Insertional Achilles TendinopathyNCT01988155
Eccentric Exercise Versus Eccentric Exercise and Astym for Insertional Achilles Tendinopathy
A study testing Eccentric Exercise and Astym in people with Insertional Achilles Tendinopathy, run by Indiana University Health Ball Memorial Hospital Rehabiliation Services at 1 site in United States.
Trial summary
The purpose of this research study is to determine if Astym® treatment is an effective treatment for patients with Achilles pain. The usual treatment for this condition is a specific exercise program that has been previously shown to be effective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insertional Achilles Tendinopathy
- What is being tested?
- Eccentric Exercise and Astym
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of insertional AT as a primary complaint*
- symptom duration of at least 6 weeks
- VISA-A score of 78 or lower
- he presence of insertional AT will be clinically determined by the primary investigator using the following criteria: pain at or within 2 cm of the posterior calcaneal insertion of the Achilles tendon along with localized tenderness and a subjective report of decreased activity levels secondary to Achilles pain.
Who cannot join
- prior treatment with eccentric exercise or Astym for Achilles tendinopathy
- currently taking anticoagulant medication
- usage of fluoroquinolone antibiotics in the previous six months
- previous Achilles surgery on the involved side
- bilateral symptoms
- pregnancy
Show all 10Show fewer
- worker's compensation or liability cases
- peripheral neuropathy
- signs of lumbar radiculopathy
- inability to complete the required outcomes forms or comply with the recommended treatment regimen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eccentric Exercise Versus Eccentric Exercise and Astym® in the Management of Insertional Achilles Tendinopathy: A Randomized Controlled Trial
The purpose of this research study is to determine if Astym® treatment is an effective treatment for patients with Achilles pain. The usual treatment for this condition is a specific exercise program that has been previously shown to be effective. The research team is trying to determine if combining Astym with the exercise program is more effective than exercise program only.
The main hypothesis for this study is that Astym plus eccentric exercise will be more effective than eccentric exercise alone at improving pain and function in patients with insertional Achilles tendinopathy.
- Conditions
- Insertional Achilles Tendinopathy
- Being tested
- Eccentric Exercise, Astym
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric ExerciseOther
Subjects in the eccentric exercise group will be instructed to perform the modified Alfredson eccentric protocol for insertional Achilles tendinopathy. To perform the eccentric exercise, subjects will be instructed to stand upright with one hand on the wall or a chair for support as needed. A heel raise exercise is then performed with the non-painful leg. Once in the elevated position, subjects are instructed to transfer all of their body weight to the painful leg and slowly lower their heel to the floor while keeping their knee extended. The eccentric exercise program will consist of 3 sets of 15 repetitions performed per session. Subjects will perform 2 sessions per day for a total of 12 weeks and a log will be kept to monitor compliance. In order to partially control for the effect of regular contact with a therapist, subjects in the control group will be contacted by telephone one time per week to discuss their progress with the program and address any questions they may have.
AstymOther
In addition to performing the same eccentric protocol as the eccentric exercise group, subjects in the Astym group will also be seen in the clinic two times per week. Astym treatment will be performed per the foot, ankle, and knee protocol as described in the Astym clinical manual. During the first visit each week, the eccentric exercise protocol will be orally reviewed to match the one time per week phone education received by the eccentric only group. Astym treatment will continue for up to six weeks but may be discontinued early if a subject scores 90 or above on the VISA-A. Subjects in the Astym group will be required to continue with the eccentric exercise protocol for the full 12 weeks even in Astym is discontinued early.
| Study group | Role | What they receive |
|---|---|---|
| Eccentric Exericse | Active comparator | Not described Receives: Other: Eccentric Exercise |
| Astym | Experimental | Not described Receives: Other: Astym |
What is being measured
The primary outcome is the main question the study is designed to answer.
Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)
Measured: 12 weeks
Secondary outcomes (2)
Numeric Pain Rating Scale (NPRS)
Average of Best, Worst, and Current pain from 0-10
Measured: 12 weeks
Global Rating of Change Score (GROC)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insertional Achilles TendinopathyStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University Health Ball Memorial Hospital Rehabiliation Services
- Sponsor type
- University, hospital or other
- Collaborators
- Performance Dynamics Inc
- Responsible party
- Principal investigator, Joshua McCormack, Indiana University Health Ball Memorial Hospital Rehabiliation Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988155
- Sponsor's protocol ID
- 13-928
- Status last verified
- Feb 2016
- First submitted
- 8 Nov 2013
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eccentric Exercise Versus Eccentric Exercise and Astym® in the Management of Insertional Achilles Tendinopathy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01988155
- Acronym / sponsor ID
- 13-928
- Conditions
- Insertional Achilles Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Indiana University Health Ball Memorial Hospital Rehabiliation ServicesUniversity, hospital or other
- Collaborators
- Performance Dynamics Inc
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Nov 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 research study is to determine if Astym® treatment is an effective treatment for patients with Achilles pain. The usual treatment for this condition is a specific exercise program that has been previously shown to be effective. The research team is trying to determine if combining Astym with the exercise program is more effective than exercise program only.
The main hypothesis for this study is that Astym plus eccentric exercise will be more effective than eccentric exercise alone at improving pain and function in patients with insertional Achilles tendinopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eccentric Exericse | Active comparator | Other: Eccentric Exercise |
| Astym | Experimental | Other: Astym |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of insertional AT as a primary complaint*
- symptom duration of at least 6 weeks
- VISA-A score of 78 or lower
Key exclusion criteria (10 listed)
- prior treatment with eccentric exercise or Astym for Achilles tendinopathy
- currently taking anticoagulant medication
- usage of fluoroquinolone antibiotics in the previous six months
- previous Achilles surgery on the involved side
- bilateral symptoms
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 |
|---|---|---|
| Eccentric ExerciseSubjects in the eccentric exercise group will be instructed to perform the modified Alfredson eccentric protocol for insertional Achilles tendinopathy. To perform the eccentric exercise, subjects will be instructed to stand upright with one hand on the wall or a chair for support as needed. A heel raise exercise is then performed with the non-painful leg. Once in the elevated position, subjects are instructed to transfer all of their body weight to the painful leg and slowly lower their heel to the floor while keeping their knee extended. The eccentric exercise program will consist of 3 sets of 15 repetitions performed per session. Subjects will perform 2 sessions per day for a total of 12 weeks and a log will be kept to monitor compliance. In order to partially control for the effect of regular contact with a therapist, subjects in the control group will be contacted by telephone one time per week to discuss their progress with the program and address any questions they may have. | Other | Eccentric Exericse |
| AstymIn addition to performing the same eccentric protocol as the eccentric exercise group, subjects in the Astym group will also be seen in the clinic two times per week. Astym treatment will be performed per the foot, ankle, and knee protocol as described in the Astym clinical manual. During the first visit each week, the eccentric exercise protocol will be orally reviewed to match the one time per week phone education received by the eccentric only group. Astym treatment will continue for up to six weeks but may be discontinued early if a subject scores 90 or above on the VISA-A. Subjects in the Astym group will be required to continue with the eccentric exercise protocol for the full 12 weeks even in Astym is discontinued early. | Other | Astym |
Primary outcome
Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)
Time frame: 12 weeks
2 secondary outcomes
Numeric Pain Rating Scale (NPRS)
Time frame: 12 weeks
Global Rating of Change Score (GROC)
Time frame: 12 weeks
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 23 Feb 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric Exercise and Astym in people with Insertional Achilles Tendinopathy, run by Indiana University Health Ball Memorial Hospital Rehabiliation Services at 1 site 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 4 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 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A) (time frame: 12 weeks). 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 23 Feb 2016.