Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000336987
Ethics application status
Approved
Date submitted
20/02/2020
Date registered
10/03/2020
Date last updated
2/07/2021
Date data sharing statement initially provided
10/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of an online education and exercise program for people with knee cap pain.
Scientific title
Effect of a Self-directed Web-based Education and Exercise program for people with Patellofemoral pain (SWEEP): A randomised controlled trial
Secondary ID [1] 300527 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SWEEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patellofemoral pain 316275 0
Condition category
Condition code
Musculoskeletal 314521 314521 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the Web-based education and exercise group will receive access to a website (www.mykneecap.trekeducation.org) for 6 weeks. The website is designed to educate participants with knee pain on how to self-manage their knee pain based on the current evidence, along with a self-directed exercise-therapy program. This website consists of a public access area which includes three main sections: (1) Understanding patellofemoral pain; (2) Treatment options and (3) Exercise program. In all sections, the content will be provided using a mix of resources, such as animated videos, infographics and small paragraphs of text.
- The “Understanding patellofemoral pain” section provides information covering a variety of subjects including diagnosis, prognosis, incidence and prevalence, crepitus, kinesiophobia, self-management of exercise load and self-management of pain.

- The “Treatment options” section includes treatment options that can be beneficial (taping/bracing, foot orthosis and exercises) and information about common treatments with inconsistent evidence (knee surgery, ultrasound, platelet-rich-plasma, dry needling and others).

- The “Exercise program” section is focused in 4 types of exercise (bridges, planks, squats and hip abduction), based primarily on a previously published exercise-therapy trial (Barton et al. doi:10.1016/j.ptsp.2019.04.010). The participants will have access to videos designed to help them performing the exercises proposed in the “exercise program” section. Options about how to progress the exercises will be also provided.

Participants will be instructed to perform the exercise program which consists of four exercises (one exercise of each type - bridges, planks, squats and hip abduction), 3 times a week, for 6 weeks. Exercises will take no longer than 30 min per day in a moderate intensity, defined by the participants' perception. All participants will receive a diary to monitor their adherence to the intervention, access to the website and frequency of exercise. The website usage and exercises practice will be entirely at the discretion of participants.
Intervention code [1] 316830 0
Treatment: Other
Comparator / control treatment
The participants randomised to the comparator group will be in a wait-and-see approach for 6 weeks. Then, participants in the wait-and-see group will receive a late access, after 6 weeks from baseline assessment, to the same website as the web-based education and exercise group
Control group
Active

Outcomes
Primary outcome [1] 322880 0
Global rating of change (GROC) assessed with a 6-point likert scale (‘completely recovered’, ‘marked improvement’, ‘moderate improvement’, ‘same’, ‘moderate worsening’, and ‘marked worsening’).
Timepoint [1] 322880 0
Baseline, 6 weeks after baseline assessment (primary timepoint), 12 weeks baseline assessment.
Primary outcome [2] 322959 0
Worst Knee pain in the last week assessed with a 100mm Visual Analogue Scale (VAS)
Timepoint [2] 322959 0
Baseline, 6 weeks after baseline assessment (primary timepoint), 12 weeks baseline assessment.
Secondary outcome [1] 379975 0
Self-reported knee related function assessed with the Anterior Knee Pain Scale (AKPS)
Timepoint [1] 379975 0
Baseline, 6 weeks after baseline assessment, 12 weeks baseline assessment.
Secondary outcome [2] 379976 0
Knee related quality of life assessed with the Quality of Life subscale of the KOOS (KOOS-QoL)
Timepoint [2] 379976 0
Baseline, 6 weeks after baseline assessment, 12 weeks baseline assessment.
Secondary outcome [3] 379977 0
Kinesiophobia assessed with the Tampa Scale for Kinesiophobia (TSK)
Timepoint [3] 379977 0
Baseline, 6 weeks after baseline assessment, 12 weeks baseline assessment.
Secondary outcome [4] 379979 0
Patient's knowledge about knee pain assessed with the Pain CAT knowledge questionnaire.
Timepoint [4] 379979 0
Baseline, 6 weeks after baseline assessment, 12 weeks after baseline assessment.
Secondary outcome [5] 380955 0
Adherence of the treatment using a participant diary
Timepoint [5] 380955 0
6 weeks after baseline assessment, 12 weeks after baseline assessment.

