Effects of Spinal Cord Stimulation

Not Applicable

Recruiting

• Conditions: Chronic Pain

• Registration Number: NCT05885061
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study Start: 2023-05-01
• Study First Submitted: 2023-05-01
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-06-01
• Last Update Submitted: 2023-06-08
• Last Update Posted: 2023-06-12
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pain intensity, Visual Analogue Scale	Every 30 minutes during study session (max 5 hours)	0-10 (0=no pain, 10=worst imaginable pain). Continual assessments to register changes.

Trial Locations

Locations (1)

Department of Neurosurgery, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark