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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03472300
Other study ID # FrbCohort-01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 5, 2018
Est. completion date October 21, 2028

Study information

Verified date February 2024
Source Frederiksberg University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Although knee pain is prevalent among community-dwelling older adults, little is known about how people in general handle their pain. We will conduct a survey to explore how knee pain affects people's lives and which treatments or self-management strategies they have chosen (or are being offered), and how these interact concerning pain reduction and maintenance of function.


Description:

Although knee pain is prevalent among community-dwelling older adults and frequently leads to consultation in primary care, little is known about how people in general manage their knee pain. Treatments of knee osteoarthritis include a variety of non-pharmaceutical, medical, and surgical interventions with highly individual and inconsistent results and with the possible exception of a longer lasting weight reduction, none of the non-surgical treatments have been able to demonstrate long-lasting effect on pain or disability. It is well recognised that patient participation in handling of disease creates better compliance and satisfaction with pharmacological treatment. Another option for taking active part in self-management is the use of complementary and alternative medicine (CAM). despite their popularity and effect, there is currently no overview of the actual extent of CAMs used for knee pain and disability at a population level, and most CAMs remain to be studied scientifically for efficacy. The incidence of knee OA shows a steep increase at age above 60 years. Furthermore, after this age an increasing prevalence of disablement to knee trouble is encountered. To prevent this development, measures must be sought to alter the course of knee OA. By asking people about how knee pain affects their life, which treatments or self-management strategies they have chosen (or are being offered), and how these interact for the reduction of pain and maintenance of function, new knowledge will be gained about the preferences and perceived effectiveness of treatments at large. The information gained will enable the prioritising of research on interventions to be tested and will align this with the primary concerns and interests of the population. This will subsequently lead to better guidance of patients by the health care providers, and will aid decision makers in choosing feasible health care policies and strategies.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 9600
Est. completion date October 21, 2028
Est. primary completion date October 21, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 69 Years
Eligibility Inclusion Criteria: - Between 60-69 years of age - Citizen in the Community of Frederiksberg Exclusion Criteria: • No formal exclusion criteria but unability to understand/answer our questionnaire is per se an exclusion criteria

Study Design


Intervention

Other:
Survey about knee pain and treatment
All citizens are surveyed to describe the prevalence of knee pain in a danish community.

Locations

Country Name City State
Denmark the Parker Institute, Bispebjerg-Frederiksberg Hospital Frederiksberg Danmark

Sponsors (1)

Lead Sponsor Collaborator
Frederiksberg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-disclosed knee trouble/pain Population incidence of self-disclosed knee trouble/pain 1 Year
Secondary Self-disclosed knee trouble/pain Population incidence of self-disclosed knee trouble/pain Annually for 10 years
Secondary Knee injury and Osteoarthritis Outcome Score (KOOS) Actual KOOS score and scores over time (respondents who report having knee pain) Annually for 10 years
Secondary Brief Illness Perception Questionnaire (IPQ-B) Actual IPQ-B score and scores over time (respondents who report having knee pain). Generic questionnaire developed to measure illness perception. The IPQ-B contains eight items and one causal scale. Items 1-8 are rated using a 0-to-10 response scale, item 9 is a memo field. Five of the items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two of the items assess emotional representations: concern (Item 6) and emotions (Item 8). One item assesses illness comprehensibility (Item 7).
A low score on items number 1,2,5,6 and 8 indicates that the illness is perceived as benign while a low score on the items 3, 4 and 7 indicates that the illness is perceived as threatening. By reversing these three items it is possible to compute an overall score. A higher score reflects a more threatening view of the illness.
Annually for 10 years
Secondary EQ-5D Actual EQ-5D score and scores over time (all respondents) Annually for 10 years
Secondary Treatments of all kinds To estimate the use of treatments of all kinds (both in the "established" health care system and as self-management), including use of non-pharmacological treatments Annually for 10 years
Secondary Influence of treatments (longitudinal) Influence of treatments and their combination on use of health care system including surgical procedures. Annually for 10 years
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