Actively Recruiting

Phase 4
Age: 30Years +
All Genders
NCT07091123

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

Led by University Hospitals Cleveland Medical Center · Updated on 2026-02-03

36

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 30Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 30 years or greater
  • Previous lumbar or thoracic spine surgery
  • Intractable trunk pain with at least 75% back pain compared to limb pain
  • Passed psychological evaluations and stable with current pain condition and medications
  • Failed conservative treatments including physical therapy, medications, and injections
Not Eligible

You will not qualify if you...

  • Untreated infection or bleeding disorder or inability to stop anticoagulants
  • Immune-compromised condition preventing implant
  • Allergy to bupivacaine or fentanyl
  • Pregnancy
  • Using more than 15 mg oral morphine equivalents daily or unable to reduce below this for 4 weeks before testing
  • Neurological weakness in lower limbs causing difficulty walking
  • Candidates for revision lumbar spine surgery as determined by spine surgery specialists

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

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Research Team

A

Ayse Ulucay, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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