Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000363189
Ethics application status
Approved
Date submitted
18/02/2019
Date registered
7/03/2019
Date last updated
25/11/2019
Date data sharing statement initially provided
7/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing non-steroidal anti-inflammatory drug use in people with knee osteoarthritis
Scientific title
Reducing non-steroidal anti-inflammatory drug use in people with knee osteoarthritis: an assessment of feasibility and acceptability of a repeated measures study for risk minimisation
Secondary ID [1] 297405 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis 311565 0
Condition category
Condition code
Musculoskeletal 310196 310196 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 310324 310324 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will involve participants receiving 6 individualised physiotherapy consultations and exercise via a web-application (Physitrack) over 12 week, following 6 weeks of usual care (total duration of study will be 18 weeks). An experienced and registered physiotherapist will be delivering one-on-one sessions for each participant. As the intervention will be delivered using a video-conferencing web-application, the sessions will be conducted at the participants’ homes. The first session (week 7) will be the longest and be approximately 60 minutes. The subsequent five sessions (week 8, 10, 12, 14, and 16) will be shorter and be approximately 30-40 minutes.

The physiotherapy intervention will involve 1) an individually-tailored progressive-resistance exercise program; 2) health coaching to a) reduce medication and b) increase physical activity; and 3) online pain coping skills training (via Pain Trainer). During the intervention, the physiotherapist will also deliver education about osteoarthritis and non-steroidal anti-inflammatory drugs, and guideline-recommended.

The home-based exercise program will be designed and administered according to the participants’ goals, abilities and preferences, using resistance bands. As per the ACSM guidelines for physical activity, participants will perform two to three sets of 6-10 repetitions of each exercise. This will be tailored to each participant. Exercise intensity will be set at equal to or more than 5 (hard) on the Modified Borg Rating of Perceived Exertion Scale.

Participants will also receive health coaching via motivational interviewing to guide them towards reducing their reliance on NSAIDs and improving their physical activity levels to managing their condition. More specifically, participants will undergo motivational interviewing with their physiotherapist to address their goals and barriers, as well as assist participants in creating strategies to meet these goals and overcome their barriers. The therapist providing the intervention will be trained to be proficient in the health coaching process. Health coaching will be integrated in the six telephysiotherapy sessions, and should last approximately 20 minutes per session.

All participants will also have access to an online pain coping skills training program, the Pain Trainer. This includes eight 40-minute modules focusing on different skills of pain coping. These modules will be introduced at the initial session but will be left to the patient to complete in their own time before the end of the study. The skills they learn will also be practiced in the scheduled sessions.

Adherence to exercise will be monitored using a log book. We will also be asking participants to record any adverse events related to the exercise intervention, as well as any medication they are taking.
Intervention code [1] 313654 0
Treatment: Other
Comparator / control treatment
Participants will be their own controls, by undergoing usual care for the first 6 weeks of the study period. During this time, participants will be asked to continue “as normal” with non-steroidal anti-inflammatory drug use and the usual care they seek. Following the 6 week usual care period, participants will undergo 12 weeks of the intervention delivered by a physiotherapist.
Control group
Active

