Pain Clinical Trial
Official title:
Spinal Cord Stimulation in the Irritable Bowel Syndrome - a Randomized Cross-over Trial
Verified date | November 2018 |
Source | Uppsala University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska University Hospital | Solna | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Uppsala University | Bengt Ihre Foundation, Medtronics, Inc., The Swedish Society of Medicine |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | To evaluate quality of life and side effects, feasibility and tolerability of SCS, validated as willingness to retain the stimulation equipment. | 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. |
According to protocol for 26 weeks | |
Primary | To investigate if typical abdominal pain of IBS can be ameliorated by SCS? | 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 |
According to protocol for 26 weeks | |
Secondary | To record effects of SCS on diarrhea/constipation | 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 |
According to protocol for 26 weeks |
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