Achilles Tendon PainNCT01902433
Astym® Compared Eccentric Exercise for Chronic Mid-substance Achilles Tendinopathy
A study testing Astym in people with Achilles Tendon Pain, run by Emily Slaven, PT, PhD at 2 sites in United States.
Trial summary
The purpose of this study is to compare the changes in pain and self-perceived function between two different treatments for Achilles tendinopathy: the Astym® protocol (a form of soft tissue mobilization using instruments) and a specific exercise protocol that involves strengthening the calf and Achilles tendon. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Achilles Tendon Pain
- What is being tested?
- Astym
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2013to Jan 2017
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Pain for 3 months or longer in the mid portion of only one Achilles tendon.
- Must read, speak and understand English
Who cannot join
- Previous surgery to the Achilles tendon that is currently painful
- An injection into the Achilles tendon in the previous 4 weeks
- Have symptoms in both Achilles tendons concurrently
- Have taken fluoroquinolone antibiotics in the past 6 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
IU Health
Indianapolis, Indiana, 46254
Utah Physical Therapy
Lehi, Utah, 84043
About this study
Official title: Astym® Treatment Compared With Eccentric Exercise in the Management of Chronic Mid-substance Achilles Tendinopathy: A Multisite a Randomized Controlled Trial
The purpose of this study is to compare the changes in pain and self-perceived function between two different treatments for Achilles tendinopathy: the Astym® protocol (a form of soft tissue mobilization using instruments) and a specific exercise protocol that involves strengthening the calf and Achilles tendon. Astym® (A-stim) is not an acronym, but rather stands for "A Stimulation" of the body's healing response, describing the physiologic process which occurs with Astym treatment. Astym is the trademark name of a non-invasive treatment where instruments are applied topically to locate unhealthy soft tissue, and to transfer mild to moderate pressure to the underlying soft tissue structures. The aim of Astym treatment is to eliminate scar tissue and stimulate tissue regeneration. Both the principal investigator and co-investigator have been trained and certified in administering the Astym treatment. The specific exercise protocol will involve exercises that strengthen the Achilles and calf through eccentric exercise. Eccentric exercise is a form of exercise where the benefit comes from applying a controlled lengthening stress to the muscle and tendon.
- Conditions
- Achilles Tendon Pain
- Being tested
- Astym
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AstymProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Astym | Experimental | A form of soft tissue mobilization using instruments Receives: Procedure: Astym |
| Eccentric Exercise | Active comparator | Eccentric exercise is a form of exercise where the benefit comes from applying a controlled lengthening stress to the muscle and tendon. Receives: Procedure: Astym |
What is being measured
The primary outcome is the main question the study is designed to answer.
VISA-A
Measured: 1 year
Secondary outcomes (1)
Numeric Pain Rating Scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: We were unable to recruit participants to the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendon PainStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emily Slaven, PT, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Performance Dynamics
- Responsible party
- Sponsor-investigator, Emily Slaven, PT, PhD, University of Indianapolis
- Investigators
- Emily J Slaven, PhD, Principal investigator, University of Indianapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902433
- Sponsor's protocol ID
- ASTYM2013
- Status last verified
- Jan 2017
- First submitted
- 15 Jul 2013
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Only two participants were recruited to the study at the closure of the study
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Astym® Treatment Compared With Eccentric Exercise in the Management of Chronic Mid-substance Achilles Tendinopathy: A Multisite a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01902433
- Acronym / sponsor ID
- ASTYM2013
- Conditions
- Achilles Tendon Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We were unable to recruit participants to the study
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Emily Slaven, PT, PhDUniversity, hospital or other
- Collaborators
- Performance Dynamics
- Study start
- Aug 2013
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 18 Jul 2013 (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.
The purpose of this study is to compare the changes in pain and self-perceived function between two different treatments for Achilles tendinopathy: the Astym® protocol (a form of soft tissue mobilization using instruments) and a specific exercise protocol that involves strengthening the calf and Achilles tendon. Astym® (A-stim) is not an acronym, but rather stands for "A Stimulation" of the body's healing response, describing the physiologic process which occurs with Astym treatment. Astym is the trademark name of a non-invasive treatment where instruments are applied topically to locate unhealthy soft tissue, and to transfer mild to moderate pressure to the underlying soft tissue structures. The aim of Astym treatment is to eliminate scar tissue and stimulate tissue regeneration. Both the principal investigator and co-investigator have been trained and certified in administering the Astym treatment. The specific exercise protocol will involve exercises that strengthen the Achilles and calf through eccentric exercise. Eccentric exercise is a form of exercise where the benefit comes from applying a controlled lengthening stress to the muscle and tendon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Astym | Experimental | Procedure: AstymA form of soft tissue mobilization using instruments |
| Eccentric Exercise | Active comparator | Procedure: AstymEccentric exercise is a form of exercise where the benefit comes from applying a controlled lengthening stress to the muscle and tendon. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pain for 3 months or longer in the mid portion of only one Achilles tendon.
- Must read, speak and understand English
Key exclusion criteria (4 listed)
- Previous surgery to the Achilles tendon that is currently painful
- An injection into the Achilles tendon in the previous 4 weeks
- Have symptoms in both Achilles tendons concurrently
- Have taken fluoroquinolone antibiotics in the past 6 months
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 | Procedure or surgery | Astym, Eccentric Exercise |
Primary outcome
VISA-A
Time frame: 1 year
1 secondary outcome
Numeric Pain Rating Scale
Time frame: 1 year
Results and safety
The study was stopped early (reason given: We were unable to recruit participants to the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Individual participant dataSharing planned: Undecided. Only two participants were recruited to the study at the closure of the study
Related trials for Achilles Tendon Pain
Not yet recruiting
Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy
Achilles Injuries Tendon, Achilles Tendinopathy (AT)
Recruiting
Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.
Tendinopathy, Insertional Achilles Tendinopathy
Not yet recruiting
Achilles Tendinopathy; the Effect of Shockwave Treatment
Achilles Tendinopathy (AT), Achilles Tendon
Recruiting
Popliteal Nerve Block for Acute Achilles Tendon Rupture Repair Surgery
Acute Achilles Tendon Rupture
Recruiting
Immediate Effects of Neuromuscular Electrical Stimulation on Pain and Function in Achilles Tendon Disorders
Achilles Tendinopathy (AT), Achilles Tendon Rupture
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.
Emily J Slaven, PhD principal investigator
University of Indianapolis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Astym in people with Achilles Tendon Pain, run by Emily Slaven, PT, PhD at 2 sites in United States.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was stopped early (reason given: We were unable to recruit participants to the study). Results are not available in the source record.
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?
VISA-A (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2017.