Eligibility
Key inclusion criteria
Participants will be considered eligible if they present with anterior or retropatellar pain: (i) corresponding to at least 30 on a 100 visual analogue scale (VAS) in the previous week; (ii) for at least 3 months; (iii) during at least two or more of the following activities: prolonged sitting, squatting, kneeling, running, ascending and descending stairs, jumping and landing; (iv) if they who could read/understand English; and (v) if they have access to computer/internet.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include a past history of any lower limb surgery; history of patellar subluxation or dislocation; history of knee ligament or meniscus tears; history and/or presence of neurologic conditions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation codes will be generated in blocks of 4 and 6 using a custom list at the website (https://www.sealedenvelope.com/)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculation for this study was made based on the findings of De Oliveira Silva et al. (doi:10.1016/j.jsams.2018.09.120) and Mills et al. (doi: 10.1136/bjsports-2011-090204). Assuming that 5% of the wait-and-see group would report improvement and to achieve 40% success in the treatment group (i.e. 35% difference between groups) with a=0.05 and power=80%, 29 participants per group are needed. Expecting a withdrawal rate of 10%, we will recruit 32 participants for each group.
Data will be analysed for each type of measure as follows:
Overall scores of questionnaires will be typed in an electronic spreadsheet. Descriptive statistics will be used to summarise the data, including mean (standard deviation), 95% confidence interval (CI), and median (interquartile interval). The normality of the final score of each measure will be tested using the Shapiro-Wilk test. To investigate the effectiveness of a web-based self-directed education and exercise program compared to wait-and-see a 2x2 analysis of variance (ANOVA) will be performed if the data was found to be normally distributed; or a Friedman test will be performed if the data was found to be non-normally distributed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/03/2020
Actual
7/07/2020
Date of last participant enrolment
Anticipated
10/01/2022
Actual
Date of last data collection
Anticipated
18/04/2022
Actual
Sample size
Target
64
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 304937 0
University
Name [1] 304937 0
La Trobe University
Country [1] 304937 0
Australia
Primary sponsor type
Individual
Name
Christian Barton
Address
La Trobe University, Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 305291 0
University
Name [1] 305291 0
La Trobe University
Address [1] 305291 0
Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Country [1] 305291 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305346 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 305346 0
La Trobe Univesity
Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Ethics committee country [1] 305346 0
Australia
Date submitted for ethics approval [1] 305346 0
Approval date [1] 305346 0
04/12/2019
Ethics approval number [1] 305346 0
HEC19478

Summary
Brief summary
Participants will be evaluated via an online survey with questions about knee pain, digital and health literacy, self-reported knee-related function, kinesiophobia and knee-related quality of life. Then, they will be randomly assigned to one of two groups. Participants in group 1 will be offered a 6 week online education and exercise program to guide them with self-management of their pain and will be reassessed after 6 weeks. Participants in group 2 will perform the baseline and receive a delayed access to the same program (i.e. after the 6 week follow up assessment). All participants will be followed up again at 12 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100078 0
Dr Christian Barton
Address 100078 0
La Trobe University
Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Country 100078 0
Australia
Phone 100078 0
+61 403012914
Fax 100078 0
Email 100078 0
[email protected]
Contact person for public queries
Name 100079 0
Dr Christian Barton
Address 100079 0
La Trobe University
Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Country 100079 0
Australia
Phone 100079 0
+61 403012914
Fax 100079 0
Email 100079 0
[email protected]
Contact person for scientific queries
Name 100080 0
Dr Christian Barton
Address 100080 0
La Trobe University
Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Country 100080 0
Australia
Phone 100080 0
+61 403012914
Fax 100080 0
Email 100080 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
We do not have ethical approval for this.


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.