BridgeMD
New treatment option for Pain, Chronic
Official title APP-based Precise Management System of Chronic Intractable Pain
ClinicalTrials.gov ID: NCT05761392
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn about a new management system in chronic and stubborn pain patients who accept therapy of spinal cord stimulation (SCS). Usually, these patients are required to take long-term follow-ups to ensure that the stimulator works well.
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
- Have been clinically diagnosed with chronic, intractable pain for more than three months.
- At enrollment, the average pain intensity is no least than 5 out of 10 cm on visual analogue scale.
- At enrollment, the age is no younger than 18-year-old.
- Ineffective or unsatisfactory conservative treatments, including but limited to: oral medication, nerve block, epidural corticosteroids, physical and...
- Voluntary to take the trial and sign the informed consent.
You likely can't join if
- Bleeding complications or coagulation disorders.
- Mental or cognitive disorders leading to inability to complete implantation surgery or post-operative follow-up.
- Issues with spinal cord or vertebrates that are not suitable for implantation surgery.
- Systemic active infections or local infections around the surgery area.
- Pregnancy, breast-feeding, plan to be pregnant or unwilling to use contraceptive methods.
- Metastatic malignant tumors or untreated malignant tumors.
See the full eligibility criteria
- Have been clinically diagnosed with chronic, intractable pain for more than three months.
- At enrollment, the average pain intensity is no least than 5 out of 10 cm on visual analogue scale.
- At enrollment, the age is no younger than 18-year-old.
- Ineffective or unsatisfactory conservative treatments, including but limited to: oral medication, nerve block, epidural corticosteroids, physical and psychological rehabilitation therapy, and chiropractic care.
- Voluntary to take the trial and sign the informed consent.
- Good compliance and ability to complete post-operative follow-ups.
- Basic ability to read and use a mobile phone or having a caregiver who can.
- Bleeding complications or coagulation disorders.
- Mental or cognitive disorders leading to inability to complete implantation surgery or post-operative follow-up.
- Issues with spinal cord or vertebrates that are not suitable for implantation surgery.
- Systemic active infections or local infections around the surgery area.
- Pregnancy, breast-feeding, plan to be pregnant or unwilling to use contraceptive methods.
- Metastatic malignant tumors or untreated malignant tumors.
- Life expectancy of less than one year.
- Already provided with a medication pump and/or other implanted devices.
- Need for therapy or examination that must not have an implanted pulse generator (IPG), such as magnetic resonance imaging (MRI) and thermo-therapy.
- Heavily addicted to alcohol or drugs.
- VAS improvement less than 50% or stimulation intolerance during the test period.
- Unable to complete long-term online follow-ups because of hardware issues such as internet, mobile phones, and so on.
- Unwilling to participate.
- Other inappropriate situations determined by the investigators.
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. 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.