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: Recruiting Phase 4 study of Persistent Spinal Pain Syndrome, sponsored by University Hospitals Cleveland Medical Center.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Numerical Rating Scale \[NRS\] is a numbered scale, from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable
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 |
What NCT07091123 shows while recruiting
NCT07091123 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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
How this trial's enrollment target compares
Where NCT07091123's enrollment target sits among peer trials
36 1490th of 2000 higher than 496 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00929006 · 36 participants · Early Phase 1
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
- NCT01891318 · 36 participants · Phase 1
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
- NCT02291848 · 36 participants · Phase 1
Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma
- NCT02366819 · 36 participants · Phase 4
Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI