NCT07091123 Patient Preference and Long-term Outcomes in Persistent Spinal Pain Syndrome: A Prospective Study Comparing Spinal Cord Stimulation to Intrathecal Drug Delivery.
| NCT ID | NCT07091123 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Hospitals Cleveland Medical Center |
| Condition | Persistent Spinal Pain Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-10-13 |
| Primary Completion | 2027-08-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 36 participants in total. It began in 2025-10-13 with a primary completion date of 2027-08-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Spinal cord stimulation (SCS) or intrathecal drug delivery (pain pump) can be effective in providing pain relief for patients with low back pain who have not responded to other treatments. While both treatments, SCS and pain pump, may help with low back pain relief, it is not known which treatment may work better for patients. SCS and pain pumps involve an implanted device in the body. In this study, we are asking patients to undergo a trial of both treatment modalities, SCS and pain pump, as screening tests prior to considering an implant. A total of 36 patients will be enrolled in this study. After both trials are completed, participants will be seen in the office and asked which treatment modality they believe has been more effective for relieving pain during the trial periods by completing questionnaires. If neither treatment was effective in improving baseline pain by at least 50%, participants would not qualify for either implant whether or not they are part of this study. Direct study participation would end here. If either or both treatment modalities improved baseline pain by at least 50%, participants will be asked to choose the treatment that worked better: SCS or pain pump. Participants will then have the option to proceed to the permanent implant of choice: SCS or pain pump. Direct study participation would end here but participants will then be followed in the doctor's office after implant as is customary for usual clinical care. The study data collection will conclude when the screening tests are completed.
Eligibility 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
Contact & Investigator
Salim Hayek, MD
PRINCIPAL INVESTIGATOR
University Hospitals
Frequently Asked Questions
Who can join the NCT07091123 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, studying Persistent Spinal Pain Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07091123 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07091123 currently recruiting?
Yes, NCT07091123 is actively recruiting participants. Contact the research team at Ayse.Ulucay@UHhospitals.org for enrollment information.
Where is the NCT07091123 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT07091123 clinical trial?
NCT07091123 is sponsored by University Hospitals Cleveland Medical Center. The principal investigator is Salim Hayek, MD at University Hospitals. The trial plans to enroll 36 participants.