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Compares treatment options for Persistent Spinal Pain Syndrome
Official title Patient Preference and Long-term Outcomes in Persistent Spinal Pain Syndrome: A Prospective Study Comparing Spinal Cord Stimulation to Intrathecal Drug Delivery.
ClinicalTrials.gov ID: NCT07091123
What this study is testing
What is Bupivacain 0.625%/Fentanyl 2mcg/ml?
Bupivacain 0.625%/Fentanyl 2mcg/ml is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for persistent spinal pain syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 and older
You may be able to join if
- 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...
- Failed more conservative management, including physical therapy, medications and injections.
You likely can't join if
- 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...
- Neurological deficits characterized as weakness in lower extremities with evidence of nerve damage resulting in difficulty ambulating
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.