Shockwave Therapy of Chronic Achilles Tendinopathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT00958620
First received: August 12, 2009
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Chronic Inflammatory Disorder
Procedure: Shock Wave Therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Shockwave Therapy of Chronic Achilles Tendinopathy. A Double-blind, Randomized Clinical Trial of Efficacy

Resource links provided by NLM:


Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • The American Orthopaedic Foot and Ankle Score (AOFAS score) [ Time Frame: June 2005 ] [ Designated as safety issue: No ]
  • Effect on pain [ Time Frame: June 2005 ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: October 2004
Study Completion Date: June 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active ESWT Procedure: Shock Wave Therapy
Extracorporal shock-wave therapy
Other Name: Extracorporal shock-wave therapy
Sham Comparator: Sham ESWT Procedure: Shock Wave Therapy
Extracorporal shock-wave therapy
Other Name: Extracorporal shock-wave therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Chronic Achilles Tendinopathy

Exclusion criteria:

  • Recent surgery in area
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00958620

Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Investigators
Principal Investigator: Sten Rasmussen, MD Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT00958620     History of Changes
Other Study ID Numbers: ON-07-001-RAS
Study First Received: August 12, 2009
Last Updated: March 28, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Northern Orthopaedic Division, Denmark:
Chronic Achilles Tendinopathy

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

ClinicalTrials.gov processed this record on July 22, 2014