Examining the Effects of Three Soft Tissue Treatments on Functional Movement and Functional Performance Enhancement
NCT ID: NCT03080220
Last Updated: 2017-03-20
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
48 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-09-01
Study Completion Date
2016-09-30
Brief Summary
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The purpose of this study is to investigate the effects of Astym® treatment, The Stick® treatment and massage treatment on performance among healthy college athletes and to investigate any relationship between functional movement and functional performance. Participants will be recruited from Division II, National Association of Intercollegiate Athletics (NAIA) basketball and volleyball teams. The participants will be randomized into one of three groups: Astym treatment (AT), The Stick treatment (ST) or massage treatment (MT). The participant will have baseline measures of vertical jump (VJ), Y-Balance Lower Quarter Screen (YBLQ), and a rating of current perceived lower extremity function using a visual analog scale (PLEF-VAS). The participants will be treated using either the AT, ST, or MT following baseline measures. Immediately following the intervention, a second measurement of VJ, YBLQ, and PLEF-VAS will take place. The data will be analyzed using mixed ANOVA tests which will be conducted for each dependent variable. In addition, functional movement is thought to be related to functional performance. A Pearson Product Correlation analysis will be used to understand any relationship between YBLQ and VJ. It is hypothesized that those in the AT group will have different percent change in their YBLQ, VJ, and PLEF-VAS compared to those in ST and MT groups. It is hypothesized that a correlation between YBLQ and VJ will exist. As a result, clinicians could use AT among basketball and volleyball athletes without hindering acute performance. Any risks the participants could encounter are minimal. Participants may withdraw themselves and their data at any time. The intervention and testing are similar to what an athlete would be exposed to during their collegiate career. Any participant injured during this study will be referred to their university sports medicine staff, health center, or the Indiana Wesleyan University health center.
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Detailed Description
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All participants will complete baseline testing, intervention, and post intervention testing in a single day. The total time for a participant to complete the entire study is anticipated to be between 1.5 and 2 hours. Upon arrival to the Athletic Training Clinic, a participant's demographic information will be collected. This information will consist of the following: age, weight, height, and percent body fat using a standard seven site skinfold measurement. Other information will be recorded, such as sport, position, gender, years of college sport experience, and year in school. The research team will ensure that the participant is dressed appropriately in athletic shorts and T-shirt. Spandex® or compression type garments will not be allowed to be worn at any time during the study.
Once the demographic information is collected, a full body warm up will be initiated. Participants will be instructed to warm up on a bike for 5 minutes at an intensity of 4 to 6 as represented on the OMNI scale of perceived exertion. This warm up is based on the guidelines set forth by the American College of Sports Medicine. Following the warm up, each participant's baseline measurements will be taken in this order: Vertical Jump (VJ), Y-Balance Lower Quarter (YBLQ), and rating of Perceived Lower Extremity Function-Visual Analog Scale (PLEF-VAS).
Following baseline data collection, participants will be randomly assigned to an intervention. One of the three treatments previously described will take place in the Athletic Training Clinic. An individual not associated with the research committee or research team will conduct the randomization. Immediately following the intervention, participants will proceed to the performance evaluation testing area for post treatment testing. The participant may elect to bring one chaperon of their choosing to the treatment area. Warm up and performance testing order will remain consistent for each participant and will follow the order as conducted during baseline measure.
Trained undergraduate research assistants, blinded from the treatment allocation will collect the testing data. The testing data will include: the VJ, YBLQ, and the PLEF-VAS. The clinicians (doctoral candidate and assisting clinician) will provide Astym treatment (AT), The Stick treatment (ST), or massage treatment (MT) and will not be present for the VJ, YBLQ, and the PLEF-VAS nor will the clinicians providing the intervention be present in the testing area during baseline test collection.
Testing Procedures Participants will perform the VJ and YBLQ Screen following a 5-minute-warm up as previously described. The highest jump of three attempts will be recorded for the counter movement VJ. The longest reach of three attempts in the anterior, posteriolateral and posteromedial directions will be recorded following the established YBLQ protocol.
