NCT03463109

Locating Nociceptive Stimuli on Digital Body Chart

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Low Back Pain
• Healthy Volunteers

Interventions

Type	Name	Description
OTHER	Electrocutaneous stimulation	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.
OTHER	Assessment + Electrocutaneous stimulation	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.

Timeline

• Start date: 2018-04-27
• Primary completion: 2020-01-31
• Completion: 2020-01-31
• First posted: 2018-03-13
• Last updated: 2020-03-23

Locations

1 site across 1 country: Italy