Spinal Cord Stimulation for Chronic Abdominal Pain Patients
ConditionPain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-130
SponsorThe Leeds Teaching Hospitals NHS Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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, post-surgical or post-traumatic abdominal pain that is of visceral origin.
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Main Group
DeviceThoracolumbar spine AP, Thoracolumbar spine LAT
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: MainExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the safety and feasibility of ECAP-controlled closed-loop SCS in treating patients with CAP.treating patients with CAP
To evaluate the safety and feasibility of ECAP-controlled closed-loop SCS in treating patients with CAP.Visual Analogue Scale (VAS) in the last week. • Incidence rates of study related adverse events will be collected and characterized.
Time frame
12 MONTHS2
• Changes in average pain intensity, in the primary region of pain on the Visual Analogue Scale (VAS) in the last week.
• Changes in average pain intensity, in the primary region of pain on the Visual Analogue Scale (VAS) in the last week.
Time frame
12 MONTHS3
• Incidence rates of study related adverse events will be collected and characterized.
• Incidence rates of study related adverse events will be collected and characterized.
Time frame
12 MONTHSSponsors and contacts
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Source ClinicalTrials.gov