Knee OsteoarthritisNCT06854237
Prevalence and Characteristics of Widespread Pain in People With Knee Osteoarthritis
An observational study of Knee Osteoarthritis and Widespread Chronic Pain, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
The goal is to evaluate whether the number of pain sites or pain estimation with Instant and Constant Osteoarthritis Pain (ICOAP) is related to functional impairment in the lower extremity in people with knee osteoarthritis (KOA). The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis, Widespread Chronic Pain
- How many people
- 114 participants
- Where
- 1 siteSweden
- Study dates
- 6 Feb 2025to 31 Dec 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with diagnosed knee osteoarthritis, with or without problems/osteoarthritis in other joints, but the knee joint should have been the most troublesome.
Who may be able to join
- Patients with diagnosed knee osteoarthritis, could have problems/osteoarthritis in other joints, but the knee joint should have been the most troublesome.
- Independent in walking, with och without walking aids.
- Understand test instructions both verbally and in writing in Swedish.
Who cannot join
- Neurological problems that affected balance or walking ability.
- Severe or serious somatic or mental illnesses that affected the ability to function or the ability to understand and follow the test instructions.
- Completed knee or hip replacement in the past six months.
- Other knee surgery in the past six months that could affect physical functional capacity.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Närhälsan Lidköping Rehabmottagning
Lidköping, Västra Götaland County, 53151
About this study
The goal is to evaluate whether the number of pain sites or pain estimation with Instant and Constant Osteoarthritis Pain (ICOAP) is related to functional impairment in the lower extremity in people with knee osteoarthritis (KOA).
The main questions it aims to answer are:
Read more
- What is the relationship between the number of pain sites and physical function when adjusted for age, sex, education level, and origin in people with KOA?
- What is the relationship between pain experience measured with ICOAP (constant and intermittent pain subscales, as well as total score) and reduced physical function when adjusted for age, sex, education level, and origin in people with KOA?
- What is the relationship between demographic data (age, sex, BMI, origin, level of education) and reduced physical function in people with KOA?
Participants were recruited from five rehabilitation clinics in primary care within the Västra Götaland region, for another study (NCT03855813). Patients with diagnosed KOA were asked to participate in the study. The patients mostly had problems in the knee joint but could also have osteoarthritis (OA) in other joints.
Read the detailed description
Background
Knee osteoarthritis (KOA) affects approximately 14% of the Swedish population over the age of 45 (1). Typical symptoms are pain, stiffness and reduced physical function (2). Most people with KOA (90%) have at least two pain sites (3). One-third of people with chronic knee pain meet criteria for widespread pain, which is associated with impaired self-rated physical function (4, 5). Female gender, ethnic background, synovitis and degree of osteoarthritis (OA) on X-ray are predictors of a deterioration in function in people with OA in the lower extremity (6). Multiple pain sites are associated with fear of movement (3), while increased fear of movement has a moderate correlation with reduced physical function in people with KOA (7). While high self-efficacy can predict an increased physical function (7).
Evaluating leg muscle strength can be critical in identifying people with OA who are at risk of worsening and who may need to strengthen their muscles to improve physical function and relieve pain. This may also help prevent sarcopenia and its metabolic consequences (8). Today, self-assessment forms and performance-based tests are used to assess patients' physical function (9). An advantage of performance-based tests compared to self-assessment forms is that they measure what the patient is actually able to do (10), and performance-based tests are better at differentiating between pain and physical function (11). These tests are usually performed in the clinic under the supervision of healthcare personnel.
For people who do not have the ability to perform functional testing, pain history can be of value in differentiating whether or not a person has lower extremity functional limitations - without being evaluated with tests or forms. Because pain in people with OA can vary, assessment with the ICOAP form can be used to describe whether the pain changes (12). However, lack of time can prevent clinics from using standardized forms or instruments (13).
More knowledge is needed that describes how common it is with widespread pain among people with KOA who seek primary care and examine the relationship between pain intensity, number of pain sites, and its impact on function, activity and quality of life. In addition, it is of interest to examine relationships between demographic data and pain history on physical function in order to assess the functional impairment according to a standardized function test with the help of common anamnesis questions in the clinical meeting with the patient without having to perform the actual test. The knowledge of these correlations is missing today.
