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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03926364
Other study ID # 2015-57-0001/2
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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