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Trial registered on ANZCTR


Registration number
ACTRN12618000253202
Ethics application status
Approved
Date submitted
8/02/2018
Date registered
16/02/2018
Date last updated
8/03/2021
Date data sharing statement initially provided
27/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Gluteal tendinopathy Education (GTED): a randomized control trial
Scientific title
Gluteal Tendinopathy Education (GTED): a randomized control trial investigating the efficacy of two online sources of information on global rating of change in those with gluteal tendinopathy.
Secondary ID [1] 293847 0
Nil known
Universal Trial Number (UTN)
Trial acronym
GTED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gluteal tendinopathy 306307 0
Condition category
Condition code
Musculoskeletal 305387 305387 0 0
Other muscular and skeletal disorders
Public Health 305653 305653 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The GTED online education brochure. This seven (7) page brochure provides an explanation of gluteal tendinopathy and advice on how to modify load on the gluteal tendons. It is based on current evidence and in consultation with patients, clinicians and researchers. This brochure will be provided on-line, and participants will be able to access it on personal computers, tablets or mobile devices. They will be able to print it as well. The brochure should take approximately 15 to 20 minutes to read. Assessment of adherence depends on patient response to Question 1 of the evaluation questionnaire sent to them at 6 weeks, which simply asks "Did you read the brochure?", before continuing with further questions re brochure evaluation.
Intervention code [1] 300106 0
Treatment: Other
Comparator / control treatment
The GTED general information pamphlet: The information pamphlet gives a description of the condition, and advice to keep active within their limitations of pain. This information pamphlet was developed by researchers and was recently used in a clinical trial (with a 52% success rate at 12 months). A benefit of this brochure is that it is simple and quick to read, within approximately 5 minutes. It will be provided online to participants, and participants will be able to access it on personal computers, tablets or mobile devices, with print capabilities.
Control group
Active

