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
About this trial
This is an interventional treatment trial for Chronic Inflammatory Disorder focused on measuring Chronic Achilles Tendinopathy
Eligibility Criteria
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
NCT ID
NCT00958620
First Posted
August 12, 2009
Last Updated
May 27, 2015
Sponsor
Northern Orthopaedic Division, Denmark
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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