Low Back PainNCT06252740
Investigation of Regional Interdependence of the Hip and Spine in Baseball Players With Low Back Pain
An observational study of Low Back Pain and Thoracic, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Thoracic
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Nov 2022to 31 Jul 2024
- 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 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: university and recreational leagues baseball teams
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Low Back Pain, Thoracic
- Being tested
- No intervention
- Keywords
- Baseball batting, Motion analysis, Regional interdependence,, Hip, Joint mobility, Muscle stiffness
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| control group | Baseball players without a history of low back pain Receives: Other: No intervention | |
| experimental group | Baseball players with a history of low back pain Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angular displacement of spine during baseball batting
Measured by the Vicon motion analysis system in the horizontal plane
Measured: immediately after enrollment
Angular displacement of hip during baseball batting
Measured by the Vicon motion analysis system in the horizontal plane
Measured: immediately after enrollment
Angular velocity of spine during baseball batting
Measured by the Vicon motion analysis system in the horizontal plane
Measured: immediately after enrollment
Angular velocity of hip during baseball batting
Measured by the Vicon motion analysis system in the horizontal plane
Measured: immediately after enrollment
Thoracic spine mobility
Measured by the Vicon motion analysis system in sitting
Measured: immediately after enrollment
Secondary outcomes (10)
Hip joint mobility
Ranges of hip internal and external rotation measured by inclinometer in sitting
Measured: immediately after enrollment
Stiffness of biceps femoris muscle
Measured by the hand-held MyotonPRO device in N/m
Measured: immediately after enrollment
Stiffness of rectus femoris muscle
Measured by the hand-held MyotonPRO device in N/m
Measured: immediately after enrollment
Stiffness of tensor fasciae latae muscle
Measured by the hand-held MyotonPRO device in N/m
Measured: immediately after enrollment
Stiffness of glutues maximus muscle
Measured by the hand-held MyotonPRO device in N/m
Measured: immediately after enrollment
Stiffness of thoracic erector spinae muscle
Measured by the hand-held MyotonPRO device in N/m
Measured: immediately after enrollment
FABER's test
Measured as distance between knee and bed in cm
Measured: immediately after enrollment
Straight leg raising test
Measured as hip flexion angle (with knee extended) in degree
Measured: immediately after enrollment
Modified Thomas test
Measured as hip flexion angle (with knee flexed) in degree
Measured: immediately after enrollment
Ober test
Measured as hip adduction angle in degree
Measured: immediately after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start2 Nov 2022
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252740
- Sponsor's protocol ID
- A-ER-110-579
- Status last verified
- Nov 2023
- First submitted
- 16 May 2023
- Last updated
- 12 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Regional Interdependence of the Hip and Spine in Baseball Players With Low Back Pain
- ClinicalTrials.gov ID
- NCT06252740
- Acronym / sponsor ID
- A-ER-110-579
- Conditions
- Low Back Pain, Thoracic
- Keywords
- Baseball batting, Motion analysis, Regional interdependence,, Hip, Joint mobility, Muscle stiffness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 12 Feb 2024 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | Other: No interventionBaseball players without a history of low back pain |
| experimental group | – | Other: No interventionBaseball players with a history of low back pain |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- university and recreational leagues baseball teams
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| No interventionComare 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 | Other | control group, experimental group |
Primary outcome
Angular displacement of spine during baseball batting
Time frame: immediately after enrollment
Measured by the Vicon motion analysis system in the horizontal plane
Angular displacement of hip during baseball batting
Time frame: immediately after enrollment
Measured by the Vicon motion analysis system in the horizontal plane
Angular velocity of spine during baseball batting
Time frame: immediately after enrollment
Measured by the Vicon motion analysis system in the horizontal plane
Angular velocity of hip during baseball batting
Time frame: immediately after enrollment
Measured by the Vicon motion analysis system in the horizontal plane
Thoracic spine mobility
Time frame: immediately after enrollment
Measured by the Vicon motion analysis system in sitting
10 secondary outcomes
Hip joint mobility
Time frame: immediately after enrollment
Stiffness of biceps femoris muscle
Time frame: immediately after enrollment
Stiffness of rectus femoris muscle
Time frame: immediately after enrollment
Stiffness of tensor fasciae latae muscle
Time frame: immediately after enrollment
Stiffness of glutues maximus muscle
Time frame: immediately after enrollment
Stiffness of thoracic erector spinae muscle
Time frame: immediately after enrollment
FABER's test
Time frame: immediately after enrollment
Straight leg raising test
Time frame: immediately after enrollment
Modified Thomas test
Time frame: immediately after enrollment
Ober test
Time frame: immediately after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: No
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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 Low Back Pain and Thoracic, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Feb 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 Taiwan. 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?
Results are not available in the source record.
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?
Angular displacement of spine during baseball batting (time frame: immediately after enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2024.