Using spinal cord stimulation to treat chronic abdominal pain

Spinal Cord Stimulation for Chronic Abdominal Pain Patients

This study is testing whether spinal cord stimulation can help people with chronic abdominal pain feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 130 Years
• Sex: All
• Sponsor: The Leeds Teaching Hospitals NHS Trust (Academic / other)
• Locations: 1 site (Leeds)
• Trial ID: NCT06533917 on ClinicalTrials.gov

What this trial studies

This study investigates the use of spinal cord stimulation (SCS) as a treatment for patients suffering from chronic abdominal pain. It aims to implant a device that delivers mild electrical signals to the spinal cord without causing uncomfortable tingling sensations. Up to 20 patients will be recruited, and their pain levels will be monitored through a series of questionnaires and follow-up visits over a year. The study seeks to determine the feasibility and effectiveness of this novel approach in managing abdominal pain symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic abdominal pain that has not responded to conservative therapies for at least three months.

Not a fit: Patients who have not been diagnosed with chronic abdominal pain or those who are not suitable candidates for surgical procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant pain relief for patients suffering from chronic abdominal pain without the unpleasant side effects of traditional SCS.

How similar studies have performed: While conventional spinal cord stimulation has shown effectiveness for various pain conditions, this specific approach is novel and has not been extensively tested in similar studies.

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.

Where this trial is running

Leeds

• Leeds Teaching Hospitals NHS Trust — Leeds, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Ganesan Baranidharan, MD — Ltht
• Study coordinator: Emma Binns, BSc

Conditions Pain