Vertical Jump A Belt Mat (University of Toronto; Toronto, Canada) vertical jump measuring device will be utilized for this study. The participant is positioned on a mat with a belt placed around the waist. The belt has a tape measure running form the belt to the mat. The participant is asked to stand erect to establish 'zero'. The participant then jumps vertically while the belt is around the waist pulling out the remaining tape measure. The vertical jump height is recorded as the displacement of the tape measure. The participant will propel vertically as high as possible. A preparatory stutter step will not be used; however, a counter movement may be used. A countermovement is where the participant quickly flexes the knees and hips while moving the thorax forward and downward while swinging the arms back. Three jump attempts will be given to each participant where a measurement will take place after each attempt. Measurements will be recorded to the nearest half inch and then converted to centimeters. The highest measurement will be used for analysis.
Y Balance Lower Quarter Screen Testing procedures for the YBLQ (Y Balance Test Kit, Move2Perform; Evansville, IN) will follow the protocol previously established by researchers The participant will have viewed a two minute instructional video prior to practicing six reaches in each of the three directions bilaterally: anterior, posteriormedial and posteriorlateral. Following the practice reaches, the participant will stand on the Y Balance center footplate with the right foot behind the start line. With the free foot, the participant will reach in the anterior direction pushing the indicator box as far as possible. Three successful measurements in as many as six attempts in the reach direction will be recorded with the best, successful reach being used for analysis. The participant will then switch stance legs. The indicator box will be reset and the participant will reach with the right foot in the anterior direction. This cycle will continue for the posteromedial and posterolateral directions. Successful reaches are those where the participant maintained contact with stance leg on the center footplate and behind the start line throughout the reach attempt. Successful reaches also will include maintaining contact with the indicator box during the reach attempt, not using the indicator box for support, and returning to start position under control. The participant will rest only as long as it takes the recorder to reset the indicator box and log the reach distance.
Rating of Perceived Lower Extremity Function The participant will be asked to rate current perceived lower extremity function on a 100mm line anywhere between 'my function is at its worst' and 'my function is at its best.' The participant will rate by placing a vertical line that intersects the 100mm horizontal line perpendicularly. A standard metric ruler will be used to measure from the farthest left to the intersecting line. This distance will be recorded.
Once the demographic information is collected, a full body warm up will be initiated. Participants will be instructed to warm up on a bike for 5 minutes at an intensity of 4 to 6 as represented on the OMNI scale of perceived exertion. This warm up is based on the guidelines set forth by the American College of Sports Medicine. Following the warm up, each participant's baseline measurements will be taken in this order: Vertical Jump (VJ), Y-Balance Lower Quarter (YBLQ), and rating of Perceived Lower Extremity Function-Visual Analog Scale (PLEF-VAS).
Following baseline data collection, participants will be randomly assigned to an intervention. One of the three treatments previously described will take place in the Athletic Training Clinic. An individual not associated with the research committee or research team will conduct the randomization. Immediately following the intervention, participants will proceed to the performance evaluation testing area for post treatment testing. The participant may elect to bring one chaperon of their choosing to the treatment area. Warm up and performance testing order will remain consistent for each participant and will follow the order as conducted during baseline measure.
Trained undergraduate research assistants, blinded from the treatment allocation will collect the testing data. The testing data will include: the VJ, YBLQ, and the PLEF-VAS. The clinicians (doctoral candidate and assisting clinician) will provide Astym treatment (AT), The Stick treatment (ST), or massage treatment (MT) and will not be present for the VJ, YBLQ, and the PLEF-VAS nor will the clinicians providing the intervention be present in the testing area during baseline test collection.
Testing Procedures Participants will perform the VJ and YBLQ Screen following a 5-minute-warm up as previously described. The highest jump of three attempts will be recorded for the counter movement VJ. The longest reach of three attempts in the anterior, posteriolateral and posteromedial directions will be recorded following the established YBLQ protocol.
