Can a nerve stimulator outsmart a placebo for chronic pain?
NCT ID NCT07779733
First seen Aug 21, 2026 · Last updated Aug 21, 2026
Summary
This trial asks whether continuing BurstDR spinal cord stimulation—a therapy that uses an implanted device to send electrical pulses to the spine—actually relieves chronic pain better than a sham (inactive) stimulation. Adults who already have the device and have experienced good, stable pain relief for at least three months will receive both active and sham stimulation in random order, without knowing which is which. Each person serves as their own comparison, and the study tracks pain levels, satisfaction, sleep, mood, and daily activities to see if the active stimulation truly makes a difference.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BurstDR spinal cord stimulation (a type of electrical nerve stimulation delivered via an implanted device)
- What this could lead to
- If active BurstDR proves better than sham, it would confirm that ongoing stimulation is what provides pain relief, supporting its continued use and possibly refining how it's delivered.
- What could go wrong
- This is a small, early-stage crossover study with only 28 participants. The sham may also provide some relief, and results may not apply to all chronic pain patients. Risks include discomfort or side effects from stimulation.
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 28 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
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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Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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 Participants must meet all of the following: 1. Be 18 years of age or older. 2. Have an implanted spinal cord stimulation system that can deliver BurstDR stimulation. 3. Have had a good and stable response to BurstDR therapy, defined as at least a 50% reduction in pain compared with pain before implantation or before starting BurstDR therapy, maintained for at least 3 months on stable stimulation settings. 4. Have had no major change in pain medication for at least 4 weeks before entering the study. 5. Be able to understand the study information and provide written informed consent. 6. Be willing and able to complete the study's electronic diaries and follow the study procedures. Exclusion Criteria Participants cannot take part if any of the following apply: 1. An active infection, wound problem, or other significant problem at the site of the implanted spinal cord stimulation system. 2. A known or suspected problem with the implanted stimulation system that could affect treatment delivery or safety. 3. A serious uncontrolled mental health condition, significant problems with memory or thinking, or another condition that could make it difficult to understand the study, provide informed consent, follow the study procedures, or provide reliable study information. 4. Planned surgery, planned changes to spinal cord stimulation programming outside the study, or an expected change in pain medication during the study period. 5. Pregnancy or breastfeeding. 6. Inability to use the electronic diary system when no practical alternative or assistance can be provided. 7. Any other medical or personal condition that, in the investigator's judgment, would make participation unsafe or inappropriate.
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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
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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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University Hospital of Northern Sweden
Umeå, 90185, Sweden
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