Using shockwave therapy to improve treatment for tendon injuries
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.
This study is testing whether adding shockwave therapy to a home exercise program can help people with chronic tendon injuries, like plantar fasciitis and tennis elbow, feel better than just doing exercises alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 720 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | University Hospitals, Leicester Academic / other |
| Locations | 1 site (Leicester) |
| Trial ID | NCT02546128 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Extra-Corporeal Shockwave Therapy (ESWT) combined with a structured home-exercise program for patients suffering from chronic tendinopathies. It focuses on six specific conditions, including plantar fasciitis and tennis elbow, with patients being randomized within sub-study groups. The aim is to determine if the addition of ESWT provides significant benefits over exercise alone. Patients will undergo objective imaging to confirm their diagnosis before participating.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with chronic symptoms of at least 12 weeks from specific tendinopathies.
Not a fit: Patients with recent steroid injections, bleeding disorders, or previous ESWT for the same condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and reduce pain for patients with chronic tendon injuries.
How similar studies have performed: Previous studies have shown promise for shockwave therapy in treating tendinopathies, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Leicester
- University Hospitals of Leicester NHS Trust — Leicester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Patrick Wheeler — UHL NHS Trust
- Study coordinator: Patrick Wheeler
- Email: patrick.wheeler@uhl-tr.nhs.uk
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.