Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000230550
Ethics application status
Approved
Date submitted
31/01/2024
Date registered
7/03/2024
Date last updated
18/08/2024
Date data sharing statement initially provided
7/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Is the addition of running retraining to best standard care beneficial in runners with medial tibial stress syndrome? a randomised controlled trial
Scientific title
What is the effect of adding running retraining to best standard care on running recovery in runners with medial tibial stress syndrome? a randomised controlled trial
Secondary ID [1] 311062 0
None
Universal Trial Number (UTN)
Trial acronym
The RUNMETRES (RUNning retraining for MEdial Tibial stREss Syndrome) study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medial Tibial Stress Syndrome 332185 0
Condition category
Condition code
Musculoskeletal 328900 328900 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 328901 328901 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will receive running retraining in addition to best standard care (see 'comparator/control treatment' section for details of best standard care). Running retraining will include a cue to reduce their running step length. Participants will be instructed to shorten their step length by the verbal cue to “land with your foot closer in and under your body”. Compliance with this cue will be assessed with 2D video footage demonstrating a change in lower limb alignment at initial contact. Participants will be issued a Garmin GPS watch (Garmin Corporation, Olathe, Kansas, USA) that supports the measurement of wrist-based running dynamics. It will be used to record their preferred running step rate and their step rate when running with the cue for a shorter step length. Although the cue provided to participants will be to “land with your foot closer in and under your body”, the mode of feedback whilst running will be haptic, via vibration offered by the GPS watch, and associated with the step rate recorded when successfully implementing the cue for a shorter step length. For each participant, their Garmin GPS watch will be setup to provide haptic feedback (vibration) when they deviate from the target running step rate.

An assessment of participants’ running gait will be performed by the primary investigator (a physiotherapist) at follow-up sessions in weeks one, two and four to ensure compliance with the running retraining cue, and they will be provided with real-time feedback on their running step length and their implementation of the running retraining cue via 2D video footage. Their targeted running step rate (i.e., step rate required to achieve a shortened step length) will be checked and adjusted if needed to ensure the best possible feedback is provided between sessions. It is anticipated running gait assessments will take up to 30min per session.

The feedback protocol will be as follows:
Week 1 and 2 (acquisition phase): Haptic feedback will be provided via participant watches during all runs; 2D video feedback will be provided at baseline, week one and week two.
Week 3 and 4 (acquisition phase): Haptic feedback will be provided via participant watches during all runs; 2D video feedback will be provided at week 4
Week 5 and 6 (transfer phase): Intermittent feedback will be provided during runs, with self-controlled feedback on alternate running sessions (i.e. participants to control the duration of haptic feedback they receive on runs)
Week 7 and 8 (transfer phase): No haptic feedback will be provided during runs in the final two weeks

Adherence will be monitored via the same custom software that will be used to monitor adherence to participants strengthening program, as well as watch analytics which are to be shared with the primary investigator each week.
Intervention code [1] 327507 0
Rehabilitation
Comparator / control treatment
All participants will receive best standard care, consisting of:

1. Load management advice
Participants will be instructed to ensure a pain level of no more than a 2 out of 10 during a run, reported on a NPRS. At the commencement of the trial an individual run program will be discussed with the primary investigator, with the first two weeks not progressing in frequency, volume, or intensity to allow adaptations to the addition of strength training. Following the first two weeks of the trial, weekly running volume will be progressed between 10 and 30% depending on the run training history, time availability, running goals and symptom behaviour of each participant. Weekly running progressions will be programmed and discussed with the primary investigator at week two and week four follow up sessions to ensure an appropriate progression of load for each participant. Participants’ running intensity will not be able to exceed a moderate intensity, rated as 6 out of 10 on an 11-point Borg Scale (0-10) (“laboured breathing, challenging and uncomfortable, but sustainable for 30-60min”) throughout the duration of the trial. Running intensity will be discussed with the primary investigator and details included in weekly run program progressions. If participants experience an exacerbation of their symptoms following a run, they are to report this to the primary investigator and rest until their symptoms have returned to ‘usual’ levels before running again. Their next run is to be completed at an intensity no greater than 4 out of 10 on an 11-point Borg Scale (“still comfortable, able to hold a conversation”). If participants experience an exacerbation of their symptoms post-run over two consecutive run sessions, they are to contact the primary investigator and a modification to their running program will be discussed based on both the severity and time of onset of their symptoms.
Participant running volume and frequency will be recorded via their Garmin GPS watch.

The following criteria will be used to guide the progression of each participants running load:
(i) volume will be programmed in minutes; with weekly progressions not exceeding 30%
(ii) intensity will be programmed using rate of perceived exertion (RPE) and rated using an 11-point Borg Scale (0-10); intensity minutes will be calculated (RPE x minutes) and monitored, with weekly progressions not exceeding 30%
(iii) frequency can be progressed, provided volume progressions do not exceed 30%
(iv) terrain is not to be progressed, and participants are to continue to run on their usual terrain (i.e., surface, elevation etc.)

