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NCT Number: NCT05885061

Effects of Spinal Cord Stimulation

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.

Recruiting

Interested in participating?

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–99 year

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 OFF

Device

Stimulation is turned OFF

Stimulation ON

Device

Stimulation is turned ON

Told ON

Drug

Verbal suggestion that stimulation is ON

Told OFF

Device

Verbal suggestion that stimulation is OFF

Primary outcomes

  1. 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.

Study contacts

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

Christina Emborg, PhD

CONTACT

[email protected]

20910215

Lene Vase

CONTACT

[email protected]

+4587165828

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 1, 2023
Registry last updated
Apr 1, 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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