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High-Volume Image-Guided Injection in chronic midportion Achilles tendinopathy

The value of a High-Volume Image-Guided Injection in chronic midportion Achilles tendinopathy: a double-blind placebo-controlled randomised clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25970
Enrollment
80
Registered
2014-11-19
Start date
2016-11-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achilles tendon Tendinopathy Injection Treatment High-Volume Achillespees Tendinopathie Injectie Behandeling Hoog-Volume

Interventions

High-Volume Image-Guided Injection (50 ml) in the peritendinous space of the Achilles tendon

Sponsors

Erasmus University Medical Centre, department of orthopaedics. Collaboration with Haaglanden Medical Centre, department of sports medicine.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Age 18-70 years. - Clinical diagnosis of chronic midportion Achilles tendinopathy: Painfull swelling of the Achilles tendon, 2-7 cm proximal to it’s calcaneal insertion. - Non-response to eccentric excercise program for 6 weeks. - Painfull Achilles tendon for more than 2 months. - Neovascularization is present using Power Doppler Ultrasonography examination

Exclusion criteria

Exclusion criteria: - Clinical suspicion of insertional disorders. - Clinical suspicion of Achilles tendon rupture. - Clinical suspicion of plantar flexor tenosynovitis. - Clinical suspicion of peroneal tendinopathy or subluxation. - Clinical suspicion of sural nerve pathology. - Condition of the Achilles tendon caused by medication, such as quinolones and statins. - Known to have the following disorders: spondylarthropathy, gout, hyperlipidemia, rheumatoid arthritis and sarcoïdosis. - Inability to perform a heavy load eccentric exercise program. - Recently prescribed drugs (within 2 years) with a putative effect on symptoms and tendon healing (quinolone antibiotics, corticosteroids). - Presence of pregnancy. - Previous Achilles tendon rupture. - Patient has received surgical intervention for his injury. - A medical condition that would affect safety of injection (e.g. peripheral vascular disease, use of anticoagulant medication) - Inability to give informed consent. - Participation in other concomitant treatment programs. - Patient has already one side included in this study. - Patient does not wish, for whatever reason, to undergo one of the two treatments.

Design outcomes

Primary

MeasureTime frame
The Victorian Institute of Sports Assessment-Achilles (VISA-A) score. This is a validated, reliable and disease-specific questionnaire to evaluate symptoms in patients with chronic midportion Achilles tendinopathy

Secondary

MeasureTime frame
- PainDETECT questionnaire - Pain Coping Inventory (PCI) questionnaire - Physical examination: waist circumference, length, weight, foot posture index, palpation pain (VAS 0-100), flexibility and strength gastrocnemius and soleus muscle, jumping height (cm) and pain during jump test (VAS 0-100) and 10 times hopping (VAS 0-100, part of the VISA-A questionnaire) - Degree of neovascularization (determined with standardized Power Doppler Ultrasonography examination) - Subjective patient satisfaction (excellent / good / fair / poor) - Return to sports (Return to desired sport on pre-injury level / return to desired sport but on a lower level / return to sports but not desired sport / no return to sports) - Compliance to the exercise program.

Contacts

Public ContactP.L.J. Veldhoven, van

Afdeling sportgeneeskunde, Haaglanden MC, Antoniushove, Postbus 411

sportafspraak@haaglandenmc.nl+31 80 979 4890

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)