- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01988155
Eccentric Exercise Versus Eccentric Exercise and Astym for Insertional Achilles Tendinopathy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
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Muncie, Indiana, United States, 47304
- IU Health BMH Rehab at CIO
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Eccentric Exericse
|
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.
|
Experimental: Astym
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Rating Scale (NPRS)
Time Frame: 12 weeks
|
Average of Best, Worst, and Current pain from 0-10
|
12 weeks
|
Global Rating of Change Score (GROC)
Time Frame: 12 weeks
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Recovered
Time Frame: 12 weeks
|
The percentage of subjects in each group that reach 90 or higher on the VISA-A by 12 weeks.
|
12 weeks
|
Percent Improved
Time Frame: 12 weeks
|
The percentage of subjects in each group that improve by the MCID (12 points) or more on the VISA-A at 12 weeks.
|
12 weeks
|
Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)
Time Frame: 4 weeks
|
4 weeks
|
|
Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)
Time Frame: 8 weeks
|
8 weeks
|
|
Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)
Time Frame: 26 weeks
|
26 weeks
|
|
Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)
Time Frame: 52 weeks
|
52 weeks
|
|
Numeric Pain Rating Scale (NPRS)
Time Frame: 4 weeks
|
Average of Best, Worst, and Current pain from 0-10
|
4 weeks
|
Numeric Pain Rating Scale (NPRS)
Time Frame: 26 weeks
|
Average of Best, Worst, and Current pain from 0-10
|
26 weeks
|
Numeric Pain Rating Scale (NPRS)
Time Frame: 52 weeks
|
Average of Best, Worst, and Current pain from 0-10
|
52 weeks
|
Numeric Pain Rating Scale (NPRS)
Time Frame: 8 weeks
|
Average of Best, Worst, and Current pain from 0-10
|
8 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-928
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Insertional Achilles Tendinopathy
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University of CalgarySport Science Association of Alberta (SSAA)UnknownAchilles Tendinopathy | Achilles Tendon Enthesopathy | Mid-Portion Achilles Tendinopathy | Insertional Achilles Tendinopathy | Non-Insertional Achilles TendinopathyCanada
-
Krankenhaus Barmherzige Schwestern LinzActive, not recruitingAchilles Tendinopathy | Insertional Achilles TendinopathyAustria
-
Guna S.p.aRecruitingTendinopathy | Achilles Tendinopathy | Insertional Achilles Tendinopathy | PeritendinitisItaly
-
University Hospital, GhentActive, not recruitingInsertional Achilles TendinopathyBelgium
-
University of DelawareRecruitingSever's Disease | Achilles Tendinopathy | Insertional Achilles Tendinopathy | Apophysitis; CalcaneusUnited States
-
Assiut UniversityNot yet recruitingInsertional Achilles Tendinopathy
-
Zimmer BiometEmbody Inc.Suspended
-
Mike O'Callaghan Military HospitalCompletedInsertional Achilles TendinopathyUnited States
-
Cairo UniversityCompletedNon Insertional Achilles TendinopathyEgypt
-
Meir Medical CenterUnknownInsertional Achilles Tendinitis
Clinical Trials on Eccentric Exercise
-
University of MalagaUnknownRotator Cuff Tendinopathy
-
Oslo University HospitalUniversity of OsloCompleted
-
Universidad Europea de MadridCompletedAchilles Tendinopathy | Diastasis RectiSpain
-
Queen Margaret UniversityUnknownTendinopathy | Achilles TendonUnited Kingdom
-
Utah State UniversityNot yet recruitingBlood Flow Restriction
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Universidad Europea de MadridCompletedTendinopathy | Achilles TendonSpain
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New York Institute of TechnologyRecruitingHypermobility SyndromeUnited States
-
Centre Hospitalier Universitaire de BesanconUnknownVentilatory Adaptation to Concentric Versus Eccentric Exercise in Patients With Severe COPD (CONvEX)Chronic Obstructive Pulmonary Disease SevereFrance
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University Hospital, Clermont-FerrandUnknown
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Uppsala UniversityThe Swedish Research Council; Uppsala County Council, Sweden; Amersham FoundationCompleted