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Shockwave Therapy of Chronic Achilles Tendinopathy

Primary Purpose

Chronic Inflammatory Disorder

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Shock Wave Therapy
Sponsored by
Northern Orthopaedic Division, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Inflammatory Disorder focused on measuring Chronic Achilles Tendinopathy

Eligibility Criteria

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

Inclusion criteria:

  • Chronic Achilles Tendinopathy

Exclusion criteria:

  • Recent surgery in area

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Active ESWT

    Sham ESWT

    Arm Description

    Outcomes

    Primary Outcome Measures

    The American Orthopaedic Foot and Ankle Score (AOFAS score)
    Effect on pain

    Secondary Outcome Measures

    Full Information

    First Posted
    August 12, 2009
    Last Updated
    May 27, 2015
    Sponsor
    Northern Orthopaedic Division, Denmark
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00958620
    Brief Title
    Shockwave Therapy of Chronic Achilles Tendinopathy
    Official Title
    Shockwave Therapy of Chronic Achilles Tendinopathy. A Double-blind, Randomized Clinical Trial of Efficacy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2004 (undefined)
    Primary Completion Date
    January 2005 (Actual)
    Study Completion Date
    June 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Northern Orthopaedic Division, Denmark

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Chronic Achilles tendinopathy is a painful condition with frequently unsatisfactory results of conservative treatment. Extracorporal Shock Wave Therapy (ESWT) has been introduced in the management of various soft tissue conditions. The objective of the study was to investigate the effect of supplementary ESWT versus placebo to conservative treatment of chronic Achilles tendinopathy.
    Detailed Description
    Chronic Achilles tendinopathy is a common disability of the foot during walking and running. Avoiding of painful activities, correction of malalignment by arch support, stretching exercise and eccentric training combined with non-steroidal anti-inflammatory pain killers are the standard treatment regimen (Wilson 2005). However, evidence to support these modalities is sparse (McLauchlan 2001). Extracorporal shock wave therapy (ESWT) originally used for treatment of renal stones became popular in the last decade for treatment of different soft tissue disorders including calcifying tendinopathy in the rotator cuff, humeral epicondylitis and plantar fasciitis (Haake 2001, Ogden 2001, Chung 2002, Gerdesmeyer 2003, Speed 2004). It is now worldwide employed and FDA-approved for the treatment of plantar fasciitis. However regarding both calcifying tendinopathy in the rotator cuff, humeral epicondylitis and plantar fasciitis the results are conflicting (Rompe 1996, Boddeker 2001, Hammer 2002, Schmitt 2002, Gross 2003, Haake 2003, Pleiner 2004, Chung 2005). A series of randomized studies on ESWT for soft tissue disorders have been reported (Rompe 1997, Krishek 1998, Loew 1999, Rompe 2001, Haake 2001, Hammer 2002, Schmitt 2002, Gerdesmeyer 2003, Gross 2003, Haake 2003, Pleiner 2004, Chung 2005, Costa 2005) only four reporting significant effect of ESWT (Rompe 1997, Krishek 1998, Loew 1999, Gerdesmeyer 2003), and only one randomised studies for chronic achilles tendinopathy (Costa 2005). Two uncontrolled (Perlick 2002, Lakshmanan 2003) and one controlled (Furia 2005) series introduce ESWT for chronic Achilles tendinopathy. The results of these papers are seriously conflicting. Some authors include training and others not. Since eccentric training has documented effect (Alfredson 2000) other conservative treatments should be introduced as a supplement. We investigated in a double blind randomized trial the supplementary effect of ESWT to enhance recovery of Achilles tendinopathy. We investigated, firstly, the effect on AOFAS score and secondly the effect on pain.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Inflammatory Disorder
    Keywords
    Chronic Achilles Tendinopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active ESWT
    Arm Type
    Active Comparator
    Arm Title
    Sham ESWT
    Arm Type
    Sham Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Shock Wave Therapy
    Other Intervention Name(s)
    Extracorporal shock-wave therapy
    Intervention Description
    Extracorporal shock-wave therapy
    Primary Outcome Measure Information:
    Title
    The American Orthopaedic Foot and Ankle Score (AOFAS score)
    Time Frame
    June 2005
    Title
    Effect on pain
    Time Frame
    June 2005

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Chronic Achilles Tendinopathy Exclusion criteria: Recent surgery in area
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sten Rasmussen, MD
    Organizational Affiliation
    Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Shockwave Therapy of Chronic Achilles Tendinopathy

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