Spinal Cord Stimulation for Pain Relief in Irritable Bowel Syndrome

This study is currently recruiting participants.
Verified November 2012 by Uppsala University
Sponsor:
Collaborators:
Medtronics, Inc.
Bengt Ihre Fund
The Swedish Society of Medicine
Information provided by (Responsible Party):
Per Hellström, Uppsala University
ClinicalTrials.gov Identifier:
NCT01726751
First received: October 30, 2012
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Spinal Cord Stimulation in the Irritable Bowel Syndrome - a Randomized Cross-over Trial

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • To investigate if typical abdominal pain of IBS can be ameliorated by SCS? [ Time Frame: According to protocol for 26 weeks ] [ Designated as safety issue: Yes ]

    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:
  • To record effects of SCS on diarrhea/constipation [ Time Frame: According to protocol for 26 weeks ] [ Designated as safety issue: Yes ]

    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:
  • 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 ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 10
Study Start Date: August 2005
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726751

Contacts
Contact: Göran Lind, MD +46 70 7663755 Goran.Lind@karolinska.se
Contact: Per M Hellström, MD, PhD 46 18 611 0000 ext 4285 Per.Hellstrom@medsci.uu.se

Locations
Sweden
Karolinska University Hospital Recruiting
Solna, Stockholm, Sweden, 17176
Contact: Göran Lind, MD    +46 70766 3755    Goran.Lind@karolinska.se   
Contact: Bengt Linderoth, MD, PhD    +46 70 732 4999    Bengt.Linderoth@karolinska.se   
Principal Investigator: Göran Lind, MD         
Sub-Investigator: Bengt Linderoth, MD, PhD         
Sponsors and Collaborators
Uppsala University
Medtronics, Inc.
Bengt Ihre Fund
The Swedish Society of Medicine
Investigators
Principal Investigator: Per M Hellström, MD, PhD Uppsala University
  More Information

No publications provided

Responsible Party: Per Hellström, Professor, senior consultant, Uppsala University
ClinicalTrials.gov Identifier: NCT01726751     History of Changes
Other Study ID Numbers: SCS-IBS-004
Study First Received: October 30, 2012
Last Updated: November 9, 2012
Health Authority: Sweden: Medical Products Agency

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

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

ClinicalTrials.gov processed this record on April 16, 2014