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Spinal Cord Stimulation for Pain Relief in Irritable Bowel Syndrome

NCT01726751 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-11-07

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Spinal Cord Stimultion (SCS)

Electric stimulation of the spinal cord

DEVICE

Spinal cord nerve stimulation

Sponsors & Collaborators

  • Medtronics, Inc.

    collaborator INDUSTRY

  • Bengt Ihre Foundation

    collaborator OTHER

  • The Swedish Society of Medicine

    collaborator OTHER

  • Uppsala University

    lead OTHER

Principal Investigators

  • Per M Hellström, MD, PhD · Uppsala University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01726751 on ClinicalTrials.gov