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

Conditions

• Persistent Spinal Pain Syndrome

Eligibility Criteria

Sex

ALL

Age

30 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pain pump — DEVICE
  Spinal catheter place under local anesthesia.
• Bupivacain 0.625%/Fentanyl 2mcg/ml — DRUG
  A solution containing fentanyl 2 mcg/mL and bupivacaine 0.625 mg/mL at an infusion rate of 0.5 ml/hr.
• Spinal Cord Stimulator (SCS) — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Oct 13, 2025

Status verified

Jan 2026

Primary completion

Aug 11, 2027

Completion

Aug 11, 2027

Study Design

Enrollment

36 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Active Comparator: Group A
  SCS prognostic test performed first followed about 2-4 weeks later with continuous IDD test with bupivacaine 0.625 mg/ml and fentanyl 2 mcg/ml for 8-23 hours.
• Active Comparator: Group B
  IDD prognostic test for 8-23 hours followed 2-4 weeks later by SCS prognostic test.

Primary Outcome Measure

Change in pain intensity as measured by Numerical Rating Scale [NRS] [ Time Frame: Baseline, up to 23 hours after catheter placement (for IDD group) Baseline, one week after lead placement (for SCS group) 3, 6, 12 months for implanted patients ]

Central Contacts

• Ayse Ulucay, MD
  216-844-3771
  [email protected]

Locations (1)

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