Can a simple muscle zap boost pain relief for back pain sufferers?
NCT ID NCT07540663
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether adding a daily 30-minute muscle stimulation session can improve pain control and quality of life for people who already have a spinal cord stimulator (BurstDR) for chronic back pain. Sixty adults with failed back surgery syndrome or persistent spinal pain syndrome type 2 will use the extra stimulation twice a day for three months. Researchers will track pain scores, disability, and side effects to see if the combination works better than the stimulator alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- muscle stimulation (tonic low frequency electrical pulses)
- What this could lead to
- If it works, this could offer a simple, at-home way to further reduce chronic back pain and improve quality of life for people already using a spinal cord stimulator.
- What could go wrong
- This is a small, early-stage study with no control group, so results may not be definitive. The added muscle stimulation might cause discomfort or side effects, and not everyone may benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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JEssa Ziekenhuis
Hasselt, Limburg, 3500, Belgium
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