Vertical Jump A Belt Mat (University of Toronto; Toronto, Canada) vertical jump measuring device will be utilized for this study. The participant is positioned on a mat with a belt placed around the waist. The belt has a tape measure running form the belt to the mat. The participant is asked to stand erect to establish 'zero'. The participant then jumps vertically while the belt is around the waist pulling out the remaining tape measure. The vertical jump height is recorded as the displacement of the tape measure. The participant will propel vertically as high as possible. A preparatory stutter step will not be used; however, a counter movement may be used. A countermovement is where the participant quickly flexes the knees and hips while moving the thorax forward and downward while swinging the arms back. Three jump attempts will be given to each participant where a measurement will take place after each attempt. Measurements will be recorded to the nearest half inch and then converted to centimeters. The highest measurement will be used for analysis.
Y Balance Lower Quarter Screen Testing procedures for the YBLQ (Y Balance Test Kit, Move2Perform; Evansville, IN) will follow the protocol previously established by researchers The participant will have viewed a two minute instructional video prior to practicing six reaches in each of the three directions bilaterally: anterior, posteriormedial and posteriorlateral. Following the practice reaches, the participant will stand on the Y Balance center footplate with the right foot behind the start line. With the free foot, the participant will reach in the anterior direction pushing the indicator box as far as possible. Three successful measurements in as many as six attempts in the reach direction will be recorded with the best, successful reach being used for analysis. The participant will then switch stance legs. The indicator box will be reset and the participant will reach with the right foot in the anterior direction. This cycle will continue for the posteromedial and posterolateral directions. Successful reaches are those where the participant maintained contact with stance leg on the center footplate and behind the start line throughout the reach attempt. Successful reaches also will include maintaining contact with the indicator box during the reach attempt, not using the indicator box for support, and returning to start position under control. The participant will rest only as long as it takes the recorder to reset the indicator box and log the reach distance.
Rating of Perceived Lower Extremity Function The participant will be asked to rate current perceived lower extremity function on a 100mm line anywhere between 'my function is at its worst' and 'my function is at its best.' The participant will rate by placing a vertical line that intersects the 100mm horizontal line perpendicularly. A standard metric ruler will be used to measure from the farthest left to the intersecting line. This distance will be recorded.
Conditions
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Functional Performance
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
OTHER
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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Astym
The Astym treatment (AT) is specifically used by medical professionals to treat musculoskeletal dysfunctions by stimulating the body's ability to break down adhesions and reabsorb dysfunctional tissue (scar tissue).6-16,19 The treatment induces collagen building, fibroblastic activity, and phagocytosis.17,18 Part of the treatment includes utilizing a series of instruments glided across the skin tissue, in a non-invasive manner, along the route of the underlying muscle fibers' direction. The treatment specifically spares healthy tissue and stimulates growth factors and cellular mediators that stimulate the repair of dysfunctional tissue in the body's internal mechanisms.17,18 Astym is an FDA approved device. Specifically, Astym is registered as having a device class as 1 and regulation number as 890.5660.
Group Type
EXPERIMENTAL
Astym
Intervention Type
DEVICE
therapeutic massage instrument
Stick
The Stick treatment (ST) utilizes an instrument to convert non-compliant muscle to compliant muscle by compressing the muscle. The individual spindles of The Stick create a stripping massage by applying progressively deeper strokes over the soft tissue.38 The Stick permits individuals to perform trigger point release on own person, allowing the muscle to become compliant to the wanted movement.
Group Type
EXPERIMENTAL
Stick
Intervention Type
DEVICE
massage instrument
Massage
Similar to the protocol previously outlined for the other two independent variables, the massage treatment (MT) will progress from anterior, to medial, to lateral and posterior shank, thigh, and hip. The treatment on each muscle tissue will follow the similar protocol as the Astym treatment (AT) group. However, the flat, non-treatment edge of the Evaluator®, Localizer®, and Isolator® will be put in contact with the muscle tissues in a direction parallel to the muscle fibers being treated, but without over pressure.7 The traditional treatment edge of the instrument has a tapered, machine edge and creates shear forces when glided across the tissue at an angle between 60 and 80 degrees.
Group Type
PLACEBO_COMPARATOR
Massage
Intervention Type
DEVICE
massage instruments
Interventions
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Astym
therapeutic massage instrument
Intervention Type
DEVICE
Stick
massage instrument
Intervention Type
DEVICE
Massage
massage instruments
Intervention Type
DEVICE
Other Intervention Names
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The Stick
Eligibility Criteria
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Inclusion Criteria
* male and female athletes
* individuals aged between 18 and 25 years
* compete in basketball or volleyball sponsored by the NAIA Division II governing body during the 2015 - 2016 or 2016 - 2017 athletic seasons
* sport eligible.
