Eccentric Exercise Versus Eccentric Exercise and Astym for Insertional Achilles Tendinopathy

Insertional Achilles Tendinopathy Clinical Trial

Official title:

Eccentric Exercise Versus Eccentric Exercise and Astym® in the Management of Insertional Achilles Tendinopathy: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988155
• Other study ID #: 13-928
• Status: Completed
• Phase: N/A
• First received: November 8, 2013
• Last updated: February 22, 2016
• Start date: December 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Indiana University Health Ball Memorial Hospital Rehabiliation Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insertional Achilles Tendinopathy
• Tendinopathy

Intervention

Other:
• Eccentric Exercise
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.
• 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.

Locations

Country	Name	City	State
United States	IU Health BMH Rehab at CIO	Muncie	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University Health Ball Memorial Hospital Rehabiliation Services	Performance Dynamics Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent Recovered	The percentage of subjects in each group that reach 90 or higher on the VISA-A by 12 weeks.	12 weeks	No
Other	Percent Improved	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	No
Other	Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)		4 weeks	No
Other	Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)		8 weeks	No
Other	Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)		26 weeks	No
Other	Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)		52 weeks	No
Other	Numeric Pain Rating Scale (NPRS)	Average of Best, Worst, and Current pain from 0-10	4 weeks	No
Other	Numeric Pain Rating Scale (NPRS)	Average of Best, Worst, and Current pain from 0-10	26 weeks	No
Other	Numeric Pain Rating Scale (NPRS)	Average of Best, Worst, and Current pain from 0-10	52 weeks	No
Other	Numeric Pain Rating Scale (NPRS)	Average of Best, Worst, and Current pain from 0-10	8 weeks	No
Primary	Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)		12 weeks	No
Secondary	Numeric Pain Rating Scale (NPRS)	Average of Best, Worst, and Current pain from 0-10	12 weeks	No
Secondary	Global Rating of Change Score (GROC)		12 weeks	No