Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07091123 · ClinicalTrials.gov registry record · Phase 4
Patient Preference and Long-term Outcomes in Persistent Spinal Pain Syndrome: A Prospective Study Comparing Spinal Cord Stimulation to Intrathecal Drug Delivery.
A Phase 4 study of Persistent Spinal Pain Syndrome, sponsored by University Hospitals Cleveland Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT07091123 is a Phase 4 study of Persistent Spinal Pain Syndrome that is actively recruiting participants, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 36 participants. The trial reports 1 study location across 1 state.
The verdict
NCT07091123, a Phase 4 study of Persistent Spinal Pain Syndrome, is actively recruiting participants, sponsored by University Hospitals Cleveland Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE Spinal Cord Stimulator (SCS)
- DEVICE Pain pump
- DRUG Bupivacain 0.625%/Fentanyl 2mcg/ml
Study Locations (1)
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-10-13 |
| Est. Completion | 2027-08-11 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07091123
The ClinicalTrials.gov registry entry for NCT07091123 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Persistent Spinal Pain Syndrome appearing as the primary indexed condition, and to 3 interventions - of which Spinal Cord Stimulator (SCS) is the first listed.
NCT07091123 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT07091123 about?
NCT07091123 is a clinical study titled "Patient Preference and Long-term Outcomes in Persistent Spinal Pain Syndrome: A Prospective Study Comparing Spinal Cord Stimulation to Intrathecal Drug Delivery.". 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 m...
What is the current status of trial NCT07091123?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2025-10-13. Estimated completion is 2027-08-11.
What conditions does trial NCT07091123 study?
This clinical trial studies the following conditions: Persistent Spinal Pain Syndrome.
What interventions are being tested in trial NCT07091123?
The interventions under investigation include: Spinal Cord Stimulator (SCS) (DEVICE), Pain pump (DEVICE), Bupivacain 0.625%/Fentanyl 2mcg/ml (DRUG).
Who is sponsoring clinical trial NCT07091123?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07091123 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.