Low Back PainNCT03463109
Locating Nociceptive Stimuli on Digital Body Chart
A study testing Electrocutaneous stimulation and Assessment + Electrocutaneous stimulation in people with Low Back Pain and Healthy Volunteers, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Healthy Volunteers
- What is being tested?
- Electrocutaneous stimulation and Assessment + Electrocutaneous stimulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- 27 Apr 2018to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chronic low back pain (duration more than three months)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Locating Nociceptive Stimuli Applied to the Lumbar Region in Healthy Subjects and in Subjects With Chronic Low Back Pain
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.
Read the 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
- Being tested
- Electrocutaneous stimulation, Assessment + Electrocutaneous stimulation
- Keywords
- Chronic low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrocutaneous stimulationOther
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 stimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Assessment + Electrocutaneous stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The distance from marked points to the representation of the stimulated point on the digital body chart.
Measured: Immediately after the electrocutaneous stimulation
Secondary outcomes (5)
Oswestry Disability Index (ODI) score
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.
Measured: Before electrocutaneous stimulation
Current pain level on Visual Analogue Scale (VAS, 0-10 cm)
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".
Measured: Before electrocutaneous stimulation
Recent pain (last week) level on Visual Analogue Scale (VAS, 0-10 cm)
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.
Measured: Before electrocutaneous stimulation
Tampa Scale for Kinesiophobia (TSK-13)
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.
Measured: Before electrocutaneous stimulation
The Short Form Health Survey (SF-36)
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.
Measured: Before electrocutaneous stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start27 Apr 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The same procedure will be used for people with chronic low back pain and for healthy volunteers.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandra Raschi, IRCCS San Raffaele
- Investigators
- Marco Barbero, Study director, University of Applied Sciences and Arts of Southern Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463109
- Sponsor's protocol ID
- Localizzazione Stimoli
- Status last verified
- Mar 2020
- First submitted
- 22 Feb 2018
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all assessments (primary and secondary outcomes) will be made available.
Publications
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.
PubMed 26992099Barbero 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.
PubMed 25565607
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locating Nociceptive Stimuli Applied to the Lumbar Region in Healthy Subjects and in Subjects With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03463109
- Acronym / sponsor ID
- Localizzazione Stimoli
- Conditions
- Low Back Pain, Healthy Volunteers
- Keywords
- Chronic low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 27 Apr 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The same procedure will be used for people with chronic low back pain and for healthy volunteers.
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Other | Other: Electrocutaneous stimulationElectrocutaneous 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. |
| Chronic Low Back Pain | Other | Other: Assessment + Electrocutaneous stimulationAssessment + 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic low back pain (duration more than three months)
Key exclusion criteria (8 listed)
- denial of informed consent;
- presence of pacemaker;
- pregnancy or possible pregnancy status;
- lumbar surgery (spinal fusion);
- documented degenerative pathology of the central nervous system;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrocutaneous stimulationPainful 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 | Healthy Volunteers |
| Assessment + Electrocutaneous stimulationPatients 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. | Other | Chronic Low Back Pain |
Primary outcome
The distance from marked points to the representation of the stimulated point on the digital body chart.
Time frame: Immediately after the electrocutaneous stimulation
5 secondary outcomes
Oswestry Disability Index (ODI) score
Time frame: Before electrocutaneous stimulation
Current pain level on Visual Analogue Scale (VAS, 0-10 cm)
Time frame: Before electrocutaneous stimulation
Recent pain (last week) level on Visual Analogue Scale (VAS, 0-10 cm)
Time frame: Before electrocutaneous stimulation
Tampa Scale for Kinesiophobia (TSK-13)
Time frame: Before electrocutaneous stimulation
The Short Form Health Survey (SF-36)
Time frame: Before electrocutaneous stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Results publication: PubMed 26992099Leoni 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.
- Results publication: PubMed 25565607Barbero 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all assessments (primary and secondary outcomes) will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Barbero study director
University of Applied Sciences and Arts of Southern Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrocutaneous stimulation and Assessment + Electrocutaneous stimulation in people with Low Back Pain and Healthy Volunteers, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The distance from marked points to the representation of the stimulated point on the digital body chart. (time frame: Immediately after the electrocutaneous stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03463109, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.