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Eccentric Exercise Versus Eccentric Exercise and Astym for Insertional Achilles Tendinopathy

Primary Purpose

Insertional Achilles Tendinopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eccentric Exercise
Astym
Sponsored by
Indiana University Health Ball Memorial Hospital Rehabiliation Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insertional Achilles Tendinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IU Health BMH Rehab at CIO

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Eccentric Exericse

Astym

Arm Description

Outcomes

Primary Outcome Measures

Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)

Secondary Outcome Measures

Numeric Pain Rating Scale (NPRS)
Average of Best, Worst, and Current pain from 0-10
Global Rating of Change Score (GROC)

Full Information

First Posted
November 8, 2013
Last Updated
February 22, 2016
Sponsor
Indiana University Health Ball Memorial Hospital Rehabiliation Services
Collaborators
Performance Dynamics Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01988155
Brief Title
Eccentric Exercise Versus Eccentric Exercise and Astym for Insertional Achilles Tendinopathy
Official Title
Eccentric Exercise Versus Eccentric Exercise and Astym® in the Management of Insertional Achilles Tendinopathy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University Health Ball Memorial Hospital Rehabiliation Services
Collaborators
Performance Dynamics Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insertional Achilles Tendinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eccentric Exericse
Arm Type
Active Comparator
Arm Title
Astym
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Eccentric Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Astym
Intervention Description
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.
Primary Outcome Measure Information:
Title
Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
Average of Best, Worst, and Current pain from 0-10
Time Frame
12 weeks
Title
Global Rating of Change Score (GROC)
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Percent Recovered
Description
The percentage of subjects in each group that reach 90 or higher on the VISA-A by 12 weeks.
Time Frame
12 weeks
Title
Percent Improved
Description
The percentage of subjects in each group that improve by the MCID (12 points) or more on the VISA-A at 12 weeks.
Time Frame
12 weeks
Title
Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)
Time Frame
4 weeks
Title
Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)
Time Frame
8 weeks
Title
Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)
Time Frame
26 weeks
Title
Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)
Time Frame
52 weeks
Title
Numeric Pain Rating Scale (NPRS)
Description
Average of Best, Worst, and Current pain from 0-10
Time Frame
4 weeks
Title
Numeric Pain Rating Scale (NPRS)
Description
Average of Best, Worst, and Current pain from 0-10
Time Frame
26 weeks
Title
Numeric Pain Rating Scale (NPRS)
Description
Average of Best, Worst, and Current pain from 0-10
Time Frame
52 weeks
Title
Numeric Pain Rating Scale (NPRS)
Description
Average of Best, Worst, and Current pain from 0-10
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
IU Health BMH Rehab at CIO
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47304
Country
United States

12. IPD Sharing Statement

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Eccentric Exercise Versus Eccentric Exercise and Astym for Insertional Achilles Tendinopathy

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