TendinopathyLEICSTESNCT02546128
LEICeSter Tendon Extracorporeal Shockwave Studies
A study testing Extra-Corporeal Shockwave Therapy (ESWT) and structured rehabilitation programme in people with Tendinopathy, run by University Hospitals, Leicester at 1 site in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Extra-Corporeal Shockwave Therapy (ESWT) and structured rehabilitation programme
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 720 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Patrick Wheeler contact
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals of Leicester NHS Trust
Leicester
Sports Medicine Department, 0116 2584365
About this study
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.
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
Read the 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
- Conditions
- Tendinopathy
- Being tested
- Extra-Corporeal Shockwave Therapy (ESWT), structured rehabilitation programme
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra-Corporeal Shockwave Therapy (ESWT)Device
The use of ESWT from a commercially available machine at approved settings already in routine clinical use
structured rehabilitation programmeOther
a structured and standardised rehabilitation programme specific to the tendon in question - already in routine clinical use
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | rehabilitation + "active-dose" ESWT (extra-corporeal shockwave therapy) Receives: Device: Extra-Corporeal Shockwave Therapy (ESWT); Other: structured rehabilitation programme |
| control | Placebo comparator | rehabilitation + "placebo-dose" ESWT (extra-corporeal shockwave therapy) Receives: Other: structured rehabilitation programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in pain as assessed by a 0-10 visual analogue scale (VAS)
Measured: primary outcome 3 months
Secondary outcomes (2)
improvement in pain as assessed by a 0-10 visual analogue scale (VAS)
Measured: 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.
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startJul 2015
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Wheeler, Principal investigator, UHL NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546128
- Sponsor's protocol ID
- UHL - 11401
- Acronym
- LEICSTES
- Status last verified
- Nov 2023
- First submitted
- 15 Jun 2015
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Wheeler PC, Tattersall C, Calver R. Radial Extracorporeal Shockwave Therapy (rESWT) Is Not Superior to "Minimal-Dose" rESWT for Patients With Chronic Noninsertional Achilles Tendinopathy: A Double-Anonymized Randomized Controlled Trial. Foot Ankle Int. 2025 Jun;46(6):633-643. doi: 10.1177/10711007251327421. Epub 2025 Apr 22.
PubMed 40263964Wheeler 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.
PubMed 33512943
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02546128
- Acronym / sponsor ID
- LEICSTES / UHL - 11401
- Conditions
- Tendinopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Device: Extra-Corporeal Shockwave Therapy (ESWT), Other: structured rehabilitation programmerehabilitation + "active-dose" ESWT (extra-corporeal shockwave therapy) |
| control | Placebo comparator | Other: structured rehabilitation programmerehabilitation + "placebo-dose" ESWT (extra-corporeal shockwave therapy) |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients age >18
- Symptoms (typically pain / stiffness) of at least 12 weeks of one of the following sites / conditions:
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extra-Corporeal Shockwave Therapy (ESWT)The use of ESWT from a commercially available machine at approved settings already in routine clinical use | Device | intervention |
| structured rehabilitation programmea structured and standardised rehabilitation programme specific to the tendon in question - already in routine clinical use | Other | control, intervention |
Primary outcome
improvement in pain as assessed by a 0-10 visual analogue scale (VAS)
Time frame: primary outcome 3 months
2 secondary outcomes
improvement in pain as assessed by a 0-10 visual analogue scale (VAS)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Derived from this study: PubMed 40263964Wheeler PC, Tattersall C, Calver R. Radial Extracorporeal Shockwave Therapy (rESWT) Is Not Superior to "Minimal-Dose" rESWT for Patients With Chronic Noninsertional Achilles Tendinopathy: A Double-Anonymized Randomized Controlled Trial. Foot Ankle Int. 2025 Jun;46(6):633-643. doi: 10.1177/10711007251327421. Epub 2025 Apr 22.
- Derived from this study: PubMed 33512943Wheeler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Wheeler contact
Patrick Wheeler principal investigator
UHL NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extra-Corporeal Shockwave Therapy (ESWT) and structured rehabilitation programme in people with Tendinopathy, run by University Hospitals, Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Wheeler (patrick.wheeler@uhl-tr.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in pain as assessed by a 0-10 visual analogue scale (VAS) (time frame: primary outcome 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02546128, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.