Recruiting

SCS & Pain Pump

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT07091123

Conditions

Persistent Spinal Pain Syndrome

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Interventions

Pain pump

Bupivacain 0.625%/Fentanyl 2mcg/ml

Spinal Cord Stimulator (SCS)

Study Details

Brief 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

Study ID

NCT07091123

Start date

Oct 13, 2025

Status verified date

Jan, 2026

Completion date

Aug 11, 2027

Anticipated

Primary completion date

Aug 11, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 30 years or greater
  • Previous lumbar or thoracic spine surgery
  • Intractable pain of trunk (more than limbs; ≥ 75%/25% ratio back/leg pain)
  • Patient who passed psychological evaluations as part of the usual clinical care prior to consideration of IDDS and are stable with current pain condition and medications
  • Failed more conservative management, including physical therapy, medications and injections.

Exclusion Criteria:

  • Untreated infection or coagulopathy/patient unable to stop anticoagulants
  • Immune compromised state precluding having an implant
  • Allergic reactions to bupivacaine or fentanyl
  • Pregnancy.
  • Patients using > 15 mg oral equivalents of morphine daily or who are unable to wean down below that dosage for 4 weeks or more before the prognostic test date
  • Neurological deficits characterized as weakness in lower extremities with evidence of nerve damage resulting in difficulty ambulating
  • Patients deemed by Spine Surgery to be candidates for revision lumbar spine surgery

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Pain pump

Spinal catheter place under local anesthesia.

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.

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.

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 ]
  • Change in pain intensity as measured by Oswestry disability index [ODI] [ 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 ]
  • Change in pain intensity as measured by painDETECT [ 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 and Locations

Central contacts

Locations

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Feb 3, 2026

Last verified

Jan, 2026

Keywords

  • Pain pump
  • neuromodulation prognostic tests

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2026-02-03.