PainNCT06533917
Spinal Cord Stimulation for Chronic Abdominal Pain Patients
A study testing Main Group in people with Pain, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Pain
- What is being tested?
- Main Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jan 2024to 4 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds
Ganesan Baranidharan, 0113 2063735, g.baranidharan@nhs.net
About this study
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.
- Conditions
- Pain
- Being tested
- Main Group
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Main GroupDevice
Thoracolumbar spine AP, Thoracolumbar spine LAT
| Study group | Role | What they receive |
|---|---|---|
| Main | Experimental | 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. Receives: Device: Main Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 MONTHS
• 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.
Measured: 12 MONTHS
• Incidence rates of study related adverse events will be collected and characterized.
- Incidence rates of study related adverse events will be collected and characterized.
Measured: 12 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start18 Jan 2024
- Primary completion4 Jun 2025 (estimated)
- Study completion4 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ganesan Baranidharan, MD, Principal investigator, LTHT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533917
- Sponsor's protocol ID
- PM23/157561
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation for Chronic Abdominal Pain Patients
- ClinicalTrials.gov ID
- NCT06533917
- Acronym / sponsor ID
- PM23/157561
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 4 Jun 2025 (estimated)
- Study completion
- 4 Jun 2025 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main | Experimental | Device: Main GroupAll 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. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Main GroupThoracolumbar spine AP, Thoracolumbar spine LAT | Device | Main |
Primary outcome
To evaluate the safety and feasibility of ECAP-controlled closed-loop SCS in treating patients with CAP.treating patients with CAP
Time frame: 12 MONTHS
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.
• 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
• Changes in average pain intensity, in the primary region of pain on the Visual Analogue Scale (VAS) in the last week.
• Incidence rates of study related adverse events will be collected and characterized.
Time frame: 12 MONTHS
• Incidence rates of study related adverse events will be collected and characterized.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ganesan Baranidharan, MD principal investigator
LTHT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Main Group in people with Pain, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emma Binns, BSc (0113 3926234, leedsth-tr.leedspainresearch@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and feasibility of ECAP-controlled closed-loop SCS in treating patients with CAP.treating patients with CAP (time frame: 12 MONTHS). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.