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

NCT07091123 | Recruiting Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: STUDY20241226
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Pain pump; neuromodulation prognostic tests

Outcome Measures

Primary Outcomes (3)

• Change in pain intensity as measured by Numerical Rating Scale [NRS]

  Numerical Rating Scale \[NRS\] is a numbered scale, from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable

  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]

  Oswestry disability index \[ODI\] is a questionnaire used to assess the impact of low back pain on a person's daily life. The ODI score ranges from 0 to 100, with lower scores indicating less disability.

  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

  painDETECT is a nine-item questionnaire. A total score of 19 or more is indicative of likely neuropathic pain.

  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

Secondary Outcomes (3)

• Change in quality of life as measured by the PROMIS-29.

  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

• Number of adverse events as measured by patient report,

  Up to 12 months

• Change in daily opioid consumption as measured by Rx report

  3, 6, 12 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

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.

Device: Pain pump; Drug: Bupivacain 0.625%/Fentanyl 2mcg/ml; Device: Spinal Cord Stimulator (SCS)

Group B

ACTIVE COMPARATOR

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

Device: Pain pump; Drug: Bupivacain 0.625%/Fentanyl 2mcg/ml; Device: Spinal Cord Stimulator (SCS)

Interventions

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.

Group A; Group B

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.

Group A; Group B

Pain pump DEVICE

Spinal catheter place under local anesthesia.

Group A; Group B

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Salim Hayek, MD

  University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayse Ulucay, MD

CONTACT

216-844-3771; Ayse.Ulucay@UHhospitals.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Division of Pain Medicine at University Hospitals

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): August 11, 2027
• Study Completion (Estimated): August 11, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)