Referred PainNCT03926364
Profile of Pain and Unpleasant Sensations in Patients With Referred Pain
An observational study of Referred Pain and Somatic Pain, run by Aalborg University at 2 sites in Denmark.
Trial summary
This feasibility study primarily aimed to assess the technology acceptance and usability of a pain tracking software in patients with spinally referred chronic pain. The secondary aim was to assess the fluctuations in pain intensity and distribution, using the pain tracking software during a 3-month period. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Referred Pain, Somatic Pain, Neuropathic Pain
- What is being tested?
- Patients with referred pain
- How many people
- 90 participants
- Where
- 2 sitesDenmark
- Study dates
- 30 Mar 2018to 31 Jul 2019
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with referred pain recruited from advertisement in public areas, social media, public and collaborating private clinics and hospitals.
Who may be able to join
- Suffer from pain in the neck or lumbar spine referring to a limb for a more than 7 consecutive days
- Participant is willing and able to give informed consent for participation in the study.
Who cannot join
- Pregnancy or breastfeeding, severe infections, cancer.
- Epilepsy, Multiple sclerosis, history of stroke, diabetes, traumatic spinal cord injury resulting in permanent functions loss
- Lack of ability to cooperate due to language barrier, cognition or inability to use technology.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aalborg University Hospital
Aalborg, 9000
Aalborg University
Aalborg, 9220
About this study
Official title: Spatiotemporal Profile of Pain and Unpleasant Sensations in Referred Pain: a Feasibility Study
This feasibility study primarily aimed to assess the technology acceptance and usability of a pain tracking software in patients with spinally referred chronic pain. The secondary aim was to assess the fluctuations in pain intensity and distribution, using the pain tracking software during a 3-month period. Additionally, the study aimed to explore the patients' behavior when self-reporting pain when given the opportunity to use a variety of pain quality descriptors, such as tingling, burning and stabbing.
Patients with spinally referred chronic pain will be recruited to participate. Participants will be asked to use a pain tracking software to create weekly pain reports for a 3-month period. These pain reports consist of pain drawings and intensity scales. Additionally, patients will complete baseline disability and pain catastrophizing online questionnaires. The project does not affect treatment or does not offer any intervention.
- Conditions
- Referred Pain, Somatic Pain, Neuropathic Pain
- Being tested
- Patients with referred pain
- Keywords
- Pain drawings, referred pain, somatic pain, neuropathic pain, e-health, pain location, biopsychosocial factors, back pain, neck pain, pain extent, function
- Medical subject headings
- Pain, Referred, Nociceptive Pain, Neuralgia, Back Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with referred painOther
The project does not affect treatment or does not offer any intervention.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Referred pain Receives: Other: Patients with referred pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain extent for 3 months
Changes in pain extent as measured by the number of pixels drawn in digital pain drawings, at weekly intervals.
Measured: 3 months
Secondary outcomes (4)
Change in pain intensity for 3 months
Changes in usual and current pain intensity as measured by a Numerical Rating Scale, at a weekly interval.
Measured: 3 months
Changes in pain location for 3 months
Changes of the location of pain measured by appearance and disappearance of pain in different body regions.
Measured: 3 months
Disability levels at baseline
Description of disability levels as assessed by the Oswestry (if pain located in back) or the Neck Disability Index (if pain located in neck) online questionnaires.
Measured: Baseline
Pain Catastrophizing score
Scores obtained from an online Pain Catastrophizing Scale (PCS) at baseline
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start30 Mar 2018
- Primary completion1 Jun 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Referred 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital
- Responsible party
- Principal investigator, Shellie A. Boudreau, Aalborg University
- Investigators
- Shellie A Boudreau, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926364
- Sponsor's protocol ID
- 2015-57-0001/2
- Status last verified
- Aug 2019
- First submitted
- 7 Jun 2018
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The location of the advanced analyses may occur in collaboration with other machine learning experts
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatiotemporal Profile of Pain and Unpleasant Sensations in Referred Pain: a Feasibility Study
- ClinicalTrials.gov ID
- NCT03926364
- Acronym / sponsor ID
- 2015-57-0001/2
- Conditions
- Referred Pain, Somatic Pain, Neuropathic Pain
- Keywords
- Pain drawings, referred pain, somatic pain, neuropathic pain, e-health, pain location, biopsychosocial factors, back pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Aalborg University Hospital
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 24 Apr 2019 (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.
This feasibility study primarily aimed to assess the technology acceptance and usability of a pain tracking software in patients with spinally referred chronic pain. The secondary aim was to assess the fluctuations in pain intensity and distribution, using the pain tracking software during a 3-month period. Additionally, the study aimed to explore the patients' behavior when self-reporting pain when given the opportunity to use a variety of pain quality descriptors, such as tingling, burning and stabbing.
Patients with spinally referred chronic pain will be recruited to participate. Participants will be asked to use a pain tracking software to create weekly pain reports for a 3-month period. These pain reports consist of pain drawings and intensity scales. Additionally, patients will complete baseline disability and pain catastrophizing online questionnaires. The project does not affect treatment or does not offer any intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Patients with referred painReferred pain |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with referred pain recruited from advertisement in public areas, social media, public and collaborating private clinics and hospitals.
Key inclusion criteria (2 listed)
- Suffer from pain in the neck or lumbar spine referring to a limb for a more than 7 consecutive days
- Participant is willing and able to give informed consent for participation in the study.
Key exclusion criteria (3 listed)
- Pregnancy or breastfeeding, severe infections, cancer.
- Epilepsy, Multiple sclerosis, history of stroke, diabetes, traumatic spinal cord injury resulting in permanent functions loss
- Lack of ability to cooperate due to language barrier, cognition or inability to use technology.
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 |
|---|---|---|
| Patients with referred painThe project does not affect treatment or does not offer any intervention. | Other | Patients |
Primary outcome
Change in pain extent for 3 months
Time frame: 3 months
Changes in pain extent as measured by the number of pixels drawn in digital pain drawings, at weekly intervals.
4 secondary outcomes
Change in pain intensity for 3 months
Time frame: 3 months
Changes in pain location for 3 months
Time frame: 3 months
Disability levels at baseline
Time frame: Baseline
Pain Catastrophizing score
Time frame: Baseline
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 21 Aug 2019.
- Individual participant dataSharing planned: Undecided. The location of the advanced analyses may occur in collaboration with other machine learning experts
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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.
Shellie A Boudreau, PhD principal investigator
Associate Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Referred Pain and Somatic Pain, run by Aalborg University at 2 sites in Denmark.
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 2 inclusion and 3 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 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Change in pain extent for 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2019.