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Completed

NCT Number: NCT03463109

Locating Nociceptive Stimuli on Digital Body Chart

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.

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Key information

Conditions

Low Back Pain Back Pain Healthy Volunteers Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Raffaele Scientific Institute

Milan, 20132, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Immediately after the electrocutaneous stimulation

Secondary outcomes

  1. Oswestry Disability Index (ODI) score

    Time frame: Before electrocutaneous stimulation

    The Oswestry Disability Index is a tool for the assessment of a patient's functional disability. It is a self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.

    Each topic category is followed by six statements describing different scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5, where 0 indicates less amount of disability and 5 indicates most severe disability.

    The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

    Italian validated version of the scale will be used.

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

    Time frame: Before electrocutaneous stimulation

    The patient will be asked to draw a vertical line on a horizontal 10 cm line, where he/she felt the current pain intensity would be better represented, in a range from the left end of the line indicating "no pain" corresponding to 0 cm to the right one indicating "worst pain imaginable" corresponding to 10 cm.

    The total score of the scale ranges from 0 = "no pain" to 10 = "worst pain imaginable".

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

    Time frame: Before electrocutaneous stimulation

    The patient will be asked to draw a vertical line on a horizontal 10 cm line, where he/she felt the recent pain intensity would be better represented, in a range from the left end of the line indicating "no pain" corresponding to 0 cm to the right one indicating "worst pain imaginable" corresponding to 10 cm.

  4. Tampa Scale for Kinesiophobia (TSK-13)

    Time frame: Before electrocutaneous stimulation

    The Tampa Scale of Kinesiophobia (TSK) is a 13 item scale developed to measure the fear of movement (kinesiophobia) related to chronic lower back pain. Respondents are asked to rate each item on a 4-point Likert scale, ranging from 1 (strongly disagree) to 4 (strongly agree). The subscale ranges scores are 13-22 suggesting "subclinical level of kinesiophobia", 23-32 suggesting "mild level of kinesiophobia", 33-42 suggesting "moderate level of kinesiophobia" and 43-52 suggesting "severe level of kinesiophobia".

    Italian validated version of the scale will be used.

  5. The Short Form Health Survey (SF-36)

    Time frame: Before electrocutaneous stimulation

    The Short Form Health Survey (SF-36) is a 36 item questionnaire which measures the quality of life across eight domains, which are both physically and emotionally based. High scores define a more favorable health state.

    Italian validated version of the scale will be used.

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

Locating Nociceptive Stimuli Applied to the Lumbar Region in Healthy Subjects and in Subjects With Chronic Low Back Pain

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 13, 2018
Registry last updated
Mar 23, 2020

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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