LEICeSter Tendon Extracorporeal Shockwave Studies

Study Overview
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Brief Summary
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To assess whether the addition of Extra-corporeal Shockwave Therapy (ESWT) to a structured home-exercise programme has any additional benefit to patients with tendinopathies

Detailed Description
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This involves patients with one of 6 different defined chronic tendinopathies. These individual sites are run as discrete sub-studies, with randomisation n occurring within sub-study grouping

Official Title
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LEICSTES = LEICeSter Tendon Extracorporeal Shockwave Studies Assessing the Benefits of the Addition of Extra-Corporeal Shockwave Treatment to a Structured Home-rehabilitation Programme for Patients With Tendinopathy.

Conditions
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Tendinopathy

Intervention / Treatment
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* Device: Extra-Corporeal Shockwave Therapy (ESWT)
* Other: structured rehabilitation programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age >18 Symptoms (typically pain / stiffness) of at least 12 weeks of one of the following sites / conditions: Plantar fasciitis Insertional Achilles tendinopathy Mid-substance Achilles tendinopathy Patella tendinopathy Trochanteric pain syndrome (gluteus medius insertional tendinopathy / trochanteric bursitis) Tennis elbow Referred for ESWT (shockwave) within the Sports Medicine Department Objective imaging of tendon / structure confirming diagnosis and excluding tear or other structural injury (US or MRI acceptable) Exclusion Criteria: Patients with the normal exclusions for ESWT - including pre-existing skin injury over tendon site, recent steroid injection (within 6 weeks of ESWT starting), patients on anticoagulation, patients with haemophilia or other bleeding tendency, patients with current febrile illness Previous ESWT treatment for the same condition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>rehabilitation + active-dose ESWT (extra-corporeal shockwave therapy) | Device: Extra-Corporeal Shockwave Therapy (ESWT)<br>* The use of ESWT from a commercially available machine at approved settings already in routine clinical use<br>Other: structured rehabilitation programme<br>* a structured and standardised rehabilitation programme specific to the tendon in question - already in routine clinical use<br>|
| Placebo Comparator: control<br>rehabilitation + placebo-dose ESWT (extra-corporeal shockwave therapy) | Other: structured rehabilitation programme<br>* a structured and standardised rehabilitation programme specific to the tendon in question - already in routine clinical use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in pain as assessed by a 0-10 visual analogue scale (VAS) |  | primary outcome 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in pain as assessed by a 0-10 visual analogue scale (VAS) |  | secondary outcome at 6 months post treatment | 
| improvement in function as assessed by several validated patient-rated outcome measures | These will use validated patient-rated outcome measures (PROMS) already in routine use in this clinical service. This include specific site questions, for example patella tendon (VISA-P), achilles tendon (VISA-A), trochanteric pain (Oxford Hip Score, Non-Arthritic Hip Score), plantar fascia (revised foot function index, MOXFQ) all of which give a wider picture of the outcome of specific conditions. these are all fully detailed in the study protocol. | 3 months and 6 months |