Clinical trial NCT00377910: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Achilles Tendinopathy
Keywords: Chronic Achilles tendinopathy
Polidocanol
Ultrasound
Efficacy
RCT
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2006-09-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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,

Primary outcomes:
measure: Pain during physical activity which usually causes pain
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Achilles tendon pressure measuring until pain release.
timeFrame: 3 and 6 months
measure: Pain while resting.
timeFrame: 3 and 6 months
measure: Patient evaluation of treatment efficacy
timeFrame: 3 and 6 months
measure: FAOS
timeFrame: 3 and 6 months
measure: AOFAS
timeFrame: 3 and 6 months
measure: Number of neo-vascularisation.
timeFrame: day 0, 1 and 3 months
measure: Localisation of the neo-vascularisation
timeFrame: day 0, 1 and 3 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
Study officials:
affiliation: Northern Orthopaedic Division, Denmark
name: Ole Simonsen, MD, DMSci
role: PRINCIPAL_INVESTIGATOR
References:
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.