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Active, Not Recruiting

NCT Number: NCT04033757

A Population-based Cohort of Osteoarthritis: the Xiangya Osteoarthritis Study

The purpose of this study is to examine the natural history, phenotypes and risk factors of osteoarthritis (OA) and pain at different joints, and to examine the association between OA structure changes, inflammation and pain for knee and hand OA.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

About this study

Objectives:

  • To understand the natural history of osteoarthritis (OA) at different joints (knee, hip, hand, foot and lumbar).
  • To identify different phenotypes of OA (e.g., generalized OA, rapidly progressive knee and hand OA, tibiofemoral OA and patellofemoral OA), their association with pain (e.g., peripheral pain, central pain, nociceptive pain and neuropathic pain) and consequences.
  • To examine risk factors of OA (lifestyle habits, nutritional, metabolic, anatomical and genetic factors, etc.) at each joint as well as multiple joints.
  • To determine the association between x-ray structure change, ultrasound synovial changes and pain and other symptoms of OA at knee and hand joints within the large-sample community-based population.
  • To predict the progression of knee and hand OA within new-onset early-stage knee and hand OA patients, and to identify the rapidly progressive knee and hand OA phenotypes and their related risk factors.
  • To investigate the association between gut microbiota and OA.
  • To investigate the association between oral microbiota and OA.

Design: This is a prospective community-based cohort study.

Participants: Subjects included in this study were a randomly selected sample of residents, aged 50 years or older from rural mountainous communities of Longshan County, Hunan Province, China. 4000 people were planned to be recruited, divided into three sub-cohorts. 1,469 participants were enrolled in sub-cohort 1 in 2015, and two follow-ups have been completed in 2016 and 2017. 1,267 participants were enrolled in sub-cohort 2 in 2018. 1,340 participants were enrolled in sub-cohort 3 in 2019. Each sub-cohort will be followed every three years regularly.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 50 years old or above
  • Residents of the randomly selected communities

Exclusion criteria

  • Inability to give informed consent
  • Terminal or mental illness
  • Pregnant women

Treatment and study plan

Primary outcomes

  1. Prevalence of multiple joints osteoarthritis.

    Time frame: At enrollment.

    Measured by radiographs of multiple joints.

  2. Incidence of multiple joints osteoarthritis.

    Time frame: At 3, 6, 9, 12 years follow-ups after enrollment.

    Measured by radiographs of multiple joints, and the incidence of osteoarthritis can be calculated at each follow-up time point.

  3. Progression of multiple joints osteoarthritis.

    Time frame: At 3, 6, 9, 12 years follow-ups after enrollment.

    The changes of joint space and osteophytes are measured by radiographs of multiple joints, to assess the progression of multiple joints osteoarthritis.

Secondary outcomes

  1. Ultrasound detected changes of knee, thigh muscle, and hand.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    Ultrasound examination of both knee joints, quadriceps, hamstrings muscle and 15 peripheral joints of wrist and hand.

  2. Changes of pain intensity of knee, hip, hand and lumbar.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    Measured by visual analog scale (VAS).

  3. Changes of pain experience of knee.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    Measured by intermittent and constant osteoarthritis pain (ICOAP) questionnaire.

  4. Changes of neuropathic pain of knee.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    Measured by painDETECT questionnaire (PDQ).

  5. Changes of patient's belief about knee pain.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    Measured by illness perception questionnaire (IPQ).

  6. Changes of pain catastrophizing of knee.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    Measured by pain catastrophizing scale (PCS).

  7. Prevalence of knee/hip/patellofemoral joint pain.

    Time frame: At enrollment.

    Measured by a question that "In the past 12 months, have you had knee/hip/patellofemoral joint pain lasting most days of at least a month?"

  8. Incidence of knee/hip/patellofemoral joint pain.

    Time frame: At 3, 6, 9, 12 years follow-ups after enrollment.

    Measured by a question that "In the past 12 months, have you had knee/hip/patellofemoral joint pain lasting most days of at least a month?", and the incidence of knee/hip/patellofemoral joint pain can be calculated at each follow-up time point.