2. Symptom management advice
If participants have been using oral or topical medicines (e.g., analgesia, anti-inflammatories, etc.) to assist with managing their symptoms, they will be advised to continue with their usual use of medicines. If they have not been using medicines in the management of their symptoms, they will be instructed to not commence using medicines to manage their symptoms during the trial. Participants will be requested to document all use of medicines used to manage Medial Tibial Stress Syndrome (MTSS) symptoms.
Participants will be instructed on the use of a foam roller / release ball on their posterior lower leg muscles. They will be advised to do this a minimum of twice per week, spending approximately five minutes on each leg.

3. Footwear and foot orthoses advice
Participants’ running footwear, and foot orthoses if being used for running, will be assessed to determine if appropriate in the opinion of the primary investigator (e.g., running footwear is not showing signs of excessive wear [either on visual observation of the sole of the shoe, or on assessment of foam to ensure no areas of significant collapse]; orthoses have not been recently prescribed, or the participant reports an increase in symptoms or discomfort whilst wearing orthoses). If considered appropriate, participants will be advised to continue to run in the same footwear and foot orthoses for the duration of the trial. If their running footwear is determined to require replacement due to excessive wear, or it is determined to require replacement during the trial, it will be recommended that participants purchase the same footwear model. If the same footwear model cannot be sourced, then a similar replacement model will be recommended following discussion with the primary investigator.

4. Strengthening program
The strengthening program targeting lower limb strength, lumbo-pelvic control, motor patterning and plyometrics will be accessible via a custom-built software (The Injury Clinic Pty Ltd., Geelong, Australia) installed on their phone using a personal login, inclusive of videos and written instructions of the exercises to be performed. Strength programs will be progressed every 2 weeks, however the load of a specific exercise can be progressed within each program according to the prescribed dosages. Each participant will receive the same program, with progression to difference exercises reviewed on an individual basis.
For exercises to progress, participants will be instructed to ensure a pain level of no more than a 2 out of 10 as rated on an 11-point NPRS. Participants will be instructed to determine the load of each exercise based on self-perceived exertion, this will be done through the programming of ‘Repetitions in Reserve’ (RIR) and, or ‘Rate of Perceived Exertion’ (RPE). Due to the inclusion of both isometric and isotonic based movements within this program (i.e., Single Leg Seated Calf Raise Isometric Hold; Single Leg Romanian Dead Lift), both RPE and RIR will be used. Progressions within a 2 week program are therefore determined by participants based on their pain and exertion levels, with program progressions every two weeks to be reviewed and prescribed by the primary investigator.
The program will be structured with exercises in order of priority to complete, and exercises prescribed in groups of two, ‘superset’ together to assist in a timely completion of prescribed exercises. Participants will be required to complete their program a minimum of two 20 minute sessions per week.
Adherence will be monitored weekly by analytics provided by the custom app.

It is anticipated participants initial assessment will take 45minutes; with follow-up sessions taking 30minutes.
Control group
Active

Outcomes
Primary outcome [1] 336712 0
Running ability
Timepoint [1] 336712 0
Baseline, week 2, week 4 (primary timepoint) and week 8 post randomisation
Secondary outcome [1] 429407 0
Exercise Induced Leg Pain
Timepoint [1] 429407 0
Baseline, week 2, week 4 and week 8 post randomisation
Secondary outcome [2] 429408 0
Change in tibial symptoms
Timepoint [2] 429408 0
Week 2, week 4 and week 8 post randomisation
Secondary outcome [3] 429409 0
Adherence to Exercise
Timepoint [3] 429409 0
Week 4 and week 8 post randomisation
Secondary outcome [4] 429410 0
Worst pain experienced during a run
Timepoint [4] 429410 0
Baseline, week 1, week 2, week 4 and week 8 post randomisation
Secondary outcome [5] 429411 0
Weekly run volume
Timepoint [5] 429411 0
Baseline, week 1, week 2, week 4 and week 8 post randomisation
Secondary outcome [6] 429412 0
Reactive strength
Timepoint [6] 429412 0
Baseline, week 2, week 4 and week 8 post randomisation
Secondary outcome [7] 429413 0
Reactive strength on a single leg
Timepoint [7] 429413 0
Baseline, week 2, week 4 and week 8 post randomisation
Secondary outcome [8] 429414 0
Maximum voluntary isometric contraction – soleus (single leg)
Timepoint [8] 429414 0
Baseline, week 2, week 4 and week 8 post randomisation
Secondary outcome [9] 429415 0
Maximum voluntary isometric contraction – gastrocnemius (single leg)
Timepoint [9] 429415 0
Baseline, week 2, week 4 and week 8 post randomisation
Secondary outcome [10] 429416 0
Plantar flexor endurance
Timepoint [10] 429416 0
Baseline, week 2, week 4 and week 8 post randomisation
Secondary outcome [11] 429417 0
Step rate
Timepoint [11] 429417 0
Baseline, week 1, week 2, week 4 and week 8 post randomisation
Secondary outcome [12] 429418 0
Step length
Timepoint [12] 429418 0
Baseline, week 1, week 2, week 4 and week 8 post randomisation

