Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001532897
Ethics application status
Approved
Date submitted
21/09/2021
Date registered
10/11/2021
Date last updated
30/06/2024
Date data sharing statement initially provided
10/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Shoes for self-managing Chronic HIP Pain: the SCHIPP randomised clinical trial
Scientific title
Shoes for self-managing Chronic HIP Pain: the SCHIPP randomised clinical trial
Secondary ID [1] 304970 0
Nil known
Universal Trial Number (UTN)
U1111-1269-3038
Trial acronym
SCHIPP (Shoes for Self-managing Chronic HIP Pain)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic hip pain 323115 0
Condition category
Condition code
Musculoskeletal 320693 320693 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This comparative effectiveness trial will compare two different classes of footwear.

The intervention treatment category is 'stable supportive shoes'. The stable supportive shoes were selected from commercially available footwear, that fulfil previously published criteria for stable supportive shoes (Paterson et al, 2017,Osteoarthritis & Cartilage). These criteria are: 1) heel height of greater than 30mm; 2) shoe pitch of greater than 10mm; 3) presence of arch support or motion control; 4) have "rigid" sole rigidity (Barton et al. 2009, J Foot Ankle Res); and 5) weigh more than 300g (+/-10%).

Participants will choose two pairs of shoes from a selection of available shoes that fulfil the above criteria for stable supportive shoes. As footwear manufacturers frequently change shoe models from season to season and year to year, we expect that shoes readily available at trial commencement may cease to be available during the course of the trial, or may be relaunched/rebranded with a different shoe name. In such instances, shoes will be replaced by a similar pair of commercially available shoes that fulfil the listed criteria.

The shoes will be provided at the University of Melbourne Human Movement Laboratory by one of the researchers experienced in the fitting shoes for participants in a randomized controlled trial. Participants will be asked to wear any combination of their 2 pairs of study shoes for at least 6 hours per day for the study duration of 6 months.

Participants will be provided with an information sheet regarding how to get used to wearing the shoes and will also complete a log book once per month where they will record the number of hours each day they wore each pair of their study shoes for a one week period (the fourth week of the month).
Intervention code [1] 321358 0
Treatment: Other
Comparator / control treatment
The comparator treatment category is 'flat flexible shoes' The flat flexible shoes were selected from commercially available footwear, that fulfill previously published criteria for flat flexible shoes (Paterson et al, 2017, Osteoarthritis & Cartilage). These criteria are: 1) heel height of less than 15mm; 2) shoe pitch of less than 10mm; 3) absence of arch support or motion control; 4) have "minimal" sole rigidity (Barton et al. 2009, J Foot Ankle Res); and 5) weigh 200g or less (+/-10%). Measurements are based on a size 9 US Men's and size 9 US Women's.

Participants will choose two pairs of shoes from a selection of available shoes that fulfil the above criteria for flat flexible shoes. As footwear manufacturers frequently change shoe models from season to season and year to year, we expect that shoes readily available at trial commencement may cease to be available during the course of the trial, or may be relaunched/rebranded with a different shoe name. In such instances, shoes will be replaced by a similar pair of commercially available shoes that fulfil the listed criteria.

The shoes will be provided at the University of Melbourne Human Movement Laboratory by one of the researchers experienced in the fitting shoes for participants in a randomized controlled trial. Participants will be asked to wear any combination of their 2 pairs of study shoes for at least 6 hours per day for the study duration of 6 months.

Participants will be provided with an information sheet regarding how to get used to wearing the shoes and will also complete a log book once per month where they will record the number of hours each day they wore each pair of their study shoes for a one week period (the fourth week of the month).
Control group
Active

Outcomes
Primary outcome [1] 328510 0
Severity of hip pain during walking
Scored on an 11-point numerical rating scale (NRS) for average overall hip pain on walking in the last week.
Ranges from 0 to 10; where 0=no pain and 10=worst pain possible.
Timepoint [1] 328510 0
Baseline and 6 months after randomisation
Secondary outcome [1] 399273 0
Hip disability and Osteoarthritis Outcome Score (HOOS) Pain subscale

Scored using 10 questions regarding hip pain in the last week with 5 Likert response options ranging from None/Never to Extreme/Always.

Total score ranges from 0 to 100; lower scores indicate worse pain
Timepoint [1] 399273 0
Baseline and 6 months after randomisation
Secondary outcome [2] 399274 0
HOOS function in daily living subscale

Scored using 17 questions regarding hip function in the last week, with 5 Likert response options ranging from None to Extreme.