Outcomes
Primary outcome [1] 304527 0
The Global Rating of Change Scale (GROC) is a 7-point Likert scale in which the participant is asked to rate their perceived overall change in condition of their hip from the time that they began the study until the present, as much worse, worse, a little worse, no change, a little better, better, much better.
Timepoint [1] 304527 0
6 weeks (primary timepoint), 12 weeks, 52 weeks
Secondary outcome [1] 342261 0
A Pain Numeric Rating Scale (PNRS) will be used to record 1) worst pain during the past week, 2) worst pain during activity in the past week that usually brings on your hip pain and 3) average pain at night during the past week. The PNRS ranges from 0= no pain to 10= worst pain imaginable.
Timepoint [1] 342261 0
Baseline, 6 weeks, 12 weeks, 52 weeks
Secondary outcome [2] 342262 0
The Active Australia Survey measures participation in leisure-time physical activity. The core questions apply to one week preceding completion of the survey, and consist of a short and reliable set of eight questions that can be easily implemented via telephone interviewing techniques or in face-to-face interviews. The Active Australia Survey has good reliability and validity and has been used in national surveys. A number of different measures of participation in physical activity during the previous week can be obtained, including how many sessions of physical activity, total time and average time spent in each activity and ultimately the proportion of people who were doing sufficient activity to gain health benefits, or those who were sedentary.
Timepoint [2] 342262 0
Baseline, 6 weeks, 12 weeks, 52 weeks
Secondary outcome [3] 342263 0
European Quality of Life Questionnaire
The EuroQoL (EQ-5DTM) is a standardised instrument for use as a measure of health-related quality of life. It is applicable to a wide range of health conditions and treatments, and provides a simple descriptive profile, where the participant indicates in tick boxes which statements about mobility, personal care, usual activities, pain and anxiety/depression best describe their health status, as well as a single index value for health status. The participant is asked to grade their current level of function in each dimension into one of three degrees of disability (severe, moderate or none), and each health state is ranked and transformed into a single score, called the utility. This utility score is an expression of the Quality Adjusted Life Years (QALY), and is commonly used to make evidence-based decisions in analyses of cost-effectiveness. It is designed for self-completion by respondents and is cognitively simple, taking only a few minutes to complete.
Timepoint [3] 342263 0
Baseline, 6 weeks, 12 weeks, 52 weeks
Secondary outcome [4] 342264 0
The Tampa Scale (TSK) is a 17-item questionnaire aimed at assessing fear of re-injury due to physical movement. Each item is scored on a 4-point Likert scale that ranges from strongly disagree (1) to strongly agree (4). The inverse scores from items 4, 8, 12, and 16 are used to calculate the total score. Total TSK scores range between 17 and 68, with higher scores suggestive of higher levels of fear of physical movement and vulnerability.
Timepoint [4] 342264 0
Baseline, 6 weeks, 12 weeks, 52 weeks
Secondary outcome [5] 342265 0
The Hospital Anxiety Depression Scale (HADS) is a 14-item scale used screen for clinically significant anxiety and depression. It has been found to be a reliable instrument for detection of anxiety and depression in an outpatient setting and a valid indicator of severity of these mood disorders.. Participants are required to select the best of four responses to questions pertaining to either anxiety or depression (seven questions each), which are scored from 0–3. The scores for the anxiety and depression questions are summed separately to give total scores for each component, where 0–7 represents no anxiety or depression, 8–10 is borderline, and 11–21 indicates the presence of an anxious or depressive state.
Timepoint [5] 342265 0
Baseline, 6 weeks, 12 weeks, 52 weeks
Secondary outcome [6] 342266 0
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire used to assess the confidence that people with chronic pain have in performing activities while in pain. It covers a range of functions, including household chores, socialising, work, as well as coping with pain without medication. It takes two minutes to complete, has a high completion rate, can be used in assessment, treatment planning, and outcome evaluation, and has been shown to be a reliable and valid measure. Participants are requested to rate how confidently they can presently perform the activities described on a 7-point Likert scale, where 0=not at all confident and 6= completely confident. The total score ranges from 0 to 60, where higher scores reflect stronger self-efficacy beliefs.
Timepoint [6] 342266 0
Baseline, 6 weeks, 12 weeks, 52 weeks
Secondary outcome [7] 342267 0
The Pain Catastrophising Scale is a 13-item self-report scale to measure pain catastrophising, and has been shown to be valid and reliable. Participants are asked to reflect on past painful experiences and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. The Pain Catastrophising Scale produces a total score, and three subscale scores assessing rumination, magnification and helplessness. The total score ranges from 0-52, with higher scores indicating higher levels of pain catastrophization. Pain catastrophising is said to relate to various levels of pain intensity reporting, physical disability and psychological disability in clinical and nonclinical populations.
Timepoint [7] 342267 0
Baseline, 6 weeks, 12 weeks, 52 weeks
Secondary outcome [8] 343074 0
Pain constancy over the past week is measured by asking participants to estimate how often their pain has been present over the past week, measured by a percentage ranging from 0% to 100% in increments of 10% (i.e. 0-10%, 10-20%, 20-30%, etc.) where 100% represents all of the time (never without pain) and 0 represents none of the time.
Timepoint [8] 343074 0
Baseline, 6 weeks, 12 weeks, 52 weeks
Secondary outcome [9] 347032 0
The VISA-G questionnaire is a self-reported, patient-specific tool for evaluating the severity of disability in people with gluteal tendinopathy, and is modelled on other VISA questionnaires previously developed for Achilles and patellar tendinopathies, that have been shown to be valid and reliable tools for establishing severity of tendinopathy. This questionnaire consists of 8 items, addressing pain and function at the present time. Scores range from 0 to 100, with higher scores indicating less pain and better function. The VISA-G demonstrates good reliability and validity providing an objective method for measuring changes in the severity of disability of people with gluteal tendinopathy.
Timepoint [9] 347032 0
Baseline, 6 weeks, 12 weeks, 52 weeks

Eligibility
Key inclusion criteria
Participants are eligible if they answered appropriately all questions in the online screening tool: (1) have lateral hip pain; (2) experience lateral hip pain while lying on their side; (3) do not have difficulties with manipulating shoes and socks; (4) rate their lateral hip pain as equal to or greater than a 3/10 on a pain numeric rating scale; (5) experience lateral hip pain on most days of the week and this is the most predominant pain in their body, (6) and experience lateral hip pain or an increase in this pain within 30 seconds of performing a single leg stance.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded by the online screening process if they do not fulfill the criteria required by the screening questionnaire, if younger than 18 or older than 70 years, if they have experienced lateral hip pain for less than three months, or if they have had physiotherapy treatment or a corticosteroid injection for their hip in the last six months.

