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Clinical Trials/NCT05885061
NCT05885061
Recruiting
N/A

Effects of Spinal Cord Stimulation

University of Aarhus1 site in 1 country25 target enrollmentMay 1, 2023
ConditionsChronic Pain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
University of Aarhus
Enrollment
25
Locations
1
Primary Endpoint
Pain intensity, Visual Analogue Scale
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
December 31, 2028
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pain intensity, Visual Analogue Scale

Time Frame: Every 30 minutes during study session (max 5 hours)

0-10 (0=no pain, 10=worst imaginable pain). Continual assessments to register changes.

Study Sites (1)

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