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| Name | Class |
|---|---|
| Dutch Arthritis Association | INDUSTRY |
| The Anna Foundation | OTHER |
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Overuse injury of the Achilles tendon is a common entity in athletes. Currently, the usual treatment for chronic midportion Achilles tendinopathy is an eccentric exercise program. In most cases this gives satisfactory results, however there is a significant group of patients in which the exercise program is not sufficient. Prior to our study, three United Kingdom based studies have investigated the efficacy of High-Volume Image-Guided Injections (HVIGI's) in chronic midportion Achilles tendinopathy. They all showed promising results. However none of these studies had an adequate control group. This double-blind, placebo-controlled, randomized clinical trial will investigate the value of a High-Volume Image-Guided Injection in chronic midportion Achilles tendinopathy.
Background of the study - Overuse injury of the Achilles tendon is a common entity in athletes. Especially middle aged athletes are at risk. Elite running athletes have a lifetime risk of sustaining an Achilles tendon injury of 52%. At the moment the usual treatment for chronic midportion Achilles tendinopathy is an excentric exercise program. In most cases this gives great results, however there is a significant group of patients in which the exercise program is not sufficient. Three United Kingdom-based case series evaluated the efficacy of High-Volume Image-Guided Injections (HVIGI's) in chronic midportion Achilles tendinopathy. They all showed promising results. However none of these studies used a comparative group. There is consequently a lack of high-quality studies in this field and therefore the investigators cannot recommend this treatment yet for this indication.
Objective of the study - To investigate the efficacy of a high-volume image guided injection (HVIGI) in chronic midportion Achilles tendinopathy.
Hypothesis - The average VISA-A score is higher in the patient group treated with a progressive exercise program in combination with a high volume image guided injection in comparison with the group treated with low volume injection as a control group in combination with a progressive exercise program.
Study design - A double-blind, randomized, placebo-controlled clinical trial. Randomization and stratification (based on activity level using the Ankle Activity Score) will be performed using a computer-generated model. Measurements will be performed at baseline, 2, 6, 12 and 24 weeks post injection. At every time point both the primary and secondary outcome measurements will be collected. The painDETECT and the Pain Coping Inventory questionnaires will be derived at baseline and 24 week post injection.
Study population - In total, 80 patients with clinically diagnosed chronic midportion Achilles tendinopathy will be included in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Volume Image-Guided Injection | Experimental | HVIGI: Injection of 50 cc ( 40 cc 0,9% sodium chloride solution + 10 cc 1% lidocain) in combination with a progressive exercise program and gradual return to sports activities. |
|
| Low-Volume Image-Guided Injection | Placebo Comparator | LVIGI: Injection of 2 cc (1.6 cc 0.9% Sodium chloride solution + 0.4 cc 1% lidocain) in combination with a progressive exercise program and gradual return to sports activities. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HVIGI | Drug | High Volume Image-Guided Injection with a saline/lidocain solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Victorian Institute of Sport Assessment - Achilles questionnaire (VISA-A) | Change in VISA-A score at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain detect questionnaire (PD-Q) | Change in pain detect score at 24 weeks | |
| The Pain Coping Inventory (PCI) | Change in PCI score at 24 weeks | |
| 10 hop test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R.J. de Vos, PhD | Erasmus MC University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC University Medical Center | Rotterdam | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36083324 | Derived | van Oosten CCM, van der Vlist AC, van Veldhoven PLJ, van Oosterom RF, Verhaar JAN, de Vos RJ. Do High-Volume Injections Affect the Ultrasonographic Neovascularization in Chronic Achilles Tendinopathy? A Randomized Placebo-Controlled Clinical Trial. Clin J Sport Med. 2022 Sep 1;32(5):451-457. doi: 10.1097/JSM.0000000000000998. Epub 2021 Dec 9. | |
| 33868707 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 13, 2019 | Aug 13, 2019 | SAP_001.pdf |
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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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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| LVIGI | Drug | Placebo control with injection of a saline/lidocain solution (low volume) |
|
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| Progressive exercise program | Other | A 12-week during progressive exercise training program consisting of isometric, isotonic and eccentric calf exercises. |
|
| Change in visual analogue scale score following a 10 hop test at 24 weeks |
| Flexibility m. gastrocnemius using a goniometer | Change in flexibility of the gastrocnemius muscle at 24 weeks |
| Flexibility m. soleus using a goniometer | Change in flexibility of the soleus muscle at 24 weeks |
| Power m. gastrocnemius using a hand-held dynamometer | Change in power of the gastrocnemius muscle at 24 weeks |
| Power m. soleus using a hand-held dynamometer | Change in power of the soleus muscle at 24 weeks |
| Degree of neovascularisation (determined with standardized Power Doppler Ultrasonography examination) | Ultrasonography examination before and after eccentric/isotonic calf exercises or rest | Change in degree of neovascularization at 24 weeks |
| Return to sports using a standardized weekly questionnaire | Change in return to sport at 24 weeks |
| Compliance to the exercise program and return to sports activity program using a standardized weekly questionnaire assessing the percentage of exercises that is performed | Change in compliance at 24 weeks |
| Patient satisfaction with treatment results | Change at 24 weeks |
| Patient Acceptable Symptom Scale (PASS) | Change at 24 weeks |
| Sleeswijk Visser TSO, van der Vlist AC, van Oosterom RF, van Veldhoven P, Verhaar JAN, de Vos RJ. Impact of chronic Achilles tendinopathy on health-related quality of life, work performance, healthcare utilisation and costs. BMJ Open Sport Exerc Med. 2021 Mar 26;7(1):e001023. doi: 10.1136/bmjsem-2020-001023. eCollection 2021. |
| 33315586 | Derived | van der Vlist AC, van Oosterom RF, van Veldhoven PLJ, Bierma-Zeinstra SMA, Waarsing JH, Verhaar JAN, de Vos RJ. Effectiveness of a high volume injection as treatment for chronic Achilles tendinopathy: randomised controlled trial. BMJ. 2020 Sep 9;370:m3027. doi: 10.1136/bmj.m3027. |
| D017670 |
| Sodium Compounds |