Tendinopathy treatment effects and mechanisms 1 (TEAM 1): A randomised clinical trial of eccentric loading, high volume injection and shock wave therapy for Achilles tendinopathy. - Tendinopathy: Treatment effects and mechanisms 1 (Tendinopathy TEAM 1)

QMUL and Bart's Health NHS trust0 个研究点目标入组 180 人开始时间: 2015年8月6日最近更新: 2015年9月28日

适应症

试验速览

暂无简介。

•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 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

发起方

QMUL and Bart's Health NHS trust