Comparing spinal cord stimulation and an implanted pain pump for persistent spinal pain
Official title: Patient Preference and Long-term Outcomes in Persistent Spinal Pain Syndrome: A Prospective Study Comparing Spinal Cord Stimulation to Intrathecal Drug Delivery.
Run by University Hospitals Cleveland Medical Center · NCT07091123 · Data updated 2026-11-12
This will try both spinal cord stimulation and an implanted pain pump in adults with persistent spinal pain who haven't improved with other treatments to see which relieves pain better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 30 Years and up |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | October 13, 2025 |
| Main results expected | August 11, 2027 |
| Study ends | August 11, 2027 |
| Registry record updated | February 3, 2026 |
| Trial ID | NCT07091123 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 30 or older with prior lumbar or thoracic spine surgery, predominantly trunk low back pain (≥75% back pain), who have failed conservative treatments and passed preimplant psychological screening are the ideal candidates.
✕Probably not a fit
Patients who do not achieve at least 50% pain reduction with either trial, as well as those who are pregnant, immunocompromised, allergic to bupivacaine or fentanyl, unable to stop anticoagulants, or on high-dose opioids (>15 mg oral morphine equivalents) who cannot wean, are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults meeting inclusion criteria will undergo short-term trial sessions of both spinal cord stimulation (SCS) and intrathecal drug delivery (IDDS, pain pump) as screening tests. Up to 36 participants will complete both trials and then report which treatment provided more relief using standardized questionnaires during clinic visits. Patients must achieve at least 50% pain reduction during a trial to qualify for implant placement; those who do not meet that threshold will not receive either device through the protocol. The study is an interventional phase 4, single-center protocol at University Hospitals Cleveland Medical Center comparing patient-reported short-term response and long-term outcomes between the two implanted therapies.
Why it matters
Potential benefit: If successful, this approach could help match patients to the implant that gives them better pain relief and reduce the number of ineffective device implants.
How similar studies have gone: Both SCS and intrathecal drug delivery have shown benefit for selected chronic back pain patients in prior studies, but direct head-to-head comparisons and long-term preference-guided approaches are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 30 years or greater * Previous lumbar or thoracic spine surgery * Intractable pain of trunk (more than limbs; ≥ 75%/25% ratio back/leg pain) * Patient who passed psychological evaluations as part of the usual clinical care prior to consideration of IDDS and are stable with current pain condition and medications * Failed more conservative management, including physical therapy, medications and injections. Exclusion Criteria: * Untreated infection or coagulopathy/patient unable to stop anticoagulants * Immune compromised state precluding having an implant * Allergic reactions to bupivacaine or fentanyl * Pregnancy. * Patients using \> 15 mg oral equivalents of morphine daily or who are unable to wean down below that dosage for 4 weeks or more before the prognostic test date * Neurological deficits characterized as weakness in lower extremities with evidence of nerve damage resulting in difficulty ambulating * Patients deemed by Spine Surgery to be candidates for revision lumbar spine surgery
Where it's running
-
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: Salim Hayek, MD — University Hospitals
- Study coordinator: Ayse Ulucay, MD
- Email: Ayse.Ulucay@UHhospitals.org
- Phone: 216-844-3771
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.