Tendinopathy
Conditions
Brief summary
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
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
Interventions
The use of ESWT from a commercially available machine at approved settings already in routine clinical use
a structured and standardised rehabilitation programme specific to the tendon in question - already in routine clinical use
Sponsors
University Hospitals, Leicester
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
1. Patients age \>18 2. Symptoms (typically pain / stiffness) of at least 12 weeks of one of the following sites / conditions: 1. Plantar fasciitis 2. Insertional Achilles tendinopathy 3. Mid-substance Achilles tendinopathy 4. Patella tendinopathy 5. Trochanteric pain syndrome (gluteus medius insertional tendinopathy / trochanteric bursitis) 6. Tennis elbow 3. Referred for ESWT (shockwave) within the Sports Medicine Department 4. Objective imaging of tendon / structure confirming diagnosis and excluding tear or other structural injury (US or MRI acceptable)
Exclusion criteria
1. 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 2. Previous ESWT treatment for the same condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| improvement in pain as assessed by a 0-10 visual analogue scale (VAS) | primary outcome 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 3 months and 6 months | 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. |
Countries
United Kingdom
Contacts
Primary ContactPatrick Wheeler
Outcome results
None listed