Investigation of Regional Interdependence of the Hip and Spine in Baseball Players With Low Back Pain

February 1, 2024 updated by: National Cheng-Kung University Hospital
Low back pain (LBP) is a common musculoskeletal symptom in athletes. More than 40% percent of high school baseball players reported incidents of LBP during the previous year. University baseball athletes were 3.23 times more likely to have lumbar intervertebral disk degeneration than the nonathletic university students. According to the regional interdependence model, a patient's chief complaints may be directly or indirectly related to or influenced by physical impairments from various body systems and regardless of proximity to the primary symptom(s). Athletes with a chief complaint of LBP frequently demonstrate with mobility restrictions in the thoracic spine and hips, which may contribute to compensatory hypermobility in the lumbar spine and subsequently lead to LBP. Few studies have examined the relationship between thoracic spine mobility and LBP, while many studies investigating the relationship between hip joint mobility and LBP in athletes showed inconsistent results. The inconsistent results may be due to different types of sports and measurement methods. Therefore, the objectives of this research project are to: (1) examine if baseball players with a history of LBP have mobility restriction in the thoracic spine and hips and movement coordination within the spine and hip regions during baseball batting that are different from those without a history of LBP; (2) identify thoracic spine and hip joint mobility and coordination related predictors for batting velocity and LBP in baseball players. This 2-year research project plans to recruitment a total of 110 male baseball players aged between 18 and 30 years from university and community recreational league baseball teams (55 players with a history of LBP and 55 age-matched players without a history of LBP). Participants will receive physical examination for the thoracic spine and hip joints (joint mobility and muscle stiffness) and 3D motion analysis for baseball batting. The results of this research project will guide the development of more specific and effective treatment and preventative training for baseball players with LBP and enhance their batting performance.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

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

  • Taiwan
      • Tainan, Taiwan, 701
        • National Cheng Kung University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

university and recreational leagues baseball teams

Description

Inclusion Criteria:

• Baseball players who had experienced at least 2 episodes of LBP that limits their performance for a period of greater than 3 days in the previous year.

Exclusion Criteria:

  • Current LBP symptoms including weakness and numbness in the lower extremities
  • Previous surgery to the back, upper or lower extremities
  • Marked spinal deformity (e.g., scoliosis, or kyphosis)
  • Any other orthopedic or medical problem that would have limited their ability to fully participate in baseball training and competition in the last year.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
control group
Baseball players without a history of low back pain
Other: No intervention
Comare the difference in batting mechanics, hip and thoracic spine mobility, and muscle stiffness in baseball players with and without a history of low back pain
experimental group
Baseball players with a history of low back pain
Other: No intervention
Comare the difference in batting mechanics, hip and thoracic spine mobility, and muscle stiffness in baseball players with and without a history of low back pain

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Angular displacement of spine during baseball batting
Time Frame: immediately after enrollment
Measured by the Vicon motion analysis system in the horizontal plane
immediately after enrollment
Angular displacement of hip during baseball batting
Time Frame: immediately after enrollment
Measured by the Vicon motion analysis system in the horizontal plane
immediately after enrollment
Angular velocity of spine during baseball batting
Time Frame: immediately after enrollment
Measured by the Vicon motion analysis system in the horizontal plane
immediately after enrollment
Angular velocity of hip during baseball batting
Time Frame: immediately after enrollment
Measured by the Vicon motion analysis system in the horizontal plane
immediately after enrollment
Thoracic spine mobility
Time Frame: immediately after enrollment
Measured by the Vicon motion analysis system in sitting
immediately after enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hip joint mobility
Time Frame: immediately after enrollment
Ranges of hip internal and external rotation measured by inclinometer in sitting
immediately after enrollment
Stiffness of biceps femoris muscle
Time Frame: immediately after enrollment
Measured by the hand-held MyotonPRO device in N/m
immediately after enrollment
Stiffness of rectus femoris muscle
Time Frame: immediately after enrollment
Measured by the hand-held MyotonPRO device in N/m
immediately after enrollment
Stiffness of tensor fasciae latae muscle
Time Frame: immediately after enrollment
Measured by the hand-held MyotonPRO device in N/m
immediately after enrollment
Stiffness of glutues maximus muscle
Time Frame: immediately after enrollment
Measured by the hand-held MyotonPRO device in N/m
immediately after enrollment
Stiffness of thoracic erector spinae muscle
Time Frame: immediately after enrollment
Measured by the hand-held MyotonPRO device in N/m
immediately after enrollment
FABER's test
Time Frame: immediately after enrollment
Measured as distance between knee and bed in cm
immediately after enrollment
Straight leg raising test
Time Frame: immediately after enrollment
Measured as hip flexion angle (with knee extended) in degree
immediately after enrollment
Modified Thomas test
Time Frame: immediately after enrollment
Measured as hip flexion angle (with knee flexed) in degree
immediately after enrollment
Ober test
Time Frame: immediately after enrollment
Measured as hip adduction angle in degree
immediately after enrollment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cheng-Kung University Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A-ER-110-579

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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