NCT05132894

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 13, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

November 20, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2022

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

September 13, 2021

Last Update Submit

June 2, 2024

Conditions

Keywords

somatic dysfunctionrunnersosteopathicosteopathic assessmentlower extremitylower extremity somatic dysfunctionrunning injury

Outcome Measures

Primary Outcomes (2)

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

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

    up to 8 weeks

  • Questionnaire to analyze data on runners' background/history

    Questionnaire to learn about runners' background

    up to 8 weeks

Study Arms (3)

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

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

Advanced RunnersModerate RunnersNovice Runners

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Touro College of Osteopathic Medicine

New York, New York, 10027, United States

Location

Related Links

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, OMS-IV

Study Record Dates

First Submitted

September 13, 2021

First Posted

November 24, 2021

Study Start

November 20, 2021

Primary Completion

January 20, 2022

Study Completion

February 20, 2022

Last Updated

June 4, 2024

Record last verified: 2024-06

Locations