- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05132894
An Osteopathic Assessment of Lower Extremity Somatic Dysfunction in Runners
Runners often experience acute/chronic pain due to pre-existing structural somatic dysfunction and/or acquired various overuse injuries of the lower extremity, specifically affecting the ligaments, tendons, muscles and bones. Common structural and function dysfunctions include but are not limited to patellofemoral pain syndrome (PFPS), Achilles tendonitis, iliotibial band syndrome (ITBS), ligamentous and muscle tears, muscle sprains/strains, stress fractures, pes planus, plantar fasciitis, and shin splints.
The purpose of this study is to assess the correlation between acute and chronic pain, overuse injuries, and observational and palpatory findings upon evaluation. With an understanding of the common trends of somatic dysfunctions and etiology of the pain/injury, modified regimen/routine and improved treatment plans can be developed and recommended for runners to better rehabilitate, minimize relapse and reduce compensatory injuries. No medical or osteopathic treatment will be provided.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10027
- Touro College of Osteopathic Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
The study population includes any adult-aged males and females that are self-proclaimed runners confirming that they run at least 1 mile per week. The runners will be categorized based on the quantity of miles run weekly.
The sampling method is non-probability for convenience to easily gather data.
Description
Inclusion Criteria:
- Self-proclaimed runners that run at least 1 mile per week consistently
- Minimum 18 years old
Exclusion Criteria:
- Non-runners
- Inconsistent runners, do not log at least 1 mile weekly
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Novice Runners
1-5 miles / week 18+ yo
|
As osteopathic structural exam will be performed to assessment somatic dysfunctions of the lower extremities.
|
|
Moderate Runners
6-15 miles / week 18+ yo
|
As osteopathic structural exam will be performed to assessment somatic dysfunctions of the lower extremities.
|
|
Advanced Runners
16+ miles / week 18+ yo
|
As osteopathic structural exam will be performed to assessment somatic dysfunctions of the lower extremities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Structural exam to determine type of Lower Extremity Somatic Dysfunctions in participants
Time Frame: up to 8 weeks
|
Osteopathic Structural Exam to assess changes to muscles, bones, bursae, and ligaments
|
up to 8 weeks
|
|
Questionnaire to analyze data on runners' background/history
Time Frame: up to 8 weeks
|
Questionnaire to learn about runners' background
|
up to 8 weeks
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
- Amount of Running and Association With Risk of All-Cause, Cardiovascular, and Cancer Mortality
- Is running associated with a lower risk of all-cause, cardiovascular and cancer mortality, and is the more the better? A systematic review and meta-analysis
- Controlled trial to compare the Achilles tendon load during running in flatfeet participants using a customized arch support orthoses vs an orthotic heel lift.
- Overuse Injury: The Result of Pathologically Altered Myofascial Force Transmission?
- Diseases and overuse injuries of the lower extremities in long distance runners
- Incidence of Running-Related Injuries Per 1000 h of running in Different Types of Runners: A Systematic Review and Meta-Analysis
- Lower Extremity Injuries in Runners
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001 (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasil (CAPES))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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