Purpose
The aim of this study is to evaluate whether the number of pain sites or pain estimation with ICOAP is related to a functional impairment in the lower extremity in people with KOA.
Research questions:
- What is the relationship between the number of pain sites and physical function when adjusted for age, sex, education level and origin for people with KOA?
- What is the relationship between pain experience measured with ICOAP (constant and intermittent pain subscales, as well as total score) and reduced physical function when adjusted for age, sex, education level and origin of people with KOA?
- What is the relationship between demographic data (age, sex, BMI, origin, level of education) and reduced physical function for people with KOA?
Method: Population/Sample
Inclusion criteria
Participants were recruited from five rehab clinics in primary care within the Västra Götaland region to a former study which this study is based on (NCT03855813). Patients with diagnosed KOA were asked to participate in the study. The patients mostly had problems in the knee joint, but could also have OA in other joints in the lower extremities. They were independent in walking, with or without walking aids, and could understand test instructions both verbally and in writing in Swedish.
Exclusion criteria
- Neurological problems that affected balance or walking ability.
- Severe or serious somatic or mental illnesses that affected the ability to function or the ability to understand and follow the test instructions.
- Had knee or hip replacement in the past six months.
- Other knee surgery in the last six months that could affect functional capacity.
Method: Data collection
Patients with established KOA received written information about the study, consent form and questionnaire about background data, either directly at the clinic or by written letter. When participating in the study, the patients filled in all the forms at home and brought them to the physiotherapist at the next visit.
Background data
Background data included age, sex, body mass index (BMI), other diseases, pain sites, pain intensity, duration of pain in the knee joint and experience of the knee problems.
Pain history
Pain intensity was measured with a numeric rating scale (NRS) 0-10 (14), where 0 corresponds to no pain and 10 the worst imaginable pain. The patient rated the pain at rest, when loaded, and on average over the past week.
ICOAP - the Swedish version, was used to assess the pain experience. The questionnaire contains two subscales with question areas about intermittent and constant pain. The total score for the subscale for intermittent pain varies between 0-24 points and between 0-20 points for constant pain. The total score, 0-44 points, is usually recalculated to a scale of 0-100 (total score/44 x 100), where 0 corresponds to no pain and 100 to extreme pain (12).
The number of pain sites was evaluated with a pain drawing with 18 predefined body areas (15).
Functional test with 30 CST
The chair test "30 seconds chair stand test" (30 CST) is part of a test battery that is recommended both in research and in the clinic for people with OA. This test is a reliable and valid method for measuring the strength and functional capacity of people with OA assessed by clinician (16, 17), and as a self-test (18).
The chair test 30 CST was performed on an approximately 45 cm high chair without armrests. The participant was asked to do as many stands as possible in 30 seconds. The starting position was sitting on the chair. The stands would be to an upright position (fully extended hips and knees), then back to a seated position. The arms were to be crossed over the chest throughout the test. In all measurements with the chair test, the patient had to indicate perceived pain intensity in the knee joint before and during the test. All physiotherapists received training on the study protocol and the chair test.
Method: Data processing/Data analysis
Sample size
The sample size was calculated with the statistical program PASS 16, for the reliability study for which the data for this study is based on (18). Sample size of 117 participants, with two observations per participant for each inter- and intra-rater test, achieved a power of 80% to detect an intraclass correlation coefficient (ICC) of 0.8 with a significance level of 0.05. A total of 114 participants were recruited for the reliability study. All participants in the reliability study (n=114) will be included in this study and are considered to be sufficiently plentiful to be able to answer the purpose and the research questions with good probability.
Statistical analysis
Demographic data will be presented in the form of central and dispersion measures depending on the data level. For nominal data, number and percent are presented.
