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Strains ThighNCT03248011

Hamstring Strain in High School Athletes

A study testing Stretching, Strengthening and Neuromuscular in people with Strains Thigh, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 14 to 18 years
Conditions the study is for
Strains Thigh
What is being tested?
Stretching, Strengthening and Neuromuscular
Could I receive a placebo?
No, everyone receives an active treatment
How many people
196 participants
Where
1 siteUnited States
Study dates
27 Sep 2017to 31 Aug 2021
Phase
Interventional
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 14 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • member of high school basketball team
  • school agreement to participate in study

Who cannot join

  • inability to ambulate independently
  • lower extremity or back surgery within 1 year of study enrollment
  • presence of neurological disease

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55405

Other trials in United States

About this study

Official title: Comparative Effectiveness of Hamstring Muscle Strain Injury Prevention Programs

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.

Read the 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.

Conditions
Strains Thigh
Being tested
Stretching, Strengthening, Neuromuscular
Keywords
hamstring, ultrasound, intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • StretchingOther

    Lower extremity flexibility exercises will be performed

  • StrengtheningOther

    Eccentric hamstring strengthening exercises will be performed

  • NeuromuscularOther

    Dynamic lower extremity balance and movement control exercises will be performed

Study groups in NCT03248011
Study groupRoleWhat they receive
FlexibilityExperimentalStretching exercise
Receives: Other: Stretching
StrengthExperimentalEccentric hamstring strengthening exercise
Receives: Other: Strengthening
NeuromuscularExperimentalBalance exercise
Receives: Other: Neuromuscular
ControlNo interventionNo exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects who sustain a hamstring strain

    Physician based diagnosis

    Measured: Duration of school basketball season, approximately 4 months

Secondary outcomes (4)
  1. Change in thigh strength

    This will be measured using an isokinetic dynamometer

    Measured: Baseline and post school basketball season, approximately 4 months

  2. Change in hamstring stiffness

    This will be measured using sheer wave elastography

    Measured: Baseline, post school basketball season, approximately 4 months

  3. Change in lower extremity power

    This will be measured using force plates

    Measured: Baseline, post school basketball season, approximately 4 months

  4. Change in lower extremity hamstring flexibility

    Measured using a goniometer

    Measured: Baseline, post school basketball season, approximately 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2017
  2. Study start27 Sep 2017
  3. Primary completion10 Jun 2020
  4. Study completion31 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a prospective, randomized, repeated measures single- blind clinical trial.
Masking
Single blind
Who is masked
Investigator
Enrolment
196 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03248011
Sponsor's protocol ID
17-003905
Status last verified
Sep 2021
First submitted
10 Aug 2017
Last updated
4 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Subject identification (ID) and study data (test results, injuries) will be shared with study co-investigators at TRIA Orthopaedics

Questions about this trial

What is this clinical trial studying?

A study testing Stretching, Strengthening and Neuromuscular in people with Strains Thigh, run by Mayo Clinic 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 3 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 Oct 2021. 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?

Number of subjects who sustain a hamstring strain (time frame: Duration of school basketball season, approximately 4 months). 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 4 Oct 2021.

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