NCT03067545

Brief Summary

This project aims to investigate whether an increase in step rate can be used to reduce pain and injury causing movement patterns in runners who are currently experiencing achilles tendonopathy, iliotibial band syndrome, patellofemoral pain syndrome and medial tibial stress syndrome. Many injuries have been reported to share similar injury causing movement patterns. For example iliotibial band syndrome and patellofemoral pain syndrome have been reported to be caused by increased side to side drop of the pelvis and inward movement of the hip. Gait retraining is a method of changing the way people run in order to change movement patterns.Increasing step rate may present a gait retraining method that does not pose further injury risks and can be used across multiple different injury populations. Studies have shown increasing step rate can reduce frontal plane movement patterns at the pelvis, hip and foot as well as reducing sagittal plane joint angles such as ankle dorsiflexion. Based on the changes in movement patterns increasing step rate has been recommended as an intervention for the treatment of patellofemoral pain syndrome, medial tibial stress syndrome, iliotibial band syndrome and achilles tendonopathy. Therefore this study aims to investigate whether an increase in step rate can reduce pain and change injury causing mechanics in runners currently running with patellofemoral pain syndrome, iliotibial band syndrome, medial tibial stress syndrome or achilles tendinopathy. The aim of the project is to use a simple gait intervention, increasing step rate to investigate if this technique change can reduce pain immediately, at short term follow up and long term follow up. The project will also look at whether an increased step rate can be maintained at follow up and whether this changes movement patterns proposed to be the cause of injury. Runners will be recruited from local running clubs and competitions using poster advertisement at running clubs and emailed to running clubs

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

March 22, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

1.7 years

First QC Date

February 17, 2017

Last Update Submit

February 27, 2019

Conditions

Outcome Measures

Primary Outcomes (5)

  • kinematic data (lower limb joint angles during running)

    lower limb joint angles during running

    change from immediate, 4 weeks & 3 months

  • lower extremity functional scale

    patient reported outcome measure of lower limb pain symptoms

    change from 4 weeks & 3 months

  • anterior knee pain scale

    patient reported outcome measure of lower limb pain symptoms

    change from 4 weeks & 3 months

  • medial tibial stress syndrome score

    patient reported outcome measure of lower limb pain symptoms

    change from 4 weeks & 3 months

  • numerical rating scale

    pain rating scale for pain experienced during running

    change from 4 weeks & 3 months

Secondary Outcomes (1)

  • questionnaire measure of self reported running distance

    change from 4 weeks & 3 months

Study Arms (1)

step rate increase

EXPERIMENTAL

increase in running stride rate by 10%

Other: Step rate increase

Interventions

increase the step rate during running by 10% steps per minute

step rate increase

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Runners presenting with patellofemoral pain syndrome, iliotibial band syndrome, medial tibial stress syndrome or achilles tendonopathy. Diagnosis to be confirmed via a qualified physiotherapist present at all sessions
  • Currently running at self reported less than normal training volume
  • Pain reported to onset during running
  • Provide written consent to participate

You may not qualify if:

  • history of a traumatic onset of injury
  • previous lower limb surgery
  • currently not running due to pain
  • cardiac or respiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Salford Health Sciences

Salford, England, m6 6PU, United Kingdom

Location

Related Publications (1)

  • Bramah C, Preece SJ, Gill N, Herrington L. A 10% Increase in Step Rate Improves Running Kinematics and Clinical Outcomes in Runners With Patellofemoral Pain at 4 Weeks and 3 Months. Am J Sports Med. 2019 Dec;47(14):3406-3413. doi: 10.1177/0363546519879693. Epub 2019 Oct 28.

MeSH Terms

Conditions

Patellofemoral Pain SyndromeMedial Tibial Stress SyndromeIliotibial Band Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesMuscular DiseasesNeuromuscular DiseasesNervous System DiseasesLeg InjuriesWounds and InjuriesKnee InjuriesCumulative Trauma DisordersSprains and Strains

Study Officials

  • Chris Bramah, MSc

    University of Salford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: single subject repeated measures design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 17, 2017

First Posted

March 1, 2017

Study Start

March 22, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 28, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations