Painful Diabetic Peripheral Neuropathy study: Spinal cord stimulator
Official title High-frequency SCS Versus SCS in the Treatment of Diabetic Peripheral Neuropathic Pain
ClinicalTrials.gov ID: NCT06158529
What this study is testing
- What it's testing
- The study compares the new high‑frequency device to the standard spinal cord stimulator to see if it improves nerve function and blood flow in people with painful diabetic peripheral neuropathy.
- Who it's for
- Adults who have painful diabetic peripheral neuropathy and are eligible for spinal cord stimulation.
- What's involved
- Participants will receive either the high‑frequency or standard spinal cord stimulator, have the device implanted, and then attend follow‑up visits for pain and function assessments.
- Time commitment
- The study lasts about 12 months, with several clinic visits for device checks and pain evaluations.
Which group you join is 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 to 80
You may be able to join if
- Diagnosed with diabetes, aged between 18 and 80 years old;
- Symmetrical pain in the distal lower extremities with or without dysesthesia;
- Duration of symptoms exceeding 6 months;
- Pain described as stabbing and/or electric shock-like and/or burning sensation;
- Abnormal Quantitative Sensory Testing (QST);
You likely can't join if
- Concurrent severe cardiovascular and cerebrovascular diseases;
- History of lumbar spine surgery, trauma, or spinal canal stenosis within the past 6 months, or a history of lumbar spine surgery, trauma, or spinal...
- Presence of radicular symptoms;
- Other spinal abnormalities, such as benign or malignant tumors, congenital abnormalities of the spine, spinal instability, etc.;
- Coexisting disorders of the coagulation system, malignant tumors, infections, and psychiatric or psychological disorders;
- Pregnancy.
See the full eligibility criteria
- Diagnosed with diabetes, aged between 18 and 80 years old;
- Symmetrical pain in the distal lower extremities with or without dysesthesia;
- Duration of symptoms exceeding 6 months;
- Pain described as stabbing and/or electric shock-like and/or burning sensation;
- Abnormal Quantitative Sensory Testing (QST);
- Presence of hyperalgesia and allodynia;
- Absence of lower limb reflexes and muscle strength abnormalities;
- Normal MRI or CT scans without spinal canal stenosis or other spinal abnormalities.
- Concurrent severe cardiovascular and cerebrovascular diseases;
- History of lumbar spine surgery, trauma, or spinal canal stenosis within the past 6 months, or a history of lumbar spine surgery, trauma, or spinal canal stenosis that would impact the SCS surgery and pain assessment in...
- Presence of radicular symptoms;
- Other spinal abnormalities, such as benign or malignant tumors, congenital abnormalities of the spine, spinal instability, etc.;
- Coexisting disorders of the coagulation system, malignant tumors, infections, and psychiatric or psychological disorders;
- Pregnancy.
The study team makes the final eligibility decision.
Where it is enrolling
- Beijing, China
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, but 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, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Beijing, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.