Total score ranges from 0 to 100; lower scores indicate worse function.
Timepoint [2] 399274 0
Baseline and 6 months after randomisation
Secondary outcome [3] 399275 0
HOOS function in sport and recreation subscale

Scored using 4 questions about function with sport and recreational activities in the last week, with 5 Likert response options ranging from None to Extreme.

Total score ranges from 0 to 100; lower scores indicate worse function.
Timepoint [3] 399275 0
Baseline and 6 months after randomisation
Secondary outcome [4] 399276 0
HOOS quality of life subscale

Scored using 4 questions about hip-related quality of life experienced in the last week, with 5 Likert response options for each question.

Total score ranges from 0 to 100; lower scores indicate worse quality of life.
Timepoint [4] 399276 0
Baseline and 6 months after randomisation
Secondary outcome [5] 399277 0
Pain severity during walking at the following sites:
a) Contralateral hip
b) Ipsilateral knee
c) Contralateral knee
d) Ipsilateral foot/ankle
e) Contralateral foot/ankle
f) Back

Scored on an 11-point NRS for average overall pain on walking in the last week.

Ranges from 0 to 10; where 0=no pain and 10=worst pain possible.
Timepoint [5] 399277 0
Baseline and 6 months after randomisation
Secondary outcome [6] 399279 0
Global change in pain

Scored using a 7-point global rating of change Likert scale with response options ranging from “much worse” to “much better” when compared to baseline.

Participants indicating they are “moderately better” or “much better” will be classified as improved. All other respondents will be classified as not improved. Number and proportion of participants classified as improved or not improved will be reported
Timepoint [6] 399279 0
6 months after randomisation
Secondary outcome [7] 399280 0
Adverse events

Adverse events will be defined as any problem experienced in the study hip or elsewhere in the body deemed by the participant to be a result of participating in the trial AND at least one of i) caused increased pain and/or disability for two days or more, and/or ii) resulted in the participant seeking treatment from a health professional. These will be self-reported by participants using a custom-developed table.

Nature, and number and proportions of participants experiencing, adverse events will be reported.
Timepoint [7] 399280 0
6 months after randomisation
Secondary outcome [8] 399281 0
Physical Activity Scale for the Elderly (PASE) score

Will be measured using the PASE, a self-reported assessment of physical activity, covering occupational, household and leisure items over the past week with one overall value representing physical activity level.

Total score ranges from 0 to 400+; higher scores indicate greater activity.
Timepoint [8] 399281 0
Baseline and 6 months after randomisation
Secondary outcome [9] 399282 0
Co-intervention use

Participants will complete a custom-developed table to indicate the use of a range of medications and other co-interventions over the prior 6 months.

Participants who indicate they have used a medication/supplement at least once per week over the past 6 months will be reported as a user of the relevant medication. Participants who have used a co-intervention at least once in the past 6 months will be reported as a co-intervention user. Number and proportion of participants using the medication and/or cointervention will be reported.
Timepoint [9] 399282 0
Baseline and 6 months after randomisation
Secondary outcome [10] 399283 0
Adherence: self-rated compliance with footwear

Participants will rate their level of compliance with the task of wearing their study shoes for a minimum of 6 hours per day each day, on average over the previous 6 months, using an 11-point NRS (where 0=shoes not worn at all and 10=shoes worn completely as instructed).

Ranges from 0 to 10; higher scores indicate better adherence.
Timepoint [10] 399283 0
6 months after randomisation
Secondary outcome [11] 399284 0
Adherence: mean hours of study shoe wear per day

Shoe wear will be recorded in log-books in the final week of each month, as the number of hours each day that each pair of allocated shoes was worn.

The hours reported for each pair of shoes will be summed each day to give a daily total and averaged over the 7 days for each month. Number and proportion of adherent (average daily shoe wear is greater than or equal to 6 hrs) and non-adherent (average daily shoe wear is less than 6 hrs) participants will be reported for each month as well as for the entire 6-month intervention period.
Timepoint [11] 399284 0
At the end of months 1, 2, 3, 4, 5 and 6 after randomisation, plus the mean of all 6 months
Secondary outcome [12] 399285 0
Number of participants who stopped wearing the study shoes

Participants will indicate whether they stopped wearing the study shoes during the 6 months on a categorical scale (Yes or No).

Participants who score Yes will describe when and why they ceased wearing their allocated shoes, and this will be reported descriptively.
Timepoint [12] 399285 0
6 months after randomisation
Secondary outcome [13] 399286 0
Comfort

Participants will rate their level of comfort with each shoe using an 11-point NRS (where 0=extremely uncomfortable and 10=extremely comfortable).

Ranges from 0 to 10; higher scores indicate greater shoe comfort.
Timepoint [13] 399286 0
6 months after randomisation
Secondary outcome [14] 400729 0
HOOS symptoms subscale

Scored using 5 questions about hip symptoms in the last week, with 5 Likert response options ranging from Never/None to Always/Extreme.

Total score ranges from 0 to 100; lower scores indicate worse function.
Timepoint [14] 400729 0
Baseline and 6 months after randomisation

Eligibility
Key inclusion criteria
a. aged greater than or equal to 45 years;
b. activity-related hip joint pain; and
c. either no morning hip joint stiffness or stiffness that lasts no longer than 30 minutes;
ii) report history of hip pain of at least 3 months duration;
iii) report hip pain on most days of the past month;
iv) report a minimum hip pain score of 4 out of 10 on an 11-point NRS (terminal descriptors of ‘no pain’ and ‘worst pain possible’) during walking over the previous week.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) diagnosed in the past 12 months by a health professional as having gluteal tendinopathy, greater trochanteric pain syndrome, referred hip pain from the lumbar spine or femoro-acetabular impingement syndrome;
ii) recent hip surgery (past 6 months) or planned surgery in next 6 months;
iii) current use of shoe orthoses, customized shoes or brace (on any joint of lower limb);
iv) current regular use of high heels, thongs or work boots that would restrict ability to wear allocated trial shoes 6 hours/day;
v) had any hip injection in the past 3 months or planning an injection in next 6 months;
vi) self-report other muscular or joint condition anywhere in the body which is worse than study hip pain;
vii) self-report any systemic or inflammatory joint disease (e.g. fibromyalgia, rheumatoid arthritis, gout);
viii) any neurological condition affecting the spine or either lower limb;
ix) current or planned use of a gait aid in the next 6 months;
x) inability to understand written/spoken English; and
xi) unable to commit to study requirements (eg wearing shoes, attending appointments, completing outcomes, do not have foot size in the range of 8 to 13US for men, and 7 to 12US for women).
xii) hip replacement on the most painful side

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)
Participants will be randomly allocated to either 1) Flat Flexible shoes; or 2) Stable Supportive shoes. Prior to randomization, participants will not be told about the types of footwear being investigated in the study, nor the hypotheses under investigation to reduce bias. Once allocated to a group, participants will also not be told the distinguishing features of their shoes in comparison to the other group.

A researcher not involved in recruitment or collection of primary/secondary outcome measures, will allocate participants to a group, using a computer program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be prepared by the biostatistician (permuted random block sizes). The schedule will be stored on a password-protected website (REDCap) maintained by a researcher not involved in either participant recruitment or administration of primary/secondary outcome measures. Group allocation will be revealed by this same researcher after baseline primary/secondary outcomes have been completed.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We aim to detect a clinically-relevant reduction in walking hip pain, The minimal clinically important differences (MCID) between groups is greater than or equal to 1.8 (out of 10) NRS units in change in hip pain intensity during walking (baseline minus follow up). Anyone achieving a pain reduction greater than or equal to the MCID of 1.8 NRS units is classified as achieving a clinically-relevant pain reduction.

We have assumed a conservative between-participant standard deviation across all participants of 2.7 units and a conservative correlation between baseline and 6-month scores of 0.20, based on our previous trial. Using analysis of covariance (ANCOVA) adjusted for baseline score, we need 48 per arm to achieve 90% power to detect the MCID in change in pain at a 0.05 significance level. Allowing for 20% attrition, we will recruit 60 people per arm (n=120 in total).

Data will be analysed on an intention to treat basis.

A biostatistician will analyse blinded data according to a Statistical Analysis Plan. Main comparative analyses between groups will be performed using intention-to-treat. Multiple imputation will be used if an outcome has greater than 5% missing data. For the primary outcome, differences in mean change in walking hip pain will be compared between groups using a linear regression model, adjusted for baseline values. Continuous secondary outcomes will be analysed using similar approaches to the primary outcome. The number and proportion of participants achieving, and not achieving, a clinically-relevant pain reduction will be reported. For these and other binary outcomes, groups will be compared using risk ratios and risk differences, using logistic regression models. The number of participants who experience an adverse event will be compared between groups using Poisson regression. A sensitivity analysis will estimate treatment effects assuming full adherence, using an instrumental variables approach. A secondary sensitivity analysis will estimate treatment effects on the primary outcome adjusted for the presence of chronic widespread pain in addition to baseline values of the primary outcome. Standard diagnostic plots will be used to check model assumptions.

