NCT07091123

Patient Preference and Long-term Outcomes in Persistent Spinal Pain Syndrome: A Prospective Study Comparing Spinal Cord Stimulation to Intrathecal Drug Delivery.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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

• Persistent Spinal Pain Syndrome

Interventions

Type	Name	Description
DEVICE	Pain pump	Spinal catheter place under local anesthesia.
DRUG	Bupivacain 0.625%/Fentanyl 2mcg/ml	A solution containing fentanyl 2 mcg/mL and bupivacaine 0.625 mg/mL at an infusion rate of 0.5 ml/hr.
DEVICE	Spinal Cord Stimulator (SCS)	Two spinal cord stimulation leads will then be advanced under fluoroscopy to the target area, typically around T7-T9 in the posterior epidural space. Currently, there are six manufacturers of spinal cord stimulation devices with implanted programmable generators or receivers.

Timeline

• Start date: 2025-10-13
• Primary completion: 2027-08-11
• Completion: 2027-08-11
• First posted: 2025-07-29
• Last updated: 2026-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study