Clinical trial NCT01954108: Hyaluronan in the Treatment of Painful Achilles Tendinopathy.
Official title: Hyaluronan in the Treatment of Painful Achilles Tendinopathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tendinopathy
Keywords: tendinopathy
hyaluronan
tendon
hyaluronic acid
extracorporeal shock wave
Lead sponsor: TRB Chemedica AG
Sponsor class: INDUSTRY
First posted: 2013-10-01
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare OSTENIL® TENDON (2% hyaluronan) and Extracorporeal Shock Wave (ESWT) therapy in the treatment of painful Achilles tendinopathy.


Eligibility criteria: Inclusion Criteria:

* Male and female patients between 18 and 75 years of age.
* Good general health condition.
* Signed written informed consent.
* Painful Achilles midportion tendinopathy since more or equal than 6 weeks.
* Pain according to VAS (Huskisson, 100 mm) more or equal than 40 mm.
* Ensured compliance of subjects over the whole study period.

Exclusion Criteria:

* Concomitant or previous participation in a clinical investigation within the last 3 months prior to study inclusion.
* Infection or relevant skin disease at study relevant site.
* Blood coagulation disorder or intake of blood thinner (e.g. Marcumar).
* Known hypersensitivity to hyaluronic acid (HA) preparations or to the constituents mannitol, sodium chloride, disodium phosphate and sodium dihydrogenphosphate.
* Contra-indications for ESWT application in study relevant area (e.g. recent surgery, malignant tumour, local osteomyelitis or open epiphysis).
* Severe intercurrent illness (e.g. uncontrolled diabetes mellitus, peripheral neuropathy), which in the opinion of the investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study.
* Concomitant disease at study relevant site (e.g. insertion tendinopathy at Achilles tendon) influencing study evaluation.
* Diseases or characteristics judged by the investigator to be incompatible with the assessments and/or procedures for the study evaluation.
* Intake of concomitant medications not allowed which might interfere with the functional assessment of the study (e.g. immunosuppressive drugs within the last 3 months).
* Previous therapies (except non-steroidal anti-inflammatory drugs (NSAID)) at study relevant site within the last 4 weeks prior to study inclusion.
* Use of NSAIDs within the last week prior to study treatment.
* Recent history of drug and/or alcohol abuse (within the last 6 months).
* Pregnant or lactating females.
* Participants of childbearing age (pre-menopausal) who do not accept the use of methods of birth control with pearl index of at least 1 (i.e. oral contraceptives, vaginal ring, hormone-releasing Intrauterine Device (IUD), implants, depot syringes, hormone patch, double barrier method, tubal ligation, vasectomised partner,...) during the treatment period and the first 4 weeks of follow-up period.
* Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts.
* Subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and / or non completion of the study according to investigator's judgement (e.g. illiteracy, insufficient knowledge of local language).

Primary outcomes:
measure: Victorian Institute of Sports Assessment-Achilles (VISA-A score)
timeFrame: Day 90 (plus or minus 3 days)
Secondary outcomes:
measure: Victorian Institute of Sports Assessment-Achilles (VISA-A score)
timeFrame: Day 0
measure: Victorian Institute of Sports Assessment-Achilles (VISA-A score)
timeFrame: Day 7 (plus or minus 1 day)
measure: Victorian Institute of Sports Assessment-Achilles (VISA-A score)
timeFrame: Day 28 (plus or minus 3 days)
measure: Victorian Institute of Sports Assessment-Achilles (VISA-A score)
timeFrame: Day 180 (plus or minus 3 days)
measure: Visual Analogue Scale of pain (VAS; 100 mm)
timeFrame: Day 0
measure: Visual Analogue Scale of pain (VAS; 100 mm)
timeFrame: Day 7 (plus or minus 1 day)
measure: Visual Analogue Scale of pain (VAS; 100 mm)
timeFrame: Day 28 (plus or minus 3 days)
measure: Visual Analogue Scale of pain (VAS; 100 mm)
timeFrame: Day 90 (plus or minus 3 days)
measure: Visual Analogue Scale of pain (VAS; 100 mm)
timeFrame: Day 180 (plus or minus 3 days)
measure: Patient's and investigator's global evaluation of study-relevant tendon complaints
timeFrame: Day 7 (plus or minus 1 day)
measure: Patient's and investigator's global evaluation of study-relevant tendon complaints
timeFrame: Day 28 (plus or minus 3 days)
measure: Patient's and investigator's global evaluation of study-relevant tendon complaints
timeFrame: Day 90 (plus or minus 3 days)
measure: Patient's and investigator's global evaluation of study-relevant tendon complaints
timeFrame: Day 180 (plus or minus 3 days)
measure: Clinical Parameters
timeFrame: Day 0
measure: Clinical Parameters
timeFrame: Day 7 (plus or minus 1 day)
measure: Clinical Parameters
timeFrame: Day 28 (plus or minus 3 days)
measure: Clinical Parameters
timeFrame: Day 90 (plus or minus 3 days)
measure: Clinical Parameters
timeFrame: Day 180 (plus or minus 3 days)
measure: Frequency of test product-related Adverse Events
timeFrame: Up to Day 180
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen, Fysische Geneeskunde en Revalidatie
city: Aachen
country: Germany
facility: Praxiszentrum Orthopädie-Unfallchirurgie Nordrhein
state: Nordrhein-Westfalen
Study officials:
affiliation: Universitair Ziekenhuis Antwerpen, Fysische Geneeskunde en Revalidatie
name: Thierry De Vroey, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Praxiszentrum Orthopädie-Unfallchirurgie Nordrhein
name: Nils Lynen, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lynen N, De Vroey T, Spiegel I, Van Ongeval F, Hendrickx NJ, Stassijns G. Comparison of Peritendinous Hyaluronan Injections Versus Extracorporeal Shock Wave Therapy in the Treatment of Painful Achilles' Tendinopathy: A Randomized Clinical Efficacy and Safety Study. Arch Phys Med Rehabil. 2017 Jan;98(1):64-71. doi: 10.1016/j.apmr.2016.08.470. Epub 2016 Sep 14.