Locating Nociceptive Stimuli on Digital Body Chart

NCT03463109 | Completed DMC

• 1 other identifier: Localizzazione Stimoli
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Healthy Volunteers

Keywords

Chronic low back pain

Outcome Measures

Primary Outcomes (1)

• The distance from marked points to the representation of the stimulated point on the digital body chart.

  Immediately after the electrocutaneous stimulation

Secondary Outcomes (5)

• Oswestry Disability Index (ODI) score

  Before electrocutaneous stimulation

• Current pain level on Visual Analogue Scale (VAS, 0-10 cm)

  Before electrocutaneous stimulation

• Recent pain (last week) level on Visual Analogue Scale (VAS, 0-10 cm)

  Before electrocutaneous stimulation

• Tampa Scale for Kinesiophobia (TSK-13)

  Before electrocutaneous stimulation

• The Short Form Health Survey (SF-36)

  Before electrocutaneous stimulation

Study Arms (2)

Healthy Volunteers

OTHER

Electrocutaneous stimulation. 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 selected at random. Participants will be blinded to the electrode locations. Sets of 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 the location on which they will perceive each painful stimulation.

Other: Electrocutaneous stimulation

Chronic Low Back Pain

OTHER

Assessment + Electrocutaneous stimulation. Patients with chronic low back pain will be asked to provide information about their lifestyle, level of disability, current pain, general pain and to undergo an assessment of kinesiophobia and health status. After the assessment, a standardized grid will be drawn over the patients' lumbar region. Circular electrodes, connected to a constant current stimulator, will be applied at points on the grid. Patients will be blinded to the electrode locations. Sets of painful electrocutaneous stimuli will be randomly delivered for each electrode. Patients 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.

Other: Assessment + Electrocutaneous stimulation

Interventions

Electrocutaneous stimulation OTHER

Painful electrocutaneous stimuli will be randomly delivered to electrodes positioned in a random order on the participants' back. 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.

Healthy Volunteers

Assessment + Electrocutaneous stimulation OTHER

Patients will be asked to provide information about their lifestyle, level of disability, actual pain and general pain, assessment of kinesiophobia and health status. Subsequently, painful electrocutaneous stimuli will be randomly delivered to electrodes positioned in a random order on the patients' back. Patients 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.

Chronic Low Back Pain

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

San Raffaele Scientific Institute

Milan, 20132, Italy

Location

Related Publications (2)

• 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.

  PMID: 26992099 RESULT

• 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.

  PMID: 25565607 RESULT

MeSH Terms

Conditions

Low Back Pain

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Marco Barbero

  University of Applied Sciences and Arts of Southern Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Every participant will recive stimulation on his back in a pre-defined random order.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The same procedure will be used for people with chronic low back pain and for healthy volunteers.

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 13, 2018
• Study Start: April 27, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: March 23, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Requestor will be required to sign a Data Access Agreement.

Locations

IT (1)