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The Effect of Astym Treatment on Muscle Performance (Astym)

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ClinicalTrials.gov Identifier: NCT02349230
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : January 28, 2015
Sponsor:
Information provided by (Responsible Party):
Benjamin Kivlan, Duquesne University

Brief Summary:
Subjects were randomized into 3 treatment groups (15 subjects per group): 1) Control - received no treatment 2) Placebo - received a sham Astym® treatment 3) Astym® Treatment - received Astym® treatment to the lower extremity. Subjects were blinded to whether they received the Astym® treatment or placebo treatment intervention. After a 5-minute warm-up on a lower body ergometer the subjects were familiarized to the operations of a computerized leg press machine that measured the maximum force output (Newtons) during a unilateral isometric squat test. A baseline measure of maximal force output (pre-test) was determined by the average of 3 trials with a 30 second rest period between the trials. The subjects then received the designated treatment intervention. Immediately following the treatment intervention (0 minutes following treatment intervention) the subjects were retested (post-test) using identical testing procedures by an investigator blinded to the treatment intervention received by the subject. Maximum force output measured in Newtons for the post-test was subtracted from the maximum force output (Newtons) pre-test and then converted to a percentage of change [(post-test - pretest)/pretest X 100). The percent change of maximal force output from pre-test to post-test measures was compared using a one-way analysis of variance with alpha set at 0.05. A Tukey's post-hoc analysis determined statistical differences between the groups.

Condition or disease Intervention/treatment Phase
Musculoskeletal Pathology to the Lower Extremity Other: Astym treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Astym Treatment on Acute Changes in Muscle Performance
Study Start Date : June 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Astym treatment
Astym treatment is a manual therapy intervention applied by certified therapists with specialized instruments
Other: Astym treatment
Astym is a manual therapy technique applied by a certified therapist with advanced training in the technique. The technique is applied to a limb or body segment with specialized instruments in a specific sequential protocol that incorporates the muscle groups and joints of the entire kinetic chain.

Sham Comparator: Sham Astym
A sham Astym treatment applied with non-therapeutic pressure and
Other: Astym treatment
Astym is a manual therapy technique applied by a certified therapist with advanced training in the technique. The technique is applied to a limb or body segment with specialized instruments in a specific sequential protocol that incorporates the muscle groups and joints of the entire kinetic chain.

No Intervention: Control
12 minutes of rest



Primary Outcome Measures :
  1. Percent Change in Maximal Force Output [ Time Frame: Immediately following treatment intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Referral for physical therapy services to the student investigator for a musculoskeletal injury to the lower extremity.
  2. Subjects must be aged between 18-65 years-old
  3. Present with a 10% or greater deficit in maximum force output on computerized leg press machine when compared to the uninvolved side
  4. Able to read and understand English language.
  5. Read, comprehend, and sign informed consent procedures.

Exclusion Criteria:

  1. Subjects who are pregnant
  2. Subjects with a medical history of hemophilia or other clotting disorders of the blood
  3. Subjects currently taking blood thinners (e.g. lovenox, Coumadin)
  4. Subjects with neuropathy of the lower extremity
  5. Subjects with a history of metastatic disease
  6. Subjects with uncontrolled hypertension
  7. Subjects that are unable to perform the strength test due to the nature of injury
  8. Subjects with a recent history (within the past 4 weeks) of lower extremity surgery.
  9. Subjects with compromised skin integrity. (e.g. open wounds, diabetic ulcers, lacerations, abrasions)
  10. Subjects with any sign of infection including skin infections to the lower limbs.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Benjamin Kivlan, Instructor, Duquesne University
ClinicalTrials.gov Identifier: NCT02349230    
Other Study ID Numbers: 10Astym
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: January 28, 2015
Last Verified: January 2015