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CompletedNCT05132894Updated Jun 4, 2024

An Osteopathic Assessment of Lower Extremity Somatic Dysfunction in Runners

An observational study in Somatic Dysfunction of Sacral Region, Somatic Dysfunction of Both Sacroiliac Joints and Somatic Dysfunction of Bilateral Lower Extremities, sponsored by The Touro College and University System. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-04.

Sponsored by The Touro College and University System · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
103
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Somatic Dysfunction of Sacral Region
  • Somatic Dysfunction of Both Sacroiliac Joints
  • Somatic Dysfunction of Bilateral Lower Extremities

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Keywords

  • somatic dysfunction
  • runners
  • osteopathic
  • osteopathic assessment
  • lower extremity
  • lower extremity somatic dysfunction
  • running injury
03

In context

Pathologic Processes

120 studies on the registry are indexed under Pathologic Processes; 28 are open to participants now.

This study's enrollment of 103 is below the median of 152 across 27 observational studies indexed under Pathologic Processes.

Browse Pathologic Processes studies →

Lead sponsor

The Touro College and University System is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Inclusion criteria

  • Self-proclaimed runners that run at least 1 mile per week consistently
  • Minimum 18 years old

Exclusion criteria

Exclusion Criteria:

  • Non-runners
  • Inconsistent runners, do not log at least 1 mile weekly
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
103 participants (actual)
Patient registry
No

Groups and cohorts

  • Novice Runners

    1-5 miles / week 18+ yo

    Other: Osteopathic Assessment

  • Moderate Runners

    6-15 miles / week 18+ yo

    Other: Osteopathic Assessment

  • Advanced Runners

    16+ miles / week 18+ yo

    Other: Osteopathic Assessment

Interventions

  • OtherOsteopathic Assessment

    As osteopathic structural exam will be performed to assessment somatic dysfunctions of the lower extremities.

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What researchers measure

Primary outcomes

  1. Structural exam to determine type of Lower Extremity Somatic Dysfunctions in participants

    Osteopathic Structural Exam to assess changes to muscles, bones, bursae, and ligaments

    Time frame: up to 8 weeks

  2. Questionnaire to analyze data on runners' background/history

    Questionnaire to learn about runners' background

    Time frame: up to 8 weeks

07

Study locations

1 site
  • Touro College of Osteopathic Medicine
    New York, New York 10027, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05132894
Lead sponsor
The Touro College and University System
Responsible party
Abbey Santanello (Principal Investigator, OMS-IV, The Touro College and University System) — Principal investigator
First posted
Nov 24, 2021
Start date
Nov 20, 2021
Primary completion
Jan 20, 2022
Completion
Feb 20, 2022
Last update
Jun 4, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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