Logistic regression will be conducted between the independent variables 1) demographic data, 2) number of pain sites, 3) ICOAP to assess the effects on the dependent variable impaired physical function measured by 30 CST. The results from the regression analysis will be presented with the odds ratio with 95% confidence interval and illustrated with graphs of the expected probabilities. The analyzes will be carried out in the statistical program Statistical Package for Social Science (SPSS) (19). The significance level is set at p< 0.05.
Expected meaning
The number of pain sites could be used to detect potential risks in functional impairment and could be helpful to clinicians when deciding how to treat patients with KOA, without having to spend time on functional tests. This patient group with multiple pain sites may need more support to maintain physical activity. An understanding of possible effects between people's background history and physical function could contribute to people with KOA being able to receive more individually tailored and preventive care.
- Conditions
- Knee Osteoarthritis, Widespread Chronic Pain
- Keywords
- Knee osteoarthritis, Widespread pain, Pain sites, Correlation
- Medical subject headings
- Osteoarthritis, Knee, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with knee osteoarthritis | Patients with knee osteoarthritis will perform the 30 seconds chair stand test to evaluate physical performance and compare with self-reported pain history and number of pain locations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function
Measured with 30 seconds chair stand test. The participant is asked to stand up from a chair as many times as possible during 30 seconds. A higher number of stands indicate a better physical function.
Measured: One occasion at baseline
Osteoarthritis pain
Osteoarthritis pain will be measured with Measure of Intermittent and Constant Osteoarthritis Pain: ICOAP. The questionnaire consists of two subscales, a) constant pain and b) intermittent pain. The total score ranges between 0 to 100 where 0 means no pain and 100 means extreme pain.
Measured: One occasion at baseline
Pain locations
Self-reporting pain assessment with pre-defines locations on a pain drawing.
Measured: One occasion at baseline
Secondary outcomes (1)
Pain intensity
Pain intensity was measured with a numeric rating scale (NRS) 0-10 (14) , where 0 corresponds to no pain and 10 the worst imaginable pain. The patient rated the pain at rest, when loaded, and on average over the past week.
Measured: One occasion at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start6 Feb 2025
- Primary completion28 Feb 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chan-Mei Ho-Henriksson, MD, Principal investigator, Västra Götalandsregionen, Närhälsan, Närhälsan Lidköping Rehabmottagning, Lidköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854237
- Sponsor's protocol ID
- KOA WSP 284125
- Status last verified
- Aug 2026
- First submitted
- 25 Feb 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to General Data Protection Regulation, to protect the participant's privacy.
Publications
Gill S, Hely R, Page RS, Hely A, Harrison B, Landers S. Thirty second chair stand test: Test-retest reliability, agreement and minimum detectable change in people with early-stage knee osteoarthritis. Physiother Res Int. 2022 Jul;27(3):e1957. doi: 10.1002/pri.1957. Epub 2022 May 19.
PubMed 35592902Gill S, McBurney H. Reliability of performance-based measures in people awaiting joint replacement surgery of the hip or knee. Physiother Res Int. 2008 Sep;13(3):141-52. doi: 10.1002/pri.411.
PubMed 18697226Bergman S, Herrstrom P, Hogstrom K, Petersson IF, Svensson B, Jacobsson LT. Chronic musculoskeletal pain, prevalence rates, and sociodemographic associations in a Swedish population study. J Rheumatol. 2001 Jun;28(6):1369-77.
PubMed 11409133Downie WW, Leatham PA, Rhind VM, Wright V, Branco JA, Anderson JA. Studies with pain rating scales. Ann Rheum Dis. 1978 Aug;37(4):378-81. doi: 10.1136/ard.37.4.378.
PubMed 686873Turner GM, Litchfield I, Finnikin S, Aiyegbusi OL, Calvert M. General practitioners' views on use of patient reported outcome measures in primary care: a cross-sectional survey and qualitative study. BMC Fam Pract. 2020 Jan 24;21(1):14. doi: 10.1186/s12875-019-1077-6.
