Saluda Medical’s SCS Study
This study is for patients who have received a spinal cord stimulator for pelvic pain.
About the Study
This study looks at whether a treatment called closed-loop spinal cord stimulation can help people with long-term pelvic pain. This treatment has been effective for patients with back and leg pain. We want to see if it can also help people with pelvic pain. This is a small pilot study that will help us learn how well the treatment works and help design future research studies.
People in the study must be receiving a SALUDA Medical Spinal Cord Stimulator as part of their medical standard of care. If they agree to join, they will try the device for 5–14 days. If their pain improves by at least 50%, they may get a permanent device implanted.
We will include up to 10 people with a permanent device and follow them for 12 months.
This study is recruiting in person at the Stanford Redwood City Pain Management Center
Who Can Join (Eligibility)
You may be able to join if you:
- Are 18 years or older
- Have had pelvic pain for more than 6 months
- Tried other treatments that did not help
- Speak English
- Get care at Stanford clinics
You cannot join if you have:
- Serious untreated medical problems (like uncontrolled diabetes or heart/lung disease)
- Another cause of pelvic pain that can be treated with surgery or medicine
- Serious untreated mental health conditions
- Body anatomy that makes it hard to place the device
- Ongoing legal or disability cases
What to Expect
- Screening: Doctors will check if you qualify. Screening is completed by a clinical research coordinator.
- Consent: Complete our electronic informed consent form
- Trial period: You will try the device for 5–14 days using temporary wires
- Decision: If your pain improves by 50% or more, you may get a permanent device
- Follow-up visits & online assessments: 3, 6, and 12 months after the device is placed
- Total participants: Up to 10 people will get the permanent device
All medical procedures are part of regular clinical care. The research part is the completion of online assessments.
What We Are Measuring
We want to see how pain changes after treatment.
We measure:
- Pain levels before treatment
- Pain levels at 3, 6, and 12 months
We also look at:
- How pain affects daily life
- Mood (anxiety and depression)
- Sleep and energy
- Social life and activities
- Thoughts about pain
- Bladder symptoms
- How the device is used
- Safety and side effects
Safety
We will carefully track any side effects or problems. This includes device-related, procedure-related, and other medical events.