Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000930886
Ethics application status
Approved
Date submitted
7/06/2021
Date registered
15/07/2021
Date last updated
23/06/2022
Date data sharing statement initially provided
15/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Understanding Knee Osteoarthritis Pain Experiences
Scientific title
Does pain sensitisation predict pain and functional outcomes based on ecological momentary and end-point assessments in people with knee osteoarthritis?
Secondary ID [1] 304417 0
None
Universal Trial Number (UTN)
Trial acronym
U-KOPE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 322220 0
Condition category
Condition code
Musculoskeletal 319914 319914 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation of people with pain and knee osteoarthritis longitudinally with follow-up occurring at 2-weeks and 9-weeks.

The baseline assessment includes Quantitative Sensory Testing, Performance Based Testing (30 second Chair test, 6 minute walk test) and completion of Patient-Report Outcome Measures assessing personal characteristics, pain characteristics, functional characteristics, psychosocial characteristics and health/lifestyle measures. This will be performed at the University of Otago School of Physiotherapy with assessment lasting for approximately 90 minutes.

Follow-up measurement will occur at two weeks and nine weeks following the baseline assessment. Follow-up measurement involves collecting pain and functional information via patient-reported questionnaires such as the Brief Pain Inventory and the Knee Injury and Osteoarthritis Outcome Score. Measures will also collect information on health-related quality of life, fatigue, physical activity and participation. The two-week follow-up will occur at the University of Otago School of Physiotherapy lasting for approximately 30 minutes. The nine week follow-up will be completed from home with participants being emailed the questionnaires via REDCap.

Using a maximum variation sampling method, a group of participants will be invited to participate in 4-5 focus groups made up for 5-6 people. These will consist of semi-structured interviews which will explore the usability and acceptability of smartphone Ecological Momentary Assessment in monitoring knee osteoarthritis pain experiences. Additionally, these focus groups will explore participant perceptions of Quantitative Sensory Testing in knee osteoarthritis. Focus groups will last for approximately one hour at the University of Otago School of Physiotherapy.
Intervention code [1] 320774 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327786 0
Pain
Timepoint [1] 327786 0
Cross sectional at baseline and prospective longitudinally at 2-weeks (including Ecological Momentary Assessment (EMA)) and 9-weeks via pain patient-reported measures (Brief Pain Inventory).
Primary outcome [2] 328074 0
Function
Timepoint [2] 328074 0
Cross sectional at baseline and prospective longitudinally at 2-weeks (including EMA) and 9-weeks via functional patient-reported measures (Knee Injury and Osteoarthritis Outcome Score)
Primary outcome [3] 328075 0
Pain interference
Timepoint [3] 328075 0
Cross-sectional, two-weeks and nine-weeks post assessment. This will be measured using the EMA pain interference item and the Brief Pain Inventory.
Secondary outcome [1] 396595 0
Fatigue
Timepoint [1] 396595 0
2-weeks (including EMA) and 9-weeks. This will be assessed using the Brief Fatigue Inventory and EMA fatigue items.
Secondary outcome [2] 397495 0
Participation
Timepoint [2] 397495 0
2-weeks and 9-weeks post initial assessment. This will be measured using the Keele Assessment of Participation
Secondary outcome [3] 397496 0
Health-related quality of life
Timepoint [3] 397496 0
Two-weeks and nine-weeks post initial assessment. This will be assessed using the 12-Item Short Form Survey
Secondary outcome [4] 397497 0
Physical Activity
Timepoint [4] 397497 0
Measured at two-weeks and nine-weeks. Measured via the International Physical Activity Questionnaire and EMA Physical Activity and Sedentary Activity Items.
Secondary outcome [5] 397505 0
Flare-ups
Timepoint [5] 397505 0
Measured at two-weeks using the EMA flare-up item.
Secondary outcome [6] 397506 0
Pain bothersomeness
Timepoint [6] 397506 0
Measured at two-weeks via the EMA pain bothersomeness item.
Secondary outcome [7] 397507 0
Sleep quality
Timepoint [7] 397507 0
Measured at two-weeks via the EMA sleep quality item and the Brief Fatigue Inventory.
Secondary outcome [8] 397508 0
Social contact
Timepoint [8] 397508 0
Measured at two-weeks via EMA social contact and loneliness items.
Secondary outcome [9] 397509 0
Affect
Timepoint [9] 397509 0
Measured cross-sectionally via the Depression, Anxiety, Stress Scale -21 and at two-weeks via EMA positive and negative affect items
Secondary outcome [10] 397510 0
Anxiety
Timepoint [10] 397510 0
Measured cross-sectionally via the Depression, Anxiety, Stress Scale -21 and at two-weeks via EMA anxiety item
Secondary outcome [11] 397511 0
Stress
Timepoint [11] 397511 0
Measured cross-sectionally via the Depression, Anxiety, Stress Scale -21 and at two-weeks via EMA stress item

Eligibility
Key inclusion criteria
Those with a diagnosis of knee osteoarthritis who experience knee pain on most days for at least three months will be eligible for inclusion.
Minimum age
45 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they are non-English speaking, are unable to use a smartphone, have an auto-immune condition or other form of inflammatory arthritis, have uncontrolled hypertension, skin conditions, lower limb sensory loss, pregnant or within six months postpartum, have undergone or are scheduled for total knee arthroplasty, have sustained a lower limb injury in the last six months (or still recovery), have a neurological condition, impaired cognition or psychiatric illness.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Baseline assessment includes the assessment of potential confounders such as psychosocial factors (mood, pain catastrophising) and personal factors (age, gender, BMI, quadriceps strength, pain medications) which can influence both dependent and independent variables.

