Hyaluronan in the Treatment of Painful Achilles Tendinopathy.

Study Overview
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Brief Summary
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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.

Official Title
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Hyaluronan in the Treatment of Painful Achilles Tendinopathy.

Conditions
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Tendinopathy

Intervention / Treatment
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* Device: hyaluronic acid sodium salt
* Device: ESWT


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ESWT (Extracorporal Shock Wave Therapy)<br>Three applications in weekly interval. | Device: ESWT<br> <br> |
| Active Comparator: hyaluronic acid sodium salt<br>Two injections of 2% (40 milligrams (mg) / 2 millilitres (ml)) hyaluronan in weekly interval. | Device: hyaluronic acid sodium salt<br> <br> * Other names: OSTENIL® TENDON;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Victorian Institute of Sports Assessment-Achilles (VISA-A score) | 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'. | Day 90 (plus or minus 3 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Victorian Institute of Sports Assessment-Achilles (VISA-A score) | 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'. | Day 0 | 
| Victorian Institute of Sports Assessment-Achilles (VISA-A score) | 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'. | Day 7 (plus or minus 1 day) | 
| Victorian Institute of Sports Assessment-Achilles (VISA-A score) | 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'. | Day 28 (plus or minus 3 days) | 
| Victorian Institute of Sports Assessment-Achilles (VISA-A score) | 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'. | Day 180 (plus or minus 3 days) | 
| Visual Analogue Scale of pain (VAS; 100 mm) | 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'. | Day 0 | 
| Visual Analogue Scale of pain (VAS; 100 mm) | 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'. | Day 7 (plus or minus 1 day) | 
| Visual Analogue Scale of pain (VAS; 100 mm) | 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'. | Day 28 (plus or minus 3 days) | 
| Visual Analogue Scale of pain (VAS; 100 mm) | 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'. | Day 90 (plus or minus 3 days) | 
| Visual Analogue Scale of pain (VAS; 100 mm) | 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'. | Day 180 (plus or minus 3 days) | 
| Patient's and investigator's global evaluation of study-relevant tendon complaints | Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition. | Day 7 (plus or minus 1 day) | 
| Patient's and investigator's global evaluation of study-relevant tendon complaints | Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition. | Day 28 (plus or minus 3 days) | 
| Patient's and investigator's global evaluation of study-relevant tendon complaints | Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition. | Day 90 (plus or minus 3 days) | 
| Patient's and investigator's global evaluation of study-relevant tendon complaints | Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition. | Day 180 (plus or minus 3 days) | 
| Clinical Parameters | Redness Warmth Swelling Tenderness on palpation Crepitus on motion Accumulation of tissue fluid Measured by 5-point scale, ranking from 'none' to 'extreme' intensity. | Day 0 | 
| Clinical Parameters | Redness Warmth Swelling Tenderness on palpation Crepitus on motion Accumulation of tissue fluid Measured by 5-point scale, ranking from 'none' to 'extreme' intensity. | Day 7 (plus or minus 1 day) | 
| Clinical Parameters | Redness Warmth Swelling Tenderness on palpation Crepitus on motion Accumulation of tissue fluid Measured by 5-point scale, ranking from 'none' to 'extreme' intensity. | Day 28 (plus or minus 3 days) | 
| Clinical Parameters | Redness Warmth Swelling Tenderness on palpation Crepitus on motion Accumulation of tissue fluid Measured by 5-point scale, ranking from 'none' to 'extreme' intensity. | Day 90 (plus or minus 3 days) | 
| Clinical Parameters | Redness Warmth Swelling Tenderness on palpation Crepitus on motion Accumulation of tissue fluid Measured by 5-point scale, ranking from 'none' to 'extreme' intensity. | Day 180 (plus or minus 3 days) | 
| Frequency of test product-related Adverse Events |  | Up to Day 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tendinopathy, hyaluronan, tendon, hyaluronic acid, extracorporeal shock wave