* individuals aged between 18 and 25 years
* compete in basketball or volleyball sponsored by the NAIA Division II governing body during the 2015 - 2016 or 2016 - 2017 athletic seasons
* sport eligible.
Exclusion Criteria
* Astym treatment (AT) in last 3 weeks
* The Stick treatment (ST) in the last 3 weeks
* Massage treatment (MT) in thelast 3 weeks
* Participants using other means of instrument assisted cutaneous tissue preparation techniques such as 'scraping' household items or stainless steel objects along the lower kinetic chain tissue.
* Currently injured or ill
* Injured in the last month before the participation date
* Not full healed from a previous injury or illness
* Participants who currently have athletic participation restrictions of any kind - Those who have known clotting dysfunctions
* Those on anticoagulation therapies
* Those with neurogenic dysfunctions
* Those who may be pregnant
* Those allergic to cocoa butter.
* The Stick treatment (ST) in the last 3 weeks
* Massage treatment (MT) in thelast 3 weeks
* Participants using other means of instrument assisted cutaneous tissue preparation techniques such as 'scraping' household items or stainless steel objects along the lower kinetic chain tissue.
* Currently injured or ill
* Injured in the last month before the participation date
* Not full healed from a previous injury or illness
* Participants who currently have athletic participation restrictions of any kind - Those who have known clotting dysfunctions
* Those on anticoagulation therapies
* Those with neurogenic dysfunctions
* Those who may be pregnant
* Those allergic to cocoa butter.
Minimum Eligible Age
18 Years
Maximum Eligible Age
25 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Performance Dynamics
UNKNOWN
Sponsor Role
collaborator
Indiana Athletic Trainers' Association
UNKNOWN
Sponsor Role
collaborator
Rocky Mountain University of Health Professions
OTHER
Sponsor Role
lead
Responsible Party
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Andrew Doyle
Associate Professor at Indiana Wesleyan University
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Andrew T Doyle, MA
Role: PRINCIPAL_INVESTIGATOR
Rocky Mountain University of Health Professions/Indiana Wesleyan University
Locations
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University of Saint Francis
Fort Wayne, Indiana, United States
Site Status
Huntington University
Huntington, Indiana, United States
Site Status
Indiana Wesleyan University
Marion, Indiana, United States
Site Status
Countries
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United States
References
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Shaffer SW, Teyhen DS, Lorenson CL, Warren RL, Koreerat CM, Straseske CA, Childs JD. Y-balance test: a reliability study involving multiple raters. Mil Med. 2013 Nov;178(11):1264-70. doi: 10.7205/MILMED-D-13-00222.
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Reference Type
BACKGROUND
Sevier TL. What is IASTM? Is it different than Astym? www.astym.com/Main [Website]. 2013; http://blog.astym.com/blog/astym-3/what-is-iastm-is-it-different-than-astym. Accessed March 1st, 2013.
Reference Type
BACKGROUND
Sevier TL. Astym and Soft Tissue Mobilization are Very Different. www.astym.com/Main [Website]. 2011; http://astym.com/blog/2011/06/27/astym-and-soft-tissue-mobilization-are-very-different.html#more-500006. Accessed September 26th, 2015.
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BACKGROUND
Sevier TL. Astym vs. IASTM: How Are They Different www.astym.com/Main 2010; http://astym.com/blog/2010/09/23/astym-vs-iastm-graston-sastm-etc-how-they-are-different.html#more-500117. Accessed September 26th, 2015.
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Davies CC, Brockopp D, Moe K. Astym therapy improves function and range of motion following mastectomy. Breast Cancer (Dove Med Press). 2016 Mar 8;8:39-45. doi: 10.2147/BCTT.S102598. eCollection 2016.
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What is The Stick? [Website]. 2014; http://thestick.com/info/about/. Accessed March 29, 2014
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Reference Type
BACKGROUND
Other Identifiers
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160231-03
Identifier Type: -
Identifier Source: org_study_id
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