Effects of Spinal Cord Stimulation

University of Aarhus

Status: Enrolling

Conditions: Chronic Pain

Treatments: Device: Spinal cord stimulation turned off (suggestions: on); Device: Spinal cord stimulation turned on with suggestions (suggestions on); Device: Spinal cord stimulation turned on (suggestions: off)

Study type: Interventional

Funder types: Other

Identifiers

NCT05885061

UAarhus_SCS

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 99 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: Crossover Assignment

Masking: Triple Blind

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25 participants in 4 patient groups, including a placebo group

Spinal cord stimulation turned on

Active Comparator group

Treatment:

Device: Spinal cord stimulation turned on (suggestions: off)

Spinal cord stimulation turned off

Placebo Comparator group

Treatment:

Device: Spinal cord stimulation turned off (suggestions: on)

Spinal cord stimulation turned on and suggestions

Active Comparator group

Treatment:

Device: Spinal cord stimulation turned on with suggestions (suggestions on)

Control

No Intervention group