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

ConditionSpinal Cord Stimulation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Aarhus

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Factorial

Treatments tested in this trial

Stimulation ON
Device
Stimulator will be turned on
Stimulation OFF
Device
Stimulation is turned off
Told ON
Device
Verbal suggestion that stimulation is on
Told OFF
Device
Verbal suggestion that stimulation is off

Treatment groups

25 Participants

are divided into 4 treatment groups

Group A: Placebo conditionPlacebo comparator 2 interventions

Group B: Total treatmentActive comparator 2 interventions

Group C: Stimulation treatmentOther 2 interventions

Group D: Control conditionOther 2 interventions

Trial 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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aarhus

Lead sponsor

Source ClinicalTrials.gov

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