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RecruitingNCT06533917Updated Aug 15, 2024

Spinal Cord Stimulation for Chronic Abdominal Pain Patients

An interventional study of Main Group in Pain, sponsored by The Leeds Teaching Hospitals NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2024-08-15.

Sponsored by The Leeds Teaching Hospitals NHS Trust · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Registered 6 months after the study started (first participant enrolled Jan 2024, registered Jul 2024).
  • Started Jan 2024; still recruiting 2 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 130 Years
Sex
All
01

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.

Read the 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 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.

02

Conditions studied

  • Pain

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03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's planned enrollment of 10 is below the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

The Leeds Teaching Hospitals NHS Trust is the lead sponsor of 101 studies on the registry; 15 are open to participants now.

Browse The Leeds Teaching Hospitals NHS Trust studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 130 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 .
  7. Be willing and able to comply with study-related requirements, procedures, and visits.

Exclusion criteria

Exclusion Criteria:

  1. Female participants of 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 ( ≥ 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 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Main

    All participants will undergo a single-stage SCS implantation procedure with 2 leads inserted in the posterior epidural space according to standard clinical practice. For ventral column stimulation SCS electrodes will be placed ventrally at T9/10 for upper abdominal pain and at T10/11 to T11/12 for lower abdominal pain.

    Device: Main Group

Interventions

  • DeviceMain Group

    Thoracolumbar spine AP, Thoracolumbar spine LAT

06

What researchers measure

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 MONTHS

  2. • 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 MONTHS

  3. • 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 MONTHS

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2024 (actual). Primary completion is estimated for Jun 2025, 16 months after the start.

Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 16 months is above that.

Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 30, 2024
First posted
Aug 1, 2024
StartActual
Jan 18, 2024
Primary completionEst.
Jun 4, 2025
CompletionEst.
Jun 4, 2025
Last update
Aug 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06533917
Lead sponsor
The Leeds Teaching Hospitals NHS Trust
Responsible party
Sponsor
First posted
Aug 1, 2024
Start date
Jan 18, 2024
Primary completion
Jun 4, 2025 (estimated)
Completion
Jun 4, 2025 (estimated)
Last update
Aug 15, 2024

Study contacts

Emma Binns, BSc
Contact
leedsth-tr.leedspainresearch@nhs.net
0113 3926234
Ganesan Baranidharan, MD
principal investigator · LTHT

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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