Tendinopathy Clinical Trial
— HATOfficial title:
The Value of a High-Volume Image-Guided Injection in Chronic Midportion Achilles Tendinopathy: a Double-blind, Randomized, Placebo-controlled Clinical Trial
NCT number | NCT02996409 |
Other study ID # | 51623 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | December 2016 |
Est. completion date | July 2019 |
Verified date | August 2019 |
Source | Erasmus Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | July 2019 |
Est. primary completion date | July 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Age 18-70 years. 2. Clinical diagnosis of chronic midportion Achilles tendinopathy: Painful swelling of the Achilles tendon, 2-7 cm proximal to it's calcaneal insertion. 3. Non-response to exercise program for 6 weeks. 4. Painful Achilles tendon for more than 2 months. 5. Neovascularisation is present on Power Doppler Ultrasonography examination Exclusion Criteria: 1. Clinical suspicion of insertional disorders (pain at the site of the insertion of the Achilles tendon on the calcaneum) 2. Clinical suspicion of an Achilles tendon rupture (Thompson test abnormal and palpable "gap") 3. Clinical suspicion of plantar flexor tenosynovitis (posteromedial pain when the toes are plantar flexed against resistance) 4. Clinical suspicion of n.suralis pathology (sensitive disorder in the area of the sural nerve) 5. Clinical suspicion of peroneal subluxation (visible luxation of the mm. Peronea spot in combination with localized pain) 6. Suspicion of internal disorders: spondylarthropathy, gout, hyperlipidemia, Rheumatoid Arthritis and sarcoidosis. 7. Condition that prevents the patients from executing an active exercise program 8. Recently prescribed drugs (within 2 years) with a putative effect on symptoms and tendon healing (quinolone antibiotics, corticosteroids). 9. Previous Achilles tendon rupture. 10. Patient has received surgical intervention for his injury. 11. Patient does not wish, for whatever reason, to undergo one of the two treatments 12. A medical condition that would affect safety of injection (e.g. peripheral vascular disease, use of anticoagulant medication) 13. Known presence of a pregnancy 14. Condition of the Achilles tendon caused by medications (arising in relation to moment of intake), such as quinolones and statins 15. Inability to give informed consent. 16. Participation in other concomitant treatment programs. 17. Patient has already one side included in this study. 18. Allergy for lidocain. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Erasmus MC University Medical Center | Rotterdam |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center | Dutch Arthritis Association, The Anna Foundation |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Victorian Institute of Sport Assessment - Achilles questionnaire (VISA-A) | Change in VISA-A score at 24 weeks | ||
Secondary | Pain detect questionnaire (PD-Q) | Change in pain detect score at 24 weeks | ||
Secondary | The Pain Coping Inventory (PCI) | Change in PCI score at 24 weeks | ||
Secondary | 10 hop test | Change in visual analogue scale score following a 10 hop test at 24 weeks | ||
Secondary | Flexibility m. gastrocnemius using a goniometer | Change in flexibility of the gastrocnemius muscle at 24 weeks | ||
Secondary | Flexibility m. soleus using a goniometer | Change in flexibility of the soleus muscle at 24 weeks | ||
Secondary | Power m. gastrocnemius using a hand-held dynamometer | Change in power of the gastrocnemius muscle at 24 weeks | ||
Secondary | Power m. soleus using a hand-held dynamometer | Change in power of the soleus muscle at 24 weeks | ||
Secondary | 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 | |
Secondary | Return to sports using a standardized weekly questionnaire | Change in return to sport at 24 weeks | ||
Secondary | 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 | ||
Secondary | Patient satisfaction with treatment results | Change at 24 weeks | ||
Secondary | Patient Acceptable Symptom Scale (PASS) | Change at 24 weeks |
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