High-Volume Image-Guided Injection in Chronic Midportion Achilles Tendinopathy

Tendinopathy Clinical Trial

— HAT  

Official title:

The Value of a High-Volume Image-Guided Injection in Chronic Midportion Achilles Tendinopathy: a Double-blind, Randomized, Placebo-controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02996409
• Other study ID #: 51623
• Status: Completed
• Phase: Phase 4
• Start date: December 2016
• Est. completion date: July 2019

Study information

• Verified date: August 2019
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Achilles Tendon Pain
• Injection Site Fibrosis
• Tendinopathy

Intervention

Drug:
• HVIGI
High Volume Image-Guided Injection with a saline/lidocain solution
• LVIGI
Placebo control with injection of a saline/lidocain solution (low volume)

Other:
• Progressive exercise program
A 12-week during progressive exercise training program consisting of isometric, isotonic and eccentric calf exercises.

Locations

Country	Name	City	State
Netherlands	Erasmus MC University Medical Center	Rotterdam

Sponsors (3)

Lead Sponsor	Collaborator
Erasmus Medical Center	Dutch Arthritis Association, The Anna Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

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