Correlation Between Abdominal Wall Stimulation and Neurostimulator Tip Location

Not Applicable

Not yet recruiting

• Conditions: Neuropathy; Neurostimulator; Complication
• Interventions: Other: Adjustment of neurostimulator settings

• Registration Number: NCT05565469
• Lead Sponsor: Jessa Hospital

Brief Summary

In this prospective interventional study, we look at the level of tip of the DTM neurostimulator and the presence of abdominal wall stimulation in patients

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-22
• Study Start: 2022-09-23
• Study First Submitted QC: 2022-09-29
• Last Update Submitted: 2022-09-29
• Study First Posted: 2022-10-04
• Last Update Posted: 2022-10-04
• Primary Completion: 2022-12-31
• Study Completion: 2023-02-27

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with a DTM neurostimulator for Failed Back Surgery Syndrome (FBSS) at the thoracic level

Exclusion Criteria

• Patients younger than 18 years of age
• Patients who are not able to exercise their will.
• Inability to understand the Dutch language

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neurostimulator group	Adjustment of neurostimulator settings	Adjustment of neurostimulator settings to see whether or not abdominal stimulation can be provoked

Primary Outcome Measures

Name	Time	Method
Abdominal stimulation	up to 15 minutes after start of the intervention	Is abdominal wall stimulation present YES/NO and if so what is the score between 0 and 10 on an NRS 1-10. This is then correlated to the position of the electrode.