Objective 1: To determine whether cross-sectional associations exist between pain sensitisation and clinical outcomes in people with knee OA.
- Independent variables: MDT’s, PPT (regional and remote), MTS, CPM (30, 60 and 90 seconds), SPA index, CSI.
- Dependent variables: Pain severity, pain interference, physical function/KOOS outcome.
- Covariates: Age, gender, BMI, quadriceps strength, psychological factors, pain medication intake.
- Analytical approach: correlations and univariate and bivariate linear and logistic regression modelling.

Objective 2: To determine the pain and other associated experiences of those with knee OA using EMA methodology.
- Variables: Pain severity, pain interference, pain bothersomeness, sedentary time, flare-up’s, sleep quality, fatigue, affect, stress, anxiety, social contact and loneliness.
- Analytical approach: Descriptive statistics [Means (standard deviations) or medians (interquartile ranges) and frequencies (percentages)] will be used to summarise all measures. This will allow for indices such as averages (mean), pain maximum, durations at different symptom severities, pain minimum as well as variability (standard deviation) to be calculated. Trajectories of pain severity, pain interference in function, psychological, social and fatigue measures collected through EMA will be characterized using a linear mixed-effects model framework. Statistical analyses will include within and between-person analyses such as multilevel modelling techniques and multivariate time-series analysis methods.

Objective 3 & 4: To determine whether pain sensitisation predicts pain and other associated experiences measured via smartphone EMA methodology and via end-point patient-report questionnaires. of those with knee OA.
- Independent (predictor) variables: MDT’s, PPT (regional and remote), MTS, CPM (0, 60 and 90 seconds), SPA index, PainDETECT classification, CSI.
- EMA-based outcome variables:
o Primary: pain severity, pain variability, time in high pain, pain interference/function, bothersomeness, sedentary activity and OA flare-ups.
o Secondary: Fatigue, sleep quality, loneliness, psychological status
- End-point self-reported outcome variables:
o Primary: KOOS function, pain severity, pain interference.
o Secondary: KAP, BFI, SF-12
- Covariates: Age, gender, BMI, quadriceps strength, psychological factors, pain medication intake.
- Analytical approach: Linear and multiple regression analyses to determine the predictive relationships between specific baseline pain sensitisation predictive variables and outcomes measured through both EMA as well as end-point patient-reported measures. A multivariable predictive model will be developed to determine absolute risks. Internal validity of the model will be tested. Model performance will be reported through calibration and discrimination measures.

Objective 5: To determine any associations between measures gathered using EMA methods with the end-point patient-reported questionnaires.
- Variables: Pain severity, pain interference/function, fatigue, sedentary activity, sleep quality, negative affect, anxiety, stress.
- Analytical approach: Pearson’s or spearman’s correlations.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/06/2021
Date of last participant enrolment
Anticipated
22/10/2022
Actual
19/01/2022
Date of last data collection
Anticipated
31/12/2022
Actual
25/03/2022
Sample size
Target
100
Accrual to date
Final
86
Recruitment outside Australia
Country [1] 23755 0
New Zealand
State/province [1] 23755 0
Otago

Funding & Sponsors
Funding source category [1] 308783 0
University
Name [1] 308783 0
University of Otago
Country [1] 308783 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Otago Medical Research Foundation
Address
P.O. Box 5726
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 309693 0
None
Name [1] 309693 0
None
Address [1] 309693 0
None
Country [1] 309693 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308696 0
Central Health and Disability Ethics Committee (NZ)
Ethics committee address [1] 308696 0
Ethics committee country [1] 308696 0
New Zealand
Date submitted for ethics approval [1] 308696 0
Approval date [1] 308696 0
20/04/2021
Ethics approval number [1] 308696 0
21/CEN/89

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111590 0
Dr Ramakrishnan Mani
Address 111590 0
School of Physiotherapy
325 Great King Street
North Dunedin
Dunedin 9016
Country 111590 0
New Zealand
Phone 111590 0
+64 3 479 3485
Fax 111590 0
Email 111590 0
[email protected]
Contact person for public queries
Name 111591 0
Mark Overton
Address 111591 0
School of Physiotherapy
325 Great King Street
North Dunedin
Dunedin 9016
Country 111591 0
New Zealand
Phone 111591 0
+64 277215944
Fax 111591 0
Email 111591 0
[email protected]
Contact person for scientific queries
Name 111592 0
Mark Overton
Address 111592 0
School of Physiotherapy
325 Great King Street
North Dunedin
Dunedin 9016
Country 111592 0
New Zealand
Phone 111592 0
+64 277215944
Fax 111592 0
Email 111592 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.