Does Spinal Cord Stimulation Have an Effect Beyond Patients' Expectations? An Investigation of Treatment and Placebo Effects

January 4, 2026 updated by: Christina Emborg, University of Aarhus

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo condition
The patient is incorrectly told that stimulation is on
Device: Stimulation OFF
Stimulation is turned off
Device: Told ON
Verbal suggestion that stimulation is on
Active Comparator: Total treatment
The patient is correctly told that stimulation is on
Device: Told ON
Verbal suggestion that stimulation is on
Device: Stimulation ON
Stimulator will be turned on
Other: Stimulation treatment
The patient is incorrectly told that stimulation is off
Device: Stimulation ON
Stimulator will be turned on
Device: Told OFF
Verbal suggestion that stimulation is off
Other: Control condition
The patient is correctly told that stimulation is off
Device: Stimulation OFF
Stimulation is turned off
Device: Told OFF
Verbal suggestion that stimulation is off

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
From enrollment to completion of four test sessions scheduled with a minimum interval of one week between each session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

September 19, 2025

First Submitted That Met QC Criteria

January 4, 2026

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 4, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Spinal Cord Stimulation
  • 3165-00146B (Other Grant/Funding Number: Independent Research Fund Denmark)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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