Hamstring Strain in High School Athletes
Primary Purpose
Strains Thigh
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stretching
Strengthening
Neuromuscular
Sponsored by
About this trial
This is an interventional prevention trial for Strains Thigh focused on measuring hamstring, ultrasound, intervention
Eligibility Criteria
Inclusion criteria:
- member of high school basketball team
- school agreement to participate in study
Exclusion criteria:
- inability to ambulate independently
- lower extremity or back surgery within 1 year of study enrollment
- presence of neurological disease
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Flexibility
Strength
Neuromuscular
Control
Arm Description
Stretching exercise
Eccentric hamstring strengthening exercise
Balance exercise
No exercise
Outcomes
Primary Outcome Measures
Number of subjects who sustain a hamstring strain
Physician based diagnosis
Secondary Outcome Measures
Change in thigh strength
This will be measured using an isokinetic dynamometer
Change in hamstring stiffness
This will be measured using sheer wave elastography
Change in lower extremity power
This will be measured using force plates
Change in lower extremity hamstring flexibility
Measured using a goniometer
Full Information
NCT ID
NCT03248011
First Posted
August 10, 2017
Last Updated
September 27, 2021
Sponsor
Mayo Clinic
Collaborators
General Electric, TRIA Orthopaedic Center
1. Study Identification
Unique Protocol Identification Number
NCT03248011
Brief Title
Hamstring Strain in High School Athletes
Official Title
Comparative Effectiveness of Hamstring Muscle Strain Injury Prevention Programs
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 27, 2017 (Actual)
Primary Completion Date
June 10, 2020 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
General Electric, TRIA Orthopaedic Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the current study is, 1) Determine the effectiveness of injury prevention programs for prevention of hamstring muscle strains, 2) Identify how these programs impact athletes' flexibility, muscle stiffness, strength, and power, and 3) Determine the ability of a state-of-the-art imaging technology, shear wave elastography to predict future hamstring muscle strain injury.
Detailed Description
Hamstring strains are a significant problem for basketball athletes across levels of play for both sexes. The impact of hamstring muscle strains (HSMS) is significant. Injuries typically result in persistent symptoms and lengthy recovery periods which limit the athlete's practice and play time. Even more significantly, HSMS have high rates of reinjury. It is estimated that approximately one-third of hamstring strains are recurrent. Given the high incidence of HSMS and the substantial tendency for injuries to recur, it has been advocated the greatest impact may be achieved by the development of improved techniques for prevention of initial injury.
Multiple risk factors for HSMS have been identified. Perhaps the strongest modifiable risk factor associated with HSMS is an imbalance between quadriceps and hamstring strength, specifically the eccentric hamstrings and concentric quadriceps strength ratio. The rationale is that sufficient eccentric capacity of the hamstring muscles is necessary to offset the concentric quadriceps contraction during the terminal swing phase of running. Not surprisingly, prevention programs that emphasize eccentric hamstring strengthening have been effective in reduction of HSMS injury rates.Prospective studies have demonstrated mixed results regarding the relationship between hamstring flexibility and hamstring injury, and the effectiveness of a flexibility program for reduction of the incidence of HSMS remains controversial. Stretching duration, frequency, timing of stretching relative to sports activities and the type of stretch being performed have been suggested as important factors in the effectiveness of a flexibility program at reducing injury occurrence. In addition, reduced hip flexor and quadriceps flexibility has been identified as a risk factor for HSMS. Further investigation is necessary to determine if a flexibility program that addresses both anterior and posterior thigh musculature reduces injury risk. The role of neuromuscular (NM) deficits as a risk factor in HSMS injuries is unclear. Inclusion of NM exercises in a six week training period improved lower extremity control and movement discrimination, which has been suggested to contribute to HSMS injury prevention. However, the impact of a NM injury prevention program on HSMS rates has not been established.
Sheer wave elastography (SWE) represents an emerging imaging technology. This real-time imaging technique evaluates the local mechanical properties of muscles. Thus, SWE has the potential to provide more sensitive insight into muscle stiffness than flexibility assessment. Recent studies have utilized this technique to evaluate the effect of lower extremity positioning on hamstring stiffness. The relationship between stiffness measures obtained using SWE and HSMS has not, however, been established.
Key gaps in knowledge regarding HSMS injury prevention programs remain. Most critically, the effectiveness of HSMS prevention programs among basketball athletes is unknown. Furthermore, the comparative effectiveness of eccentric, flexibility, and NM training for reduction of HSMS injuries is also unknown. Assessment of lower extremity strength, rate of power production, flexibility, and stiffness (captured with SWE) may elucidate the mechanisms underlying the effectiveness of injury prevention training, and aid in enhancement of injury prevention programs. Thus, the potential impact of this proposal is profound as our investigative team aims to fill these gaps in knowledge. Ultimately, the results of this study have the potential to 1) reduce injuries among basketball athletes and consequently enhance and lengthen athletic careers, 2) provide scientific rationale underlying the effects of HSMS injury prevention training, and 3) determine if a novel ultrasound imaging technique may be effective in determining risk for HSMS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strains Thigh
Keywords
hamstring, ultrasound, intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a prospective, randomized, repeated measures single- blind clinical trial.
Masking
Investigator
Masking Description
Group assignment will be masked to investigator.
Allocation
Randomized
Enrollment
196 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flexibility
Arm Type
Experimental
Arm Description
Stretching exercise
Arm Title
Strength
Arm Type
Experimental
Arm Description
Eccentric hamstring strengthening exercise
Arm Title
Neuromuscular
Arm Type
Experimental
Arm Description
Balance exercise
Arm Title
Control
Arm Type
No Intervention
Arm Description
No exercise
Intervention Type
Other
Intervention Name(s)
Stretching
Intervention Description
Lower extremity flexibility exercises will be performed
Intervention Type
Other
Intervention Name(s)
Strengthening
Intervention Description
Eccentric hamstring strengthening exercises will be performed
Intervention Type
Other
Intervention Name(s)
Neuromuscular
Intervention Description
Dynamic lower extremity balance and movement control exercises will be performed
Primary Outcome Measure Information:
Title
Number of subjects who sustain a hamstring strain
Description
Physician based diagnosis
Time Frame
Duration of school basketball season, approximately 4 months
Secondary Outcome Measure Information:
Title
Change in thigh strength
Description
This will be measured using an isokinetic dynamometer
Time Frame
Baseline and post school basketball season, approximately 4 months
Title
Change in hamstring stiffness
Description
This will be measured using sheer wave elastography
Time Frame
Baseline, post school basketball season, approximately 4 months
Title
Change in lower extremity power
Description
This will be measured using force plates
Time Frame
Baseline, post school basketball season, approximately 4 months
Title
Change in lower extremity hamstring flexibility
Description
Measured using a goniometer
Time Frame
Baseline, post school basketball season, approximately 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
member of high school basketball team
school agreement to participate in study
Exclusion criteria:
inability to ambulate independently
lower extremity or back surgery within 1 year of study enrollment
presence of neurological disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Schilaty, DC, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55405
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Subject identification (ID) and study data (test results, injuries) will be shared with study co-investigators at TRIA Orthopaedics
IPD Sharing Time Frame
Co-Investigators will have access to the data as it is collected, for the duration of the study.
IPD Sharing Access Criteria
Secured file transfer protocols will be utilized to transfer files between investigators. Only study co-investigators may access study data.
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Hamstring Strain in High School Athletes
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