The Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles. Tendinopathy - Full Text View

Sponsor:	Northern Orthopaedic Division, Denmark
Collaborator:	Aarhus University Hospital
Information provided by (Responsible Party):	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 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.

Condition	Intervention	Phase
Chronic Achilles Tendinopathy	Drug: Aethoxysclerol	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Placebo Controlled Trial, Testing the Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles Tendinopathy.

Resource links provided by NLM:

MedlinePlus related topics: Tendinitis

Drug Information available for: Lidocaine

U.S. FDA Resources

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 ]

Enrollment:	48
Study Start Date:	March 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1, drug Injections of polidocanol	Drug: Aethoxysclerol 2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocaine 10mg/ml Other Names: 1. drug: Polidocanol 2. drug: Lidocaine
Placebo Comparator: 2 drug injections of lidocaine	Drug: Aethoxysclerol 2 ml Aethoxysclerol 10 mg/ml 2 ml. lidocaine 10mg/ml Other Names: 1. drug: Polidocanol 2. drug: Lidocaine

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.

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 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,

Contacts and Locations

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

Locations

Denmark
Aalborg University Hospital
Aalborg, Denmark, 9100

Sponsors and Collaborators

Northern Orthopaedic Division, Denmark

Aarhus University Hospital

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
ClinicalTrials.gov Identifier:	NCT00377910 History of Changes
Other Study ID Numbers:	ON-02-012-OSi
Study First Received:	September 18, 2006
Last Updated:	December 13, 2011
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency

Keywords provided by Northern Orthopaedic Division, Denmark:

Chronic Achilles tendinopathy
Polidocanol
Ultrasound
Efficacy
RCT

Additional relevant MeSH terms:

Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Lidocaine
Polidocanol
Anesthetics, Local
Anesthetics
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Sclerosing Solutions

ClinicalTrials.gov processed this record on February 12, 2012