Spinal Cord Stimulation for Chronic Abdominal Pain Patients

Last updated: August 13, 2024
Sponsor: The Leeds Teaching Hospitals NHS Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colic

Ulcerative Colitis (Pediatric)

Dysmenorrhea (Painful Periods)

Treatment

Main Group

Clinical Study ID

NCT06533917
PM23/157561
  • Ages 18-130
  • All Genders

Study 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

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 orpost-traumatic abdominal pain that is of visceral origin.

  2. Have been refractory to conservative therapy for a minimum of 3-months, includingassessment of at least 2 different classes of medications and/or an anaestheticblock 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 basedon 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, andvisits.

Exclusion

Exclusion Criteria:

  1. Female participants of childbearing potential who are pregnant/nursing or plan tobecome pregnant during the trial.

  2. Escalating or changing pain condition within the past month as evidenced byinvestigator 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 programmerhandset.

  10. Participant is morbidly obese (BMI ≥ 40 kg/m2).

  11. Participant has had a spinal surgical procedure or has spinal pathology that wouldsignificantly impede lead implantation at the level planned for implantation.

  12. Participant has another persistent painful condition other than persistentrefractory 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.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Main Group
Phase:
Study Start date:
January 18, 2024
Estimated Completion Date:
June 04, 2025

Study 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 a number of questionnaires. Participants will then attend the hospital to have the device implanted and the treatment settings of the stimulation adjusted. Once the stimulation is started, participants will be continuously monitored for their well-being through a series of in-person visits at the pain clinic on a regular basis. These will happen at 1 week and 3, 6 and 12 months after having the device implanted.

Connect with a study center

  • Leeds Teaching Hospitals NHS Trust

    Leeds,
    United Kingdom

    Active - Recruiting

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