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CompletedNCT00958620Updated May 28, 2015

Shockwave Therapy of Chronic Achilles Tendinopathy

A Phase 4 interventional study of Shock Wave Therapy in Chronic Inflammatory Disorder, sponsored by Northern Orthopaedic Division, Denmark. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-28.

Sponsored by Northern Orthopaedic Division, Denmark · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Inflammatory Disorder

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Keywords

  • Chronic Achilles Tendinopathy
03

In context

Tendinopathy

413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.

This study's enrollment of 48 is close to the median of 50 across 339 interventional studies indexed under Tendinopathy.

Browse Tendinopathy studies →

Lead sponsor

Northern Orthopaedic Division, Denmark is the lead sponsor of 61 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Chronic Achilles Tendinopathy

Exclusion criteria

Exclusion criteria:

  • Recent surgery in area
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Active comparator
    Active ESWT

    Procedure: Shock Wave Therapy

  • Sham comparator
    Sham ESWT

    Procedure: Shock Wave Therapy

Interventions

  • ProcedureShock Wave Therapy

    Extracorporal shock-wave therapy

    Also known as: Extracorporal shock-wave therapy

06

What researchers measure

Primary outcomes

  1. The American Orthopaedic Foot and Ankle Score (AOFAS score)

    Time frame: June 2005

  2. Effect on pain

    Time frame: June 2005

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00958620
Lead sponsor
Northern Orthopaedic Division, Denmark
Responsible party
Sponsor
First posted
Aug 13, 2009
Start date
Oct 2004
Primary completion
Jan 2005
Completion
Jun 2005
Last update
May 28, 2015

Study contacts

Sten Rasmussen, MD
principal investigator · Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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