Spinal Cord StimulationNCT07330466
Does Spinal Cord Stimulation Have an Effect Beyond Patients' Expectations? An Investigation of Treatment and Placebo Effects
A study testing Stimulation ON, Stimulation OFF and Told ON in people with Spinal Cord Stimulation, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of the study is to evaluate treatment outcomes of Spinal Cord Stimulation. In the study each patient participates in four test sessions of 4-5 hours. Patients arrive for test days with their stimulation on. In each test session, baseline pain is first evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Stimulation
- What is being tested?
- Stimulation ON, Stimulation OFF and Told ON
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- 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.
About this study
Official title: Does Spinal Cord Stimulation (SCS) Have an Effect Beyond Patients' Expectations? An Investigation of Treatment and Placebo Effects
The aim of the study is to evaluate treatment outcomes of Spinal Cord Stimulation. In the study each patient participates in four test sessions of 4-5 hours. Patients arrive for test days with their stimulation on. In each test session, baseline pain is first evaluated. Then, SCS is regulated (on/off) and patients evaluate their pain intensity immidiately and every 15 minutes during the test sessions. Patients are blinded to the treatment conditions during their participation in the study. At all times, patients can resume their usual treatment.
- Conditions
- Spinal Cord Stimulation
- Being tested
- Stimulation ON, Stimulation OFF, Told ON, Told OFF
- Keywords
- Spinal Cord Stimulation, Chronic pain
- 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 ONDevice
Stimulator will be turned on
Stimulation OFFDevice
Stimulation is turned off
Told ONDevice
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; Device: Told ON |
| Total treatment | Active comparator | The patient is correctly told that stimulation is on Receives: Device: Stimulation ON; Device: 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.
Patients' subjective pain intensity evaluated on a 0-10 Mechanical Visual Analogue Scale (M-VAS)
Measured: From enrollment to completion of four test sessions scheduled with a minimum interval of one week between each session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Sep 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Why it stopped: Registration deleted due to duplicate registration (see study "Effects of Spinal Cord Stimulation", ID NCT05885061)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord StimulationStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Emborg, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330466
- Sponsor's protocol ID
- Spinal Cord Stimulation
- Other IDs
- 3165-00146B
- Status last verified
- Aug 2026
- First submitted
- 19 Sep 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Spinal Cord Stimulation (SCS) Have an Effect Beyond Patients' Expectations? An Investigation of Treatment and Placebo Effects
- ClinicalTrials.gov ID
- NCT07330466
- Acronym / sponsor ID
- Spinal Cord Stimulation
- Conditions
- Spinal Cord Stimulation
- Keywords
- Spinal Cord Stimulation, Chronic pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Registration deleted due to duplicate registration (see study "Effects of Spinal Cord Stimulation", ID NCT05885061)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 9 Jan 2026 (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 aim of the study is to evaluate treatment outcomes of Spinal Cord Stimulation. In the study each patient participates in four test sessions of 4-5 hours. Patients arrive for test days with their stimulation on. In each test session, baseline pain is first evaluated. Then, SCS is regulated (on/off) and patients evaluate their pain intensity immidiately and every 15 minutes during the test sessions. Patients are blinded to the treatment conditions during their participation in the study. At all times, patients can resume their usual treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo condition | Placebo comparator | Device: Stimulation OFF, Device: Told ONThe patient is incorrectly told that stimulation is on |
| Total treatment | Active comparator | Device: Stimulation ON, Device: 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 years and older
- 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 ONStimulator will be turned on | Device | Stimulation treatment, Total treatment |
| Stimulation OFFStimulation is turned off | Device | Control condition, Placebo condition |
| Told ONVerbal suggestion that stimulation is on | Device | Placebo condition, Total treatment |
| Told OFFVerbal suggestion that stimulation is off | Device | Control condition, Stimulation treatment |
Primary outcome
Patients' subjective pain intensity evaluated on a 0-10 Mechanical Visual Analogue Scale (M-VAS)
Time frame: From enrollment to completion of four test sessions scheduled with a minimum interval of one week between each session.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 ON, Stimulation OFF and Told ON in people with Spinal Cord Stimulation, 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: withdrawn, as of the sponsor's last update on 3 Sep 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' subjective pain intensity evaluated on a 0-10 Mechanical Visual Analogue Scale (M-VAS) (time frame: From enrollment to completion of four test sessions scheduled with a minimum interval of one week between each session.). 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 3 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.