Achilles tendinopathy MedDRA version: 18.0 Level: LLT Classification code 10050471 Term: Achilles tendon pain System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Marcaine
Product Name: Bupivacaine Hydrochloride 0.5%w/v solution for Injection.
Pharmaceutical Form: Solution for injection
INN or Proposed INN: anhydrous bupivacaine hydrochloride
Other
Sponsors
QMUL and Bart's Health NHS trust
Eligibility
Sex/Gender
All
Inclusion criteria
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: Exclusion criteria include o having had a steroid injection to the area in the last 1 year o history of known fluorquinolone antibiotic use in the last two years o Concurrent Participation on another Clinical Trial of an Investigational Medicinal Product • Participation in other trials for Achilles tendon or musculoskeletal lower limb pathology o having had SWT to Achilles in the last 1 year • Allergies to any of the potential injectates o a history of a previous Achilles tear o have 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overarching aim is to test the effectiveness and cost effectiveness of Radial Shock Wave Therapy (RSWT) and High Volume Image Guided Injection (HVIGI) when added to usual practice (progressive eccentric loading - EL). The primary aim will be realised by a three-centre, three-armed randomised clinical trial of EL (usual treatment) compared to EL plus RSWT and HVIGI plus EL. The primary outcome measure will be the Victorian Institute of Sport Assessment – Achilles (VISA-A), a well validated and reliable measure of function and recent pain at twelve months. Subjects will be stratified by activity level. To identify a clinically meaningful difference between groups of 15 on the VISA-A at a power of 90% and a significance level of 2.5% (Bonferroni correction for multiple comparisons) at the twelve month post treatment follow-up we will recruit 180 participants. Subsequent follow-ups at one and two years will assess long-term treatment effects.;Secondary Objective: Secondary measures will include: recent pain (VAS score); treatment satisfaction (Likert scale); adherence (exercise diaries); adverse events (overtly solicited self report); global perceived change (Likert scale); ankle and foot function (FAOS); self-reported exercise levels (modified IPAQ); health-related quality of life (EQ-5D); calf function (using a clinical graded loading challenge). Further, we will collect data on costs and interview participants and care delivery staff concerning trial delivery. All measures will be applied at baseline and 6 weeks, then 3, 6, 12 and 24 months post-randomisation. ;Primary end point(s): The primary outcome measure will be the Victorian Institute of Sport Assessment – Achilles (VISA-A), a well validated and reliable measure of function and recent pain, at twelve months.;Timepoint(s) of evaluation of this end point: 12 months after trial entry. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A range of secondary outcomes have been selected for three purposes. 1: to explore the trial results. 2: to evaluate cost-effectiveness 3: a process evaluation to understand factors explaining the success or otherwise of the interventions. ;Timepoint(s) of evaluation of this end point: Up to two years. | — |
Countries
United Kingdom
Contacts
Public ContactBurtles
QMUL
Outcome results
None listed