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NCT Number: NCT07330466

Does Spinal Cord Stimulation 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.

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Key information

Conditions

Spinal Cord Stimulation Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Stimulation ON

Device

Stimulator will be turned on

Stimulation OFF

Device

Stimulation is turned off

Told ON

Device

Verbal suggestion that stimulation is on

Told OFF

Device

Verbal suggestion that stimulation is off

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Emborg, Postdoc

CONTACT

[email protected]

+4520910215

Lene Vase, Professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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