The Effect of Astym Treatment on Muscle Performance

NCT ID: NCT02349230

Last Updated: 2015-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-12-31

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.

Conditions

Musculoskeletal Pathology to the Lower Extremity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Astym treatment

Astym treatment is a manual therapy intervention applied by certified therapists with specialized instruments

Group Type: EXPERIMENTAL

Astym treatment

Intervention Type: 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.

Sham Astym

A sham Astym treatment applied with non-therapeutic pressure and

Group Type: SHAM_COMPARATOR

Astym treatment

Intervention Type: 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.

Control

12 minutes of rest

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duquesne University

OTHER

Sponsor Role: lead

Responsible Party

Benjamin Kivlan

Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 26510526 (View on PubMed)

Other Identifiers

10Astym

Identifier Type: -

Identifier Source: org_study_id