Spinal Cord Stimulation vs Pain Pump for Chronic Back Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two treatments to determine which provides better relief for chronic low back pain: spinal cord stimulation (SCS) and a pain pump. Both treatments involve implanted devices, but their relative effectiveness remains unclear. Participants will try both treatments to identify which alleviates their pain the most. The trial suits individuals who have undergone previous back surgeries, experience more pain in their back than in their legs, and have not found relief from other treatments like physical therapy or medications. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, allowing researchers to understand how they benefit more patients.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications, but it does require that patients using more than 15 mg of oral morphine daily reduce their dosage below that level for at least 4 weeks before the test date.
What is the safety track record for these treatments?
A previous study found that using a pain pump with bupivacaine and fentanyl provided excellent pain relief for most patients, with no serious side effects reported. Another study showed that injecting bupivacaine into the spinal canal effectively relieved pain, with rare complications.
Research has shown that spinal cord stimulation (SCS) is generally safe and well-tolerated, with many patients experiencing significant pain reduction and continuing to use their devices for several years. However, one review noted limited clinical data on its long-term effectiveness for back pain.
Both treatments have demonstrated good tolerance and few safety concerns, making them viable options for managing chronic back pain.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about spinal cord stimulation (SCS) and pain pumps for chronic back pain because they offer different ways to tackle pain management. Unlike oral medications, which are a common treatment, SCS uses electrical impulses to interfere with pain signals before they reach the brain, offering a non-drug approach to relief. Pain pumps, on the other hand, deliver medication directly to the spinal fluid, allowing for lower doses and potentially fewer side effects compared to systemic drugs. Both methods aim to provide targeted pain relief, which could lead to better outcomes and improved quality of life for patients.
What evidence suggests that this trial's treatments could be effective for chronic back pain?
This trial will compare spinal cord stimulation (SCS) with the use of a pain pump for managing chronic back pain. Studies have shown that SCS can effectively reduce chronic pain, with 60% of patients experiencing a significant decrease in back pain. In this trial, some participants will receive SCS, while others will receive treatment with a pain pump, which delivers medication directly to the spine and effectively manages chronic low back pain. Most patients report good-to-excellent pain relief with this method. Both treatments offer benefits, and the choice may depend on individual response.678910
Who Is on the Research Team?
Salim Hayek, MD
Principal Investigator
University Hospitals
Are You a Good Fit for This Trial?
This trial is for individuals over 30 years old with chronic back pain, primarily in the trunk compared to limbs, who have had previous spine surgery and haven't found relief from physical therapy, medications, or injections. They must have passed psychological evaluations and be stable on their current pain treatments.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment - SCS Prognostic Test
Participants undergo a spinal cord stimulation (SCS) prognostic test to evaluate pain relief effectiveness
Treatment - IDD Prognostic Test
Participants undergo an intrathecal drug delivery (IDD) prognostic test to evaluate pain relief effectiveness
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bupivacain 0.625%/Fentanyl 2mcg/ml
- Pain pump
- Spinal Cord Stimulator (SCS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Hospitals Cleveland Medical Center
Lead Sponsor