NCT03080220

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
Last Updated

March 20, 2017

Status Verified

March 1, 2017

Enrollment Period

29 days

First QC Date

March 11, 2017

Last Update Submit

March 16, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Vertical Jump

    A Belt Mat (University of Toronto; Toronto, Canada) vertical jump measuring device will be utilized for this study.28

    1 day

  • Dynamic Balance

    A Y Balance test kit will be used to measure the distance reached while the participant stabilizes on one leg.

    1 day

Secondary Outcomes (1)

  • Rating of Perceived Lower Extremity Function

    1 day

Study Arms (3)

Astym

EXPERIMENTAL

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

Stick

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Interventions

AstymDEVICE

therapeutic massage instrument

Astym
StickDEVICE

massage instrument

Also known as: The Stick
Stick
MassageDEVICE

massage instruments

Massage

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Saint Francis

Fort Wayne, Indiana, 46808, United States

Location

Huntington University

Huntington, Indiana, 46750, United States

Location

Indiana Wesleyan University

Marion, Indiana, 46953, United States

Location

Related Publications (39)

  • Mikesky AE, Bahamonde RE, Stanton K, Alvey T, Fitton T. Acute effects of The Stick on strength, power, and flexibility. J Strength Cond Res. 2002 Aug;16(3):446-50.

    PMID: 12173961BACKGROUND
  • Healey KC, Hatfield DL, Blanpied P, Dorfman LR, Riebe D. The effects of myofascial release with foam rolling on performance. J Strength Cond Res. 2014 Jan;28(1):61-8. doi: 10.1519/JSC.0b013e3182956569.

    PMID: 23588488BACKGROUND
  • Fletcher IM. The effects of precompetition massage on the kinematic parameters of 20-m sprint performance. J Strength Cond Res. 2010 May;24(5):1179-83. doi: 10.1519/JSC.0b013e3181ceec0f.

    PMID: 20386129BACKGROUND
  • Goodwin JE, Glaister M, Howatson G, Lockey RA, McInnes G. Effect of pre-performance lower-limb massage on thirty-meter sprint running. J Strength Cond Res. 2007 Nov;21(4):1028-31. doi: 10.1519/R-20275.1.

    PMID: 18076229BACKGROUND
  • Arroyo-Morales M, Fernandez-Lao C, Ariza-Garcia A, Toro-Velasco C, Winters M, Diaz-Rodriguez L, Cantarero-Villanueva I, Huijbregts P, Fernandez-De-las-Penas C. Psychophysiological effects of preperformance massage before isokinetic exercise. J Strength Cond Res. 2011 Feb;25(2):481-8. doi: 10.1519/JSC.0b013e3181e83a47.

    PMID: 21240029BACKGROUND
  • Sevier TL, Stegink-Jansen CW. Astym treatment vs. eccentric exercise for lateral elbow tendinopathy: a randomized controlled clinical trial. PeerJ. 2015 May 19;3:e967. doi: 10.7717/peerj.967. eCollection 2015.

    PMID: 26038722BACKGROUND
  • Kivlan BR, Carcia CR, Clemente FR, Phelps AL, Martin RL. The effect of Astym(R) Therapy on muscle strength: a blinded, randomized, clinically controlled trial. BMC Musculoskelet Disord. 2015 Oct 29;16:325. doi: 10.1186/s12891-015-0778-9.

    PMID: 26510526BACKGROUND
  • Chughtai M, Mont MA, Cherian C, Cherian JJ, Elmallah RD, Naziri Q, Harwin SF, Bhave A. A Novel, Nonoperative Treatment Demonstrates Success for Stiff Total Knee Arthroplasty after Failure of Conventional Therapy. J Knee Surg. 2016 Apr;29(3):188-93. doi: 10.1055/s-0035-1569482. Epub 2015 Dec 29.

    PMID: 26713596BACKGROUND
  • Slaven EJ, Mathers J. Management of chronic ankle pain using joint mobilization and ASTYM(R) treatment: a case report. J Man Manip Ther. 2011 May;19(2):108-12. doi: 10.1179/2042618611Y.0000000004.

    PMID: 22547921BACKGROUND
  • McCormack JR. The management of bilateral high hamstring tendinopathy with ASTYM(R) treatment and eccentric exercise: a case report. J Man Manip Ther. 2012 Aug;20(3):142-6. doi: 10.1179/2042618612Y.0000000003.

    PMID: 23904753BACKGROUND
  • McCormack JR. The management of mid-portion achilles tendinopathy with astym(R) and eccentric exercise: a case report. Int J Sports Phys Ther. 2012 Dec;7(6):672-7.

