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Completed

NCT Number: NCT04668482

Sweat Gland Function in Patients With Failed Back Surgery Syndrome, Treated With Spinal Cord Stimulation

This study is investigating sweat gland function during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome.

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Key information

Conditions

Failed Back Surgery Syndrome Back Pain Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is at least 18 years old.
  • Diagnosis of FBSS (Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy) and currently being treated with spinal cord stimulation.
  • Cognitive and language functioning enabling coherent communication between the examiner and the participant.

Exclusion criteria

  • Patients with major psychiatric problems.

Treatment and study plan

SCS is switched off

Device

Spinal cord stimulator is switched off for 12 hours

SCS is switched on

Device

Spinal cord stimulator is functioning

Primary outcomes

  1. Sweat gland function by measuring Electrochemical Skin Conductances (ESC)

    Time frame: The change between the measurement while SCS is switched off and while SCS is switched on. Total study duration lasts one day.

    The investigators will examine the difference in sweat gland function between both measurements (SCS on versus SCS off), measured with the Sudoscan.

Secondary outcomes

  1. Pain intensity scores using the Visual Analogue Scale

    Time frame: Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.

    Pain intensity score on that time on a Visual Analogue Scale (VAS) from zero (no pain) towards 10 cm (worst possible pain) for the pain intensity.

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 16, 2020
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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