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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001162303
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
1/09/2026
Date registered
Help: Date registered
17/09/2026
Date last updated
Help: Date last updated
17/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
17/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
What is the immediate effect of a maximalist running shoe on the knee joint load of runners with patellofemoral pain?
Scientific title
The immediate effect of a maximal cushioning running shoe compared to a sham on patellofemoral joint force in runners with patellofemoral pain
Additional trial identifiers [1] 318322 0
Nill
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Patellofemoral pain 343451 0
Condition category
Condition code
Musculoskeletal 339543 339543 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Arm 1 (maximal-cushioning running shoes)
Participants randomised to this arm will complete the intervention running assessment in a black Brooks Ghost Max 2 maximal-cushioning running shoe. Before the intervention, participants will complete the baseline running assessment in a white Brooks Ghost 16 standardised neutral running shoe.

For the baseline assessment, participants will first complete a 5-minute treadmill run in the white Brooks Ghost 16 at 3.0–3.5 m/s. This will be followed by two familiarisation runs and eight acceptable 40-metre overground running trials at 3.0–3.5 m/s. Running speed will be measured using timing gates positioned around the force plates. Participants will walk back to the starting position between trials, with additional rest and water provided as needed. Perceived exertion will be measured after the complete set of running trials using the 6–20 Borg Rating of Perceived Exertion scale.

After completing the baseline running assessment, participants will change into the black Brooks Ghost Max 2 and rest for 10 minutes before starting the post-running assessment. Participants will then complete a 5-minute treadmill familiarisation run at 3.0–3.5 m/s, followed by two familiarisation runs and eight acceptable 40-metre overground running trials at 3.0–3.5 m/s. The same running procedures, speed-monitoring method and rest arrangements used during the baseline assessment will be followed. Perceived exertion will again be measured after the complete set of running trials using the 6–20 Borg scale.

The Brooks Ghost Max 2 is characterised by a high stack height, increased midsole volume, a mass of 298 g in a US men’s size 9, and pronounced rocker geometry. It is classified as a maximally cushioned neutral running shoe and does not incorporate motion-control or stability features. It scores 4/25 on the minimalist index, indicating a highly non-minimalist running shoe.
Intervention code [1] 335215 0
Treatment: Devices
Description of the comparator or control
Arm 2 (sham neutral cushioning running shoes)
Participants randomised to this sham arm will complete the running assessment in a black Brooks Ghost 16 neutral-cushioning running shoe. Before the intervention, participants will complete the baseline running assessment in a white Brooks Ghost 16 standardised neutral running shoe.

For the baseline assessment, participants will first complete a 5-minute treadmill run in the white Brooks Ghost 16 at 3.0–3.5 m/s. This will be followed by two familiarisation runs and eight acceptable 40-metre overground running trials at 3.0–3.5 m/s. Running speed will be measured using timing gates positioned around the force plates. Participants will walk back to the starting position between trials, with additional rest and water provided as needed. Perceived exertion will be measured after the complete set of running trials using the 6–20 Borg Rating of Perceived Exertion scale.

After completing the baseline running assessment, participants will change into the black Brooks Ghost 16 and rest for 10 minutes before starting the post-running assessment. Participants will then complete a 5-minute treadmill familiarisation run at 3.0–3.5 m/s, followed by two familiarisation runs and eight acceptable 40-metre overground running trials at 3.0–3.5 m/s. The same running procedures, speed-monitoring method and rest arrangements used during the baseline assessment will be followed. Perceived exertion will again be measured after the complete set of running trials using the 6–20 Borg scale.

The Brooks Ghost 16 is characterised by moderate cushioning, a mass of 267 g in a US men’s size 9, and a stack height of 46.3 mm. It is classified as a neutral running shoe with no motion-control or stability features. Its midsole has a traditional profile without the pronounced rocker geometry characteristic of maximal-cushioning footwear. It scores 6/25 on the minimalist index, indicating a low level of minimalism.
Control group
Placebo

Outcomes
Primary outcome [1] 346727 0
Peak patellofemoral joint force
Timepoint [1] 346727 0
Baseline (during running) Post-intervention (during running)
Secondary outcome [1] 467178 0
Knee confidence
Timepoint [1] 467178 0
Baseline (during running) Post-intervention (during running)
Secondary outcome [2] 467179 0
Perceived exertion
Timepoint [2] 467179 0
Baseline (after running trials) Post-intervention (after running trials)
Secondary outcome [3] 467180 0
Knee pain intensity after running
Timepoint [3] 467180 0
Baseline (after running trials) Post-intervention (after running trials)
Secondary outcome [4] 467181 0
Patellofemoral joint force impulse
Timepoint [4] 467181 0
Baseline (during running) Post-intervention (during running)
Secondary outcome [5] 467905 0
Patellofemoral joint force loading rate
Timepoint [5] 467905 0
Secondary time point: Baseline (during running) Post-intervention (during running)
Secondary outcome [6] 467906 0
Ankle sagittal-plane angle
Timepoint [6] 467906 0
Secondary time point: Baseline (during running) Post-intervention (during running)
Secondary outcome [7] 467907 0
Ankle sagittal-plane moment
Timepoint [7] 467907 0
Secondary time point: Baseline (during running) Post-intervention (during running)
Secondary outcome [8] 467908 0
Knee sagittal-plane angle
Timepoint [8] 467908 0
Secondary time point: Baseline (during running) Post-intervention (during running)
Secondary outcome [9] 467909 0
Knee sagittal-plane moment
Timepoint [9] 467909 0
Secondary time point: Baseline (during running) Post-intervention (during running)
Secondary outcome [10] 467910 0
Hip sagittal-plane angle
Timepoint [10] 467910 0
Secondary time point: Baseline (during running) Post-intervention (during running)
Secondary outcome [11] 467911 0
Hip sagittal-plane moment
Timepoint [11] 467911 0
Secondary time point: Baseline (during running) Post-intervention (during running)
Secondary outcome [12] 467912 0
Hip frontal-plane angle
Timepoint [12] 467912 0
Secondary time point: Baseline (during running) Post-intervention (during running)
Secondary outcome [13] 467913 0
Hip frontal-plane moment
Timepoint [13] 467913 0
Secondary time point: Baseline (during running) Post-intervention (during running)
Secondary outcome [14] 467914 0
Trunk sagittal-plane angle
Timepoint [14] 467914 0
Secondary time point: Baseline (during running) Post-intervention (during running)

