Actively Recruiting
Spinal Cord Stimulation for Chronic Abdominal Pain Patients
Led by The Leeds Teaching Hospitals NHS Trust · Updated on 2024-08-15
10
Participants Needed
1
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. Spinal cord stimulation (SCS) is a minimally invasive, therapeutic option for managing chronic abdominal pain. This involves implanting a device that delivers mild electrical signals to the spinal cord to reduce pain. Conventional SCS has been shown to improve abdominal pain caused by different disorders, but it causes feelings of unpleasant tingling in the tummy area. This feasibility study aims to explore relief from chronic abdominal pain symptoms when using a device that does not cause uncomfortable tingling feelings in the tummy area.
CONDITIONS
Official Title
Spinal Cord Stimulation for Chronic Abdominal Pain Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically diagnosed with chronic abdominal pain from inguinal crease to T12 ribs, including abdominal wall pain, chronic pancreatitis, gastroparesis, gastric dysmotility, irritable bowel syndrome, post-surgical or post-traumatic visceral abdominal pain.
- Refractory to conservative therapy for at least 3 months, including at least 2 medication classes and/or an anesthetic block.
- Baseline visceral pain score of 5 or higher on a 0-10 Visual Analogue Scale.
- Age 18 years or older at enrollment.
- Suitable candidate for surgical procedures as judged by the implanting physician.
- Willing and able to give informed consent.
- Willing and able to comply with study procedures and visits.
You will not qualify if you...
- Female participants who are pregnant, nursing, or planning pregnancy during the trial.
- Pain condition escalating or changing within the past month.
- Sphlanchnectomy or radiofrequency treatment within the past 6 months.
- Active or previous implantable devices such as pacemakers, spinal cord stimulators, or intrathecal drug delivery systems.
- Active infection as judged by the investigator.
- Participation in another clinical trial within 30 days.
- Medical conditions that prevent surgical intervention.
- Unable to understand or respond to study questionnaires.
- Unable to understand or operate the patient programmer device.
- Morbid obesity with BMI 40 kg/m2 or higher.
- Prior spinal surgery or spinal pathology that would prevent lead implantation.
- Other persistent painful conditions besides refractory visceral pain due to chronic abdominal pain.
- History of alcohol abuse in the past year or intravenous drug abuse in the past 3 years.
- No increase over 40% from baseline amylase levels.
- Conditions requiring or likely to require diathermy use.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Actively Recruiting
Research Team
E
Emma Binns, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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