Status:
RECRUITING
Spinal Cord Stimulation for Chronic Abdominal Pain Patients
Lead Sponsor:
The Leeds Teaching Hospitals NHS Trust
Conditions:
Pain
Eligibility:
All Genders
18-130 years
Phase:
NA
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 sid...
Detailed Description
Up to 20 patients with chronic abdominal pain will be recruited to participate in this study. They will attend an initial visit prior to having the device implanted and they will be asked to complete ...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 4 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06533917
Start Date
January 18 2024
End Date
June 4 2025
Last Update
August 15 2024
Active Locations (1)
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1
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom