Somatic Dysfunction of Sacral RegionNCT05132894
An Osteopathic Assessment of Lower Extremity Somatic Dysfunction in Runners
An observational study of Somatic Dysfunction of Sacral Region and Somatic Dysfunction of Both Sacroiliac Joints, run by The Touro College and University System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Somatic Dysfunction of Sacral Region, Somatic Dysfunction of Both Sacroiliac Joints, Somatic Dysfunction of Bilateral Lower Extremities
- What is being tested?
- Osteopathic Assessment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2021to 20 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Self-proclaimed runners that run at least 1 mile per week consistently
- Minimum 18 years old
Who cannot join
- Non-runners
- Inconsistent runners, do not log at least 1 mile weekly
Trial locations and contacts
1 site in 1 country.
United States1 site
Touro College of Osteopathic Medicine
New York, New York, 10027
About this study
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.
- Conditions
- Somatic Dysfunction of Sacral Region, Somatic Dysfunction of Both Sacroiliac Joints, Somatic Dysfunction of Bilateral Lower Extremities
- Being tested
- Osteopathic Assessment
- Keywords
- somatic dysfunction, runners, osteopathic, osteopathic assessment, lower extremity, lower extremity somatic dysfunction, running injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic AssessmentOther
As osteopathic structural exam will be performed to assessment somatic dysfunctions of the lower extremities.
| Study group | Role | What they receive |
|---|---|---|
| Novice Runners | 1-5 miles / week 18+ yo Receives: Other: Osteopathic Assessment | |
| Moderate Runners | 6-15 miles / week 18+ yo Receives: Other: Osteopathic Assessment | |
| Advanced Runners | 16+ miles / week 18+ yo Receives: Other: Osteopathic Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural exam to determine type of Lower Extremity Somatic Dysfunctions in participants
Osteopathic Structural Exam to assess changes to muscles, bones, bursae, and ligaments
Measured: up to 8 weeks
Questionnaire to analyze data on runners' background/history
Questionnaire to learn about runners' background
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start20 Nov 2021
- Primary completion20 Jan 2022
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Somatic Dysfunction of Sacral RegionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Touro College and University System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abbey Santanello, The Touro College and University System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132894
- Sponsor's protocol ID
- 001
- Status last verified
- Jun 2024
- First submitted
- 13 Sep 2021
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Santanello A, Volokitin M, Matthew P, Modica A, McKellar C, Thakkar K, Schear M, Tai A, Nagler J, Suarez S. An osteopathic assessment of lower extremity somatic dysfunctions in runners. J Osteopath Med. 2024 Dec 5;125(3):135-141. doi: 10.1515/jom-2024-0006. eCollection 2025 Mar 1.
PubMed 39632413
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Osteopathic Assessment of Lower Extremity Somatic Dysfunction in Runners
- ClinicalTrials.gov ID
- NCT05132894
- Acronym / sponsor ID
- 001
- Conditions
- Somatic Dysfunction of Sacral Region, Somatic Dysfunction of Both Sacroiliac Joints, Somatic Dysfunction of Bilateral Lower Extremities
- Keywords
- somatic dysfunction, runners, osteopathic, osteopathic assessment, lower extremity, lower extremity somatic dysfunction, running injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- The Touro College and University SystemUniversity, hospital or other
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Novice Runners | – | Other: Osteopathic Assessment1-5 miles / week 18+ yo |
| Moderate Runners | – | Other: Osteopathic Assessment6-15 miles / week 18+ yo |
| Advanced Runners | – | Other: Osteopathic Assessment16+ miles / week 18+ yo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Self-proclaimed runners that run at least 1 mile per week consistently
- Minimum 18 years old
Key exclusion criteria (2 listed)
- Non-runners
- Inconsistent runners, do not log at least 1 mile weekly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic AssessmentAs osteopathic structural exam will be performed to assessment somatic dysfunctions of the lower extremities. | Other | Advanced Runners, Moderate Runners, Novice Runners |
Primary outcome
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
Questionnaire to analyze data on runners' background/history
Time frame: up to 8 weeks
Questionnaire to learn about runners' background
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Derived from this study: PubMed 39632413Santanello A, Volokitin M, Matthew P, Modica A, McKellar C, Thakkar K, Schear M, Tai A, Nagler J, Suarez S. An osteopathic assessment of lower extremity somatic dysfunctions in runners. J Osteopath Med. 2024 Dec 5;125(3):135-141. doi: 10.1515/jom-2024-0006. eCollection 2025 Mar 1.
- Amount of Running and Association With Risk of All-Cause, Cardiovascular, and Cancer MortalityLink provided by the sponsor.
- 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-analysisLink provided by the sponsor.
- Controlled trial to compare the Achilles tendon load during running in flatfeet participants using a customized arch support orthoses vs an orthotic heel lift.Link provided by the sponsor.
- Overuse Injury: The Result of Pathologically Altered Myofascial Force Transmission?Link provided by the sponsor.
- Diseases and overuse injuries of the lower extremities in long distance runnersLink provided by the sponsor.
- Incidence of Running-Related Injuries Per 1000 h of running in Different Types of Runners: A Systematic Review and Meta-AnalysisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Somatic Dysfunction of Sacral Region and Somatic Dysfunction of Both Sacroiliac Joints, run by The Touro College and University System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structural exam to determine type of Lower Extremity Somatic Dysfunctions in participants (time frame: up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05132894, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.