Effects of Spinal Cord Stimulation

NCT ID: NCT05885061

Last Updated: 2023-06-12

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

2023-05-01

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Spinal cord stimulation turned on

Group Type ACTIVE_COMPARATOR

Spinal cord stimulation turned on (suggestions: off)

Intervention Type DEVICE

Spinal cord stimulation turned on with verbal suggestions of treatment off

Spinal cord stimulation turned off

Group Type PLACEBO_COMPARATOR

Spinal cord stimulation turned off (suggestions: on)

Intervention Type DEVICE

Spinal cord stimulation turned off with verbal suggestions of treatment on

Spinal cord stimulation turned on and suggestions

Group Type ACTIVE_COMPARATOR

Spinal cord stimulation turned on with suggestions (suggestions on)

Intervention Type DEVICE

Spinal cord stimulation turned on with verbal suggestions of treatment on

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Spinal cord stimulation turned on (suggestions: off)

Spinal cord stimulation turned on with verbal suggestions of treatment off

Intervention Type DEVICE

Spinal cord stimulation turned off (suggestions: on)

Spinal cord stimulation turned off with verbal suggestions of treatment on

Intervention Type DEVICE

Spinal cord stimulation turned on with suggestions (suggestions on)

Spinal cord stimulation turned on with verbal suggestions of treatment on

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

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Neurosurgery, Aarhus University Hospital

Aarhus, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Lene Vase

Role: CONTACT

+4587165828

Sophie Rosenkjær

Role: CONTACT

Facility Contacts

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Lene Vase

Role: primary

Sophie Rosenkjær

Role: backup

Other Identifiers

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UAarhus_SCS

Identifier Type: -

Identifier Source: org_study_id

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