ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000188932

Ethics application status

Approved

Date submitted

3/12/2019

Date registered

19/02/2020

Date last updated

19/02/2020

Date data sharing statement initially provided

19/02/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

Current management of patients with knee osteoarthritis in community physiotherapy practice: an observational study

Scientific title

Current management of patients with knee osteoarthritis in community physiotherapy practice: an observational study

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1228-5999

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Knee Osteoarthritis

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

This is an observational study that will examine current practice for the management of knee OA. Nine metropolitan-based, community physiotherapy practices and 30 patients with knee OA will be recruited. Patients will be included if they have activity-related joint pain, morning stiffness lasting <30 minutes and are aged over 45 years. All patients who who consent will have their physiotherapy notes audited using a proforma and participate in an interview with the researcher at 6 weeks taking approximately 30 minutes. Patients will also complete three patient reported outcome measures at baseline and 12 weeks taking up to 1 hr. All physiotherapists who consent will be interviewed by the researcher at 6 weeks after the final patient is recruited, each taking approximately 20 minutes.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Primary outcome 1 - Proportion of patients who are recorded as receiving care according to guidelines, as assessed by audit of patient treatment notes.

Timepoint [1]

Timepoint. at 6 weeks post enrolment.

Primary outcome [2]

Primary outcome 2 - Proportion of patients who have patient-reported outcomes incorporated into their assessment and management plan, as assessed by audit of patient treatment notes.

Timepoint [2]

Timepoint. at 6 weeks post enrolment.

Secondary outcome [1]

Secondary outcome 1 – knee stiffness, as assessed by patient reported outcome (Knee injury and Osteoarthritis Outcome Score)

Timepoint [1]

Timepoint. Baseline and 12 weeks post enrolment.

Secondary outcome [2]

Secondary outcome 2 – knee pain, as assessed by patient reported outcomes (Knee injury and Osteoarthritis Outcome Score and Multidimensional Health Assessment Questionnaire)

Timepoint [2]

Timepoint. Baseline and 12 weeks post enrolment.

Secondary outcome [3]

Secondary outcome 3 – knee function, as assessed by patient reported outcomes (Knee injury and Osteoarthritis Outcome Score and Multidimensional Health Assessment Questionnaire)

Timepoint [3]

Timepoint. Baseline and 12 weeks post enrolment.

Secondary outcome [4]

Secondary outcome 3 – Polysymptomatic distress, as assessed by patient reported outcomes (2011 Fibromyalgia criteria questionnaire)

Timepoint [4]

Timepoint. Baseline and 12 weeks post enrolment.

Eligibility

Key inclusion criteria

People who present with knee OA defined as
• activity related joint pain
• morning stiffness<30 mins
• over 45 years old
These participants may also have
. bony enlargement
• crepitus on active motion
• deformity fixed flexion
• +/-varus/valgus
• knee instability
• peri-articular or joint tenderness
• pain on patellar femoral compression
• swelling

All physiotherapists working in the practices, who have given consent, will be included in the study.

Minimum age

45 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Patients will be excluded from participation if they have
• inflammatory arthritis
• rheumatoid arthritis
• gout
• history of/or current infection in the joint
• cognitive impairment
• significant trauma
• hemi or total knee replacement of affected joint
• have had knee surgery in the last 12 months
• or are being treated under workers compensation

Physiotherapists will be excluded from participation if they choose to opt out and do not consent, or withdraw consent at any time during the project.

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Both

Statistical methods / analysis

We are aiming for an opportunistic sample size of 30 participants, ideally achieving 3-4 patients per practice. Whilst 12 people typically provide sufficient information for theme saturation in qualitative studies, we aim to enrol participants from each clinic in order to get a mix of socioeconomic backgrounds. Further, the relatively large sample will provide evidence of a trend in efficacy (if there is one), that will inform sample size calculations for future studies.
We are aiming to recruit a minimum of 25 physiotherapists across nine community physiotherapy practices in the Sydney area.

Analysis
Audit of Treatment Notes
Data collected through the auditing of treatment notes will be recorded in Microsoft excel spreadsheets and analysed using descriptive statistics (mean, standard deviation, and proportion) as follows: The percent of patients who received each of the core guideline treatments and the percent of patients who were referred to another healthcare professional for each of the core guideline treatments.
Audited treatment notes will be compared against care that is recommended in guidelines for the conservative management of knee OA. However, descriptive statistics of the patient will determine if all core guideline treatments need to be address. For example, if the patient is obese, weight-management should be discussed, and a referral to a dietician made. But, if they had a BMI < 25, this treatment would be made null.

