Tendinopathy treatment effects and mechanisms 1 (TEAM 1):

• Conditions: Achilles tendinopathy; MedDRA version: 18.0Level: LLTClassification code 10050471Term: Achilles tendon painSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-000196-27-GB
• Lead Sponsor: QMUL and Bart's Health NHS trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-06
• Last Update Posted: 28 September 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Patients will be included if they are aged between 18 and 64 with a greater than three month history of pain in the mid-Achilles area.
Clinical diagnosis will be established by
•gradual onset of pain in the relevant area
•pain that worsens during and soon after exercise
•confirmation by palpation of the mid-tendon
•positive London Hospital test (King, 2000)
•ankle joint examination
•The squeeze and Simmonds tests must be negative to exclude rupture.
•an absence of a frank tear history.
•Ultrasound confirmation of clinical findings

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Exclusion criteria include
ohaving had a steroid injection to the area in the last 1 year
ohistory of known fluorquinolone antibiotic use in the last two years
oConcurrent Participation on another Clinical Trial of an Investigational Medicinal Product
•Participation in other trials for Achilles tendon or musculoskeletal lower limb pathology
ohaving had SWT to Achilles in the last 1 year
•Allergies to any of the potential injectates
oa history of a previous Achilles tear
ohave pain predominantly at the tendon insertion to exclude those with insertional tendinopathy
o known to have an inherited disorder of connective tissue disease or autoimmune diseases of connective tissue
?Known chronic kidney disease at grade 4 (Known CDK4)
•unable to provide informed consent
•current or suspected pregnancy or breastfeeding
•or have any further medical and/or social reason that would preclude involvement as determined by an Investigator.
•Participation in a clinical trial of an investigational medicinal product in the last 90 days.
•A serious mental health problems that would preclude adherence to study or treatment protocols
•Known hypersensitivity to study drugs
•Local infection or active systematic infection that would be a contra-indication to use of glucocorticoid drugs (e.g. chickenpox or measles)
•Known immune deficiency

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified