Patient Preference and Long-term Outcomes in Persistent Spinal Pain Syndrome: A Prospective Study Comparing Spinal Cord Stimulation to Intrathecal Drug Delivery.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pain pump, Bupivacain 0.625%/Fentanyl 2mcg/ml, Spinal Cord Stimulator (SCS).
- Who it may be relevant to
- Registry conditions: Persistent Spinal Pain Syndrome. Basic parameters: from 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Pain pump
Spinal catheter place under local anesthesia. - Drug Bupivacain 0.625%/Fentanyl 2mcg/ml
A solution containing fentanyl 2 mcg/mL and bupivacaine 0.625 mg/mL at an infusion rate of 0.5 ml/hr. - Device Spinal Cord Stimulator (SCS)
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 outcome measures
- 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]
- 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]
- 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]
Secondary outcome measures (3)
- 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]
- Number of adverse events as measured by patient report, [Time frame: Up to 12 months]
- Change in daily opioid consumption as measured by Rx report [Time frame: 3, 6, 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University Hospitals Cleveland Medical Center — Cleveland
Identifiers
NCT: NCT07091123 · STUDY20241226