Completed

NCT Number: NCT02349230

The Effect of Astym Treatment on Muscle Performance

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.

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Key information

Conditions

Musculoskeletal Pathology to the Lower Extremity

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Subjects who are pregnant
Subjects with a medical history of hemophilia or other clotting disorders of the blood
Subjects currently taking blood thinners (e.g. lovenox, Coumadin)
Subjects with neuropathy of the lower extremity
Subjects with a history of metastatic disease
Subjects with uncontrolled hypertension
Subjects that are unable to perform the strength test due to the nature of injury
Subjects with a recent history (within the past 4 weeks) of lower extremity surgery.
Subjects with compromised skin integrity. (e.g. open wounds, diabetic ulcers, lacerations, abrasions)
Subjects with any sign of infection including skin infections to the lower limbs.

Treatment and study plan

Astym treatment

Other

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.

Primary outcomes

Percent Change in Maximal Force Output

Time frame: Immediately following treatment intervention

Sponsors and collaborators

Lead sponsor

Duquesne University

Other

Registry information

Official study title

The Effect of Astym Treatment on Acute Changes in Muscle Performance

Acronym: Astym

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Jan 28, 2015
Registry last updated: Jan 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.