Back to resultsLEICeSter Tendon Extracorporeal Shockwave Studies (LEICSTES)
Primary Purpose
Tendinopathy
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Extra-Corporeal Shockwave Therapy (ESWT)
structured rehabilitation programme
Sponsored by
About this trial
This is an interventional treatment trial for Tendinopathy
Eligibility Criteria
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
Sites / Locations
- University Hospitals of Leicester NHS TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
intervention
control
Arm Description
rehabilitation + "active-dose" ESWT (extra-corporeal shockwave therapy)
rehabilitation + "placebo-dose" ESWT (extra-corporeal shockwave therapy)
Outcomes
Primary Outcome Measures
improvement in pain as assessed by a 0-10 visual analogue scale (VAS)
Secondary Outcome Measures
improvement in pain as assessed by a 0-10 visual analogue scale (VAS)
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.
Full Information
NCT ID
NCT02546128
First Posted
June 15, 2015
Last Updated
May 20, 2022
Sponsor
University Hospitals, Leicester
1. Study Identification
Unique Protocol Identification Number
NCT02546128
Brief Title
LEICeSter Tendon Extracorporeal Shockwave Studies
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Recruiting
Study Start Date
July 2015 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals, Leicester
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
720 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Experimental
Arm Description
rehabilitation + "active-dose" ESWT (extra-corporeal shockwave therapy)
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
rehabilitation + "placebo-dose" ESWT (extra-corporeal shockwave therapy)
Intervention Type
Device
Intervention Name(s)
Extra-Corporeal Shockwave Therapy (ESWT)
Intervention Description
The use of ESWT from a commercially available machine at approved settings already in routine clinical use
Intervention Type
Other
Intervention Name(s)
structured rehabilitation programme
Intervention Description
a structured and standardised rehabilitation programme specific to the tendon in question - already in routine clinical use
Primary Outcome Measure Information:
Title
improvement in pain as assessed by a 0-10 visual analogue scale (VAS)
Time Frame
primary outcome 3 months
Secondary Outcome Measure Information:
Title
improvement in pain as assessed by a 0-10 visual analogue scale (VAS)
Time Frame
secondary outcome at 6 months post treatment
Title
improvement in function as assessed by several validated patient-rated outcome measures
Description
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.
Time Frame
3 months and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Wheeler
Email
patrick.wheeler@uhl-tr.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Wheeler
Organizational Affiliation
UHL NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals of Leicester NHS Trust
City
Leicester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sports Medicine Department
Phone
0116 2584365
12. IPD Sharing Statement
Citations:
PubMed Identifier
33512943
Citation
Wheeler PC, Dudson C, Calver R, Goodall D, Gregory KM, Singh H, Boyd KT. Three Sessions of Radial Extracorporeal Shockwave Therapy Gives No Additional Benefit Over "Minimal-Dose" Radial Extracorporeal Shockwave Therapy for Patients With Chronic Greater Trochanteric Pain Syndrome: A Double-Blinded, Randomized, Controlled Trial. Clin J Sport Med. 2022 Jan 1;32(1):e7-e18. doi: 10.1097/JSM.0000000000000880.
Results Reference
derived
Learn more about this trial
LEICeSter Tendon Extracorporeal Shockwave Studies
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