CClinicalTrials.gg
CompletedNCT03926364Updated Aug 21, 2019

Profile of Pain and Unpleasant Sensations in Patients With Referred Pain

An observational study in Referred Pain, Somatic Pain and Neuropathic Pain, sponsored by Aalborg University. Completed at 2 sites in Denmark. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-08-21.

Sponsored by Aalborg University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
18 Years to 85 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Referred Pain
  • Somatic Pain
  • Neuropathic Pain

Keywords

  • Pain drawings
  • referred pain
  • somatic pain
  • neuropathic pain
  • e-health
  • pain location
  • biopsychosocial factors
  • back pain
  • neck pain
  • pain extent
  • function
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 90 is close to the median of 100 across 260 observational studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

Aalborg University is the lead sponsor of 178 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with referred pain recruited from advertisement in public areas, social media, public and collaborating private clinics and hospitals.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients

    Referred pain

    Other: Patients with referred pain

Interventions

  • OtherPatients with referred pain

    The project does not affect treatment or does not offer any intervention.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

Secondary outcomes

  1. 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.

    Time frame: 3 months

  2. Changes in pain location for 3 months

    Changes of the location of pain measured by appearance and disappearance of pain in different body regions.

    Time frame: 3 months

  3. 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.

    Time frame: Baseline

  4. Pain Catastrophizing score

    Scores obtained from an online Pain Catastrophizing Scale (PCS) at baseline

    Time frame: Baseline

Other outcomes

  1. Demographic information

    Online demographic information

    Time frame: At baseline

07

Study locations

2 sites
  • Aalborg University Hospital
    Aalborg, 9000, Denmark
  • Aalborg University
    Aalborg, 9220, Denmark
08

References and documents

Individual participant data

Plan to share: Undecided — The location of the advanced analyses may occur in collaboration with other machine learning experts

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03926364
Lead sponsor
Aalborg University
Collaborators
Aalborg University Hospital
Responsible party
Shellie A. Boudreau (Associate Professor, Aalborg University) — Principal investigator
First posted
Apr 24, 2019
Start date
Mar 30, 2018
Primary completion
Jun 1, 2019
Completion
Jul 31, 2019
Last update
Aug 21, 2019

Study contacts

Shellie A Boudreau, PhD
principal investigator · Associate Professor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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