Profile of Pain and Unpleasant Sensations in Patients With Referred Pain

NCT03926364 | Completed DMC

• 1 other identifier: 2015-57-0001/2
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

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.

  3 months

Secondary Outcomes (4)

• Change in pain intensity for 3 months

  3 months

• Changes in pain location for 3 months

  3 months

• Disability levels at baseline

  Baseline

• Pain Catastrophizing score

  Baseline

Other Outcomes (1)

• Demographic information

  At baseline

Study Arms (1)

Patients

Referred pain

Other: Patients with referred pain

Interventions

Patients with referred pain OTHER

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

Patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aalborg University: lead
• Aalborg University Hospital: collaborator

Study Sites (2)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Aalborg University

Aalborg, 9220, Denmark

Location

MeSH Terms

Conditions

Pain, Referred; Nociceptive Pain; Neuralgia; Back Pain; Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Shellie A Boudreau, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: April 24, 2019
• Study Start: March 30, 2018
• Primary Completion: June 1, 2019
• Study Completion: July 31, 2019
• Last Updated: August 21, 2019

Record last verified: 2019-08

Locations

DK (2)