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Effects of Spinal Cord Stimulation

Primary Purpose

Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Spinal cord stimulation turned on (suggestions: off)
Spinal cord stimulation turned off (suggestions: on)
Spinal cord stimulation turned on with suggestions (suggestions on)
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Department of Neurosurgery, Aarhus University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

No Intervention

Arm Label

Spinal cord stimulation turned on

Spinal cord stimulation turned off

Spinal cord stimulation turned on and suggestions

Control

Arm Description

Outcomes

Primary Outcome Measures

Pain intensity, Visual Analogue Scale
0-10 (0=no pain, 10=worst imaginable pain). Continual assessments to register changes.

Secondary Outcome Measures

Full Information

First Posted
May 1, 2023
Last Updated
June 8, 2023
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05885061
Brief Title
Effects of Spinal Cord Stimulation
Official Title
Effects of Spinal Cord Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this interventional study is to test effects of spinal cord stimulation in patients receiving treatment for their chronic pain. The main question of the study is: • What is the effect of spinal cord stimulation when compared to placebo? Participants will rate their pain with their usual spinal cord stimulation on and off.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spinal cord stimulation turned on
Arm Type
Active Comparator
Arm Title
Spinal cord stimulation turned off
Arm Type
Placebo Comparator
Arm Title
Spinal cord stimulation turned on and suggestions
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Spinal cord stimulation turned on (suggestions: off)
Intervention Description
Spinal cord stimulation turned on with verbal suggestions of treatment off
Intervention Type
Device
Intervention Name(s)
Spinal cord stimulation turned off (suggestions: on)
Intervention Description
Spinal cord stimulation turned off with verbal suggestions of treatment on
Intervention Type
Device
Intervention Name(s)
Spinal cord stimulation turned on with suggestions (suggestions on)
Intervention Description
Spinal cord stimulation turned on with verbal suggestions of treatment on
Primary Outcome Measure Information:
Title
Pain intensity, Visual Analogue Scale
Description
0-10 (0=no pain, 10=worst imaginable pain). Continual assessments to register changes.
Time Frame
Every 30 minutes during study session (max 5 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lene Vase
Phone
+4587165828
Email
lenevase@psy.au.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Rosenkjær
Email
sr@psy.au.dk
Facility Information:
Facility Name
Department of Neurosurgery, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lene Vase
Email
lenevase@psy.au.dk
First Name & Middle Initial & Last Name & Degree
Sophie Rosenkjær
Email
sr@psy.au.dk

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Spinal Cord Stimulation

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