Eligibility
Key inclusion criteria
- Insidious onset of anterior or peripatellar knee pain, with a duration of at least 2 months.
- Worst pain intensity equal or greater than 30 on a 0-100 numerical rating scale during the previous month.
- Pain around or behind the patella during at least two of the following activities: sitting for a prolonged period, rising from sitting, squatting, kneeling, running, walking up stairs, walking down stairs, jumping, landing, heavy household activities and after sports and recreational activities.
- Individuals who have maintained an average running volume of at least 5 km per week during the past 2 months.
- Individuals must be able to understand and speak English.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
- History of knee surgery.
- History of patellar dislocation.
- Clinical evidence of meniscal injury or ligamentous instability.
- Self-reported current or recent hip, ankle, or foot pain that could interfere with running biomechanics.
- Use of any knee injection (e.g., PRP, hyaluronic acid, cortiscosteroid) in the previous 6 months
- Pregnant.

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)
Allocation will be concealed using REDCap's randomisation module. The allocation sequence will be uploaded to and securely stored within REDCap and will not be accessible to researchers responsible for participant recruitment, eligibility assessment, consent, or baseline data collection. Participants will be randomised only after eligibility has been confirmed, informed consent obtained, and all baseline assessments completed. The treatment allocation will be revealed only after the participant has been irrevocably entered into the trial and randomised.

Following randomisation, allocation information will be accessible only to a designated unblinded researcher responsible for preparing the allocated footwear, who will have no role in participant recruitment, outcome assessment, or data analysis. Footwear will be stored securely onsite and prepared by this researcher before the testing session
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated in a 1:1 ratio to the maximal-cushioning running shoe or the sham group using a computer-generated allocation sequence, with permuted blocks of fixed size (block size = 4) to ensure balanced group allocation throughout recruitment. Randomisation will be stratified by sex to maintain equal representation of male and female participants, and by symptom duration (less than or more than 2 years).
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
The sample-size calculation was based on the prespecified analysis of covariance (ANCOVA) model, which will compare post-intervention outcomes between groups while adjusting for the corresponding baseline measurement.

The calculation was based on a target between-group difference of 0.52 BW, informed by a recent study that reported a 0.52 BW difference in peak PFJ contact force between footwear conditions during running in people with patellofemoral pain. An SD of 0.88 BW was informed by a study of runners wearing maximalist shoes. Assuming a baseline-to-post-intervention correlation of 0.60, these parameters corresponded to a baseline-adjusted effect size of Cohen’s (f=0.37). With 90% power, a two-sided significance level of 0.05 and equal allocation, 80 participants are required (40 per group). To allow for approximately 10% of randomised participants having missing or unusable primary outcome data due to marker loss, equipment failure or other biomechanical data-processing issues, we will randomise 90 participants, with 45 assigned to each group. Sample-size calculations were performed using G*Power, version 3.1.9.7.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/10/2026
Actual
Date of last participant enrolment
Anticipated
3/12/2027
Actual
Date of last data collection
Anticipated
3/12/2027
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 322881 0
University
Name [1] 322881 0
La Trobe University
Country [1] 322881 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 325808 0
Individual
Name [1] 325808 0
A/Prof Danilo De Oliveira Silva - La Trobe University
Address [1] 325808 0
Country [1] 325808 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321313 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 321313 0
Ethics committee country [1] 321313 0
Australia
Date submitted for ethics approval [1] 321313 0
27/02/2026
Approval date [1] 321313 0
06/05/2026
Ethics approval number [1] 321313 0
HEC26085

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

Contacts
Principal investigator
Name 153326 0
A/Prof Danilo De Oliveira Silva
Address 153326 0
La Trobe University, Kingsbury Drive, Bundoora, 3086, Melbourne, VIC
Country 153326 0
Australia
Phone 153326 0
+61426188766
Fax 153326 0
Email 153326 0
[email protected]
Contact person for public queries
Name 153327 0
Danilo De Oliveira Silva
Address 153327 0
La Trobe University, Kingsbury Drive, Bundoora, 3086, Melbourne, VIC
Country 153327 0
Australia
Phone 153327 0
+61426188766
Fax 153327 0
Email 153327 0
[email protected]
Contact person for scientific queries
Name 153328 0
Danilo De Oliveira Silva
Address 153328 0
La Trobe University, Kingsbury Drive, Bundoora, 3086, Melbourne, VIC
Country 153328 0
Australia
Phone 153328 0
+61426188766
Fax 153328 0
Email 153328 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Email to [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.