NCT06533917 Spinal Cord Stimulation for Chronic Abdominal Pain Patients
| NCT ID | NCT06533917 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Leeds Teaching Hospitals NHS Trust |
| Condition | Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-01-18 |
| Primary Completion | 2025-06-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2024-01-18 with a primary completion date of 2025-06-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. 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. 2. 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. 3. Minimum baseline pain score of 5 on a VAS scale (0-10) for their visceral pain. 4. Be 18 years of age or older at the time of enrolment. 5. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician. 6. Be willing and capable of giving informed consent. 7. Be willing and able to comply with study-related requirements, procedures, and visits. Exclusion Criteria: 1. Female participants of childbearing potential who are pregnant/nursing or plan to become pregnant during the trial. 2. Escalating or changing pain condition within the past month as evidenced by investigator examination. 3. Sphlanchnectomy or radiofrequency treatment within the past 6-months. 4. Currently has an active or had an active implantable device including pacemakers, SCS or intrathecal drug delivery system. 5. In the investigators opinion has an active infection. 6. Participated in another clinical investigation within 30-days. 7. Medical co-morbidities that preclude surgical intervention. 8. Participant is incapable of understanding or responding to the study questionnaires. 9. Participant is incapable of understanding or operating the patient programmer handset. 10. Participant is morbidly obese (BMI ≥ 40 kg/m2). 11. Participant has had a spinal surgical procedure or has spinal pathology that would significantly impede lead implantation at the level planned for implantation. 12. Participant has another persistent painful condition other than persistent refractory visceral pain secondary to chronic abdominal pain. 13. History of alcohol abuse in the last year or IV drug abuse in the last 3-years. 14. No increases of more than 40% from baseline amylase. 15. Have a condition currently requiring or likely to require the use of diathermy.
Contact & Investigator
Ganesan Baranidharan, MD
PRINCIPAL INVESTIGATOR
LTHT
Frequently Asked Questions
Who can join the NCT06533917 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 130 Years, studying Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06533917 currently recruiting?
Yes, NCT06533917 is actively recruiting participants. Contact the research team at leedsth-tr.leedspainresearch@nhs.net for enrollment information.
Where is the NCT06533917 trial being conducted?
This trial is being conducted at Leeds, United Kingdom.
Who is sponsoring the NCT06533917 clinical trial?
NCT06533917 is sponsored by The Leeds Teaching Hospitals NHS Trust. The principal investigator is Ganesan Baranidharan, MD at LTHT. The trial plans to enroll 10 participants.