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.
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
Untreated infection or coagulopathy/patient unable to stop anticoagulants
Immune compromised state precluding having an implant
Allergic reactions to bupivacaine or fentanyl
Pregnancy.
Crossover
Pain pump
DeviceSpinal catheter place under local anesthesia.
Bupivacain 0.625%/Fentanyl 2mcg/ml
DrugA 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)
DeviceTwo 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.
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
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.
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.
Change in quality of life as measured by the PROMIS-29.
PROMIS-29 is 29 item patient reported outcome tool measuring health-related quality of life. With higher scores indicating higher quality of life.
Number of adverse events as measured by patient report,
Change in daily opioid consumption as measured by Rx report
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