Effects of Spinal Cord Stimulation

University of Aarhus25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Pain

Interventions

Stimulation OFFDEVICE

Stimulation is turned OFF

Stimulation ONDEVICE

Stimulation is turned ON

Told ONDRUG

Verbal suggestion that stimulation is ON

Told OFF

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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).

Locations (1)

Department of Neurosurgery, Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Outcomes

Primary Outcomes

Pain intensity, Visual Analogue Scale

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

Time frame: Every 15 minutes during study session (max 4 hours)

Central Contacts

Lene Vase

CONTACT

+4587165828 lenevase@psy.au.dk

Christina Emborg, PhD

CONTACT

20910215 chrisemb@psy.au.dk

Data from ClinicalTrials.gov

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