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

University of Aarhus

Status: Enrolling

Conditions: Spinal Cord Stimulation

Treatments: Device: Told OFF; Device: Stimulation OFF; Device: Told ON; Device: Stimulation ON

Study type: Interventional

Funder types: Other

Identifiers

NCT07330466

3165-00146B (Other Grant/Funding Number)

Spinal Cord Stimulation

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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25 participants in 4 patient groups, including a placebo group

Placebo condition

Placebo Comparator group

Description:

The patient is incorrectly told that stimulation is on

Treatment:

Device: Told ON

Device: Stimulation OFF

Total treatment

Active Comparator group

Description:

The patient is correctly told that stimulation is on

Treatment:

Device: Stimulation ON

Device: Told ON

Stimulation treatment

Other group

Description:

The patient is incorrectly told that stimulation is off

Treatment:

Device: Stimulation ON

Device: Told OFF

Control condition

Other group

Description:

The patient is correctly told that stimulation is off

Treatment:

Device: Stimulation OFF

Device: Told OFF