NCT00377910

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.

Trial Health

87
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 Mar 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2006

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

March 31, 2014

Status Verified

March 1, 2014

Enrollment Period

10 months

First QC Date

September 18, 2006

Last Update Submit

March 28, 2014

Conditions

Chronic Achilles Tendinopathy

Keywords

Chronic Achilles tendinopathyPolidocanolUltrasoundEfficacyRCT

Outcome Measures

Primary Outcomes (1)

  • Pain during physical activity which usually causes pain

    3 and 6 months

Secondary Outcomes (7)

  • Achilles tendon pressure measuring until pain release.

    3 and 6 months

  • Pain while resting.

    3 and 6 months

  • Patient evaluation of treatment efficacy

    3 and 6 months

  • FAOS

    3 and 6 months

  • AOFAS

    3 and 6 months

  • +2 more secondary outcomes

Study Arms (2)

1, drug

ACTIVE COMPARATOR

Injections of polidocanol

Drug: Aethoxysclerol

2 drug

PLACEBO COMPARATOR

injections of lidocaine

Drug: Aethoxysclerol

Interventions

AethoxysclerolDRUG

2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocaine 10mg/ml

Also known as: 1. drug: Polidocanol, 2. drug: Lidocaine
1, drug2 drug

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University Hospital

Aalborg, 9100, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 15688235BACKGROUND

MeSH Terms

Interventions

Polidocanol

Intervention Hierarchy (Ancestors)

Polyethylene GlycolsEthylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Ole Simonsen, MD, DMSci

    Northern Orthopaedic Division, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2006

First Posted

September 19, 2006

Study Start

March 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

March 31, 2014

Record last verified: 2014-03

Locations

DK(1)