PubMed 31980021Hawker GA, Davis AM, French MR, Cibere J, Jordan JM, March L, Suarez-Almazor M, Katz JN, Dieppe P. Development and preliminary psychometric testing of a new OA pain measure--an OARSI/OMERACT initiative. Osteoarthritis Cartilage. 2008 Apr;16(4):409-14. doi: 10.1016/j.joca.2007.12.015.
PubMed 18381179Stratford PW, Kennedy DM, Woodhouse LJ. Performance measures provide assessments of pain and function in people with advanced osteoarthritis of the hip or knee. Phys Ther. 2006 Nov;86(11):1489-96. doi: 10.2522/ptj.20060002.
PubMed 17079748Terwee CB, Mokkink LB, Steultjens MP, Dekker J. Performance-based methods for measuring the physical function of patients with osteoarthritis of the hip or knee: a systematic review of measurement properties. Rheumatology (Oxford). 2006 Jul;45(7):890-902. doi: 10.1093/rheumatology/kei267. Epub 2006 Feb 3.
PubMed 16461441Jordan KP, Wilkie R, Muller S, Myers H, Nicholls E; Arthritis Research Campaign National Primary Care Centre. Measurement of change in function and disability in osteoarthritis: current approaches and future challenges. Curr Opin Rheumatol. 2009 Sep;21(5):525-30. doi: 10.1097/BOR.0b013e32832e45fc.
PubMed 19525848Sanada K, Iemitsu M, Murakami H, Gando Y, Kawano H, Kawakami R, Tabata I, Miyachi M. Adverse effects of coexistence of sarcopenia and metabolic syndrome in Japanese women. Eur J Clin Nutr. 2012 Oct;66(10):1093-8. doi: 10.1038/ejcn.2012.43. Epub 2012 May 9.
PubMed 22569087Odole A, Ekediegwu E, Ekechukwu END, Uchenwoke C. Correlates and predictors of pain intensity and physical function among individuals with chronic knee osteoarthritis in Nigeria. Musculoskelet Sci Pract. 2019 Feb;39:150-156. doi: 10.1016/j.msksp.2018.11.014. Epub 2018 Nov 28.
PubMed 30623891Sandhar S, Smith TO, Toor K, Howe F, Sofat N. Risk factors for pain and functional impairment in people with knee and hip osteoarthritis: a systematic review and meta-analysis. BMJ Open. 2020 Aug 7;10(8):e038720. doi: 10.1136/bmjopen-2020-038720.
PubMed 32771991Aydemir B, Muhammad LN, Song J, Chang AH, Dunlop DD, Chang RW, Lee YC. Modifiable physical and behavioural factors associated with widespread pain in older adults with radiographic evidence of knee osteoarthritis. Musculoskeletal Care. 2023 Dec;21(4):1090-1097. doi: 10.1002/msc.1789. Epub 2023 Jun 4.
PubMed 37271894Turkiewicz A, Petersson IF, Bjork J, Hawker G, Dahlberg LE, Lohmander LS, Englund M. Current and future impact of osteoarthritis on health care: a population-based study with projections to year 2032. Osteoarthritis Cartilage. 2014 Nov;22(11):1826-32. doi: 10.1016/j.joca.2014.07.015. Epub 2014 Jul 30.
PubMed 25084132Peral Perez J, Mortensen SR, Lluch Girbes E, Gronne DT, Thorlund JB, Roos EM, Skou ST. Association between widespread pain and psychosocial factors in people with knee osteoarthritis: a cross-sectional study of patients from primary care in Denmark. Physiother Theory Pract. 2025 Apr;41(4):752-762. doi: 10.1080/09593985.2024.2372381. Epub 2024 Jul 1.
PubMed 38946473
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Characteristics of Widespread Pain in People With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06854237
- Acronym / sponsor ID
- KOA WSP 284125
- Conditions
- Knee Osteoarthritis, Widespread Chronic Pain
- Keywords
- Knee osteoarthritis, Widespread pain, Pain sites, Correlation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Mar 2025 (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.
The goal is to evaluate whether the number of pain sites or pain estimation with Instant and Constant Osteoarthritis Pain (ICOAP) is related to functional impairment in the lower extremity in people with knee osteoarthritis (KOA).
