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
• Status: Recruiting
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Chronic Pain

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)