MSCS in BURSTDR Patients

Enrolling by invitation · Not applicable

Conditions studied: FBSS, PSPSII, Neuropathic Pain

In brief

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.

Key facts

Study ID

NCT07540663

Run by

Jessa Hospital

People needed

60

Starts

2026-03-15

Expected to finish

2028-03-15

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with PSPS type 2
• Patients with predominant back pain
• Patients with SCS(BurstDR) stimulation in situ with >50% pain relief. Patients have to be satisfied with their existing SCS therapy and predominantly use a BurstDR stimulation program. ) (Only responders to that therapy should be included, not patients who have not responded to their therapy so far.)
• Patient must be willing and able to provide written informed consent before any clinical investigation-related procedure
• Age ≥18 y
• Low back pain baseline score of ≥6 on NRS before spinal cord stimulation therapy and a MCID (Minimal clinically important difference) of >30% with SCS(BurstDR) stimulation.
• Willing and able to comply with the instructions for use, operate the study device, and comply with this clinical investigation plan

You may not qualify if…

• Pathology seen on imaging tests that is clearly identified and is likely the cause of the CLBP, that can be addressed with surgery, or related to these origins:
• vascular causes (eg, aortic aneurysm)
• spinal infection (eg, osteomyelitis)
• inflammation or damage to the spinal cord (eg, arachnoiditis or syringomyelia)
• tumor or spinal metastases
• Severe scoliotic deformity (>11◦ in thoracic or lumbar spine)
• Primary symptom of leg pain, or leg pain is greater than back pain
• Has widespread pain (eg, fibromyalgia) or pain in other area(s), not intended to be treated in this study (eg, neck pain, shoulder pain)
• Patient has used a morphine equivalent daily dose of >50 MME in the last 30 d
• Patients with regular intake of systemic steroids (except inhaled steroids used to treat asthma)
• Known allergic reaction to implanted materials
• Patient has a history of or existing intrathecal drug pump
• Patient has previous experience with neuromodulation devices, including a failed trial
• BMI >40
• Patient is enrolled, or intends to participate, in another clinical drug and/or device study or registry that may interfere with the results of this study.
• Presence of other anatomic or comorbid conditions, or other medical, social, or psychologic conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results
• Failed psychologic evaluation
• Suspicion or evidence of untreated mental illness, substance abuse, or drug-seeking behavior
• Patient is in current litigation for back pain/injury, or is currently receiving worker's compensation
• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.

Where it is running

• JEssa Ziekenhuis — Hasselt, Limburg, Belgium

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.