The main questions it aims to answer are:
- What is the relationship between the number of pain sites and physical function when adjusted for age, sex, education level, and origin in people with KOA?
- What is the relationship between pain experience measured with ICOAP (constant and intermittent pain subscales, as well as total score) and reduced physical function when adjusted for age, sex, education level, and origin in people with KOA?
- What is the relationship between demographic data (age, sex, BMI, origin, level of education) and reduced physical function in people with KOA?
Participants were recruited from five rehabilitation clinics in primary care within the Västra Götaland region, for another study (NCT03855813). Patients with diagnosed KOA were asked to participate in the study. The patients mostly had problems in the knee joint but could also have osteoarthritis (OA) in other joints.
Detailed description
Background
Knee osteoarthritis (KOA) affects approximately 14% of the Swedish population over the age of 45 (1). Typical symptoms are pain, stiffness and reduced physical function (2). Most people with KOA (90%) have at least two pain sites (3). One-third of people with chronic knee pain meet criteria for widespread pain, which is associated with impaired self-rated physical function (4, 5). Female gender, ethnic background, synovitis and degree of osteoarthritis (OA) on X-ray are predictors of a deterioration in function in people with OA in the lower extremity (6). Multiple pain sites are associated with fear of movement (3), while increased fear of movement has a moderate correlation with reduced physical function in people with KOA (7). While high self-efficacy can predict an increased physical function (7).
Evaluating leg muscle strength can be critical in identifying people with OA who are at risk of worsening and who may need to strengthen their muscles to improve physical function and relieve pain. This may also help prevent sarcopenia and its metabolic consequences (8). Today, self-assessment forms and performance-based tests are used to assess patients' physical function (9). An advantage of performance-based tests compared to self-assessment forms is that they measure what the patient is actually able to do (10), and performance-based tests are better at differentiating between pain and physical function (11). These tests are usually performed in the clinic under the supervision of healthcare personnel.
For people who do not have the ability to perform functional testing, pain history can be of value in differentiating whether or not a person has lower extremity functional limitations - without being evaluated with tests or forms. Because pain in people with OA can vary, assessment with the ICOAP form can be used to describe whether the pain changes (12). However, lack of time can prevent clinics from using standardized forms or instruments (13).
More knowledge is needed that describes how common it is with widespread pain among people with KOA who seek primary care and examine the relationship between pain intensity, number of pain sites, and its impact on function, activity and quality of life. In addition, it is of interest to examine relationships between demographic data and pain history on physical function in order to assess the functional impairment according to a standardized function test with the help of common anamnesis questions in the clinical meeting with the patient without having to perform the actual test. The knowledge of these correlations is missing today.
Purpose
The aim of this study is to evaluate whether the number of pain sites or pain estimation with ICOAP is related to a functional impairment in the lower extremity in people with KOA.
Research questions:
- What is the relationship between the number of pain sites and physical function when adjusted for age, sex, education level and origin for people with KOA?
- What is the relationship between pain experience measured with ICOAP (constant and intermittent pain subscales, as well as total score) and reduced physical function when adjusted for age, sex, education level and origin of people with KOA?
- What is the relationship between demographic data (age, sex, BMI, origin, level of education) and reduced physical function for people with KOA?
Method: Population/Sample
Inclusion criteria
Participants were recruited from five rehab clinics in primary care within the Västra Götaland region to a former study which this study is based on (NCT03855813). Patients with diagnosed KOA were asked to participate in the study. The patients mostly had problems in the knee joint, but could also have OA in other joints in the lower extremities. They were independent in walking, with or without walking aids, and could understand test instructions both verbally and in writing in Swedish.
Exclusion criteria
- Neurological problems that affected balance or walking ability.
- Severe or serious somatic or mental illnesses that affected the ability to function or the ability to understand and follow the test instructions.
- Had knee or hip replacement in the past six months.
- Other knee surgery in the last six months that could affect functional capacity.
