Prevalence and Characteristics of Widespread Pain in People With Knee Osteoarthritis

NCT06854237 | Active Not Recruiting

• 1 other identifier: KOA WSP 284125
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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. 1.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?
2. 2.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?
3. 3.What is the relationship between demographic data (age, sex, BMI, origin, level of education) and reduced physical function in people with KOA?

Conditions

Knee Osteoarthritis; Widespread Chronic Pain

Keywords

Knee osteoarthritis; Widespread pain; Pain sites; Correlation

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  One occasion at baseline

• Pain locations

  Self-reporting pain assessment with pre-defines locations on a pain drawing.

  One occasion at baseline

Secondary Outcomes (1)

• Pain intensity

  One occasion at baseline

Other Outcomes (1)

• Demographic data

  Baseline

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Närhälsan Lidköping Rehabmottagning

Lidköping, Västra Götaland County, 53151, Sweden

Location

Related Publications (16)

• 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.

  PMID: 35592902 BACKGROUND

• Gill 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.

  PMID: 18697226 BACKGROUND

• Bergman 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.

  PMID: 11409133 BACKGROUND

• Downie 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.

  PMID: 686873 BACKGROUND

• Turner 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.

  PMID: 31980021 BACKGROUND

• Hawker 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.

  PMID: 18381179 BACKGROUND

• Stratford 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.

  PMID: 17079748 BACKGROUND

• Terwee 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.

  PMID: 16461441 BACKGROUND

• Jordan 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.

  PMID: 19525848 BACKGROUND

• Sanada 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.

  PMID: 22569087 BACKGROUND

• Odole 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.

  PMID: 30623891 BACKGROUND

• Sandhar 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.

  PMID: 32771991 BACKGROUND

• Aydemir 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.

  PMID: 37271894 BACKGROUND

• Turkiewicz 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.

  PMID: 25084132 BACKGROUND

• Peral 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.

  PMID: 38946473 BACKGROUND

• Bergman S, Thorstensson C, Andersson MLE. Chronic widespread pain and its associations with quality of life and function at a 20- year follow-up of individuals with chronic knee pain at inclusion. BMC Musculoskelet Disord. 2019 Dec 9;20(1):592. doi: 10.1186/s12891-019-2976-3.

  PMID: 31818282 BACKGROUND

Related Links

• Research database, Research and development in Region Västra Götaland

MeSH Terms

Conditions

Osteoarthritis, Knee; Chronic Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chan-Mei Ho-Henriksson, MD

  Västra Götalandsregionen, Närhälsan, Närhälsan Lidköping Rehabmottagning, Lidköping, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: February 6, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)