Efficacy of Tendon Strip Injections compared to sham following failure of conservative therapy for Achilles tendinopathy

Not Applicable

Completed

• Conditions: Achilles Tendinopathy; Musculoskeletal - Other muscular and skeletal disorders; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12619001455156
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-22
• Study Completion: 2023-07-07
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

• Previously trialled first line recommended treatment
• Aged 18 years or above
• more than 3 months of pain in the mid-portion Achilles area proximal to the Achilles
tendon insertion in the calcaneum)
• Primary complaint of mid-portion Achilles pain on one or both lower limbs
• VISA-A <75 points
• Clinical diagnosis of mid-portion Achilles tendinopathy based on the following
criteria:
o Gradual onset pain in the relevant area;
o Midportion Achilles pain during or after Achilles tendon loading activities (e.g. walking, running)
• Ankle joint examination, and especially passive plantar-flexion is essentially normal,
• Confirm diagnosis with ultrasound imaging of the Achilles tendon. One or more of the
following features present in the mid-portion area: (i) hypoechoic regions; and/or (ii)
Doppler signal indicative of vascularisation.

Exclusion Criteria

•Previous Achilles tendon surgery in the symptomatic lower limb(s)
•Previous Achilles tendon rupture in the symptomatic lower limb(s)
•Other ankle conditions including impingement syndrome, insertional Achilles tendinosis,
Achilles paratenonitis without tendinopathy
•Tendinopathy caused by inflammatory conditions (e.g. ankylosing spondylitis)
•Neurological disorders (i.e. Parkinson’s syndrome, stroke)
•Inherited connective tissue disorders (i.e. Ehlers- Danlos syndrome, Marfan’s syndrome)
•Use of fluoroquinolone antibiotics within the previous two years
•Injection of local anaesthetic, corticosteroid, platelet rich plasma or other pharmaceutical agent into the Achilles tendon or surrounding area within the previous three months
•Any medical and/or social reason that, in the opinion of the investigators, makes the participant unsuitable for inclusion
•Serious mental health problem that would preclude adherence to study or treatment protocols
•Known allergies or hypersensitivity to the study drugs
•Needle phobia or a blood clotting disorder

Study & Design

• Study Type: Interventional
• Study Design: Not specified