Hyaluronan in the Treatment of Painful Achilles Tendinopathy.

Not Applicable

Completed

• Conditions: Tendinopathy
• Interventions: Device: ESWT; Device: hyaluronic acid sodium salt

• Registration Number: NCT01954108
• Lead Sponsor: TRB Chemedica AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-26
• Study First Submitted QC: 2013-09-26
• Study First Posted: 2013-10-01
• Study Start: 2013-12
• Primary Completion: 2015-07
• Study Completion: 2015-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-06
• Last Update Posted: 2015-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESWT (Extracorporal Shock Wave Therapy)	ESWT	Three applications in weekly interval.
hyaluronic acid sodium salt	hyaluronic acid sodium salt	Two injections of 2% (40 milligrams (mg) / 2 millilitres (ml)) hyaluronan in weekly interval.

Primary Outcome Measures

Name	Time	Method
Victorian Institute of Sports Assessment-Achilles (VISA-A score)	Day 90 (plus or minus 3 days)	The validated questionnaire will be used to evaluate the outcome in Achilles tendinopathy. The score ranges from '0' to '100' whereas '0' denotes 'no activity / maximum pain' and '100' denote 'maximum activity / no pain'.

Secondary Outcome Measures

Name	Time	Method
Patient's and investigator's global evaluation of study-relevant tendon complaints	Day 180 (plus or minus 3 days)	Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.
Visual Analogue Scale of pain (VAS; 100 mm)	Day 180 (plus or minus 3 days)	Intensity of pain will be evaluated on the Huskisson VAS pain scale on which 0 mm indicate 'no pain' and 100 mm indicate 'extreme pain'.
Clinical Parameters	Day 180 (plus or minus 3 days)	* Redness; * Warmth; * Swelling; * Tenderness on palpation; * Crepitus on motion; * Accumulation of tissue fluid; Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.
Frequency of test product-related Adverse Events	Up to Day 180
Victorian Institute of Sports Assessment-Achilles (VISA-A score)	Day 180 (plus or minus 3 days)	The validated questionnaire will be used to evaluate the outcome in Achilles tendinopathy. The score ranges from '0' to '100' whereas '0' denotes 'no activity / maximum pain' and '100' denote 'maximum activity / no pain'.

Trial Locations

Locations (2)

Praxiszentrum Orthopädie-Unfallchirurgie Nordrhein; 🇩🇪 Aachen, Nordrhein-Westfalen, Germany

Universitair Ziekenhuis Antwerpen, Fysische Geneeskunde en Revalidatie; 🇧🇪 Edegem, Belgium