Profile of Pain and Unpleasant Sensations in Patients With Referred Pain

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03926364
• Other study ID #: 2015-57-0001/2
• Status: Completed
• Start date: March 30, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: August 2019
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 31, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Nociceptive Pain
• Pain, Referred
• Referred Pain
• Somatic Pain

Intervention

Other:
• Patients with referred pain
The project does not affect treatment or does not offer any intervention.

Locations

Country	Name	City	State
Denmark	Aalborg University	Aalborg
Denmark	Aalborg University Hospital	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University	Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic information	Online demographic information	At baseline
Primary	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	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
Secondary	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
Secondary	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
Secondary	Pain Catastrophizing score	Scores obtained from an online Pain Catastrophizing Scale (PCS) at baseline	Baseline