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The Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles. Tendinopathy

Primary Purpose

Chronic Achilles Tendinopathy

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Aethoxysclerol
Sponsored by
Northern Orthopaedic Division, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Achilles Tendinopathy focused on measuring Chronic Achilles tendinopathy, Polidocanol, Ultrasound, Efficacy, RCT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 year old, Ultrasound verified Achilles tendinopathy with neo-vascularisation, pain duration more than three months, excentric exercises for at least three months, women: negative pregnancy test, safe anticonceptive

Exclusion Criteria:

  • Dementia, mental disease or other illness incompatible with participation, no ultrasound verified neo-vascularisation, any illness which contraindicate the use of Polidocanol or Lidocaine, granulation tissue of more than 50 % of the Achilles tendon, ability of lying in prone position, women: pregnancy or breastfeeding,

Sites / Locations

  • Aalborg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1, drug

2 drug

Arm Description

Injections of polidocanol

injections of lidocaine

Outcomes

Primary Outcome Measures

Pain during physical activity which usually causes pain

Secondary Outcome Measures

Achilles tendon pressure measuring until pain release.
Pain while resting.
Patient evaluation of treatment efficacy
FAOS
AOFAS
Number of neo-vascularisation.
Localisation of the neo-vascularisation

Full Information

First Posted
September 18, 2006
Last Updated
March 28, 2014
Sponsor
Northern Orthopaedic Division, Denmark
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00377910
Brief Title
The Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles. Tendinopathy
Official Title
Placebo Controlled Trial, Testing the Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles Tendinopathy.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northern Orthopaedic Division, Denmark
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Chronic achilles tendinopathy is a common disease especially in adults. The golden standard in treatment has up to now been excentric exercises but with varying success. A new hypothesis is that this chronic pain is due to neo vascularisation. In a pilot study sclerosing injections with polidocanol have had a successful efficacy. Our aim is to study the efficacy of polidocanol as a treatment in a randomised controlled setting on a larger scale.
Detailed Description
48 patients with chronic achilles tendinopathy for more than 3 months who have tried excentric exercises without success will be randomised to either polidocanol or lidocaine injections if having ultrasound verified neo-vascularisation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Achilles Tendinopathy
Keywords
Chronic Achilles tendinopathy, Polidocanol, Ultrasound, Efficacy, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1, drug
Arm Type
Active Comparator
Arm Description
Injections of polidocanol
Arm Title
2 drug
Arm Type
Placebo Comparator
Arm Description
injections of lidocaine
Intervention Type
Drug
Intervention Name(s)
Aethoxysclerol
Other Intervention Name(s)
1. drug: Polidocanol, 2. drug: Lidocaine
Intervention Description
2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocaine 10mg/ml
Primary Outcome Measure Information:
Title
Pain during physical activity which usually causes pain
Time Frame
3 and 6 months
Secondary Outcome Measure Information:
Title
Achilles tendon pressure measuring until pain release.
Time Frame
3 and 6 months
Title
Pain while resting.
Time Frame
3 and 6 months
Title
Patient evaluation of treatment efficacy
Time Frame
3 and 6 months
Title
FAOS
Time Frame
3 and 6 months
Title
AOFAS
Time Frame
3 and 6 months
Title
Number of neo-vascularisation.
Time Frame
day 0, 1 and 3 months
Title
Localisation of the neo-vascularisation
Time Frame
day 0, 1 and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 year old, Ultrasound verified Achilles tendinopathy with neo-vascularisation, pain duration more than three months, excentric exercises for at least three months, women: negative pregnancy test, safe anticonceptive Exclusion Criteria: Dementia, mental disease or other illness incompatible with participation, no ultrasound verified neo-vascularisation, any illness which contraindicate the use of Polidocanol or Lidocaine, granulation tissue of more than 50 % of the Achilles tendon, ability of lying in prone position, women: pregnancy or breastfeeding,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ole Simonsen, MD, DMSci
Organizational Affiliation
Northern Orthopaedic Division, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
15688235
Citation
Alfredson H, Ohberg L. Sclerosing injections to areas of neo-vascularisation reduce pain in chronic Achilles tendinopathy: a double-blind randomised controlled trial. Knee Surg Sports Traumatol Arthrosc. 2005 May;13(4):338-44. doi: 10.1007/s00167-004-0585-6. Epub 2005 Feb 2.
Results Reference
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The Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles. Tendinopathy

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