Method: Data collection
Patients with established KOA received written information about the study, consent form and questionnaire about background data, either directly at the clinic or by written letter. When participating in the study, the patients filled in all the forms at home and brought them to the physiotherapist at the next visit.
Background data
Background data included age, sex, body mass index (BMI), other diseases, pain sites, pain intensity, duration of pain in the knee joint and experience of the knee problems.
Pain history
Pain intensity was measured with a numeric rating scale (NRS) 0-10 (14), where 0 corresponds to no pain and 10 the worst imaginable pain. The patient rated the pain at rest, when loaded, and on average over the past week.
ICOAP - the Swedish version, was used to assess the pain experience. The questionnaire contains two subscales with question areas about intermittent and constant pain. The total score for the subscale for intermittent pain varies between 0-24 points and between 0-20 points for constant pain. The total score, 0-44 points, is usually recalculated to a scale of 0-100 (total score/44 x 100), where 0 corresponds to no pain and 100 to extreme pain (12).
The number of pain sites was evaluated with a pain drawing with 18 predefined body areas (15).
Functional test with 30 CST
The chair test "30 seconds chair stand test" (30 CST) is part of a test battery that is recommended both in research and in the clinic for people with OA. This test is a reliable and valid method for measuring the strength and functional capacity of people with OA assessed by clinician (16, 17), and as a self-test (18).
The chair test 30 CST was performed on an approximately 45 cm high chair without armrests. The participant was asked to do as many stands as possible in 30 seconds. The starting position was sitting on the chair. The stands would be to an upright position (fully extended hips and knees), then back to a seated position. The arms were to be crossed over the chest throughout the test. In all measurements with the chair test, the patient had to indicate perceived pain intensity in the knee joint before and during the test. All physiotherapists received training on the study protocol and the chair test.
Method: Data processing/Data analysis
Sample size
The sample size was calculated with the statistical program PASS 16, for the reliability study for which the data for this study is based on (18). Sample size of 117 participants, with two observations per participant for each inter- and intra-rater test, achieved a power of 80% to detect an intraclass correlation coefficient (ICC) of 0.8 with a significance level of 0.05. A total of 114 participants were recruited for the reliability study. All participants in the reliability study (n=114) will be included in this study and are considered to be sufficiently plentiful to be able to answer the purpose and the research questions with good probability.
Statistical analysis
Demographic data will be presented in the form of central and dispersion measures depending on the data level. For nominal data, number and percent are presented.
Logistic regression will be conducted between the independent variables 1) demographic data, 2) number of pain sites, 3) ICOAP to assess the effects on the dependent variable impaired physical function measured by 30 CST. The results from the regression analysis will be presented with the odds ratio with 95% confidence interval and illustrated with graphs of the expected probabilities. The analyzes will be carried out in the statistical program Statistical Package for Social Science (SPSS) (19). The significance level is set at p< 0.05.
Expected meaning
The number of pain sites could be used to detect potential risks in functional impairment and could be helpful to clinicians when deciding how to treat patients with KOA, without having to spend time on functional tests. This patient group with multiple pain sites may need more support to maintain physical activity. An understanding of possible effects between people's background history and physical function could contribute to people with KOA being able to receive more individually tailored and preventive care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with knee osteoarthritis | – | –Patients with knee osteoarthritis will perform the 30 seconds chair stand test to evaluate physical performance and compare with self-reported pain history and number of pain locations. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with diagnosed knee osteoarthritis, with or without problems/osteoarthritis in other joints, but the knee joint should have been the most troublesome.
Key inclusion criteria (3 listed)
- Patients with diagnosed knee osteoarthritis, could have problems/osteoarthritis in other joints, but the knee joint should have been the most troublesome.
- Independent in walking, with och without walking aids.
- Understand test instructions both verbally and in writing in Swedish.
Key exclusion criteria (4 listed)
- Neurological problems that affected balance or walking ability.
- Severe or serious somatic or mental illnesses that affected the ability to function or the ability to understand and follow the test instructions.
- Completed knee or hip replacement in the past six months.
