Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001266853
Ethics application status
Approved
Date submitted
23/06/2021
Date registered
20/09/2021
Date last updated
23/03/2022
Date data sharing statement initially provided
20/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The influence of education on pain responses to acute exercise in people with knee osteoarthritis
Scientific title
The influence of education on pain responses to acute exercise in people with knee osteoarthritis
Secondary ID [1] 304601 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 322513 0
Condition category
Condition code
Musculoskeletal 320150 320150 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will involve explicit education about the pain-relieving effects of exercise. The education will be delivered face to face (Group A) or online (Group B) via videoconferencing software by an Accredited Exercise Physiologist on an individual basis but will not be personalised for each participant. The intervention education component of the experiment will last approximately 15 minutes including content covering the pain-relieving effects of exercise such as exercise-induced hypoalgesia (EIH) and the benefits of exercise for knee OA. The education will be delivered using pictures and analogies. The entire experimental session will last approximately 60 - 90 minutes, with the rest of the experimental session to consist of participants completing questionnaires relating to their health and level of physical activity (20 min), a bout of exercise (Group A: 20 min of moderate-intensity aerobic exercise at 60% of heart rate reserve performed on a stationary cycle ergometer (Monark 828e, Vansbro, Sweden)); (Group B: 20 min of home-based strengthening exercise at moderate intensity (e.g. rating of perceived exertion of 14/15 on Borg's 6-20 scale)) and pain assessments before and after exercise including pressure pain threshold testing for Group A (10min) and clinical pain ratings using a numeric pain rating scale for Group A and B (5min). All testing for Group A will be performed at the University of New South Wales and all testing for Group B will be conducted online via telehealth.
Intervention code [1] 320952 0
Treatment: Other
Comparator / control treatment
The comparator treatment will involve general education about knee osteoarthritis guidelines. The education will be delivered face to face (Group A) or online (Group B) via videoconferencing software by an Accredited Exercise Physiologist on an individual basis but will not be personalised for each participant. The comparator education component of the experiment will last approximately 15 minutes and include content covering the clinical practice guidelines for knee OA. The education will be delivered using pictures and analogies. The entire experimental session will last approximately 60 - 90 minutes, with the rest of the experimental session to consist of participants completing questionnaires relating to their health and level of physical activity (20 min), a bout of exercise (Group A: 20 min of moderate intensity aerobic exercise at 60% of heart rate reserve performed on a stationary cycle ergometer (Monark 828e, Vansbro, Sweden)); (Group B: 20 min of home-based strengthening exercise at moderate intensity (e.g. rating of perceived exertion of 14/15 on Borg's 6-20 scale)) and pain assessment will be conducted before and after exercise including pressure pain threshold testing for Group A (10min) and clinical pain ratings using a numeric pain rating scale for Group A and B (5min). All testing for Group A will be performed at the University of New South Wales and all testing for Group B will be conducted online via telehealth.
Control group
Active

Outcomes
Primary outcome [1] 328022 0
Change in pressure pain threshold assessed using a handheld algometer.
Timepoint [1] 328022 0
Immediately prior to exercise and immediately following exercise
Primary outcome [2] 328024 0
Change in self-reported pain intensity assessed using a 0-10 numeric ratings scale
Timepoint [2] 328024 0
Immediately before exercise, every 5 minutes during exercise (e.g. at 5, 10, 15 and 20 minutes of the exercise protocol), and then 5 minutes following exercise cessation. The assessment of pain intensity 5 minutes following exercise is considered the primary endpoint.
Secondary outcome [1] 397264 0
Assessment of knowledge and beliefs about exercise and pain arising from the education intervention assessed using a questionnaire designed specifically for this study. The questionnaire consists of 5 questions that are each scored on a 7-point Likert scale anchored at one end with "Strongly agree" and at the other end with "Strongly disagree".
Timepoint [1] 397264 0
The questionnaire is administered immediately after the education intervention prior to the assessment of pressure pain thresholds and the exercise bout.

