NCT02567123

Brief Summary

The purpose of this study is to determine whether changing foot strike pattern from a rearfoot strike to a forefoot strike reduces chronic running-related knee pain. It is believed that switching foot strike pattern from a rearfoot strike to a forefoot strike pattern will reduce associated running-related patellofemoral knee pain.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

November 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2015

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

September 30, 2015

Last Update Submit

March 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain

    6 weeks

Secondary Outcomes (8)

  • Knee abduction

    6 weeks

  • Knee range of motion

    6 weeks

  • ankle flexion

    6 weeks

  • ankle range of motion

    6 weeks

  • Knee flexion

    6 weeks

  • +3 more secondary outcomes

Study Arms (2)

Experimental

EXPERIMENTAL

Runners are switched from a rearfoot strike running pattern to a forefoot strike running pattern.

Behavioral: Experimental

Control

NO INTERVENTION

Runners continue to use their normal rearfoot strike running pattern with no intervention in place.

Interventions

ExperimentalBEHAVIORAL
Experimental

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Presence of patellofemoral pain
  • No history of any cardiovascular issues.
  • Currently running as part of training program

You may not qualify if:

  • No patellofemoral pain present.
  • Not currently running as part of training program
  • Other lower extremity pain and/or injury that interferes with ability to run.
  • Pregnant
  • Not in the selected age ranges
  • Presence of cardiovascular or cardiopulmonary diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (2)

  • Relph N, Greaves H, Armstrong R, Prior TD, Spencer S, Griffiths IB, Dey P, Langley B. Running shoes for preventing lower limb running injuries in adults. Cochrane Database Syst Rev. 2022 Aug 22;8(8):CD013368. doi: 10.1002/14651858.CD013368.pub2.

  • Roper JL, Harding EM, Doerfler D, Dexter JG, Kravitz L, Dufek JS, Mermier CM. The effects of gait retraining in runners with patellofemoral pain: A randomized trial. Clin Biomech (Bristol). 2016 Jun;35:14-22. doi: 10.1016/j.clinbiomech.2016.03.010. Epub 2016 Apr 7.

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Christine M Mermier, PhD

    University of New Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 2, 2015

Study Start

November 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations