Clinical trial NCT03463109: Locating Nociceptive Stimuli on Digital Body Chart
Official title: Locating Nociceptive Stimuli Applied to the Lumbar Region in Healthy Subjects and in Subjects With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Healthy Volunteers
Keywords: Chronic low back pain
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The same procedure will be used for people with chronic low back pain and for healthy volunteers.
Primary purpose: BASIC_SCIENCE

Brief summary: Digital body charts are used to assess the pain experience in people with pain. People are asked to report their pain by shading a human body template on a digital tablet. The aim of this study is to investigate whether people with chronic low back pain, compared to healthy volunteers, consistently locate on a digital body chart all nociceptive stimuli induced in the lumbar region.

Detailed description: Healthy volunteers and people presenting chronic low back pain, will be recruited. A standardized grid will be drawn over the participants' lumbar region. Circular electrodes, connected to a constant current stimulator, will be applied at points on the grid. All participants will be blinded to the electrode locations. Painful electrocutaneous stimuli will be randomly delivered for each electrode. Participants will be instructed to draw with a stylus pen on a digital body chart displayed on a tablet where they will perceive each painful stimulation.

The body chart will be centred on a canvas 768x1024 pixels (pxl), and pain location will be defined by X and Y coordinates. The consistency in reporting the location of each painful stimulation will be described through coordinates.

In addition, only people presenting chronic low back pain will be asked to provide information about their lifestyle, level of disability, actual pain and general pain, assessment of kinesiophobia and health status.

Eligibility criteria: Inclusion Criteria:

* Chronic low back pain (duration more than three months)

Exclusion Criteria:

* denial of informed consent;
* presence of pacemaker;
* pregnancy or possible pregnancy status;
* lumbar surgery (spinal fusion);
* documented degenerative pathology of the central nervous system;
* documented concomitant pathology altering sensitivity (e.g. diabetes, fibromyalgia);
* reduced motor control of the dominant hand (reported by every subject as conditioning the writing and therefore the ability to compile the body chart);
* presence of skin moles and/or scars on the back that may interfere with the conduction of the electrical stimulus.

Primary outcomes:
measure: The distance from marked points to the representation of the stimulated point on the digital body chart.
timeFrame: Immediately after the electrocutaneous stimulation
Secondary outcomes:
measure: Oswestry Disability Index (ODI) score
timeFrame: Before electrocutaneous stimulation
measure: Current pain level on Visual Analogue Scale (VAS, 0-10 cm)
timeFrame: Before electrocutaneous stimulation
measure: Recent pain (last week) level on Visual Analogue Scale (VAS, 0-10 cm)
timeFrame: Before electrocutaneous stimulation
measure: Tampa Scale for Kinesiophobia (TSK-13)
timeFrame: Before electrocutaneous stimulation
measure: The Short Form Health Survey (SF-36)
timeFrame: Before electrocutaneous stimulation
Other outcomes:
Locations:
city: Milan
country: Italy
facility: San Raffaele Scientific Institute
Study officials:
affiliation: University of Applied Sciences and Arts of Southern Switzerland
name: Marco Barbero
role: STUDY_DIRECTOR
References:
citation: Leoni D, Falla D, Heitz C, Capra G, Clijsen R, Egloff M, Cescon C, Baeyens JP, Barbero M. Test-retest Reliability in Reporting the Pain Induced by a Pain Provocation Test: Further Validation of a Novel Approach for Pain Drawing Acquisition and Analysis. Pain Pract. 2017 Feb;17(2):176-184. doi: 10.1111/papr.12429. Epub 2016 Mar 15.
citation: Barbero M, Moresi F, Leoni D, Gatti R, Egloff M, Falla D. Test-retest reliability of pain extent and pain location using a novel method for pain drawing analysis. Eur J Pain. 2015 Sep;19(8):1129-38. doi: 10.1002/ejp.636. Epub 2015 Jan 6.