LEICeSter Tendon Extracorporeal Shockwave Studies

Tendinopathy Clinical Trial

— LEICSTES  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02546128
• Other study ID #: UHL - 11401
• Status: Recruiting
• Phase: N/A
• Start date: July 2015
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: University Hospitals, Leicester
• Contact: Patrick Wheeler
• Email: patrick.wheeler[@]uhl-tr.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 720
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Tendinopathy

Intervention

Device:
• Extra-Corporeal Shockwave Therapy (ESWT)
The use of ESWT from a commercially available machine at approved settings already in routine clinical use

Other:
• structured rehabilitation programme
a structured and standardised rehabilitation programme specific to the tendon in question - already in routine clinical use

Locations

Country	Name	City	State
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in pain as assessed by a 0-10 visual analogue scale (VAS)		primary outcome 3 months
Secondary	improvement in pain as assessed by a 0-10 visual analogue scale (VAS)		secondary outcome at 6 months post treatment
Secondary	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