  9. Changes of global assessment of knee and hip.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    Measured by the Western Ontario and McMaster Universities (WOMAC) score.

  10. Changes of global hand function.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    Measured by the Functional Index for Hand Osteoarthritis (FIHOA).

  11. Changes of pain-related disability of lumbar osteoarthritis.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    Measured by the Roland-Morris Disability Questionnaire (RMDQ).

  12. Changes of the results of 30s repetition chair stand test.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    To test the ability to rise from a chair. Record the times a participant stand up and sit down from a chair within 30 seconds.

  13. Changes of the results of 20-meter walk test.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    Record the time a participant spent on walking for 20 meters.

  14. Changes of the results of timed up and go test.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    Record the time a participant to rise from a standard armchair, walk as quickly but as safely as possible distance of 3 meters, turn, walk back to the chair and sit down.

  15. Changes of the results of standing balance test.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    Record the score of standing balance using a standard test protocol. Tests of standing balance included full tandem, semi-tandem, and side-by-side stands.

  16. Changes of grip strength.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    Measured by a Jamar Hydraulic Hand Dynamometer.

  17. Changes of pinch strength.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    Measured by a Jamar Hydraulic Pinch Gauge.

  18. Changes of quadriceps strength.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    Measured by a 'Nicholas Manual Muscle Tester' (Lafayette Instruments).

  19. Changes of hamstrings strength.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    Measured by a 'Nicholas Manual Muscle Tester' (Lafayette Instruments).

  20. Changes of hip abductor.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    Measured by a 'Nicholas Manual Muscle Tester' (Lafayette Instruments).

  21. Changes of the results of squatting ability test.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    The squatting ability was evaluated by using a 1-4 scale (1 = full squat, no use of arms; 2 = full squat, arms used for support; 3= full squat, examiner assistance needed; 4 = attempted, unable to attain full squat).

  22. Changes of the results of stair climbing test.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    Record the time a participant to ascended and descended a flight of five 14 cm steps stair as quickly as possible.

  23. Changes of the results of quantitative sensory testing.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    Measured by a hand-held pressure algometer (Wagner, FDIX25) .

  24. Changes of the results of body composition analysis.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    Measured by a InBody 770 Body Composition Analyser.

  25. Prevalence of nodal osteoarthritis.

    Time frame: At enrollment.

    Nodal osteoarthritis was determined using a validated line diagram and classified as present in those reporting nodes on at least two rays of both hands.

  26. Prevalence of widespread pain.

    Time frame: At enrollment.

    A modified body pain mannequin with two questions on symptom severity and widespread pain index (2011 ACR criteria on fibromyalgia) was included to allow scoring of fibromyalgia as a diagnosis with binary (present/absent) classification using a validated tool.

  27. Incidence of widespread pain.

    Time frame: At 3, 6, 9, 12 years follow-ups after enrollment.

    A modified body pain mannequin with two questions on symptom severity and widespread pain index (2011 ACR criteria on fibromyalgia) was included to allow scoring of fibromyalgia as a diagnosis with binary (present/absent) classification using a validated tool. The incidence of knee/hip/patellofemoral joint pain can be calculated at each follow-up time point.

  28. Changes of physical and mental health.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    Measured by the 12-Item Short-Form Health Survey (SF-12).

  29. Changes of sleep quality.

    Time frame: At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.

    Measured by the Medical Outcomes Study (MOS) Sleep Scale.

  30. Prevalence of sarcopenia.

    Time frame: Every round of surveys since year 2018.

    Sarcopenia would be diagnosed according to the Asian Working Group for Sarcopenia 2019 algorithm.

  31. Incidence of sarcopenia.

    Time frame: At 3, 6, 9, 12 years follow-ups after enrollment.

    Sarcopenia would be diagnosed according to the Asian Working Group for Sarcopenia 2019 algorithm. And the incidence of sarcopenia can be calculated at each follow-up time point.

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Collaborators

  • Harvard University
  • University of Nottingham

Registry information

Important dates

Study start
2015
Primary completion
2031
Study completion
2031
First posted
Jul 26, 2019
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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