Effects of Spinal Cord Stimulation
1 other identifier
interventional
25
1 country
1
Brief 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 stimulation on and off.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable chronic-pain
Started Jan 2025
Longer than P75 for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2023
CompletedFirst Posted
Study publicly available on registry
June 1, 2023
CompletedStudy Start
First participant enrolled
January 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
April 1, 2026
March 1, 2026
4 years
May 1, 2023
March 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Pain intensity, Visual Analogue Scale
0-10 (0=no pain, 10=worst imaginable pain). Continual assessments to register changes.
Every 15 minutes during study session (max 4 hours)
Study Arms (4)
Placebo condition
PLACEBO COMPARATORThe patient is incorrectly told that stimulation is on
Total treatment
ACTIVE COMPARATORThe patient is correctly told that stimulation is on
Stimulation treatment
OTHERThe patient is incorrectly told that stimulation is off
Control condition
OTHERThe patient is correctly told that stimulation is off
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aarhus University Hospitalcollaborator
Study Sites (1)
Department of Neurosurgery, Aarhus University Hospital
Aarhus, 8200, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2023
First Posted
June 1, 2023
Study Start
January 2, 2025
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
April 1, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share