LEICeSter Tendon Extracorporeal Shockwave Studies (LEICSTES)

November 29, 2023 updated by: University Hospitals, Leicester

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.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

720

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Leicester, United Kingdom
        • Recruiting
        • University Hospitals Of Leicester Nhs Trust
        • Contact:
          • Sports Medicine Department
          • Phone Number: 0116 2584365

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention
rehabilitation + "active-dose" ESWT (extra-corporeal shockwave therapy)
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
Placebo Comparator: control
rehabilitation + "placebo-dose" ESWT (extra-corporeal shockwave therapy)
Other: structured rehabilitation programme
a structured and standardised rehabilitation programme specific to the tendon in question - already in routine clinical use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
improvement in pain as assessed by a 0-10 visual analogue scale (VAS)
Time Frame: primary outcome 3 months
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)
Time Frame: secondary outcome at 6 months post treatment
secondary outcome at 6 months post treatment
improvement in function as assessed by several validated patient-rated outcome measures
Time Frame: 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.
3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals, Leicester

Investigators

  • Principal Investigator: Patrick Wheeler, UHL NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 15, 2015

First Submitted That Met QC Criteria

September 7, 2015

First Posted (Estimated)

September 10, 2015

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHL - 11401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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