Does Spinal Cord Stimulation Have an Effect Beyond Patients' Expectations? An Investigation of Treatment and Placebo Effects

University of Aarhus

Overview

The aim of the study is to evaluate treatment outcomes of Spinal Cord Stimulation. In the study each patient participates in four test sessions of 4-5 hours. Patients arrive for test days with their stimulation on. In each test session, baseline pain is first evaluated. Then, SCS is regulated (on/off) and patients evaluate their pain intensity immidiately and every 15 minutes during the test sessions. Patients are blinded to the treatment conditions during their participation in the study. At all times, patients can resume their usual treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Spinal Cord Stimulation

Interventions

Stimulation ONDEVICE

Stimulator will be turned on

Stimulation OFFDEVICE

Stimulation is turned off

Told ONDEVICE

Verbal suggestion that stimulation is on

Told OFF

Eligibility

Sex: ALLMin age: 18 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)

Aarhus University Hospital

Aarhus N, Denmark

Outcomes

Primary Outcomes

Patients' subjective pain intensity evaluated on a 0-10 Mechanical Visual Analogue Scale (M-VAS)

Time frame: From enrollment to completion of four test sessions scheduled with a minimum interval of one week between each session.

Data from ClinicalTrials.gov

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