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)
The randomisation schedule will be generated by a computer software program prior to commencement of the trial. Once participants are deemed eligible for the trial and have provided online informed consent, they are randomly allocated into either 1) the group receiving the online GTED brochure or 2) the group receiving the online general information brochure. As this study will be an online study only, there will be no blinding for the involved researchers on treatment. Data will be de-identified into a coded form and analysed by an independent statistician blinded to group allocation codes.
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).
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
Sample size was calculated using GPower (G*Power, Version 3.1.9.2, Universität Kiel, Germany). This trial aims to evaluate the efficacy of an online education brochure, with a primary endpoint of 6 weeks. The sample size calculation was calculated a priori, based on the difference between two independent means (of the two groups). We aimed for a moderate effect size of 0.4 with alpha = 0.05 and a power of 80%, which would require 100 participants in each group. A dropout rate of 20% was allowed for, resulting in a sample size of 125 participants in each group (250 in total).
The statistical analyses will be performed on a blinded intention-to-treat basis using SPSS Version 25.0 (SPSS Inc). Baseline data for all outcome measures will be presented as means and standard deviations for continuous data and numbers and percentages for categorical data. Independent t-tests and Chi-square tests will be conducted for respectively continuous and categorical data to assess differences in baseline variables between participants. Descriptive statistics (age, gender, level of education, occupation) will be used to describe the patient groups.
To answer the primary aim, the primary outcome GROC at 6 weeks will be dichotomized (success or non-success), success defined as better to much better. Proportions of success and non-success will be calculated and two-sided confidence intervals for the proportions will be calculated with the Wilson score method. Differences in the secondary outcomes at 6 weeks will be calculated using a linear mixed regression model. Subjects will be included as a random effect, intervention (education brochure or general information brochure) as a fixed factor, and respective baseline scores as a covariate.
Comparisons between group means will be performed using a Bonferroni post-hoc test. A priori significance will be set at P less than or equal to 0.05. Measures will be checked for normality and homogeneity of variance when appropriate to do so.
Secondary aim 1) will be an exploratory analysis on the patients’ perceptions of the impact and effectiveness of the brochure and its influence on their behaviour.
To assess possible prognostic variables of pain and disability, secondary aim 2) will be assessed by a multivariate linear regression analyses using the stepwise method. This will be done separately for both 12 weeks and 12 months. The dependent variable will be the VISA-G and the independent variables will include all secondary outcome measures. Assumptions of normality and multi-collinearity will be checked a priori. Variables were excluded if P is greater than or equal to 0.05. The first model including the remaining variables with a significance of P less than or equal to 0.05 will be considered.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
15/06/2018
Actual
27/07/2018
Date of last participant enrolment
Anticipated
15/06/2019
Actual
28/03/2019
Date of last data collection
Anticipated
29/06/2020
Actual
11/04/2020
Sample size
Target
250
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 298466 0
Government body
Name [1] 298466 0
National Health and Medical Research Program Grant #631717
Country [1] 298466 0
Australia
Primary sponsor type
Individual
Name
Prof Bill Vicenzino
Address
Therapies Building (84A),
School of Health & Rehab Sciences,
The University of Queensland,
St Lucia, Qld 4067
Country
Australia
Secondary sponsor category [1] 297606 0
None
Name [1] 297606 0
Address [1] 297606 0
Country [1] 297606 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299456 0
NHMRC Human Research Ethics Committee
Ethics committee address [1] 299456 0
Ethics committee country [1] 299456 0
Australia
Date submitted for ethics approval [1] 299456 0
28/02/2018
Approval date [1] 299456 0
08/05/2018
Ethics approval number [1] 299456 0

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

Contacts
Principal investigator
Name 80462 0
Prof Bill Vicenzino
Address 80462 0
Therapies Building(84A)
School of Health & Rehab Sciences,
The University of Queensland,
St Lucia, Qld. 4067
Country 80462 0
Australia
Phone 80462 0
+61 7 336 52781
Fax 80462 0
Email 80462 0
b.vicenzino@uq.edu.au
Contact person for public queries
Name 80463 0
Bill Vicenzino
Address 80463 0
Therapies Building(84A)
School of Health & Rehab Sciences,
The University of Queensland,
St Lucia, Qld. 4067
Country 80463 0
Australia
Phone 80463 0
+61 7 336 52781
Fax 80463 0
Email 80463 0
b.vicenzino@uq.edu.au
Contact person for scientific queries
Name 80464 0
Bill Vicenzino
Address 80464 0
Therapies Building(84A)
School of Health & Rehab Sciences,
The University of Queensland,
St Lucia, Qld. 4067
Country 80464 0
Australia
Phone 80464 0
+61 7 336 52781
Fax 80464 0
Email 80464 0
b.vicenzino@uq.edu.au

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.