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Is the addition of running retraining to best standard care beneficial in runners with medial tibial stress syndrome? a randomised controlled trial

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000230550
Acronym
The RUNMETRES (RUNning retraining for MEdial Tibial stREss Syndrome) study
Enrollment
14
Registered
2024-03-07
Start date
2024-05-31
Completion date
2025-06-02
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary objective of this study is to determine if the addition of running retraining, by reducing step length, to best standard care is beneficial in the management of medial tibial stress syndrome in runners. A double-blinded, randomised controlled trial will recruit participants with MTSS. Participants will receive standard care (control) or standard care with running retraining (intervention) over eight weeks. Standard care involves load management and strengthening exercises, while running retraining includes step length reduction cues. The primary outcome measure will be the University of Wisconsin Running Injury and Recovery Index at week 4.

Interventions

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 alig

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.

Sponsors

La Trobe University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 6, 2026