    PMID: 23316430BACKGROUND
  • Henry P, Panwitz B, Wilson J. Rehabilitation of a Post-surgical Patella Fracture. Physiother. March 2000;86(3):139-142.

    BACKGROUND
  • 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.

    BACKGROUND
  • Haller KH, Helfst RH, Jr., Wilson JK, Sevier TL. Treatment of chronic elbow pain. Phys Ther Case Rep. 1999;2(5):195-200.

    BACKGROUND
  • Melham TJ, Sevier TL, Malnofski MJ, Wilson JK, Helfst RH Jr. Chronic ankle pain and fibrosis successfully treated with a new noninvasive augmented soft tissue mobilization technique (ASTM): a case report. Med Sci Sports Exerc. 1998 Jun;30(6):801-4. doi: 10.1097/00005768-199806000-00004.

    PMID: 9624634BACKGROUND
  • Baker D, Wilson JK. Bilateral carpal tunnel syndrome in a piano teacher. Phys Ther Case Rep. 1999;2(2):73-76.

    BACKGROUND
  • Davidson CJ, Ganion LR, Gehlsen GM, Verhoestra B, Roepke JE, Sevier TL. Rat tendon morphologic and functional changes resulting from soft tissue mobilization. Med Sci Sports Exerc. 1997 Mar;29(3):313-9. doi: 10.1097/00005768-199703000-00005.

    PMID: 9139169BACKGROUND
  • Gehlsen GM, Ganion LR, Helfst R. Fibroblast responses to variation in soft tissue mobilization pressure. Med Sci Sports Exerc. 1999 Apr;31(4):531-5. doi: 10.1097/00005768-199904000-00006.

    PMID: 10211847BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • Cook G. Athletic body in balance. Champaign, IL: Human Kinetics; 2003.

    BACKGROUND
  • Lockie RG, Schultz AB, Callaghan SJ, Jeffriess MD. The Relationship Between Dynamic Stability and Multidirectional Speed. J Strength Cond Res. 2016 Nov;30(11):3033-3043. doi: 10.1519/JSC.0b013e3182a744b6.

    PMID: 23942170BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • Heyward VH, Gibson AL. Designing Cardiorespiratory Exercise Programs. Advanced Fitness Assessment and Exercise Prescription. Champaign, IL: Human Kinetics; 2014:131, 393-396.

    BACKGROUND
  • Heyward VH, Gibson AL. Assessing Cardiorespiratory Fitness. Advanced Fitness Assessment and Exercise Prescription. Champaign, IL: Human Kinetics; 2014:83-86.

    BACKGROUND
  • 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.

    PMID: 24183777BACKGROUND
  • Buckthorpe M, Morris J, Folland JP. Validity of vertical jump measurement devices. J Sports Sci. 2012;30(1):63-9. doi: 10.1080/02640414.2011.624539. Epub 2011 Nov 23.

    PMID: 22111944BACKGROUND
  • Plisky PJ, Gorman PP, Butler RJ, Kiesel KB, Underwood FB, Elkins B. The reliability of an instrumented device for measuring components of the star excursion balance test. N Am J Sports Phys Ther. 2009 May;4(2):92-9.

    PMID: 21509114BACKGROUND
  • 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.

    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.

    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.

    BACKGROUND
  • 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.

    BACKGROUND
  • Potach D, Grindstaff T. Rehabilitation and Reconditioning. Essentials of Strength Training and Conditioning. 3rd ed: Human Kinetics; 2008.

    BACKGROUND
  • Steindler A. Kinesiology of the Human Body Under Normal and Pathological Conditions. Springfield; IL: C.C. Thomas; 1955.

    BACKGROUND
  • Prentice WE. Rehabilitation techniques in sports medicine and athletic training. 4th ed. Boston, MA: McGraw-Hill; 2004.

    BACKGROUND
  • 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.

    PMID: 27022302BACKGROUND
  • What is The Stick? [Website]. 2014; http://thestick.com/info/about/. Accessed March 29, 2014

    BACKGROUND
  • The Stick Instructions. [The Stick Web Site]. http://www.thestick.co.nz/how-to-use.html. Accessed July 7, 2012.

    BACKGROUND

MeSH Terms

Interventions

CanesMassage

Intervention Hierarchy (Ancestors)

Orthopedic EquipmentSurgical EquipmentEquipment and SuppliesTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Andrew T Doyle, MA

    Rocky Mountain University of Health Professions/Indiana Wesleyan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor at Indiana Wesleyan University

Study Record Dates

First Submitted

March 11, 2017

First Posted

March 15, 2017

Study Start

September 1, 2016

Primary Completion

September 30, 2016

Study Completion

September 30, 2016

Last Updated

March 20, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data at this point.

Locations