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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental | rehabilitation + "active-dose" ESWT (extra-corporeal shockwave therapy) |
|
| control | Placebo Comparator | rehabilitation + "placebo-dose" ESWT (extra-corporeal shockwave therapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extra-Corporeal Shockwave Therapy (ESWT) | Device | The use of ESWT from a commercially available machine at approved settings already in routine clinical use |
|
| Measure | Description | Time Frame |
|---|---|---|
| improvement in pain as assessed by a 0-10 visual analogue scale (VAS) | primary outcome 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
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)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick Wheeler | Contact | patrick.wheeler@uhl-tr.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Patrick Wheeler | UHL NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Leicester NHS Trust | Recruiting | Leicester | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40263964 | Derived | 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. | |
| 33512943 |
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| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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| structured rehabilitation programme | Other | a structured and standardised rehabilitation programme specific to the tendon in question - already in routine clinical use |
|
| 3 months and 6 months |
| 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. |