Placebo-Controlled Trial, Testing the Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles Tendinopathy - Full Text View

Sponsors and Collaborators:	Northern Orthopaedic Division, Denmark University of Aarhus
Information provided by:	Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:	NCT00377910

Purpose

Chronic Achilles tendinopathy is a common disease especially in adults. The golden standard in treatment has up to now been excentric exercise, but with varying success.A new hypothesis is that this chronic pain is due to neo vascularisation, and in a pilot study, sclerosing injections with polidocanol has been successfully used. The aim of our study is to try the hypothesis and the efficacy of polidocanol as a treatment in a randomised controlled setting on a larger scale.

Condition	Intervention	Phase
Chronic Achilles Tendinopathy	Drug: Aethoxysclerol	Phase IV

MedlinePlus related topics: Tendinitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	Placebo Controlled Trial, Testing the Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles Tendinopathy

Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:

Pain during physical activity which usually causes pain [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Achilles tendon pressure measuring until pain release. [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
Pain while resting. [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
Patient evaluation of treatment efficacy [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
FAOS [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
AOFAS [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
Number of neo-vascularisation. [ Time Frame: day 0, 1 and 3 months ] [ Designated as safety issue: Yes ]
Localisation of the neo-vascularisation [ Time Frame: day 0, 1 and 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	February 2007
Estimated Study Completion Date:	February 2010

Arms	Assigned Interventions
1, drug: Active Comparator Injections of polidocanol	Drug: Aethoxysclerol 2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocain 10mg/ml
2 drug: Placebo Comparator injections of lidocain	Drug: Aethoxysclerol 2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocain 10mg/ml

Detailed Description:

48 patients with Chronic achilles tendinopathy for more than 3 month,who have tried excentric exercise without success, will be randomised to either polidocanol or lidocaine injections if having ultrasound verified neo-vascularisation.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 pregnancytest, 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,

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377910

Contacts

Contact: Kirsten Ø Christensen, MD

004599321111

kooc@rn.dk

Locations

Denmark
Aalborg University Hospital	Recruiting
Aalborg, Denmark, 9100
Contact: Kirsten Ø Christensen, MD kooc@rn.dk
Contact: Kirsten Ø Christensen, MD +4599321111 kooc@rn.dk
Principal Investigator: Henrik E Gregersen, MD,consultant
Aalborg University Hospital	Recruiting
Aalborg, Denmark, 9100
Contact: Kirsten Ø Christensen, MD ki.c@jubii.dk
Contact: Kirsten Ø Christensen, MD +4599321111 kooc@rn.dk
Principal Investigator: Henrik E Gregersen, MD,consultant

Sponsors and Collaborators

Northern Orthopaedic Division, Denmark

University of Aarhus

Investigators

Principal Investigator:

Ole Simonsen, MD, DMSci

Northern Orthopaedic Division, Denmark

More Information

Publications:

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. Epub 2005 Feb 2.

Responsible Party:	Northern Orthopaedic Division, Denmark ( Kirsten Ø Christensen )
Study ID Numbers:	ON-02-012-OSi
Study First Received:	September 18, 2006
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00377910
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Northern Orthopaedic Division, Denmark:

Chronic Achilles tendinopathy
Polidocanol
Ultrasound
Efficacy
RCT

Study placed in the following topic categories:

Tendinopathy
Tendon Injuries
Muscular Diseases
Musculoskeletal Diseases

Wounds and Injuries
Polidocanol
Disorders of Environmental Origin

Additional relevant MeSH terms:

Therapeutic Uses
Sclerosing Solutions
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009