Running Study for Runners With Chronic Knee Pain
Primary Purpose
Patellofemoral Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental
Sponsored by
About this trial
This is an interventional treatment trial for Patellofemoral Pain Syndrome
Eligibility Criteria
Inclusion Criteria:
- Presence of patellofemoral pain
- No history of any cardiovascular issues.
- Currently running as part of training program
Exclusion Criteria:
- 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
Sites / Locations
- University of New Mexico
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Control
Arm Description
Runners are switched from a rearfoot strike running pattern to a forefoot strike running pattern.
Runners continue to use their normal rearfoot strike running pattern with no intervention in place.
Outcomes
Primary Outcome Measures
Pain
Secondary Outcome Measures
Knee abduction
Knee range of motion
ankle flexion
ankle range of motion
Knee flexion
Patellofemoral Stress
Patellofemoral contact force
Achilles tendon force
Full Information
NCT ID
NCT02567123
First Posted
September 30, 2015
Last Updated
September 30, 2015
Sponsor
Jenevieve Lynn Roper
1. Study Identification
Unique Protocol Identification Number
NCT02567123
Brief Title
Running Study for Runners With Chronic Knee Pain
Official Title
The Effects of Gait Retraining in Runners With Patellofemoral Pain: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jenevieve Lynn Roper
4. Oversight
5. Study Description
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.
Detailed Description
Runners will come to the Gait Analysis Lab on north campus of the University of New Mexico, HSSB 168, for the first running trial. During this time you will fill out a health questionnaire, receive an assessment by a physical therapist, and be given a new pair of running shoes to use for the duration of the study.
Runners will be equipped with several reflective markers, which will be placed on your lower body. Runners will then complete several passes across a runway while we record your running with a motion analysis system. Runners will be equipped with a mouthpiece and nose clip. You will run for 10 minutes while we collect the gases you breathe.Twenty-four hours after you complete this running trial, you will come to our Exercise Physiology lab in Johnson Center, B143 to perform the training sessions. During this time you will run for about 10-30 minutes in front of a mirror and receive feedback from the research team. You will perform these training sessions eight times over two weeks. Twenty-four hours after your last training session, you will perform another follow-up running trial, which will be the same as the first trial. After completing the second running trial, you will be allowed to return to your normal running routine for about one month. After one month, you will return to the Gait Analysis lab to perform a final running trial, which will be the same as the first and second running trials.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Runners are switched from a rearfoot strike running pattern to a forefoot strike running pattern.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Runners continue to use their normal rearfoot strike running pattern with no intervention in place.
Intervention Type
Behavioral
Intervention Name(s)
Experimental
Primary Outcome Measure Information:
Title
Pain
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Knee abduction
Time Frame
6 weeks
Title
Knee range of motion
Time Frame
6 weeks
Title
ankle flexion
Time Frame
6 weeks
Title
ankle range of motion
Time Frame
6 weeks
Title
Knee flexion
Time Frame
6 weeks
Title
Patellofemoral Stress
Time Frame
6 weeks
Title
Patellofemoral contact force
Time Frame
6 weeks
Title
Achilles tendon force
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of patellofemoral pain
No history of any cardiovascular issues.
Currently running as part of training program
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine M Mermier, PhD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35993829
Citation
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.
Results Reference
derived
PubMed Identifier
27111879
Citation
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, Avon). 2016 Jun;35:14-22. doi: 10.1016/j.clinbiomech.2016.03.010. Epub 2016 Apr 7.
Results Reference
derived
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Running Study for Runners With Chronic Knee Pain
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