SCS vs Conventional Management for Chronic Pain

(SOLIS Trial)

No longer recruiting at 22 trial locations

Overseen By Alexander Chernyak

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Disqualifiers: Vascular pain, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety and effectiveness of Spinal Cord Stimulation (SCS) compared to regular treatments for individuals with chronic low back and/or leg pain. The focus is on those who haven't undergone back surgery and will use the Boston Scientific WaveWriter SCS System. One group will try the SCS, while the other will continue with their usual pain treatments, known as Conventional Medical Management (CMM). This trial suits individuals who have experienced low back pain, with or without leg pain, for at least six months and have tried other pain management options for at least 90 days. As an unphased trial, it offers an opportunity to explore new treatment options for managing chronic pain.

Do I have to stop taking 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 managing chronic pain?

Research has shown that Spinal Cord Stimulation (SCS) systems, such as the WaveWriter, are generally well-tolerated by patients. One study on the long-term safety of these systems found no significant harm even after more than two years of use, suggesting that the treatment could be safe for managing chronic pain.

The FDA has reviewed the safety of SCS systems, including the WaveWriter, for treating chronic low back and leg pain. Their review identified no major safety issues, providing reassurance about its safety for this type of pain.

While any medical treatment can have side effects, current evidence supports the safety of the WaveWriter SCS system for people with chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Spinal Cord Stimulation (SCS) with WaveWriter for chronic pain because it offers a unique approach compared to conventional treatments like medications and physical therapy. Unlike standard pain management, which often relies on opioids or anti-inflammatory drugs, SCS directly targets the spinal cord to modulate pain signals before they reach the brain. This technique can provide more precise pain relief with potentially fewer side effects. Additionally, the WaveWriter technology allows for customizable pain relief, tailoring the stimulation to individual patient needs, which is a significant advancement over one-size-fits-all treatments.

What evidence suggests that this trial's treatments could be effective for chronic pain?

Research shows that Spinal Cord Stimulation (SCS), one of the treatments studied in this trial, can effectively relieve long-lasting nerve pain, such as chronic low back and leg pain. Studies have found that SCS not only eases pain but also reduces the need for pain medications over time. Patients using SCS have reported significant, lasting pain relief and a better quality of life. A thorough review of research found that SCS manages chronic pain more effectively than standard medical treatments. This trial will compare the WaveWriter SCS System with Conventional Medical Management, another treatment option in this study. These findings suggest that the WaveWriter SCS System could be a promising option for those who haven't found relief through other treatments. ^{2 4 6 7 8}

Who Is on the Research Team?

Natalie Bloom Lyons

Principal Investigator

Boston Scientific Corporation

Are You a Good Fit for This Trial?

This trial is for adults with chronic low back and/or leg pain lasting at least 6 months, who have tried other pain management treatments like medication or physical therapy for over 90 days. Women of childbearing age must not be pregnant. Participants must understand English to give informed consent. Those with vascular-origin pain, cervical lead implant needs, significant cognitive issues, or previous SCS trials are excluded.

Inclusion Criteria

I am not pregnant, confirmed by a test.

I have had chronic low back pain, with or without leg pain, for at least 6 months.

I have been receiving pain management for my main pain issue for at least 90 days.

Exclusion Criteria

I have had a spinal cord stimulation trial that did not work or I have an implant like a pacemaker.

I need a procedure for leads in my neck area.

My main pain is due to a blood vessel condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Spinal Cord Stimulation or Conventional Medical Management

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Conventional Medical Management
• WaveWriter

Trial Overview The study compares the effectiveness of Spinal Cord Stimulation (SCS) using Boston Scientific's WaveWriter Systems against Conventional Medical Management (CMM) in managing chronic back/leg pain without spinal surgery. It aims to determine if SCS can be a viable alternative to traditional treatment methods.

How Is the Trial Designed?

Group I: Spinal Cord Stimulation Experimental Treatment 1 Intervention

To receive Spinal Cord Stimulation programming

Group II: Conventional Medical Management Experimental Treatment 1 Intervention

To receive conventional medical management

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10889739/

Improved Outcomes and Therapy Longevity after Salvage ... Spinal cord stimulation (SCS) is proven to effectively relieve chronic neuropathic pain. However, some implanted patients may face loss of ...

2. bostonscientific.com bostonscientific.com/en-US/medical-specialties/pain-management/scs-clinical-data.html

Spinal Cord Stimulation (SCS) Clinical Data Improved outcomes and therapy longevity after salvage using a novel spinal cord stimulation system for chronic pain: multicenter, observational, European case ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2826172

Spinal Cord Stimulation vs Medical Management for ... This systematic review and network meta-analysis evaluates the efficacy associated with conventional and novel spinal cord stimulation ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37067600/

a systematic review and meta-analysis Conclusions: SCS is an effective treatment to relieve the pain level of chronic pain, decrease analgesic usage, and increase long-term ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S277259442300095X

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.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf3/P030017S363B.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) The SOLIS study was designed to evaluate the safety and effectiveness of Spinal Cord. Stimulation (SCS) in patients with chronic low back and/or leg pain who ...

7. tandfonline.com tandfonline.com/doi/full/10.2217/pmt-2022-0091

Long-term Safety of Spinal Cord Stimulation Systems in A ... Research article: Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain.

8. pubmed.ncbi.nlm.nih.gov pubmed.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 ...