Profile of Pain and Unpleasant Sensations in Patients With Referred Pain

Completed

• Conditions: Neuropathic Pain; Referred Pain; Somatic Pain
• Interventions: Other: Patients with referred pain

• Registration Number: NCT03926364
• Lead Sponsor: Aalborg University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-30
• Study First Submitted: 2018-06-07
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-24
• Primary Completion: 2019-06-01
• Study Completion: 2019-07-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Patients with referred pain	Referred pain

Primary Outcome Measures

Name	Time	Method
Change in pain extent for 3 months	3 months	Changes in pain extent as measured by the number of pixels drawn in digital pain drawings, at weekly intervals.

Secondary Outcome Measures

Name	Time	Method
Changes in pain location for 3 months	3 months	Changes of the location of pain measured by appearance and disappearance of pain in different body regions.
Pain Catastrophizing score	Baseline	Scores obtained from an online Pain Catastrophizing Scale (PCS) at baseline
Change in pain intensity for 3 months	3 months	Changes in usual and current pain intensity as measured by a Numerical Rating Scale, at a weekly interval.
Disability levels at baseline	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.

Trial Locations

Locations (2)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Aalborg University; 🇩🇰 Aalborg, Denmark