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Completed

NCT Number: NCT03926364

Profile of Pain and Unpleasant Sensations in Patients With Referred Pain

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.

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Key information

Conditions

Referred Pain Back Pain Neck Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Nociceptive Pain Pain Pain, Referred Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Somatic Pain

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg University, Aalborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Patients with referred pain

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in pain intensity for 3 months

    Time frame: 3 months

    Changes in usual and current pain intensity as measured by a Numerical Rating Scale, at a weekly interval.

  2. Changes in pain location for 3 months

    Time frame: 3 months

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

  3. Disability levels at baseline

    Time frame: 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.

  4. Pain Catastrophizing score

    Time frame: Baseline

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

Other outcomes

  1. Demographic information

    Time frame: At baseline

    Online demographic information

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Collaborators

  • Aalborg University Hospital

Registry information

Official study title

Spatiotemporal Profile of Pain and Unpleasant Sensations in Referred Pain: a Feasibility Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 24, 2019
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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