The efficacy of radial shockwave therapy compared with sham shockwave therapy in insertional Achilles tendinopathy. A randomised controlled trial

Not Applicable

Completed

• Conditions: Tendinopathy; Physical Medicine / Rehabilitation - Physiotherapy; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12620000035921
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-21
• Study Completion: 2022-11-25
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Aged 18 years or older
>3 months of pain at the insertion of the Achilles to the posterior calcaneal surface
Primary complaint of insertional Achilles pain on one or both lower limbs
Clinical diagnosis of insertional Achilles tendinopathy based on the following criteria:
oGradual onset pain in the relevant area;
oPain during or after Achilles tendon loading activities (e.g. walking, running)
Ankle joint examination is normal and passive plantar-flexion is painfree;
Confirm diagnosis with ultrasound imaging of the Achilles tendon. One or more of the following features present in the insertion area: (i) thickening of the anteroposterior tendon insertion; and/or (ii) hypoechoic regions with or without thickening/fluid within the retrocalcaneal bursa

Exclusion Criteria

• Previous rSWT treatment for any condition
• Previous Achilles tendon surgery in the most symptomatic Achilles tendon
• Previous Achilles tendon rupture in the most symptomatic Achilles tendon
• Other ankle conditions including impingement syndrome or any midportion Achilles symptoms that are worse than the insertional Achilles pain
• 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain and function will be assessed with VISA-A score (this is a composite instriment measuring both pain and function). The VISA-A is a disease specific and validated tool for assessing Achilles tendon pain and function.[baseline in person and 6 and 12 (primary endpoint) weeks via email or text link to online questionnaire.]