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

NCT02996409 | Completed Phase 4

• 1 other identifier: 51623
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Tendinopathy; Achilles Tendon Pain; Injection Site Fibrosis

Outcome Measures

Primary Outcomes (1)

• Victorian Institute of Sport Assessment - Achilles questionnaire (VISA-A)

  Change in VISA-A score at 24 weeks

Secondary Outcomes (12)

• 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

  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

Study Arms (2)

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.

Drug: HVIGI; Other: Progressive exercise program

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.

Drug: LVIGI; Other: Progressive exercise program

Interventions

HVIGI DRUG

High Volume Image-Guided Injection with a saline/lidocain solution

Also known as: Saline 0.9% 40 ml, Lidocain 1.0% 10 ml

High-Volume Image-Guided Injection

LVIGI DRUG

Placebo control with injection of a saline/lidocain solution (low volume)

Also known as: Saline 0.9% 1.6 ml, Lidocain 1.0% 0.4 ml

Low-Volume Image-Guided Injection

Progressive exercise program OTHER

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

High-Volume Image-Guided Injection; Low-Volume Image-Guided Injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years.
• Clinical diagnosis of chronic midportion Achilles tendinopathy: Painful swelling of the Achilles tendon, 2-7 cm proximal to it's calcaneal insertion.
• Non-response to exercise program for 6 weeks.
• Painful Achilles tendon for more than 2 months.
• Neovascularisation is present on Power Doppler Ultrasonography examination

You may not qualify if:

• Clinical suspicion of insertional disorders (pain at the site of the insertion of the Achilles tendon on the calcaneum)
• Clinical suspicion of an Achilles tendon rupture (Thompson test abnormal and palpable "gap")
• Clinical suspicion of plantar flexor tenosynovitis (posteromedial pain when the toes are plantar flexed against resistance)
• Clinical suspicion of n.suralis pathology (sensitive disorder in the area of the sural nerve)
• Clinical suspicion of peroneal subluxation (visible luxation of the mm. Peronea spot in combination with localized pain)
• Suspicion of internal disorders: spondylarthropathy, gout, hyperlipidemia, Rheumatoid Arthritis and sarcoidosis.
• Condition that prevents the patients from executing an active exercise program
• Recently prescribed drugs (within 2 years) with a putative effect on symptoms and tendon healing (quinolone antibiotics, corticosteroids).
• Previous Achilles tendon rupture.
• Patient has received surgical intervention for his injury.
• Patient does not wish, for whatever reason, to undergo one of the two treatments
• A medical condition that would affect safety of injection (e.g. peripheral vascular disease, use of anticoagulant medication)
• Known presence of a pregnancy
• Condition of the Achilles tendon caused by medications (arising in relation to moment of intake), such as quinolones and statins
• Inability to give informed consent.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Dutch Arthritis Association: collaborator
• The Anna Foundation: collaborator

Study Sites (1)

Erasmus MC University Medical Center

Rotterdam, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 36083324 DERIVED

• 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.

  PMID: 33868707 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.

  PMID: 33315586 DERIVED

MeSH Terms

Conditions

Tendinopathy

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• R.J. de Vos, PhD

  Erasmus MC University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: December 19, 2016
• Study Start: December 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: August 15, 2019

Record last verified: 2019-08

Locations

NL (1)