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New treatment option for Lower Back Pain
Official title Peripheral Nerve Stimulation With the SPRINT® System in Chronic PSIJC Pain
ClinicalTrials.gov ID: NCT07166952
What this study is testing
- What it's testing
- Chronic lower back pain is a significant cause of disability, affecting 21-68% of people 60 years of age and older (source). Of these cases, 15-30% are attributed to posterior sacroiliac joint complex (PSIJC) pain (source), making it a target for treatment.
- Time commitment: about 1 week
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Sacroiliac pain as diagnosed above
- Subject greater than 18 years old
- Subject is severely debilitated by SIJ pain, with initial ODI score \> 40%
- Subject received conservative treatment for at least three months including physiotherapy and pain medication
- Subject is able to understand and consent to the study and device management and participating in follow-up surveys
You likely can't join if
- Pregnancy
- Subject is under the age of 18 years
- Acute traumatic injury of the sacral iliac joint
- Active inflammation or neoplastic infiltration of the SIJ
- Neoplastic diseases of the spine
- Spinal surgery within the last three months
See the full eligibility criteria
- Sacroiliac pain as diagnosed above
- Subject greater than 18 years old
- Subject is severely debilitated by SIJ pain, with initial ODI score \> 40%
- Subject received conservative treatment for at least three months including physiotherapy and pain medication
- Subject is able to understand and consent to the study and device management and participating in follow-up surveys
- Subject is scheduled for a commercial SPRINT case that has been authorized through their healthcare insurance
- Pregnancy
- Subject is under the age of 18 years
- Acute traumatic injury of the sacral iliac joint
- Active inflammation or neoplastic infiltration of the SIJ
- Neoplastic diseases of the spine
- Spinal surgery within the last three months
- Sacroiliac joint steroid injection within the past 1 month or sacral lateral branch radiofrequency ablation within the past 6 months
- Contraindication for Neuromodulation Device (severe psychiatric disease, severe coagulation disorder, acute infection, active autoimmune disease with immunosuppression)
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 study runs about 1 week per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, 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.