Locating Nociceptive Stimuli on Digital Body Chart

San Donato Group (GSD)

Status: Completed

Conditions: Healthy Volunteers; Low Back Pain

Treatments: Other: Electrocutaneous stimulation; Other: Assessment + Electrocutaneous stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03463109

Localizzazione Stimoli

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

72 participants in 2 patient groups

Healthy Volunteers

Other group

Description:

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.

Treatment:

Other: Electrocutaneous stimulation

Chronic Low Back Pain

Other group

Description:

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.

Treatment:

Other: Assessment + Electrocutaneous stimulation