University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Location status: Recruiting
NCT Number: NCT07091123
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.
Interested in participating?
Request Info30 year and older
All sexes
Interventional
Phase 4
Cleveland, Ohio, 44106, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Spinal catheter place under local anesthesia.
A solution containing fentanyl 2 mcg/mL and bupivacaine 0.625 mg/mL at an infusion rate of 0.5 ml/hr.
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.
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
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.
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.
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.
Time frame: Up to 12 months
Time frame: 3, 6, 12 months
Contact information is provided by the study sponsor or research team.
University Hospitals Cleveland Medical Center
Other
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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.