Eligibility
Key inclusion criteria
(i) have a clinical diagnosis of MTSS; according to subjective history and clinical examination:
- presence of exercise-induced pain along the tibial periosteum
- pain provoked by (during or after) physical activity and reduced with relative rest
- diffuse tenderness on palpation of the tibial periosteum
(ii) have running as a primary exercise activity, participating in running greater than, or equal to, twice per week
(iii) have a history of MTSS that has affected their running activity for greater than, or equal to, four weeks
(iv) have pain consistent with MTSS rated greater than, or equal to, 3 out of 10 on a numeric pain rating scale (NPRS)
(v) be willing to commit to an eight-week strengthening program that requires completion a minimum of twice per week
(vi) be agreeable to not receive any other forms of treatment for the duration of the trial
(vii) have an ability to understand written and spoken English
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) any co-existing lower limb injury in the past three months that limits running participation
(ii) an inability to attend the required follow-up sessions
(iii) the presence of any symptoms suggestive of alternate lower leg pathology inclusive of stress fracture; cramping or burning pain; paraesthesia; severe swelling or erythema
(iv) an inability to run due to the severity of symptoms

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 concealment will be undertaken using www.sealedenvelope.com
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation with random block sizes, stratified by sex at birth
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
- Sample Size
Sample size was calculated based on the primary outcome measure, the University of Wisconsin Running Injury and Recovery Index (UWRI). Using a power of 80%, previously reported standard deviation of 6.7 (13), medium effect size (Cohen's d=0.75) of 5 points on the 36-point UWRI and a significance level set at a < 0.05, we estimated using GPower 3.1 (Kiel University, Germany) that a total of 60 participants (i.e., approximately 30 per group) will be required. When estimating sample size we were limited with data available and have opted to use the medium effect size for our estimation. To allow for any imprecision in these estimates, we will have a recruitment target of 32 participants per group.

- Descriptive analysis
Differences between the control and intervention group in demographic and clinical characteristics and for the primary and secondary outcome measures (2, 4, and 8 weeks) will be described and assessed using t tests for continuous and chi-square for categorical variables. If after assessment of the assumptions of the t test (such as the homogeneity of variance) are violated, we will use alternatives such as the Welch’s test with Satterhwaite approximation as a sensitivity analysis. For cell counts <5, p values from chi-square tests will not be reported.

- Mixed effects analysis
A mixed effects model will be used to assess the mean differences between the groups for the outcomes considered. The fixed effects are between-participant variables such as age, sex, BMI, symptom management and footwear. These models incorporate time as the random effects which is a within-subject variable. All assumptions for mixed effects modelling will be checked. As most of the outcome measures will be considered as continuous, normality and homogeneity of variance assumptions will be assessed If violated alternative modelling approaches will be considered. Effect modification by age, BMI and sex will be explored using likelihood ratio tests, taking into consideration the sample sizes of the subgroups. Strata-specific results will be reported if the p value for the interaction terms is <0.1, and if at least one of the observed associations from the strata-specific models are statistically significant at p <0.05. Results from these models will be presented as estimated effect sizes (both unadjusted and adjusted), standard errors, 95% confidence intervals (CI) and p values. All statistical analyses will be performed using the latest version of Stata (StataCorp, College Station,TX, USA).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/04/2024
Actual
31/05/2024
Date of last participant enrolment
Anticipated
2/06/2025
Actual
Date of last data collection
Anticipated
28/07/2025
Actual
Sample size
Target
64
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315319 0
Government body
Name [1] 315319 0
Department of Education: PhD Scholarship
Country [1] 315319 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Melbourne
Country
Australia
Secondary sponsor category [1] 317444 0
None
Name [1] 317444 0
None
Address [1] 317444 0
Country [1] 317444 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314241 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 314241 0
Ethics committee country [1] 314241 0
Australia
Date submitted for ethics approval [1] 314241 0
15/11/2023
Approval date [1] 314241 0
29/01/2024
Ethics approval number [1] 314241 0

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

Contacts
Principal investigator
Name 130910 0
Miss Laura Anderson
Address 130910 0
La Trobe University, Plenty Road, Bundoora, Melbourne, VIC 3086
Country 130910 0
Australia
Phone 130910 0
+61 03 5229 3911
Fax 130910 0
Email 130910 0
[email protected]
Contact person for public queries
Name 130911 0
Laura Anderson
Address 130911 0
La Trobe University, Plenty Road, Bundoora, Melbourne, VIC 3086
Country 130911 0
Australia
Phone 130911 0
+61 03 5229 3911
Fax 130911 0
Email 130911 0
[email protected]
Contact person for scientific queries
Name 130912 0
Hylton Menz
Address 130912 0
La Trobe University, Plenty Road, Bundoora, Melbourne, VIC 3086
Country 130912 0
Australia
Phone 130912 0
+61 3 94795801
Fax 130912 0
Email 130912 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?
Individual participant data of published results will be made available via figshare
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Unrestricted access via web address or via contacting Laura Anderson at [email protected]


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.