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NCT05885061 Clinical Trial

Effects of Spinal Cord Stimulation

Chronic Pain Clinical Trial

Official title:
Effects of Spinal Cord Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05885061
Other study ID # UAarhus_SCS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date December 31, 2028

Study information
Verified date May 2023
Source University of Aarhus
Contact Lene Vase
Phone +4587165828
Email lenevase@psy.au.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 25
Est. completion date December 31, 2028
Est. primary completion date December 31, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Spinal cord stimulation turned on (suggestions: off)
Spinal cord stimulation turned on with verbal suggestions of treatment off
• Spinal cord stimulation turned off (suggestions: on)
Spinal cord stimulation turned off with verbal suggestions of treatment on
• Spinal cord stimulation turned on with suggestions (suggestions on)
Spinal cord stimulation turned on with verbal suggestions of treatment on

Locations
Country Name City State
Denmark Department of Neurosurgery, Aarhus University Hospital Aarhus

Sponsors (2)
Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain intensity, Visual Analogue Scale 0-10 (0=no pain, 10=worst imaginable pain). Continual assessments to register changes. Every 30 minutes during study session (max 5 hours)
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