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

NCT07330466 | Recruiting

• 2 other identifiers: Spinal Cord Stimulation3165-00146B
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Stimulation

Keywords

Spinal Cord Stimulation; Chronic pain

Outcome Measures

Primary Outcomes (1)

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

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

Study Arms (4)

Placebo condition

PLACEBO COMPARATOR

The patient is incorrectly told that stimulation is on

Device: Stimulation OFF; Device: Told ON

Total treatment

ACTIVE COMPARATOR

The patient is correctly told that stimulation is on

Device: Stimulation ON; Device: Told ON

Stimulation treatment

OTHER

The patient is incorrectly told that stimulation is off

Device: Stimulation ON; Device: Told OFF

Control condition

OTHER

The patient is correctly told that stimulation is off

Device: Stimulation OFF; Device: Told OFF

Interventions

Stimulation ON DEVICE

Stimulator will be turned on

Stimulation treatment; Total treatment

Stimulation OFF DEVICE

Stimulation is turned off

Control condition; Placebo condition

Told ON DEVICE

Verbal suggestion that stimulation is on

Placebo condition; Total treatment

Told OFF DEVICE

Verbal suggestion that stimulation is off

Control condition; Stimulation treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christina Emborg, Postdoc

CONTACT

+4520910215; chrisemb@psy.au.dk

Lene Vase, Professor

CONTACT

lenevase@psy.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoc

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: January 9, 2026
• Study Start: September 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2025-09

Locations

DK (1)