High-Volume Image-Guided Injection in Chronic Midportion Achilles Tendinopathy (HAT)

• ClinicalTrials.gov Identifier: NCT02996409
• Recruitment Status: Completed
• First Posted: December 19, 2016
• Last Update Posted: August 15, 2019
• Sponsor: Erasmus Medical Center
• Collaborators: Dutch Arthritis Association; The Anna Foundation
• Information provided by (Responsible Party): A.C. van der Vlist, Erasmus Medical Center

Tracking Information

• First Submitted Date: October 20, 2016
• First Posted Date: December 19, 2016
• Last Update Posted Date: August 15, 2019
• Actual Study Start Date: December 2016
• Actual Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 14, 2016): Victorian Institute of Sport Assessment - Achilles questionnaire (VISA-A) [ Time Frame: Change in VISA-A score at 24 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 28, 2019)

• Pain detect questionnaire (PD-Q) [ Time Frame: Change in pain detect score at 24 weeks ]
• The Pain Coping Inventory (PCI) [ Time Frame: Change in PCI score at 24 weeks ]
• 10 hop test [ Time Frame: Change in visual analogue scale score following a 10 hop test at 24 weeks ]
• Flexibility m. gastrocnemius using a goniometer [ Time Frame: Change in flexibility of the gastrocnemius muscle at 24 weeks ]
• Flexibility m. soleus using a goniometer [ Time Frame: Change in flexibility of the soleus muscle at 24 weeks ]
• Power m. gastrocnemius using a hand-held dynamometer [ Time Frame: Change in power of the gastrocnemius muscle at 24 weeks ]
• Power m. soleus using a hand-held dynamometer [ Time Frame: Change in power of the soleus muscle at 24 weeks ]
• Degree of neovascularisation (determined with standardized Power Doppler Ultrasonography examination) [ Time Frame: Change in degree of neovascularization at 24 weeks ]
  Ultrasonography examination before and after eccentric/isotonic calf exercises or rest
• Return to sports using a standardized weekly questionnaire [ Time Frame: 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 [ Time Frame: Change in compliance at 24 weeks ]
• Patient satisfaction with treatment results [ Time Frame: Change at 24 weeks ]
• Patient Acceptable Symptom Scale (PASS) [ Time Frame: Change at 24 weeks ]

Original Secondary Outcome Measures (submitted: December 14, 2016)

• Pain detect questionnaire (PD-Q) [ Time Frame: Change in pain detect score at 24 weeks ]
• The Pain Coping Inventory (PCI) [ Time Frame: Change in PCI score at 24 weeks ]
• 10 hop test [ Time Frame: Change in visual analogue scale score following a 10 hop test at 24 weeks ]
• Flexibility m. gastrocnemius using a goniometer [ Time Frame: Change in flexibility of the gastrocnemius muscle at 24 weeks ]
• Flexibility m. soleus using a goniometer [ Time Frame: Change in flexibility of the soleus muscle at 24 weeks ]
• Power m. gastrocnemius using a hand-held dynamometer [ Time Frame: Change in power of the gastrocnemius muscle at 24 weeks ]
• Power m. soleus using a hand-held dynamometer [ Time Frame: Change in power of the soleus muscle at 24 weeks ]
• Degree of neovascularisation (determined with standardized Power Doppler Ultrasonography examination) [ Time Frame: Change in degree of neovascularization at 24 weeks ]
  Ultrasonography examination before and after eccentric/isotonic calf exercises or rest
• Return to sports using a standardized weekly questionnaire [ Time Frame: 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 [ Time Frame: Change in compliance at 24 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

Detailed 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Tendinopathy
• Achilles Tendon Pain
• Injection Site Fibrosis

Intervention

• Drug: HVIGI
  High Volume Image-Guided Injection with a saline/lidocain solution
  Other Names:

  • Saline 0.9% 40 ml
  • Lidocain 1.0% 10 ml
• Drug: LVIGI
  Placebo control with injection of a saline/lidocain solution (low volume)
  Other Names:

  • Saline 0.9% 1.6 ml
  • Lidocain 1.0% 0.4 ml
• Other: Progressive exercise program
  A 12-week during progressive exercise training program consisting of isometric, isotonic and eccentric calf exercises.

Study Arms

• Experimental: High-Volume Image-Guided Injection
  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.
  Interventions:

  • Drug: HVIGI
  • Other: Progressive exercise program
• Placebo Comparator: Low-Volume Image-Guided Injection
  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.
  Interventions:

  • Drug: LVIGI
  • Other: Progressive exercise program

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 14, 2016): 80
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2019
• Actual Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT02996409
• Other Study ID Numbers: 51623
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: A.C. van der Vlist, Erasmus Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Erasmus Medical Center
• Original Study Sponsor: Same as current

Collaborators

• Dutch Arthritis Association
• The Anna Foundation

Investigators

• Principal Investigator: R.J. de Vos, PhD; Erasmus MC University Medical Center

• PRS Account: Erasmus Medical Center
• Verification Date: August 2019