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ENROLLING BY INVITATION
NCT07540663
NA

MSCS in BURSTDR Patients

Sponsor: Jessa Hospital

View on ClinicalTrials.gov

Summary

The patients included in this study have already undergone the process of probe implantation and adjustment to their individually suitable stimulation pattern. Patients will be selected if the probe was implanted 0 - 5 years ago. Patients with implanted percutaneous electrodes (octrodes) and plate electrodes (surgical lead group) will be included in the study. The aim of this study is to investigate whether additional muscle stimulation can optimize the current pain therapy. After being informed about the study and providing informed consent, the questionnaires (baseline) are completed before the start of the study. Then, in addition to the existing BurstDR stimulation, additional muscle stimulation is started twice a day for 30 minutes and continued for 3 months. During this time, the pain values are also determined every 4 weeks using the visual analog scale (VAS), Oswestry Disabillity Index (ODI), EQ5D-5L, Pain Catastrophizing Scale (PCS), Pain Disability Index (PDI), Patient Global Impression of Change (PGIC). At the end of 3 months, the questionnaires are completed again. The VAS values and the values from the questionnaires are compared with the baseline values. In addition, possible side effects and adverse reactions that could be triggered by the stimulation are recorded at this time. This study makes it possible to investigate the combination of pain treatment with BurstDR and simultaneous muscle stimulation with an Octrodes and pentaleads for chronic back pain in a prospective study.

Official title: Study Muscle SCS (MSCS) in Patients Treated With Burst DR Neuromodulation: an Addtional Program for Improved Pain Suppression and Life-quality

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-03-15

Completion Date

2028-03-15

Last Updated

2026-04-20

Healthy Volunteers

No

Interventions

OTHER

muscle simulation

patients will be programmed in a tonic low frequency program which they will use 2x a day for 30 minutes besides their regular stimulation

Locations (1)

JEssa Ziekenhuis

Hasselt, Limburg, Belgium