To assess whether the effect of the intervention on the primary outcome is moderated by either of the pre-specified moderators of BMI or foot posture, interaction terms between randomised group and each of these variables will be included in regression models for the primary outcome at 6 months, for each potential effect modifier separately. The rationale for the a priori choice of treatment effect modifiers is as follows:

• BMI- we hypothesise that decreases in hip pain with stable supportive shoes (relative to flat flexible shoes) will be greater in people with a higher BMI, given that these people have a greater vertical loading rate compared to adults of a healthy weight, and thus have greater scope for a reduction in loading rate with stable supportive shoes.
• Foot posture- we hypothesise that decreases in hip pain with stable supportive shoes (relative to flat flexible) will be greater in people with a more pronated foot posture, given stable supportive shoes are designed to reduce foot pronation, and foot pronation is associated with lower limb pathology.

In addition, to assess whether the effect of the intervention on shoe comfort is moderated by foot posture, appropriate interaction terms between randomised group and foot posture variables will be included in regression models for the outcome of shoe comfort at 6 months. The rationale is because flat flexible shoes may be perceived as being less comfortable in people with more pronated feet.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/11/2021
Actual
19/01/2022
Date of last participant enrolment
Anticipated
22/11/2023
Actual
30/11/2023
Date of last data collection
Anticipated
22/05/2024
Actual
30/05/2024
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 34870 0
3010 - University Of Melbourne

Funding & Sponsors
Funding source category [1] 309356 0
University
Name [1] 309356 0
University of Melbourne
Country [1] 309356 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
School of Health Sciences
Level 7, Alan Gilbert Building, 161 Barry St, Carlton
University of Melbourne
VIC 3010
Country
Australia
Secondary sponsor category [1] 310323 0
None
Name [1] 310323 0
Address [1] 310323 0
Country [1] 310323 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309172 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 309172 0
Ethics committee country [1] 309172 0
Australia
Date submitted for ethics approval [1] 309172 0
27/07/2021
Approval date [1] 309172 0
10/09/2021
Ethics approval number [1] 309172 0
2021-22380-21619-3

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

Contacts
Principal investigator
Name 113234 0
Dr Kade Paterson
Address 113234 0
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
School of Health Sciences
Level 7, Alan Gilbert Building, 161 Barry St, Carlton
University of Melbourne
VIC 3010
Country 113234 0
Australia
Phone 113234 0
+61 3 8344 0425
Fax 113234 0
Email 113234 0
[email protected]
Contact person for public queries
Name 113235 0
Jesse Pardo
Address 113235 0
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
School of Health Sciences
Level 7, Alan Gilbert Building, 161 Barry St, Carlton
University of Melbourne
VIC 3010
Country 113235 0
Australia
Phone 113235 0
+61 433 681 740
Fax 113235 0
Email 113235 0
[email protected]
Contact person for scientific queries
Name 113236 0
Kade Paterson
Address 113236 0
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
School of Health Sciences
Level 7, Alan Gilbert Building, 161 Barry St, Carlton
University of Melbourne
VIC 3010
Country 113236 0
Australia
Phone 113236 0
+61 3 8344 0425
Fax 113236 0
Email 113236 0
[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?
Deidentified individual participant data of published results only
When will data be available (start and end dates)?
Immediately following publication to 15 years following publication
Available to whom?
Available to researchers by request on a case-by-case basis at the discretion of the principal researcher
Available for what types of analyses?
Meta analyses
How or where can data be obtained?
From the principal researcher (email: [email protected]), with the appropriate Data Sharing Agreements as approved by the sponsor (the University of Melbourne).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13682Study protocol  [email protected] Upon direct request to the principal researcher
13683Statistical analysis plan  [email protected] Upon direct request to the principal researcher



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseShoes for self-managing chronic hip Pain: the SCHIPP randomized clinical trial protocol.2023https://dx.doi.org/10.1186/s12891-023-06235-x
N.B. These documents automatically identified may not have been verified by the study sponsor.