Profile of Pain and Unpleasant Sensations in Patients With Referred Pain

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.

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain; Somatic Pain; Referred Pain
• Intervention / Treatment: Other: Patients with referred pain

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg University Hospital
  • Aalborg, Denmark, 9220
    • Aalborg University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Referred pain	Other: Patients with referred pain; The project does not affect treatment or does not offer any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline
Pain Catastrophizing score	Scores obtained from an online Pain Catastrophizing Scale (PCS) at baseline	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic information	Online demographic information	At baseline

Collaborators and Investigators

• Sponsor: Aalborg University
• Collaborators: Aalborg University Hospital
• Investigators: Principal Investigator: Shellie A Boudreau, PhD, Associate Professor

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 30, 2018
• Primary Completion (ACTUAL): June 1, 2019
• Study Completion (ACTUAL): July 31, 2019

Study Registration Dates

• First Submitted: June 7, 2018
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (ACTUAL): April 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: back pain; neck pain; function; neuropathic pain; e-health; referred pain; Pain drawings; somatic pain; pain location; biopsychosocial factors; pain extent
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Nociceptive Pain; Pain, Referred
• Other Study ID Numbers: 2015-57-0001/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The location of the advanced analyses may occur in collaboration with other machine learning experts

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No