Primary outcomes of the study include identifying the proportion of patients who are recorded as receiving care according to guidelines, and proportion of patients who have patient-reported outcomes incorporated into their assessment and management plan.
Secondary outcomes of the study include changes in knee pain, knee stiffness, knee function, and polysymptomatic distress at 12 weeks compared to baseline as assessed by Patient Reported outcome Measures (PROMs).

Demographic and clinical characteristics will be collected through the use of PROMs at initial recruitment and 12 weeks. The baseline characteristics of the two cohorts will be presented to demonstrate comparability. The change in PROMS across time for each cohort will also be presented.
Patients experience and perspectives of how their knee OA was managed will be gathered using a semi-structured face to face interview at 6 weeks post recruitment.
Physiotherapists experience and perspectives of how they manage knee OA will be gathered using a semi -structured face to face interview 6 weeks after recruitment is completed.
Semi-structured interviews will be conducted, audio-recorded and transcribed. Data collected from interviews will be recorded in nVivo were it will be categorised and classified. This will reflect both the patients and physiotherapists experiences and perceptions.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

8/03/2019

Date of last participant enrolment

Anticipated

Actual

7/08/2019

Date of last data collection

Anticipated

Actual

8/01/2020

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2000 - Haymarket

Recruitment postcode(s) [2]

2560 - Campbelltown

Recruitment postcode(s) [3]

2068 - Willoughby

Recruitment postcode(s) [4]

2063 - Northbridge

Recruitment postcode(s) [5]

2170 - Mount Pritchard

Recruitment postcode(s) [6]

2170 - Liverpool

Recruitment postcode(s) [7]

2154 - Castle Hill

Recruitment postcode(s) [8]

2000 - Sydney

Recruitment postcode(s) [9]

2033 - Kensington

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Sydney Translational Research and Education Alliance for Musculoskeletal (STREAM) Health

Address [1]

Ingham Institute
2 Campbell St
Liverpool 2170
NSW Australia

Country [1]

Australia

Primary sponsor type

University

Name

University of New South Wales

Address

UNSW Sydney
High St
Kensington, NSW 2052
Australia

Country

Australia

Secondary sponsor category [1]

Other

Name [1]

Neuroscience Research Australia (NeuRA)

Address [1]

Neuroscience Research Australia
Margarete Ainsworth Building
Baker Street
Randwick, Sydney,
NSW 2031

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of New South Wales Human Research Ethics Advisory Panel D

Ethics committee address [1]

High St
Kensington, NSW 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/11/2018

Approval date [1]

05/02/2019

Ethics approval number [1]

HC180864

Summary

Brief summary

Historically, the management of knee OA has been variable, and often limited to pharmaceutical management and total joint replacement. Recently, evidence-based recommendations for the management of knee OA have been developed by scientific societies and health organisations. Best-practice guidelines for the treatment of knee OA focus on conservative (non-operative) multidisciplinary management that encompasses education, exercise, lifestyle modification and weight-loss where relevant, while promoting self-management. This body of evidence demonstrates that multidisciplinary conservative management of knee OA is efficacious. This observational study aims to discover how knee osteoarthritis patients are currently been managed by community physiotherapists, and if this aligns with recommended guidelines.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mrs Rebecca Livings

Address

Neuroscience Research Australia
Margarete Ainsworth Building
Baker Street, Randwick, Sydney, NSW 2031

Country

Australia

Phone

+61 0428071588

Fax

[email protected]

Contact person for public queries

Name

Rebecca Livings

Address

Neuroscience Research Australia
Margarete Ainsworth Building
Baker Street, Randwick, Sydney, NSW 2031

Country

Australia

Phone

+61 0428071588

Fax

[email protected]

Contact person for scientific queries

Name

Rebecca Livings

Address

Neuroscience Research Australia
Margarete Ainsworth Building
Baker Street, Randwick, Sydney, NSW 2031

Country

Australia

Phone

+61 0428071588

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All of the individual data collected during the study, after de-identification

When will data be available (start and end dates)?

Beginning 3 months following main results publication, no end date determined.

Available to whom?

Case-by-case basis at the discretion of Primary Sponsor

Available for what types of analyses?

Only to achieve the aims in the approved proposal

How or where can data be obtained?

Access subject to approvals by Principal Investigator
[email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
6734	Study protocol			[email protected]
6735	Ethical approval			[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Implementation of a community-based, physiotherapy-led, multidisciplinary model of care for the management of knee osteoarthritis: Protocol for a feasibility study.	2020	https://dx.doi.org/10.1136/bmjopen-2020-039152

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically