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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47722
Enrollment
84
Registered
2019-02-05
Start date
2016-12-21
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 tendinopathy overuse injury Achilles tendon

Interventions

Both groups receive an injection anterior to the Achilles tendon on the medial side. The sports physician injects a mixture of 0,9% saline solution and lidocaïne in the peritendinous space of the Ac
Injection
Tendinopathy
Treatment

Sponsors

Haaglanden Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

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 excercise program for 6 weeks. - Painfull Achilles tendon for more than 2 months. - Neovascularisation is present on 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. - Clicical 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 pregancy. - 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. - Allergy for lidocain.

Design outcomes

Primary

MeasureTime frame
Our primary outcome measurement is the VISA-A score. This measures pain, function and activity level. It is validated en reliable for the chronic Achilles tendinopathy.

Secondary

MeasureTime frame
Our secundary outcome measurements are as follows: - The painDETECT questionnaire. - The Pain Coping Inventory (PCI) questionnaire - Subjective function of the Achilles tendon (5-point Likert scale) and subjective recovery (7-point Patient's Global Assessment scale) - 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) (First 66 patients) - Degree of neovascularisation (determined with standarised Power Doppler Ultrasonography examination) before and after eccentric/isotonic calf exercises or rest (First 66 patients) - 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) - Time to return to full training in desired sport. - Compliance to the exercise programme and return to sports activity programme (RPE score x duration of activity)

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)