- Other knee surgery in the past six months that could affect physical functional capacity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical function
Time frame: One occasion at baseline
Measured with 30 seconds chair stand test. The participant is asked to stand up from a chair as many times as possible during 30 seconds. A higher number of stands indicate a better physical function.
Osteoarthritis pain
Time frame: One occasion at baseline
Osteoarthritis pain will be measured with Measure of Intermittent and Constant Osteoarthritis Pain: ICOAP. The questionnaire consists of two subscales, a) constant pain and b) intermittent pain. The total score ranges between 0 to 100 where 0 means no pain and 100 means extreme pain.
Pain locations
Time frame: One occasion at baseline
Self-reporting pain assessment with pre-defines locations on a pain drawing.
1 secondary outcome
Pain intensity
Time frame: One occasion at baseline
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 28 Aug 2026.
- Background: PubMed 35592902Gill S, Hely R, Page RS, Hely A, Harrison B, Landers S. Thirty second chair stand test: Test-retest reliability, agreement and minimum detectable change in people with early-stage knee osteoarthritis. Physiother Res Int. 2022 Jul;27(3):e1957. doi: 10.1002/pri.1957. Epub 2022 May 19.
- Background: PubMed 18697226Gill S, McBurney H. Reliability of performance-based measures in people awaiting joint replacement surgery of the hip or knee. Physiother Res Int. 2008 Sep;13(3):141-52. doi: 10.1002/pri.411.
- Background: PubMed 11409133Bergman S, Herrstrom P, Hogstrom K, Petersson IF, Svensson B, Jacobsson LT. Chronic musculoskeletal pain, prevalence rates, and sociodemographic associations in a Swedish population study. J Rheumatol. 2001 Jun;28(6):1369-77.
- Background: PubMed 686873Downie WW, Leatham PA, Rhind VM, Wright V, Branco JA, Anderson JA. Studies with pain rating scales. Ann Rheum Dis. 1978 Aug;37(4):378-81. doi: 10.1136/ard.37.4.378.
- Background: PubMed 31980021Turner GM, Litchfield I, Finnikin S, Aiyegbusi OL, Calvert M. General practitioners' views on use of patient reported outcome measures in primary care: a cross-sectional survey and qualitative study. BMC Fam Pract. 2020 Jan 24;21(1):14. doi: 10.1186/s12875-019-1077-6.
- Background: PubMed 18381179Hawker GA, Davis AM, French MR, Cibere J, Jordan JM, March L, Suarez-Almazor M, Katz JN, Dieppe P. Development and preliminary psychometric testing of a new OA pain measure--an OARSI/OMERACT initiative. Osteoarthritis Cartilage. 2008 Apr;16(4):409-14. doi: 10.1016/j.joca.2007.12.015.
- Background: PubMed 17079748Stratford PW, Kennedy DM, Woodhouse LJ. Performance measures provide assessments of pain and function in people with advanced osteoarthritis of the hip or knee. Phys Ther. 2006 Nov;86(11):1489-96. doi: 10.2522/ptj.20060002.
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- Background: PubMed 22569087Sanada K, Iemitsu M, Murakami H, Gando Y, Kawano H, Kawakami R, Tabata I, Miyachi M. Adverse effects of coexistence of sarcopenia and metabolic syndrome in Japanese women. Eur J Clin Nutr. 2012 Oct;66(10):1093-8. doi: 10.1038/ejcn.2012.43. Epub 2012 May 9.
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- Research database, Research and development in Region Västra GötalandLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared due to General Data Protection Regulation, to protect the participant's privacy.
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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.
Chan-Mei Ho-Henriksson, MD principal investigator
Västra Götalandsregionen, Närhälsan, Närhälsan Lidköping Rehabmottagning, Lidköping, Sweden
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 Widespread Chronic Pain, run by Vastra Gotaland Region at 1 site in Sweden.
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 3 inclusion and 4 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 28 Aug 2026. 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 Sweden. 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?
Physical function (time frame: One occasion at baseline). The study lists 3 primary outcomes in all. 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 NCT06854237, which also lists 16 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 28 Aug 2026.