Clinical trial NCT01988155: 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
Overall status: COMPLETED
Phase: NA
Conditions: Insertional Achilles Tendinopathy
Lead sponsor: Indiana University Health Ball Memorial Hospital Rehabiliation Services
Sponsor class: OTHER
Collaborators: name: Performance Dynamics Inc
First posted: 2013-11-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)
timeFrame: 12 weeks
Secondary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 12 weeks
measure: Global Rating of Change Score (GROC)
timeFrame: 12 weeks
Other outcomes:
measure: Percent Recovered
timeFrame: 12 weeks
measure: Percent Improved
timeFrame: 12 weeks
measure: Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)
timeFrame: 4 weeks
measure: Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)
timeFrame: 8 weeks
measure: Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)
timeFrame: 26 weeks
measure: Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)
timeFrame: 52 weeks
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 4 weeks
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 26 weeks
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 52 weeks
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 8 weeks
Locations:
city: Muncie
country: United States
facility: IU Health BMH Rehab at CIO
state: Indiana
Study officials:
References: