Musculoskeletal Pathology to the Lower ExtremityAstymNCT02349230
The Effect of Astym Treatment on Muscle Performance
A study testing Astym treatment in people with Musculoskeletal Pathology to the Lower Extremity, run by Duquesne University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Musculoskeletal Pathology to the Lower Extremity
- What is being tested?
- Astym treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
About this study
Official title: 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.
- Being tested
- Astym treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astym treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Astym treatment | Experimental | Astym treatment is a manual therapy intervention applied by certified therapists with specialized instruments Receives: Other: Astym treatment |
| Sham Astym | Sham comparator | A sham Astym treatment applied with non-therapeutic pressure and Receives: Other: Astym treatment |
| Control | No intervention | 12 minutes of rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Maximal Force Output
Measured: Immediately following treatment intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startJun 2014
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal Pathology to the Lower ExtremityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duquesne University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Kivlan, Duquesne University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349230
- Sponsor's protocol ID
- 10Astym
- Acronym
- Astym
- Status last verified
- Jan 2015
- First submitted
- 19 Jan 2015
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26510526
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Astym Treatment on Acute Changes in Muscle Performance
- ClinicalTrials.gov ID
- NCT02349230
- Acronym / sponsor ID
- Astym / 10Astym
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Duquesne UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Astym treatment | Experimental | Other: Astym treatmentAstym treatment is a manual therapy intervention applied by certified therapists with specialized instruments |
| Sham Astym | Sham comparator | Other: Astym treatmentA sham Astym treatment applied with non-therapeutic pressure and |
| Control | No intervention | –12 minutes of rest |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Astym treatmentAstym 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. | Other | Astym treatment, Sham Astym |
Primary outcome
Percent Change in Maximal Force Output
Time frame: Immediately following treatment intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
- Derived from this study: PubMed 26510526Kivlan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Astym treatment in people with Musculoskeletal Pathology to the Lower Extremity, run by Duquesne University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Maximal Force Output (time frame: Immediately following treatment intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02349230, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2015.