Chronic Inflammatory DisorderPhase 4NCT00958620
Shockwave Therapy of Chronic Achilles Tendinopathy
A Phase 4 study testing Shock Wave Therapy in people with Chronic Inflammatory Disorder, run by Northern Orthopaedic Division, Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Disorder
- What is being tested?
- Shock Wave Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Jun 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Achilles Tendinopathy
Who cannot join
- Recent surgery in area
About this study
Official title: Shockwave Therapy of Chronic Achilles Tendinopathy. A Double-blind, Randomized Clinical Trial of Efficacy
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.
- Conditions
- Chronic Inflammatory Disorder
- Being tested
- Shock Wave Therapy
- Keywords
- Chronic Achilles Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shock Wave TherapyProcedure or surgery
Also called Extracorporal shock-wave therapy
Extracorporal shock-wave therapy
| Study group | Role | What they receive |
|---|---|---|
| Active ESWT | Active comparator | Not described Receives: Procedure: Shock Wave Therapy |
| Sham ESWT | Sham comparator | Not described Receives: Procedure: Shock Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The American Orthopaedic Foot and Ankle Score (AOFAS score)
Measured: June 2005
Effect on pain
Measured: June 2005
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startOct 2004
- Primary completionJan 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sten Rasmussen, MD, Principal investigator, Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958620
- Sponsor's protocol ID
- ON-07-001-RAS
- Status last verified
- May 2015
- First submitted
- 12 Aug 2009
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shockwave Therapy of Chronic Achilles Tendinopathy. A Double-blind, Randomized Clinical Trial of Efficacy
- ClinicalTrials.gov ID
- NCT00958620
- Acronym / sponsor ID
- ON-07-001-RAS
- Conditions
- Chronic Inflammatory Disorder
- Keywords
- Chronic Achilles Tendinopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active ESWT | Active comparator | Procedure: Shock Wave Therapy |
| Sham ESWT | Sham comparator | Procedure: Shock Wave Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic Achilles Tendinopathy
Key exclusion criteria (1 listed)
- Recent surgery in area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shock Wave TherapyAlso: Extracorporal shock-wave therapyExtracorporal shock-wave therapy | Procedure or surgery | Active ESWT, Sham ESWT |
Primary outcome
The American Orthopaedic Foot and Ankle Score (AOFAS score)
Time frame: June 2005
Effect on pain
Time frame: June 2005
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sten Rasmussen, MD principal investigator
Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Shock Wave Therapy in people with Chronic Inflammatory Disorder, run by Northern Orthopaedic Division, Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The American Orthopaedic Foot and Ankle Score (AOFAS score) (time frame: June 2005). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.