The Effect of Astym Treatment on Muscle Performance

Not Applicable

Completed

• Conditions: Musculoskeletal Pathology to the Lower Extremity
• Interventions: Other: Astym treatment

• Registration Number: NCT02349230
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2014-10
• Study Completion: 2014-12
• Status Verified: 2015-01
• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-01-23
• Last Update Submitted: 2015-01-23
• Study First Posted: 2015-01-28
• Last Update Posted: 2015-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Astym	Astym treatment	A sham Astym treatment applied with non-therapeutic pressure and
Astym treatment	Astym treatment	Astym treatment is a manual therapy intervention applied by certified therapists with specialized instruments

Primary Outcome Measures

Name	Time	Method
Percent Change in Maximal Force Output	Immediately following treatment intervention