Does Spinal Cord Stimulation Have an Effect Beyond Patients' Expectations? An Investigation of Treatment and Placebo Effects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stimulation ON, Stimulation OFF, Told ON, Told OFF.
- Who it may be relevant to
- Registry conditions: Spinal Cord Stimulation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Does Spinal Cord Stimulation (SCS) Have an Effect Beyond Patients' Expectations? An Investigation of Treatment and Placebo Effects
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.
Interventions
- Device Stimulation ON
Stimulator will be turned on - Device Stimulation OFF
Stimulation is turned off - Device Told ON
Verbal suggestion that stimulation is on - Device Told OFF
Verbal suggestion that stimulation is off
Primary outcome measures
- 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.]
Eligibility 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Aarhus University Hospital — Aarhus N
Identifiers
NCT: NCT07330466 · Spinal Cord Stimulation · 3165-00146B