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New treatment option for Pain
Official title Spinal Cord Stimulation for Chronic Abdominal Pain Patients
ClinicalTrials.gov ID: NCT06533917
What this study is testing
- What it's testing
- Chronic abdominal pain is a common disorder that can have significant impact on the lives of patients. Treatment options include medication which can have limited effectiveness, be associated with side effects and may lead to tolerance and dependency.
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 130
You may be able to join if
- Have been clinically diagnosed with CAP (from inguinal crease to T12 ribs), including diagnoses such as abdominal wall pain, chronic pancreatitis...
- Have been refractory to conservative therapy for a minimum of 3-months, including assessment of at least 2 different classes of medications and/or an...
- Minimum baseline pain score of 5 on a VAS scale (0-10) for their visceral pain.
- Be 18 years of age or older at the time of enrolment.
- Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician.
You likely can't join if
- Female participants of childbearing potential who are pregnant/nursing or plan to become pregnant during the trial.
- Escalating or changing pain condition within the past month as evidenced by investigator examination.
- Sphlanchnectomy or radiofrequency treatment within the past 6-months.
- Currently has an active or had an active implantable device including pacemakers, SCS or intrathecal drug delivery system.
- In the investigators opinion has an active infection.
- Participated in another clinical investigation within 30-days.
See the full eligibility criteria
- Have been clinically diagnosed with CAP (from inguinal crease to T12 ribs), including diagnoses such as abdominal wall pain, chronic pancreatitis, gastroparesis, gastric dysmotility, irritable bowel syndrome...
- Have been refractory to conservative therapy for a minimum of 3-months, including assessment of at least 2 different classes of medications and/or an anaesthetic block as clinically appropriate.
- Minimum baseline pain score of 5 on a VAS scale (0-10) for their visceral pain.
- Be 18 years of age or older at the time of enrolment.
- Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician.
- Be willing and capable of giving informed consent.
- Be willing and able to comply with study-related requirements, procedures, and visits.
- Female participants of childbearing potential who are pregnant/nursing or plan to become pregnant during the trial.
- Escalating or changing pain condition within the past month as evidenced by investigator examination.
- Sphlanchnectomy or radiofrequency treatment within the past 6-months.
- Currently has an active or had an active implantable device including pacemakers, SCS or intrathecal drug delivery system.
- In the investigators opinion has an active infection.
- Participated in another clinical investigation within 30-days.
- Medical co-morbidities that preclude surgical intervention.
- Participant is incapable of understanding or responding to the study questionnaires.
- Participant is incapable of understanding or operating the patient programmer handset.
- Participant is morbidly obese (BMI ≥ 40 kg/m2).
- Participant has had a spinal surgical procedure or has spinal pathology that would significantly impede lead implantation at the level planned for implantation.
- Participant has another persistent painful condition other than persistent refractory visceral pain secondary to chronic abdominal pain.
- History of alcohol abuse in the last year or IV drug abuse in the last 3-years.
- No increases of more than 40% from baseline amylase.
- Have a condition currently requiring or likely to require the use of diathermy.
The study team makes the final eligibility decision.
Where it's taking place
- Leeds, United Kingdom
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 to 130 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leeds, United Kingdom. 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.