Shockwave Therapy of Chronic Achilles Tendinopathy

NCT ID: NCT00958620

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2005-06-30

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.

Conditions

Chronic Inflammatory Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active ESWT

Group Type: ACTIVE_COMPARATOR

Shock Wave Therapy

Intervention Type: PROCEDURE

Extracorporal shock-wave therapy

Sham ESWT

Group Type: SHAM_COMPARATOR

Shock Wave Therapy

Intervention Type: PROCEDURE

Extracorporal shock-wave therapy

Interventions

Shock Wave Therapy

Extracorporal shock-wave therapy

Intervention Type: PROCEDURE

Other Intervention Names

Extracorporal shock-wave therapy

Eligibility Criteria

Inclusion Criteria

• Chronic Achilles Tendinopathy

Exclusion Criteria

• Recent surgery in area

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northern Orthopaedic Division, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sten Rasmussen, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark

Other Identifiers

ON-07-001-RAS

Identifier Type: -

Identifier Source: org_study_id