study, 55% of patients using SCS experienced significant pain relief and treatment success after five years. Another study found that SCS worked better than standard pain treatments in most cases after six months. However, some reviews have shown mixed results, suggesting SCS might not be more effective than a placebo for certain types of back pain. Overall, SCS has shown promise in helping many patients manage chronic pain effectively.678910
Who Is on the Research Team?
Svetlana Pundik, MD
Principal Investigator
Louis Stokes VA Medical Center, Cleveland, OH
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
SCS Trial Period
Participants naive to SCS undergo a trial period to evaluate the effectiveness of spinal cord stimulation
Long-term SCS Use
Participants with effective implanted SCS for 6 months are evaluated for changes in brain connectivity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Spinal Cord Stimulation
Spinal Cord Stimulation is already approved in United States, European Union, Canada for the following indications:
- Failed back surgery syndrome (FBSS)
- Adhesive arachnoiditis
- Peripheral causalgia/neuropathy
- Reflex sympathetic dystrophy (RSD)
- Phantom limb/stump pain
- Ischemic pain of vascular origin
- Complex regional pain syndrome
- Pain after an amputation
- Visceral abdominal pain and perineal pain
- Chronic pain
- Neuropathic pain
- Spinal cord injury pain
- Failed back surgery syndrome (FBSS)
- Adhesive arachnoiditis
- Peripheral causalgia/neuropathy
- Reflex sympathetic dystrophy (RSD)
- Chronic pain
- Neuropathic pain
- Spinal cord injury pain
- Failed back surgery syndrome (FBSS)
- Adhesive arachnoiditis
- Peripheral causalgia/neuropathy
- Reflex sympathetic dystrophy (RSD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Citations
Spinal Cord Stimulation: Clinical Efficacy and Potential ...
Results in the SCS group were sustained over time, with 80% of patients using their devices and 55% of patients achieving treatment success at 5 years. Despite ...
Spinal Cord Stimulation vs Medical Management for ...
Analysis results suggest statistical superiority of conventional and novel SCS therapies over CMM in 5 of the 6 outcomes evaluated at 6-month ...
A systematic review of evidence comparing spinal cord ...
The primary outcome (>50% leg pain relief) in the intent-to-treat analysis was achieved by 40% (95% CI: 27–54%) of SCS patients at 9 months, 31% (18–43%) at 12 ...
4.
sydney.edu.au
sydney.edu.au/news-opinion/news/2023/03/07/spinal-cord-stimulation-doesn-t-help-with-back-pain-says-new-rev.htmlSpinal cord stimulation doesn t help with back pain says ...
The review concluded that spinal cord stimulation is no better than a placebo for treating low back pain, with probably little to no benefit for people with ...
A Review of Functional Restoration From Spinal Cord ...
This review aims to assess the efficacy of spinal cord stimulation, both epidural (eSCS) and transcutaneous (tSCS), on the return of function in individuals ...
SUMMARY OF SAFETY AND EFFECTIVENESS DATA ( ...
Spinal cord stimulation is the application of mild electrical stimulation to the spinal cord to relieve chronic, intractable pain of the trunk and/or limbs.
Spinal Cord Stimulators: An Analysis of the Adverse Events ...
Five hundred twenty adverse events were reported for spinal cord stimulators. Most events were rated as severe (79%) or life-threatening (13%).
Cardiovascular safety of transcutaneous spinal cord ...
This study supports the safety profile of cervical tSCS paired with rehabilitation in individuals with cervical spinal cord injury.
Long-term Safety of Spinal Cord Stimulation Systems in A ...
Results obtained from this prospective, real-world, international registry demonstrate an overall good safety profile with use of SCS systems for chronic pain ...
Transcutaneous Spinal Cord Stimulation (ARC-EX Therapy ...
Clinic and home-based ARC EX Therapy is safe and effectively improves upper extremity strength and function in people living with chronic, cervical SCI.
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