Eligibility
Key inclusion criteria
• You are aged 18 years or older and are able to speak, read and write English
• You have a diagnosis of osteoarthritis in one or both knees and no other leg injuries/disabilities or surgeries
• It is medically suitable for you to perform moderate intensity exercise
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Any other type of arthritis apart from osteoarthritis of the knee or another cause of chronic pain other than knee osteoarthritis
• You have been diagnosed with a serious psychiatric illness (e.g. major depression or severe anxiety)
• You have been diagnosed with a serious cardiovascular, cardiopulmonary or neurological disease
• Unable to refrain from pain medication for 24 h prior to the study
• Unable to perform 20 minutes of moderate intensity exercise

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Screening to determine eligibility for the study will be performed without knowledge of the allocation for an enrolled participant. Allocation concealment will be done using sealed opaque envelopes. These will be created and provided to the research team by someone external to the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). This will be done by someone external to the research team.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Participants will be aware that they are receiving education about exercise and pain. however, they will be blinded to the different types of education being provided in the Intervention and Control arms as well as the overall study hypotheses. Pressure pain threshold will be assessed by an investigator who is blind to the education received by participants. Data analysis will be blinded.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size planning:
Sample size calculations were made in G*Power (version 3.1.9.2) using a two-tailed independent samples t-test (difference between two independent means (two groups)) with an alpha of 0.05 and power of 0.90. This sample size was based on detecting the smallest effect size of interest between groups, which for people with chronic pain, including knee osteoarthritis, is a change in pain of 1/10 on a numeric rating scale (Chou et al, 2017; Perrot & Bertin, 2013). Fleng-Sandall showed a single bout of exercise to acutely increase pain (~0.75/10) in people with knee osteoarthritis, with the standard deviation of this increase being approximately 1.25 points on a 0-10 scale. Assuming this same standard deviation for the general education group in our study, a slightly lower standard deviation of 1.10 for the intervention education group (on the hypothesis that this education will reduce variability of the pain response to exercise), and a between group difference of 1, then 62 participants (31 per group) are required to detect a change of this size with 90% power and alpha of 0.05. To account for the possibility of participant drop out, we will aim to recruit up to 70 participants.

Analysis of outcomes:
Between-group differences in the effect of intervention education + exercise versus control education +exercise on pain threshold and clinical pain will be examined using analysis of covariance (ANCOVA) on the post-test score with the baseline value included as the covariate. Significant main effects will be examined post hoc using Bonferroni corrected t-tests. Effect sizes with 95% confidence intervals will be calculated to complement these data. The threshold for statistical significance will be set at p< 0.05. The minimal clinically important difference for the change in self-reported clinical pain will be set at 1 or more out of 10.

For the assessment of knowledge and beliefs about exercise and pain, descriptive statistics will be generated from the Likert scale responses to the questions regarding exercise and pain; differences between the intervention and comparator arms for these responses will be analysed using independent t-tests or Mann-Whitney U tests depending on the normality of the data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/10/2021
Actual
5/10/2021
Date of last participant enrolment
Anticipated
31/03/2022
Actual
Date of last data collection
Anticipated
31/03/2022
Actual
Sample size
Target
70
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308964 0
University
Name [1] 308964 0
The University of New South Wales
Country [1] 308964 0
Australia
Primary sponsor type
University
Name
The University of New South Wales
Address
The University of New South Wales
Sydney, NSW, 2052. Australia
Country
Australia
Secondary sponsor category [1] 309897 0
None
Name [1] 309897 0
Address [1] 309897 0
Country [1] 309897 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308851 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 308851 0
Ethics committee country [1] 308851 0
Australia
Date submitted for ethics approval [1] 308851 0
04/05/2021
Approval date [1] 308851 0
13/08/2021
Ethics approval number [1] 308851 0
HC210343

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

Contacts
Principal investigator
Name 112118 0
Dr Matthew Jones
Address 112118 0
School of Health Sciences
The University of New South Wales
Sydney, NSW 2052
Country 112118 0
Australia
Phone 112118 0
+61 2 9348 0032
Fax 112118 0
Email 112118 0
[email protected]
Contact person for public queries
Name 112119 0
Adrian Ram
Address 112119 0
School of Health Sciences
The University of New South Wales
Sydney, NSW 2052
Country 112119 0
Australia
Phone 112119 0
+61 2 9348 0032
Fax 112119 0
Email 112119 0
[email protected]
Contact person for scientific queries
Name 112120 0
Adrian Ram
Address 112120 0
School of Health Sciences
The University of New South Wales
Sydney, NSW 2052
Country 112120 0
Australia
Phone 112120 0
+61 2 9348 0032
Fax 112120 0
Email 112120 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.