MSCS in BURSTDR Patients

NCT07540663 | Enrolling By Invitation

• 1 other identifier: 2025/048
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

FBSS; PSPSII; Neuropathic Pain

Keywords

Spinal Cord Stimulation; Low Back Pain; SCS; PSPSII; MSCS; Muscle SCS

Outcome Measures

Primary Outcomes (1)

• visual Analogue SCALE (VAS)

  visual analogue scale for pain difference

  4 weeks, 8 weeks and 12 weeks

Secondary Outcomes (5)

• PDI

  4 weeks, 8 weeks and 12 weeks

• PCS

  4 weeks, 8 weeks and 12 weeks

• ODI

  4 weeks, 8 weeks and 12 weeks

• EQ5D

  4 weeks, 8 weeks and 12 weeks

• PGIC

  4 weeks, 8 weeks and 12 weeks

Study Arms (1)

active additional program arm

EXPERIMENTAL

active additional stimulation on regular stimulation settings

Other: muscle simulation

Interventions

muscle simulation OTHER

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

active additional program arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Jessa Hospital: lead
• The Leeds Teaching Hospitals NHS Trust: collaborator
• Medizinische Einrichtungen der Universität Düsseldorf: collaborator

Study Sites (1)

JEssa Ziekenhuis

Hasselt, Limburg, 3500, Belgium

Location

Related Publications (1)

• Cameron, T. (März 2004). Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review. Journal of Neurosurgery: Spine, S. 254-267. Version 1.0 February 2025 16 Dienst Neurochirurgie - Virga Jessa Ziekenhuis Deer, Timothy, Konstantin V. Slavin, Kasra Amirdelfan, Richard B. North, Allen W. Burton, Thomas L. Yearwood, Ed Tavel et al. "Success using neuromodulation with BURST (SUNBURST) study: results from a prospective, randomized controlled trial using a novel burst waveform." Neuromodulation 21, no. 1 (2018): 56-66. Deer T, Slavin KV, Amirdelfan K, et al. Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Neuromodulation. 2017. De Ridder D, P. M. (November 2013). Burst Spinal Cord Stimulation for Limb and Back Pain. World neurosurgery, S. 642-649. De Ridder D, V. S. (Mai 2010). Burst spinal cord stimulation: toward paresthesia-free pain suppression. Neurosurgery, S. 986-990. de Vos CC, B. M. (Februar 2014). Burst spinal cord stimulation evaluated in patients with failed back surgery syndrome and painful diabetic neuropathy. Neuromodulation, S. 152- 159. Dirk De Ridder, M. P., & Sven Vanneste, P. (1. Juni 2015). Burst and Tonic Spinal Cord Stimulation: Different and Common Brain Mechanisms. Neuromodulation, S. 47-59. Falowski SM, Benison A. Prospective Analysis Utilizing Intraoperative Neuromonitoring for the Evaluation of Inter-Burst Frequencies. J Pain Res. 2021 Mar 11;14:703-710. Kuechmann, C. (2009). Could automatic position adaptive stimulation be useful in spinal cord stimulation? European Journal of Pain, S. 243. Kumar K, T. C. (50 (2). August 1998). Epidural spinal cord stimulation for treatment of chronic pain--some predictors of success. A 15-year experience. Surgical neurology, S. 110-120. Melzack R, W. P. (Nov 1965). Pain mechanisms: a new theory. Science, S. 971-979.

  BACKGROUND

MeSH Terms

Conditions

Neuralgia; Low Back Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD.

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 20, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 15, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)