The Effect of Astym Treatment on Muscle Performance (Astym)

The Effect of Astym Treatment on Acute Changes in 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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pathology to the Lower Extremity
• Intervention / Treatment: Other: Astym treatment

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change in Maximal Force Output	Immediately following treatment intervention

Collaborators and Investigators

• Sponsor: Duquesne University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 19, 2015
• First Submitted That Met QC Criteria: January 23, 2015
• First Posted (Estimate): January 28, 2015

Study Record Updates

• Last Update Posted (Estimate): January 28, 2015
• Last Update Submitted That Met QC Criteria: January 23, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 10Astym