An Osteopathic Assessment of Lower Extremity Somatic Dysfunction in Runners

June 2, 2024 updated by: Abbey Santanello, The Touro College and University System

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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10027
        • Touro College of Osteopathic Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Novice Runners
1-5 miles / week 18+ yo
Other: Osteopathic Assessment
As osteopathic structural exam will be performed to assessment somatic dysfunctions of the lower extremities.
Moderate Runners
6-15 miles / week 18+ yo
Other: Osteopathic Assessment
As osteopathic structural exam will be performed to assessment somatic dysfunctions of the lower extremities.
Advanced Runners
16+ miles / week 18+ yo
Other: Osteopathic Assessment
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

This is where you will find people and organizations involved with this study.

Sponsor

The Touro College and University System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2021

Primary Completion (Actual)

January 20, 2022

Study Completion (Actual)

February 20, 2022

Study Registration Dates

First Submitted

September 13, 2021

First Submitted That Met QC Criteria

November 12, 2021

First Posted (Actual)

November 24, 2021

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

June 2, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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