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

NCT ID: NCT07091123

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-13
• Study Completion Date: 2027-08-11

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Pain pump

Intervention Type: DEVICE

Spinal catheter place under local anesthesia.

Bupivacain 0.625%/Fentanyl 2mcg/ml

Intervention Type: 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)

Intervention Type: 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.

Group B

IDD prognostic test for 8-23 hours followed 2-4 weeks later by SCS prognostic test.

Group Type: ACTIVE_COMPARATOR

Pain pump

Intervention Type: DEVICE

Spinal catheter place under local anesthesia.

Bupivacain 0.625%/Fentanyl 2mcg/ml

Intervention Type: 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)

Intervention Type: 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.

Interventions

Pain pump

Spinal catheter place under local anesthesia.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Salim M Hayek

Chief of the Division of Pain Medicine at University Hospitals

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Salim Hayek, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals

Locations

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ayse Ulucay, MD

Role: CONTACT

Ayse.Ulucay@UHhospitals.org

216-844-3771

Other Identifiers

STUDY20241226

Identifier Type: -

Identifier Source: org_study_id