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Spinal Cord Stimulation for Pain Relief in Irritable Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT01726751
Recruitment Status : Completed
First Posted : November 15, 2012
Last Update Posted : April 21, 2014
Sponsor:
Collaborators:
Medtronics, Inc.
Bengt Ihre Foundation
The Swedish Society of Medicine
Information provided by (Responsible Party):
Per Hellström, Uppsala University

Brief Summary:

To elucidate Spinal Cord Stimulation (SCS) as treatment for IBS. An SCS system with a 4-polar electrode at the T5-8 level is implanted. In a randomized, cross-over study design, active stimulation is compared to a period without stimulation, with an ensuing tailing stimulation period, twice as long. Patients recorded average pain level, pain attacks, number of diarrheas and global quality of life. At the end of the study patients can choose to retain their SCS stimulation system or have it removed.

The outcome of the present trial will show whether SCS is a useful treatment of IBS. The long-term follow-up will show the continuous amelioration of SCS over at least six months.


Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Constipation Diarrhea Pain Device: Spinal Cord Stimultion (SCS) Device: Spinal cord nerve stimulation Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Spinal Cord Stimulation in the Irritable Bowel Syndrome - a Randomized Cross-over Trial
Study Start Date : August 2005
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Arm Intervention/treatment
Early off-stimulation (group B)
Late SCS treatment. After 2 weeks without SCS, randomization to either of two study arms: Group B starting with no SCS for a period of six weeks (A) followed by a period of active SCS (on-period for 6 weeks). Thereafter, free stimulation for 12 weeks, followed by a concluding 2 sweeks of no SCS.
Device: Spinal Cord Stimultion (SCS)
Electric stimulation of the spinal cord
Other Name: Quad-plus®, Medtronic Inc., MN, USA
Device: Spinal cord nerve stimulation
Early on-stimulation (group A)
Early SCS treatment. After 2 weeks without SCS, randomization to either of two study arms: Group A starting with SCS for a period of six weeks (A) followed by a period of no SCS (off-period for 6 weeks). Thereafter, free stimulation for 12 weeks, followed by a concluding 2 sweeks of no SCS.
Device: Spinal Cord Stimultion (SCS)
Electric stimulation of the spinal cord
Other Name: Quad-plus®, Medtronic Inc., MN, USA
Device: Spinal cord nerve stimulation



Primary Outcome Measures :
  1. To investigate if typical abdominal pain of IBS can be ameliorated by SCS? [ Time Frame: According to protocol for 26 weeks ]

    During the whole study period each patient will record the number of pain attacks.

    Patients are scheduled for regular outpatient controls, at 2, 8, 14, 26 and 28 weeks after implantation



Secondary Outcome Measures :
  1. To record effects of SCS on diarrhea/constipation [ Time Frame: According to protocol for 26 weeks ]

    During the whole study period each patient recorded, on a daily basis: 1) number of pain attacks, 2) number of diarrhea episodes, 3) average pain level for the day and 4) assessment of average quality of life. For the latter two items patients were instructed to use a numerical rating scale (NRS) with a range of 0-10.

    Patients were scheduled for regular outpatient controls, at 2, 8, 14, 26 and 28 weeks after implantation



Other Outcome Measures:
  1. To evaluate quality of life and side effects, feasibility and tolerability of SCS, validated as willingness to retain the stimulation equipment. [ Time Frame: According to protocol for 26 weeks ]

    During the whole study period each patient recorded, on a daily basis: 1) number of pain attacks, 2) number of diarrhea episodes, 3) average pain level for the day and 4) assessment of average quality of life. For the latter two items patients were instructed to use a numerical rating scale (NRS) with a range of 0-10.

    Patients were scheduled for regular outpatient controls, at 2, 8, 14, 26 and 28 weeks after implantation.




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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-60, Rome II criteria, abdominal pain >4 (0-10 VAS), stable symptoms for >2 years

Exclusion Criteria:

  • other gastrointestinal disease, somatic or psychiatric co-morbidity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726751


Locations
Sweden
Karolinska University Hospital
Solna, Stockholm, Sweden, 17176
Sponsors and Collaborators
Uppsala University
Medtronics, Inc.
Bengt Ihre Foundation
The Swedish Society of Medicine
Investigators
Principal Investigator: Per M Hellström, MD, PhD Uppsala University

Responsible Party: Per Hellström, Professor, senior consultant, Uppsala University
ClinicalTrials.gov Identifier: NCT01726751     History of Changes
Other Study ID Numbers: SCS-IBS-004
First Posted: November 15, 2012    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: April 2014

Keywords provided by Per Hellström, Uppsala University:
Spinal cord stimulation
Irritable bowel syndrome
Abdominal pain
Diarrhea

Additional relevant MeSH terms:
Syndrome
Constipation
Diarrhea
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases