Osteoarthritis, KneeNCT03899272
Psychological Strengths and Burden Among Osteoarthritis Patient
An observational study of Osteoarthritis, Knee and Psychological, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Osteoarthritis (OA) is a common and debilitating disease, For the majority of patients, pain in OA is episodic in nature. The experience of pain is generated or modified by nociception, neuropathic symptoms, psychological and personality factors, genetic influences, past painful experiences, comorbid conditions, and… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Psychological
- How many people
- 150 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2018to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 150 patients, based on previous studies (Psychological Profiles and Pain Characteristics of Older Adults With Knee Osteoarthritis; Psychological factors and their relation to osteoarthritis pain) and the number of patients and study time available in our clinic Those are all the new patient present to AHNH clinic referred for osteoarthritis for considering joint replacement
Who may be able to join
- all new patient present to AHNH clinic referred for osteoarthritis for considering joint replacement
- Present with knee pain (unilateral or bilateral) contributed by osteoarthritis
Who cannot join
- mentally unsound
- dialectic speaker that difficult to communicate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Positive and Negative Affects Among Osteoarthritis Patient
Osteoarthritis (OA) is a common and debilitating disease, For the majority of patients, pain in OA is episodic in nature.
The experience of pain is generated or modified by nociception, neuropathic symptoms, psychological and personality factors, genetic influences, past painful experiences, comorbid conditions, and expectations related to future pain Previous studies have shown psychological well-being has been significantly associated with disability in patients with OA, and anxiety has been found to be associated with knee pain in women.
Read more
Previous studies also found that there are large interindividual differences among persons with knee osteoarthritis (OA) with respect to psychological function.
Psychological strengths and weaknesses are evaluated among new patient with osteoarthritis presented to joint replacement clinic, to facilitate our understanding of those patients need, and correlating with their radiological and clinical findings. Psychological strengths and weaknesses, positive and negative affects are evaluated in form of questionaires.
Reference:
Adaptation to disability: Applying selective optimization with compensation to the behaviors of older adults with osteoarthritis.
MAM Gignac, C Cott, EM Badley - Psychology and aging, 2002
Analgesic effects of multisensory illusions in osteoarthritis C Preston, R Newport - Rheumatology, 2011
Psychological factors and their relation to osteoarthritis pain BL Wise, J Niu, Y Zhang, N Wang, JM Jordan… - Osteoarthritis Cartilage. , 2010 - Elsevier
Read the detailed description
Introduction:
Osteoarthritis (OA) is a prevalent painful condition that may cause disability among older adults (Cruz-Almeida et al., 2013). Psychological traits and emotional states of patients were found to be correlated with symptoms of OA and daily functioning of patients (Cruz-Almeida et al., 2013; Dezutter et al., 2015).
The experience of pain is generated or modified by nociception, neuropathic symptoms, psychological and personality factors, genetic influences, past painful experiences, comorbid conditions, and expectations related to future pain. Previous studies have shown psychological well-being has been significantly associated with disability in patients with OA, and anxiety has been found to be associated with knee pain in women.
Previous studies also found that there are large interindividual differences among persons with knee osteoarthritis (OA) with respect to psychological function.
Aim of project:
This research is trying to find out what psychological strengths or factors could attenuate the chronic pain of knee OA patients. The purpose of the study is to find psychological evidences that may be used in the future to help chronic pain patients for improving their daily functioning and well-being.
- Conditions
- Osteoarthritis, Knee, Psychological
- Keywords
- osteoarthritis, psychology
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
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 |
|---|---|---|
| Osteoarthritis | All new patient present to clinic referred for osteoarthritis for considering joint replacement Present with knee pain (unilateral or bilateral) contributed by osteoarthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Affect Scale (PANAS)
This scale consists of a number of questions that describe different feelings and emotions.
Measured: 1 day
The Centre for Epidemiologic Studies (CES-D Scale)
A list of the ways the subject might have felt or behaved.
Measured: 1 day
The Chronic Pain Acceptance Questionnaire (CPAQ)
Statements on feelings on pain as it applies to the subject.
Measured: 1 day
Chronic Pain Coping Inventory (CPCI-42)
Measured: 1 day
VIA-72
Questions reflect statements that the subject would find desirable.
Measured: 1 day
Kellgren & Lawrence (K & L) grading system
To classify the severity of knee osteoarthritis (OA)
Measured: 1 day
Oxford knee scores
Consists of 12 questions that cover function and pain of the knee.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Jun 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lawrence CM Lau, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899272
- Sponsor's protocol ID
- 2018.113
- Status last verified
- Jan 2020
- First submitted
- 28 Mar 2019
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive and Negative Affects Among Osteoarthritis Patient
- ClinicalTrials.gov ID
- NCT03899272
- Acronym / sponsor ID
- 2018.113
- Conditions
- Osteoarthritis, Knee, Psychological
- Keywords
- osteoarthritis, psychology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 2 Apr 2019 (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.
Osteoarthritis (OA) is a common and debilitating disease, For the majority of patients, pain in OA is episodic in nature.
The experience of pain is generated or modified by nociception, neuropathic symptoms, psychological and personality factors, genetic influences, past painful experiences, comorbid conditions, and expectations related to future pain Previous studies have shown psychological well-being has been significantly associated with disability in patients with OA, and anxiety has been found to be associated with knee pain in women.
Previous studies also found that there are large interindividual differences among persons with knee osteoarthritis (OA) with respect to psychological function.
Psychological strengths and weaknesses are evaluated among new patient with osteoarthritis presented to joint replacement clinic, to facilitate our understanding of those patients need, and correlating with their radiological and clinical findings. Psychological strengths and weaknesses, positive and negative affects are evaluated in form of questionaires.
Reference:
Adaptation to disability: Applying selective optimization with compensation to the behaviors of older adults with osteoarthritis.
MAM Gignac, C Cott, EM Badley - Psychology and aging, 2002
Analgesic effects of multisensory illusions in osteoarthritis C Preston, R Newport - Rheumatology, 2011
Psychological factors and their relation to osteoarthritis pain BL Wise, J Niu, Y Zhang, N Wang, JM Jordan… - Osteoarthritis Cartilage. , 2010 - Elsevier
Detailed description
Introduction:
Osteoarthritis (OA) is a prevalent painful condition that may cause disability among older adults (Cruz-Almeida et al., 2013). Psychological traits and emotional states of patients were found to be correlated with symptoms of OA and daily functioning of patients (Cruz-Almeida et al., 2013; Dezutter et al., 2015).
The experience of pain is generated or modified by nociception, neuropathic symptoms, psychological and personality factors, genetic influences, past painful experiences, comorbid conditions, and expectations related to future pain. Previous studies have shown psychological well-being has been significantly associated with disability in patients with OA, and anxiety has been found to be associated with knee pain in women.
Previous studies also found that there are large interindividual differences among persons with knee osteoarthritis (OA) with respect to psychological function.
Aim of project:
This research is trying to find out what psychological strengths or factors could attenuate the chronic pain of knee OA patients. The purpose of the study is to find psychological evidences that may be used in the future to help chronic pain patients for improving their daily functioning and well-being.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteoarthritis | – | –All new patient present to clinic referred for osteoarthritis for considering joint replacement Present with knee pain (unilateral or bilateral) contributed by osteoarthritis |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 150 patients, based on previous studies (Psychological Profiles and Pain Characteristics of Older Adults With Knee Osteoarthritis; Psychological factors and their relation to osteoarthritis pain) and the number of patients and study time available in our clinic Those are all the new patient present to AHNH clinic referred for osteoarthritis for considering joint replacement
Key inclusion criteria (2 listed)
- all new patient present to AHNH clinic referred for osteoarthritis for considering joint replacement
- Present with knee pain (unilateral or bilateral) contributed by osteoarthritis
Key exclusion criteria (2 listed)
- mentally unsound
- dialectic speaker that difficult to communicate
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
Positive and Negative Affect Scale (PANAS)
Time frame: 1 day
This scale consists of a number of questions that describe different feelings and emotions.
The Centre for Epidemiologic Studies (CES-D Scale)
Time frame: 1 day
A list of the ways the subject might have felt or behaved.
The Chronic Pain Acceptance Questionnaire (CPAQ)
Time frame: 1 day
Statements on feelings on pain as it applies to the subject.
Chronic Pain Coping Inventory (CPCI-42)
Time frame: 1 day
VIA-72
Time frame: 1 day
Questions reflect statements that the subject would find desirable.
Kellgren & Lawrence (K & L) grading system
Time frame: 1 day
To classify the severity of knee osteoarthritis (OA)
Oxford knee scores
Time frame: 1 day
Consists of 12 questions that cover function and pain of the knee.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteoarthritis, Knee and Psychological, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 2 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: finished, as of the sponsor's last update on 23 Jan 2020. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Positive and Negative Affect Scale (PANAS) (time frame: 1 day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2020.