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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-13-07-011543 | Other Identifier | EUDAMED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESWT (Extracorporal Shock Wave Therapy) | Other | Three applications in weekly interval. |
|
| hyaluronic acid sodium salt | Active Comparator | Two injections of 2% (40 milligrams (mg) / 2 millilitres (ml)) hyaluronan in weekly interval. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyaluronic acid sodium salt | Device |
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| |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thierry De Vroey, Dr. med. | Universitair Ziekenhuis Antwerpen, Fysische Geneeskunde en Revalidatie | Principal Investigator |
| Nils Lynen, Dr. med. | Praxiszentrum Orthopädie-Unfallchirurgie Nordrhein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Antwerpen, Fysische Geneeskunde en Revalidatie | Edegem | 2650 | Belgium | |||
| Praxiszentrum Orthopädie-Unfallchirurgie Nordrhein |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27639439 | Derived | 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. |
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| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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| ESWT |
| Device |
|
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 |
Measured by 5-point scale, ranking from 'none' to 'extreme' intensity. | Day 0 |
| Clinical Parameters |
Measured by 5-point scale, ranking from 'none' to 'extreme' intensity. | Day 7 (plus or minus 1 day) |
| Clinical Parameters |
Measured by 5-point scale, ranking from 'none' to 'extreme' intensity. | Day 28 (plus or minus 3 days) |
| Clinical Parameters |
Measured by 5-point scale, ranking from 'none' to 'extreme' intensity. | Day 90 (plus or minus 3 days) |
| Clinical Parameters |
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 |
| Aachen |
| North Rhine-Westphalia |
| 52062 |
| Germany |