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

NCT ID: NCT07330466

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo condition

The patient is incorrectly told that stimulation is on

Group Type PLACEBO_COMPARATOR

Stimulation OFF

Intervention Type DEVICE

Stimulation is turned off

Told ON

Intervention Type DEVICE

Verbal suggestion that stimulation is on

Total treatment

The patient is correctly told that stimulation is on

Group Type ACTIVE_COMPARATOR

Stimulation ON

Intervention Type DEVICE

Stimulator will be turned on

Told ON

Intervention Type DEVICE

Verbal suggestion that stimulation is on

Stimulation treatment

The patient is incorrectly told that stimulation is off

Group Type OTHER

Stimulation ON

Intervention Type DEVICE

Stimulator will be turned on

Told OFF

Intervention Type DEVICE

Verbal suggestion that stimulation is off

Control condition

The patient is correctly told that stimulation is off

Group Type OTHER

Stimulation OFF

Intervention Type DEVICE

Stimulation is turned off

Told OFF

Intervention Type DEVICE

Verbal suggestion that stimulation is off

Interventions

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Stimulation ON

Stimulator will be turned on

Intervention Type DEVICE

Stimulation OFF

Stimulation is turned off

Intervention Type DEVICE

Told ON

Verbal suggestion that stimulation is on

Intervention Type DEVICE

Told OFF

Verbal suggestion that stimulation is off

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Christina Emborg

Postdoc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aarhus University Hospital

Aarhus N, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Christina Emborg, Postdoc

Role: CONTACT

+4520910215

Lene Vase, Professor

Role: CONTACT

Facility Contacts

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Kaare Meier

Role: primary

+45 24 99 50 34

Other Identifiers

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3165-00146B

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Spinal Cord Stimulation

Identifier Type: -

Identifier Source: org_study_id

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