Outcomes
Primary outcome [1] 319083 0
recruitment rate
Timepoint [1] 319083 0
18 week follow up
Primary outcome [2] 319210 0
Data completeness
Timepoint [2] 319210 0
18 week follow up
Primary outcome [3] 319211 0
Acceptability
This outcome will be assessed using a survey that will ask participants whether they found the intervention useful (yes/no), whether they recommend the intervention to others (yes/no), and whether they would continue with the exercises and the strategies they have been taught to manage their pain (yes/no).
Timepoint [3] 319211 0
18 week follow up
Secondary outcome [1] 366936 0
Daily analgesic dosage and type
Timepoint [1] 366936 0
Taken daily during the 18 week study period via a logbook
Secondary outcome [2] 366937 0
Beliefs on medication use (Beliefs about Medicines Questionnaire)
Timepoint [2] 366937 0
Baseline, 6 week (assessment #1) and 18 week (assessment #2) assessments
Secondary outcome [3] 366938 0
Views on exercise (Exercise Benefits/Barriers Scale)
Timepoint [3] 366938 0
Baseline, 6 week (assessment #1) and 18 week (assessment #2) assessments
Secondary outcome [4] 366939 0
Adverse events from the exercise (e.g. muscle strain)
Timepoint [4] 366939 0
Weekly during the study period, via the logbook
Secondary outcome [5] 366940 0
Knee related pain and physical function (Western Ontario and McMaster Universities Osteoarthritis Index)
Timepoint [5] 366940 0
Baseline, 6 week (assessment #1) and 18 week (assessment #2) assessments
Secondary outcome [6] 366941 0
Levels of physical activity (International Physical Activity Questionnaire, short form)
Timepoint [6] 366941 0
Baseline, 6 week (assessment #1) and 18 week (assessment #2) assessments
Secondary outcome [7] 377208 0
Physical activity levels using objective measures through activity monitors using a wrist-worn accelorometer.
Timepoint [7] 377208 0
Baseline, 6 week (assessment #1) and 18 week (assessment #2) assessments

Eligibility
Key inclusion criteria
- Aged 45 years or older
- Activity-related joint pain
- Morning stiffness lasting <30 minutes
- Report regular use of non-steroidal anti-inflammatory drugs of any class (the participants must have used them on average of 5 or more days in the previous 4 weeks before the commencement of the trial)
- Have access to the Internet
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Chronic systemic inflammatory conditions
- Neurological condition affecting a participant’s ability to ambulate
- Unstable cardiovascular condition
- Regular use of strong opioids (e.g. morphine)
- Participants must not be involved in any active therapy for their knee osteoarthritis such as a structured exercise program, designed by a physiotherapist but they can be involved in their own leisurely physical activity

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The study design for this study is a repeated measures design, whereby a single group of participants will be monitored over 6 weeks under their usual care, followed by a 12-week physiotherapy and exercise intervention, delivered using a web-application, Physitrack. During these 12 weeks, a physiotherapist will deliver 6 consultations.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics, such as frequency, mean and standard deviations of primary outcome measures will be evaluated using SPSS (IBM).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/03/2019
Actual
11/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 301974 0
Other
Name [1] 301974 0
Australia and New Zealand Musculoskeletal Clinical Trials Network Centre of Research Excellence Seeding Grant
Country [1] 301974 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney, Faculty of Health Sciences
75 East Street
Lidcombe
NSW 2141
Country
Australia
Secondary sponsor category [1] 301749 0
None
Name [1] 301749 0
Address [1] 301749 0
Country [1] 301749 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302654 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 302654 0
Ethics committee country [1] 302654 0
Australia
Date submitted for ethics approval [1] 302654 0
19/11/2018
Approval date [1] 302654 0
01/07/2019
Ethics approval number [1] 302654 0
2018/931

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

Contacts
Principal investigator
Name 90946 0
Dr Milena Simic
Address 90946 0
University of Sydney, Faculty of Health Sciences
Discipline of Physiotherapy
75 East Street
Lidcombe
NSW 2141
Country 90946 0
Australia
Phone 90946 0
+61 2 9351 9254
Fax 90946 0
Email 90946 0
[email protected]
Contact person for public queries
Name 90947 0
Sarah Kobayashi
Address 90947 0
University of Sydney, Faculty of Health Sciences
Musculoskeletal Health Research Group
75 East Street
Lidcombe
NSW 2141
Country 90947 0
Australia
Phone 90947 0
+61 2 9351 9560
Fax 90947 0
Email 90947 0
[email protected]
Contact person for scientific queries
Name 90948 0
Milena Simic
Address 90948 0
University of Sydney, Faculty of Health Sciences
Discipline of Physiotherapy
75 East Street
Lidcombe
NSW 2141
Country 90948 0
Australia
Phone 90948 0
+61 2 9351 9254
Fax 90948 0
Email 90948 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.