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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04033757
• Other study ID #: 201510506
• Status: Active, not recruiting
• Start date: November 17, 2015
• Est. completion date: December 2031

Study information

• Verified date: March 2022
• Source: Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

Objectives:

1. To understand the natural history of osteoarthritis (OA) at different joints (knee, hip, hand, foot and lumbar).

2. 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.

3. To examine risk factors of OA (lifestyle habits, nutritional, metabolic, anatomical and genetic factors, etc.) at each joint as well as multiple joints.

4. 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.

5. 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.

6. To investigate the association between gut microbiota and OA.

7. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4080
• Est. completion date: December 2031
• Est. primary completion date: December 2031
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. 50 years old or above

2. Residents of the randomly selected communities

Exclusion Criteria:

1. Inability to give informed consent

2. Terminal or mental illness

3. Pregnant women

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
China	Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (3)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University	Harvard University, University of Nottingham

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of multiple joints osteoarthritis.	Measured by radiographs of multiple joints.	At enrollment.
Primary	Incidence of multiple joints osteoarthritis.	Measured by radiographs of multiple joints, and the incidence of osteoarthritis can be calculated at each follow-up time point.	At 3, 6, 9, 12 years follow-ups after enrollment.
Primary	Progression of multiple joints osteoarthritis.	The changes of joint space and osteophytes are measured by radiographs of multiple joints, to assess the progression of multiple joints osteoarthritis.	At 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Ultrasound detected changes of knee, thigh muscle, and hand.	Ultrasound examination of both knee joints, quadriceps, hamstrings muscle and 15 peripheral joints of wrist and hand.	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of pain intensity of knee, hip, hand and lumbar.	Measured by visual analog scale (VAS).	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of pain experience of knee.	Measured by intermittent and constant osteoarthritis pain (ICOAP) questionnaire.	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of neuropathic pain of knee.	Measured by painDETECT questionnaire (PDQ).	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of patient's belief about knee pain.	Measured by illness perception questionnaire (IPQ).	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of pain catastrophizing of knee.	Measured by pain catastrophizing scale (PCS).	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Prevalence of knee/hip/patellofemoral joint pain.	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?"	At enrollment.
Secondary	Incidence of knee/hip/patellofemoral joint pain.	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.	At 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of global assessment of knee and hip.	Measured by the Western Ontario and McMaster Universities (WOMAC) score.	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of global hand function.	Measured by the Functional Index for Hand Osteoarthritis (FIHOA).	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of pain-related disability of lumbar osteoarthritis.	Measured by the Roland-Morris Disability Questionnaire (RMDQ).	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of the results of 30s repetition chair stand test.	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.	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of the results of 20-meter walk test.	Record the time a participant spent on walking for 20 meters.	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of the results of timed up and go test.	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.	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of the results of standing balance test.	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.	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of grip strength.	Measured by a Jamar Hydraulic Hand Dynamometer.	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of pinch strength.	Measured by a Jamar Hydraulic Pinch Gauge.	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of quadriceps strength.	Measured by a 'Nicholas Manual Muscle Tester' (Lafayette Instruments).	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of hamstrings strength.	Measured by a 'Nicholas Manual Muscle Tester' (Lafayette Instruments).	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of hip abductor.	Measured by a 'Nicholas Manual Muscle Tester' (Lafayette Instruments).	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of the results of squatting ability test.	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).	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of the results of stair climbing test.	Record the time a participant to ascended and descended a flight of five 14 cm steps stair as quickly as possible.	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of the results of quantitative sensory testing.	Measured by a hand-held pressure algometer (Wagner, FDIX25) .	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of the results of body composition analysis.	Measured by a InBody 770 Body Composition Analyser.	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Prevalence of nodal osteoarthritis.	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.	At enrollment.
Secondary	Prevalence of widespread pain.	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.	At enrollment.
Secondary	Incidence of widespread pain.	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.	At 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of physical and mental health.	Measured by the 12-Item Short-Form Health Survey (SF-12).	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Changes of sleep quality.	Measured by the Medical Outcomes Study (MOS) Sleep Scale.	At enrollment, and 3, 6, 9, 12 years follow-ups after enrollment.
Secondary	Prevalence of sarcopenia.	Sarcopenia would be diagnosed according to the Asian Working Group for Sarcopenia 2019 algorithm.	Every round of surveys since year 2018.
Secondary	Incidence of sarcopenia.	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.	At 3, 6, 9, 12 years follow-ups after enrollment.