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Patient Preference and Long-term Outcomes in Persistent Spinal Pain Syndrome: A Prospective Study Comparing Spinal Cord Stimulation to Intrathecal Drug Delivery.
NCT07091123 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07091123 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07091123?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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