An interventional study of Information material in Low Back Pain, sponsored by Aalborg University Hospital. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-27.
Sponsored by Aalborg University Hospital · Not applicable, Interventional, and Treatment
This project studies the effects of involving patients in the development of a web-application.
The point-prevalence of low back pain (LBP) has been estimated to 9.4 % and LBP is in many countries the most frequent reason to consult a general practitioner. However, general practitioners are under pressure with increasing workloads. The increasing number of patients and the typical 10-15 minutes of available time for each patient are challenging the provision of sufficient information and advice. According to international guidelines information and advice are recommended for every patient with LBP, therefore, new methods to support general practitioners (GPs) are very much needed. Online technologies give new opportunities to extend the treatment. Furthermore, involving patients with LBP in the development of online information material may produce more user friendly content and design and thereby increasing patients' acceptance and usage. Thus, optimizing clinical outcome. This project will study patients' satisfaction and clinical outcomes of a web-application for patients with LBP consulted in general practice compared to best existing technology (the Patient Handbook).
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
Browse Back Pain studies →Aalborg University Hospital is the lead sponsor of 195 studies on the registry; 39 are open to participants now.
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Exclusion Criteria:
Information material developed in a participatory design together with patients.
Other: Information material
Public available information.
Other: Information material
Online web-application developed together with patients with low back pain
General satisfaction
The question: 'how likely is it that you would recommend this web-application to a friend or colleague?' will be applied to measure satisfaction. The patients will be asked to choose between 11 boxes displayed on a horizontal line (10-0 Points, higher score indicating more satisfaction). The scales will be labelled to the left at 10 (extremely likely) and at the right side as 0 (not at all likely). It is only possible to tick off one box, if the patient change decision while filling in the online questionnaire, another box can be ticked off and the first choice will automatically delete. Responses of 10-9 are grouped as 'satisfied' of the web-application and patients replying 8-0 will be grouped as 'not satisfied'. The proportion of patients being satisfied after 12 weeks is the primary analysis. The proportion of patients being satisfied after 1, 2, 4, and 8 weeks will be carried out as secondary analyses.
Time frame: 12 weeks
Functional improvement
Roland Morris functional disability score (RMDQ, the Patrick version, 0-23 points)
Time frame: 12 weeks
Pain intensity
Numerical pain rating of current pain (0-10 Points, rating from 'no pain' to 'maximal pain' )
Time frame: 1, 2, 4, 8, and 12 weeks
Improvement in self-rated health
EQ-5D-5L (EuroQol - 5 Diminsions - 5 Levels)
Time frame: 12 weeks
Employment status
Self reported current employment status (yes/no)
Time frame: 12 weeks
Sick leave
Self reported number of hours of sick leave during the study
Time frame: 12 weeks
Contacts to general practice
Self reported number of general practice contacts since study inclusion
Time frame: 12 weeks
Contacts to primary care physiotherapists
Self reported number of physiotherapy contacts since study inclusion
Time frame: 12 weeks
Contacts to primary care chiropractors
Self reported number of chiropractor contacts since study inclusion
Time frame: 12 weeks
Contacts to secondary care
Contact to secondary care because of low back pain during the study (yes/no)
Time frame: 12 weeks
Cost utility analysis
A analysis comparing the intervention group with the control group from a healthcare perspective. Including primary care costs such as public paid costs for GP contacts, physiotherapy services, and chiropractic services. Quality adjusted life years (QALYs) will be applied as measure of effect based on EQ-5D-5L. We will not include costs for developing and maintaining the new technology or other protocol driven costs. Based on the relative short time-horizon costs and effects will not be discounted.
Time frame: 12 weeks
Specific satisfaction
For further exploration of reasons for the primary outcome we include a question regarding the general satisfaction with the web-application (10-0) and detailed questions/items regarding satisfaction with design (very, some, little, none), satisfaction with customisation (very, some, little, none ), satisfaction with usability (very, some, little, none ), satisfaction with readability (very, some, little, none), and satisfaction with credibility (very, some, little, none). It is only possible to tick off one box to each item, if the patient change decision while filling in the online questionnaire, another box can be ticked off and the first choice will automatically delete. Furthermore, these items will be validated against the primary outcome.
Time frame: 1, 2, 4, 8, and 12 weeks
No study locations are listed for this record.
Plan to share: No
This study is withdrawn, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Aalborg University Hospital