10 Participants Needed

Spinal Cord Stimulation for Chronic Pain

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of North Carolina, Chapel Hill
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how spinal cord stimulation (SCS) changes sensations in people with chronic pain. Researchers seek to understand how different stimulator settings affect these sensations. The trial is for individuals receiving an SCS implant, who can walk 10 meters unassisted, and have long-lasting pain issues. Those who meet these criteria might consider joining to help advance pain management research. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research in pain management.

Will 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 trial coordinators or your doctor.

What prior data suggests that spinal cord stimulation is safe for chronic pain?

Research has shown that spinal cord stimulation (SCS) is generally safe for treating chronic pain. One study found that SCS was safe for long-term use in people with chronic pain, with most patients not experiencing serious side effects. Another study found that patients using SCS often experienced a significant reduction in pain without major problems. Overall, existing evidence suggests that SCS is well-tolerated and rarely causes severe side effects.12345

Why are researchers excited about this trial?

Spinal cord stimulation (SCS) is unique because it offers a different approach to managing chronic pain compared to standard treatments like medication or physical therapy. Unlike these common methods, SCS works by sending electrical pulses to the spinal cord, which helps disrupt the pain signals before they reach the brain. This technique can potentially provide significant pain relief without the side effects associated with long-term medication use. Researchers are excited about SCS because it has the potential to improve quality of life for people who haven't found relief through other treatments.

What evidence suggests that spinal cord stimulation is effective for chronic pain?

Research has shown that spinal cord stimulation (SCS), the treatment under study in this trial, can significantly reduce long-term pain. Studies have found that individuals using SCS are more likely to experience at least a 50% decrease in pain, particularly in the back or legs. In practical application, 90.1% of patients had a successful trial with SCS, and 80.4% proceeded to receive a permanent implant. This treatment also alleviates symptoms for many and reduces the need for painkillers like opioids. Overall, SCS offers a promising approach to managing chronic pain effectively.25678

Who Is on the Research Team?

AY

Amol Yadav, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for individuals with chronic pain conditions such as peripheral neuropathy. Participants should be experiencing ongoing pain and may have difficulty recognizing the onset of their own pain (anosognosia). Specific eligibility criteria are not provided, but typically include age, health status, and type of chronic pain.

Inclusion Criteria

I am between 18 and 85 years old.
Provides written consent for the study
I am getting a spinal cord stimulator for chronic pain.
See 1 more

Exclusion Criteria

I am at high risk of falling.
I do not want to participate in the study.
I am unable to give consent by myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo spinal cord stimulation to assess sensory perceptions and changes with modified parameters

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Spinal cord stimulation (SCS)
Trial Overview The study is exploring how spinal cord stimulation (SCS) can create sensations that might help manage chronic pain. It will also investigate how changing the settings on the SCS device affects these sensations.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Assessing sensations using spinal cord stimulationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials
1,588
Recruited
4,364,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Citations

The effectiveness of spinal cord stimulation combined with ...Results. Eight studies comprising 777 patients were included. Spinal cord stimulation alone led to significant pain reductions, with responder ...
Spinal Cord Stimulation vs Medical Management for ...Specifically, patients treated with SCS therapies were more likely to achieve at least 50% pain reduction in either back or leg when measured at ...
Real World Characterization of Chronic Pain, Success ...Overall, 90.1% of the patients had a successful SCSeval, and 80.4% of those converted to permanent implant, with the highest rates among those ...
Spinal Cord Stimulation (SCS) Clinical DataImproved outcomes and therapy longevity after salvage using a novel spinal cord stimulation system for chronic pain: multicenter, observational, European case ...
addressing persistent doubts in spinal cord stimulationIn conclusion, SCS offers significant benefits for many patients with chronic pain, including substantial pain relief and a reduction in opioid ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36691862/
Long-term safety of spinal cord stimulation systems in a ...Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry ...
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 ...
Real-world outcomes of single-stage spinal cord ...SS-SCS can provide significant long-term pain relief and improve quality of life in chronic pain patients.
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