Knee OsteoarthritisNCT03472300
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
An observational study of Knee Osteoarthritis and Survey, Family Life, run by Frederiksberg University Hospital at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 60 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis, Survey, Family Life, Complementary Therapies
- What is being tested?
- Survey about knee pain and treatment
- How many people
- 9,600 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Sep 2018to 21 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will comprise the sample of all elderly individuals 60-69 years old, living in the Frederiksberg municipality (central part of Copenhagen) Denmark
Who may be able to join
- Between 60-69 years of age
- Citizen in the Community of Frederiksberg
Who cannot join
- No formal exclusion criteria but unability to understand/answer our questionnaire is per se an exclusion criteria
Trial locations and contacts
1 site in 1 country.
Denmark1 site
the Parker Institute, Bispebjerg-Frederiksberg Hospital
Frederiksberg, Danmark, 2000
About this study
Official title: Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals From Frederiksberg Municipality - A Prospective Cohort Study
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.
Read the detailed 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.
- Being tested
- Survey about knee pain and treatment
- Keywords
- Knee Osteoarthritis, pain, Complementary Therapies, Survey, questionnaire
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey about knee pain and treatmentOther
All citizens are surveyed to describe the prevalence of knee pain in a danish community.
| Study group | Role | What they receive |
|---|---|---|
| Frederiksberg Citizens | All citizen in the Frederiksberg Community aged 60-69 Receives: Other: Survey about knee pain and treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-disclosed knee trouble/pain
Population incidence of self-disclosed knee trouble/pain
Measured: 1 Year
Secondary outcomes (6)
Self-disclosed knee trouble/pain
Population incidence of self-disclosed knee trouble/pain
Measured: Annually for 10 years
Knee injury and Osteoarthritis Outcome Score (KOOS)
Actual KOOS score and scores over time (respondents who report having knee pain)
Measured: Annually for 10 years
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.
Measured: Annually for 10 years
EQ-5D
Actual EQ-5D score and scores over time (all respondents)
Measured: Annually for 10 years
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
Measured: Annually for 10 years
Influence of treatments (longitudinal)
Influence of treatments and their combination on use of health care system including surgical procedures.
Measured: Annually for 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start5 Sep 2018
- Primary completion21 Oct 2028 (estimated)
- Study completion21 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frederiksberg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henning Bliddal, Frederiksberg University Hospital
- Investigators
- Elisabeth Ginnerup, Study chair, The Parker Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472300
- Sponsor's protocol ID
- FrbCohort-01
- Status last verified
- Aug 2025
- First submitted
- 13 Mar 2018
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ginnerup-Nielsen E, Christensen R, Heitmann BL, Altman RD, March L, Woolf A, Bliddal H, Henriksen M. Prognostic value of illness perception on changes in knee pain among elderly individuals: Two-year results from the Frederiksberg Cohort study. Osteoarthr Cartil Open. 2023 Aug 19;5(4):100403. doi: 10.1016/j.ocarto.2023.100403. eCollection 2023 Dec.
PubMed 37671176Ginnerup-Nielsen EM, Henriksen M, Christensen R, Heitmann BL, Altman R, March L, Woolf A, Karlsen H, Bliddal H. Prevalence of self-reported knee symptoms and management strategies among elderly individuals from Frederiksberg municipality: protocol for a prospective and pragmatic Danish cohort study. BMJ Open. 2019 Sep 4;9(9):e028087. doi: 10.1136/bmjopen-2018-028087.
PubMed 31488473
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals From Frederiksberg Municipality - A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03472300
- Acronym / sponsor ID
- FrbCohort-01
- Keywords
- Knee Osteoarthritis, pain, Complementary Therapies, Survey, questionnaire
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 9,600 participants (estimated)
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 21 Oct 2028 (estimated)
- Study completion
- 21 Oct 2028 (estimated)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frederiksberg Citizens | – | Other: Survey about knee pain and treatmentAll citizen in the Frederiksberg Community aged 60-69 |
Who may qualify
- Ages
- 60 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will comprise the sample of all elderly individuals 60-69 years old, living in the Frederiksberg municipality (central part of Copenhagen) Denmark
Key inclusion criteria (2 listed)
- Between 60-69 years of age
- Citizen in the Community of Frederiksberg
Key exclusion criteria (1 listed)
- No formal exclusion criteria but unability to understand/answer our questionnaire is per se an exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey about knee pain and treatmentAll citizens are surveyed to describe the prevalence of knee pain in a danish community. | Other | Frederiksberg Citizens |
Primary outcome
Self-disclosed knee trouble/pain
Time frame: 1 Year
Population incidence of self-disclosed knee trouble/pain
6 secondary outcomes
Self-disclosed knee trouble/pain
Time frame: Annually for 10 years
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Annually for 10 years
Brief Illness Perception Questionnaire (IPQ-B)
Time frame: Annually for 10 years
EQ-5D
Time frame: Annually for 10 years
Treatments of all kinds
Time frame: Annually for 10 years
Influence of treatments (longitudinal)
Time frame: Annually for 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Derived from this study: PubMed 37671176Ginnerup-Nielsen E, Christensen R, Heitmann BL, Altman RD, March L, Woolf A, Bliddal H, Henriksen M. Prognostic value of illness perception on changes in knee pain among elderly individuals: Two-year results from the Frederiksberg Cohort study. Osteoarthr Cartil Open. 2023 Aug 19;5(4):100403. doi: 10.1016/j.ocarto.2023.100403. eCollection 2023 Dec.
- Derived from this study: PubMed 31488473Ginnerup-Nielsen EM, Henriksen M, Christensen R, Heitmann BL, Altman R, March L, Woolf A, Karlsen H, Bliddal H. Prevalence of self-reported knee symptoms and management strategies among elderly individuals from Frederiksberg municipality: protocol for a prospective and pragmatic Danish cohort study. BMJ Open. 2019 Sep 4;9(9):e028087. doi: 10.1136/bmjopen-2018-028087.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Ginnerup study chair
The Parker Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Survey, Family Life, run by Frederiksberg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-disclosed knee trouble/pain (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03472300, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.