Chronic PainNCT05885061
Effects of Spinal Cord Stimulation
A study testing Stimulation OFF, Stimulation ON and Told ON in people with Chronic Pain, run by University of Aarhus at 1 site in Denmark.
Trial summary
The goal of this interventional study is to test effects of spinal cord stimulation in patients receiving treatment for their chronic pain. The main question of the study is: What is the effect of spinal cord stimulation when compared to placebo? Participants will rate their pain with their usual spinal cord… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Stimulation OFF, Stimulation ON and Told ON
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Jan 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (>18 years of age) with SCS implanted to treat chronic pain.
- Patients who consent to participation and can cooperate in the study.
- Use of continuous paresthesia-free SCS for minimum 6 months prior to participation in the study.
- Pain score of 7 or less on a 0-10 scale in the most painful area treated with SCS, rated upon inclusion.
- Patients not receiving other neuromodulation treatment.
- Patients who have not undergone changes in their (pain relevant) medication during the last 30 days (pro necessitate medication allowed).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, Aarhus University Hospital
Aarhus, 8200
Lene Vase, lenevase@psy.au.dk
Christina Emborg, PhD, 20910215, chrisemb@psy.au.dk
About this study
The goal of this interventional study is to test effects of spinal cord stimulation in patients receiving treatment for their chronic pain. The main question of the study is:
- What is the effect of spinal cord stimulation when compared to placebo? Participants will rate their pain with their usual spinal cord stimulation on and off.
- Conditions
- Chronic Pain
- Being tested
- Stimulation OFF, Stimulation ON, Told ON, Told OFF
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulation OFFDevice
Stimulation is turned OFF
Stimulation ONDevice
Stimulation is turned ON
Told ONDrug
Verbal suggestion that stimulation is ON
Told OFFDevice
Verbal suggestion that stimulation is OFF
| Study group | Role | What they receive |
|---|---|---|
| Placebo condition | Placebo comparator | The patient is incorrectly told that stimulation is on Receives: Device: Stimulation OFF; Drug: Told ON |
| Total treatment | Active comparator | The patient is correctly told that stimulation is on Receives: Device: Stimulation ON; Drug: Told ON |
| Stimulation treatment | Other | The patient is incorrectly told that stimulation is off Receives: Device: Stimulation ON; Device: Told OFF |
| Control condition | Other | The patient is correctly told that stimulation is off Receives: Device: Stimulation OFF; Device: Told OFF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity, Visual Analogue Scale
0-10 (0=no pain, 10=worst imaginable pain). Continual assessments to register changes.
Measured: Every 15 minutes during study session (max 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start2 Jan 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885061
- Sponsor's protocol ID
- UAarhus_SCS
- Status last verified
- Mar 2026
- First submitted
- 1 May 2023
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Spinal Cord Stimulation
- ClinicalTrials.gov ID
- NCT05885061
- Acronym / sponsor ID
- UAarhus_SCS
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this interventional study is to test effects of spinal cord stimulation in patients receiving treatment for their chronic pain. The main question of the study is:
- What is the effect of spinal cord stimulation when compared to placebo? Participants will rate their pain with their usual spinal cord stimulation on and off.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo condition | Placebo comparator | Device: Stimulation OFF, Drug: Told ONThe patient is incorrectly told that stimulation is on |
| Total treatment | Active comparator | Device: Stimulation ON, Drug: Told ONThe patient is correctly told that stimulation is on |
| Stimulation treatment | Other | Device: Stimulation ON, Device: Told OFFThe patient is incorrectly told that stimulation is off |
| Control condition | Other | Device: Stimulation OFF, Device: Told OFFThe patient is correctly told that stimulation is off |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients (>18 years of age) with SCS implanted to treat chronic pain.
- Patients who consent to participation and can cooperate in the study.
- Use of continuous paresthesia-free SCS for minimum 6 months prior to participation in the study.
- Pain score of 7 or less on a 0-10 scale in the most painful area treated with SCS, rated upon inclusion.
- Patients not receiving other neuromodulation treatment.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stimulation OFFStimulation is turned OFF | Device | Control condition, Placebo condition |
| Stimulation ONStimulation is turned ON | Device | Stimulation treatment, Total treatment |
| Told ONVerbal suggestion that stimulation is ON | Drug | Placebo condition, Total treatment |
| Told OFFVerbal suggestion that stimulation is OFF | Device | Control condition, Stimulation treatment |
Primary outcome
Pain intensity, Visual Analogue Scale
Time frame: Every 15 minutes during study session (max 4 hours)
0-10 (0=no pain, 10=worst imaginable pain). Continual assessments to register changes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulation OFF, Stimulation ON and Told ON in people with Chronic Pain, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lene Vase (+4587165828, lenevase@psy.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity, Visual Analogue Scale (time frame: Every 15 minutes during study session (max 4 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.