Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Examining the Effects of Three Soft Tissue Treatments on Functional Movement and Functional Performance Enhancement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03080220
Recruitment Status : Completed
First Posted : March 15, 2017
Last Update Posted : March 20, 2017
Sponsor:
Collaborators:
Performance Dynamics
Indiana Athletic Trainers' Association
Information provided by (Responsible Party):
Andrew Doyle, Rocky Mountain University of Health Professions

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Functional Performance Device: Astym Device: Stick Device: Massage Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Effects of Pre-Event Soft Tissue Treatment on Functional Movement and Functional Performance
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : September 30, 2016
Actual Study Completion Date : September 30, 2016

Arm Intervention/treatment
Experimental: 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.
Device: Astym
therapeutic massage instrument

Experimental: 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.
Device: Stick
massage instrument
Other Name: The Stick

Placebo Comparator: 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.
Device: Massage
massage instruments




Primary Outcome Measures :
  1. Vertical Jump [ Time Frame: 1 day ]
    A Belt Mat (University of Toronto; Toronto, Canada) vertical jump measuring device will be utilized for this study.28

  2. Dynamic Balance [ Time Frame: 1 day ]
    A Y Balance test kit will be used to measure the distance reached while the participant stabilizes on one leg.


Secondary Outcome Measures :
  1. Rating of Perceived Lower Extremity Function [ Time Frame: 1 day ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080220


Locations
Layout table for location information
United States, Indiana
University of Saint Francis
Fort Wayne, Indiana, United States, 46808
Huntington University
Huntington, Indiana, United States, 46750
Indiana Wesleyan University
Marion, Indiana, United States, 46953
Sponsors and Collaborators
Rocky Mountain University of Health Professions
Performance Dynamics
Indiana Athletic Trainers' Association
Investigators
Layout table for investigator information
Principal Investigator: Andrew T Doyle, MA Rocky Mountain University of Health Professions/Indiana Wesleyan University
Publications:
Henry P, Panwitz B, Wilson J. Rehabilitation of a Post-surgical Patella Fracture. Physiother. March 2000;86(3):139-142.
McCrea EC, George SZ. Outcomes following augmented soft tissue mobilization for patients with knee pain: a case series. Orthop Phys Ther Pract. 2010;22(2):69-74.
Haller KH, Helfst RH, Jr., Wilson JK, Sevier TL. Treatment of chronic elbow pain. Phys Ther Case Rep. 1999;2(5):195-200.
Baker D, Wilson JK. Bilateral carpal tunnel syndrome in a piano teacher. Phys Ther Case Rep. 1999;2(2):73-76.
Davies CC, Brockopp DY. Use of ASTYM® treatment on scar tissue following surgical treatment for breast cancer: a pilot study. Rehabil Oncology. 2010;28(3):3-12
Sevier TL. ASTYM and the NFL. www.astym.com/Main 2011; http://blog.astym.com/blog/astym-3/astym-and-the-nfl. Accessed July 24th, 2012.
Cook G. Athletic body in balance. Champaign, IL: Human Kinetics; 2003.
Health-Related Physical Fitness Testing and Interpretation In: Pescatello L, Riebe D, Thompson P, eds. American College of Sports Medicine's Guidelines for Exercise Testing and Prescription. Philadelphia, PA: Wolters Kluwer; 2014:60-109.
General Principles of Exercise Prescription. In: Riche D, ed. American College of Sports Medicine's Guidelines for Exercise Testing and Prescription. Philadelphia, PA: Wolters Kluwer; 2014:164-166.
Heyward VH, Gibson AL. Designing Cardiorespiratory Exercise Programs. Advanced Fitness Assessment and Exercise Prescription. Champaign, IL: Human Kinetics; 2014:131, 393-396.
Heyward VH, Gibson AL. Assessing Cardiorespiratory Fitness. Advanced Fitness Assessment and Exercise Prescription. Champaign, IL: Human Kinetics; 2014:83-86.
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.
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.
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.
Cook G, Burton L, Kiesel K, Rose G, Bryant MF. Movement Functional Movement Systems: Screening, Assessment, and Corrective Strategies. Aptos, CA: On Target Publications; 2010.
Potach D, Grindstaff T. Rehabilitation and Reconditioning. Essentials of Strength Training and Conditioning. 3rd ed: Human Kinetics; 2008.
Steindler A. Kinesiology of the Human Body Under Normal and Pathological Conditions. Springfield; IL: C.C. Thomas; 1955.
Prentice WE. Rehabilitation techniques in sports medicine and athletic training. 4th ed. Boston, MA: McGraw-Hill; 2004.
What is The Stick? [Website]. 2014; http://thestick.com/info/about/. Accessed March 29, 2014
The Stick Instructions. [The Stick Web Site]. http://www.thestick.co.nz/how-to-use.html. Accessed July 7, 2012.

Layout table for additonal information
Responsible Party: Andrew Doyle, Associate Professor at Indiana Wesleyan University, Rocky Mountain University of Health Professions
ClinicalTrials.gov Identifier: NCT03080220    
Other Study ID Numbers: 160231-03
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data at this point.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No