36 Participants Needed

Spinal Cord Stimulation vs Pain Pump for Chronic Back Pain

AU
Overseen ByAyse Ulucay, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University Hospitals Cleveland Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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?

SH

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

I passed a psychological evaluation and my pain condition is stable.
I am 30 years old or older.
I have had surgery on my lower back or mid-back.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment - SCS Prognostic Test

Participants undergo a spinal cord stimulation (SCS) prognostic test to evaluate pain relief effectiveness

1 week
1 visit (in-person)

Treatment - IDD Prognostic Test

Participants undergo an intrathecal drug delivery (IDD) prognostic test to evaluate pain relief effectiveness

8-23 hours
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3, 6, 12 months for implanted patients
3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Bupivacain 0.625%/Fentanyl 2mcg/ml
  • Pain pump
  • Spinal Cord Stimulator (SCS)
Trial Overview The study compares two types of implanted devices for low back pain: a Spinal Cord Stimulator (SCS) and an Intrathecal Drug Delivery system (pain pump). Patients will try both methods before deciding which one provides better relief through questionnaires.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Group BActive Control3 Interventions
Group II: Group AActive Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials
348
Recruited
394,000+

Citations

Intrathecal Drug Delivery for Intractable PainMost respondents reported good-to-excellent pain relief (63.8%), high satisfaction with TDD (80.7%), improvement in physical functioning (75.0%) ...
Implantable Intrathecal Drug Delivery System - StatPearls - NCBIIntrathecal drug delivery can achieve effective analgesia and spasticity reduction with significantly lower medication dosages than traditional ...
Report from the National Outcomes Registry for Low Back PainWe conclude that IDDSs are successful in managing chronic low back pain in patients who have not found effective relief with other therapies.
Evaluation of long-term outcomes with intrathecal opioid ...In this study we utilized the ePPOC data, as intended, to compare the effectiveness of pain management over time in a specific group of long- ...
Long-term experience with implanted intrathecal drug ...Continuous intrathecal drug delivery has been shown in open studies to improve pain and quality of life in those with intractable back pain ...
Efficacy of Continuous Intrathecal Infusion Trialing with a ...Significantly greater decreases in pain scores occurred at the end of the screening trial in patients receiving intrathecal fentanyl/bupivacaine compared to ...
Intrathecal Bupivacaine for Chronic Pain: A Review of ...Bupivacaine administration is more effective intrathecally, providing better pain relief than epidural administration. Reports of complications are infrequent.
Intrathecal Hydromorphone and Bupivacaine Combination ...IT hydromorphone and bupivacaine are effective in treating chronic pain of FBSS, as demonstrated by the reduction of pain intensity and oral opioid consumption.
Evidence-Based Review of the Literature on Intrathecal ...Pain relief was reported to be “excellent” in 73% and “good” in 26.5% of patients; no serious side effects were noted. Another study described the treatment of ...
Safety and tolerability of high doses of intrathecal fentanyl ...The patient was discharged with good pain control and tolerable side effects. Over the next three years, the IT fentanyl dose was slowly titrated at an average ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security