Eccentric Exercise Versus Eccentric Exercise and Astym for Insertional Achilles Tendinopathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Indiana University Health Ball Memorial Hospital Rehabiliation Services
Sponsor:
Collaborator:
Performance Dynamics Inc
Information provided by (Responsible Party):
Joshua McCormack, Indiana University Health Ball Memorial Hospital Rehabiliation Services
ClinicalTrials.gov Identifier:
NCT01988155
First received: November 8, 2013
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Insertional Achilles Tendinopathy
Other: Eccentric Exercise
Other: Astym

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Eccentric Exercise Versus Eccentric Exercise and Astym® in the Management of Insertional Achilles Tendinopathy: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Indiana University Health Ball Memorial Hospital Rehabiliation Services:

Primary Outcome Measures:
  • Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Numeric Pain Rating Scale (NPRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Average of Best, Worst, and Current pain from 0-10

  • Global Rating of Change Score (GROC) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Percent Recovered [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The percentage of subjects in each group that reach 90 or higher on the VISA-A by 12 weeks.

  • Percent Improved [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The percentage of subjects in each group that improve by the MCID (12 points) or more on the VISA-A at 12 weeks.

  • Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Numeric Pain Rating Scale (NPRS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Average of Best, Worst, and Current pain from 0-10

  • Numeric Pain Rating Scale (NPRS) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Average of Best, Worst, and Current pain from 0-10

  • Numeric Pain Rating Scale (NPRS) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Average of Best, Worst, and Current pain from 0-10

  • Numeric Pain Rating Scale (NPRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Average of Best, Worst, and Current pain from 0-10


Estimated Enrollment: 20
Study Start Date: December 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Eccentric Exericse 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.
Experimental: Astym Other: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988155

Contacts
Contact: Joshua R McCormack, PT, OCS, PhD (c) 765-213-3870 jmccormack@iuhealth.org

Locations
United States, Indiana
IU Health BMH Rehab at CIO Recruiting
Muncie, Indiana, United States, 47304
Sponsors and Collaborators
Indiana University Health Ball Memorial Hospital Rehabiliation Services
Performance Dynamics Inc
  More Information

No publications provided

Responsible Party: Joshua McCormack, Physical Therapist, Indiana University Health Ball Memorial Hospital Rehabiliation Services
ClinicalTrials.gov Identifier: NCT01988155     History of Changes
Other Study ID Numbers: 13-928
Study First Received: November 8, 2013
Last Updated: August 11, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on August 26, 2014