NCT00958620

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2004

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

3 months

First QC Date

August 12, 2009

Last Update Submit

May 27, 2015

Conditions

Chronic Inflammatory Disorder

Keywords

Chronic Achilles Tendinopathy

Outcome Measures

Primary Outcomes (2)

  • The American Orthopaedic Foot and Ankle Score (AOFAS score)

    June 2005

  • Effect on pain

    June 2005

Study Arms (2)

Active ESWT

ACTIVE COMPARATOR
Procedure: Shock Wave Therapy

Sham ESWT

SHAM COMPARATOR
Procedure: Shock Wave Therapy

Interventions

Shock Wave TherapyPROCEDURE

Extracorporal shock-wave therapy

Also known as: Extracorporal shock-wave therapy
Active ESWTSham ESWT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic Achilles Tendinopathy

You may not qualify if:

  • Recent surgery in area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Sten Rasmussen, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2009

First Posted

August 13, 2009

Study Start

October 1, 2004

Primary Completion

January 1, 2005

Study Completion

June 1, 2005

Last Updated

May 28, 2015

Record last verified: 2015-05