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NCT Number: NCT07091123

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

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.

Recruiting

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

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

  2. 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

    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.

  3. 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

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

Secondary outcomes

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

    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

    PROMIS-29 is 29 item patient reported outcome tool measuring health-related quality of life. With higher scores indicating higher quality of life.

  2. Number of adverse events as measured by patient report,

    Time frame: Up to 12 months

  3. Change in daily opioid consumption as measured by Rx report

    Time frame: 3, 6, 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Ayse Ulucay, MD

CONTACT

[email protected]

216-844-3771

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 29, 2025
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.