Spinal Cord Stimulation for Pain Relief in Irritable Bowel Syndrome
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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 |
- 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
- 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
- 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 |
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| 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 |
| 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 | |
| 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 May 19, 2013