LEICeSter Tendon Extracorporeal Shockwave Studies (LEICSTES)

NHS Trust

Status: Enrolling

Conditions: Tendinopathy

Treatments: Other: structured rehabilitation programme; Device: Extra-Corporeal Shockwave Therapy (ESWT)

Study type: Interventional

Funder types: Other

Identifiers

NCT02546128

UHL - 11401

Details and patient eligibility

About

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

Full 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

Enrollment: 720 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

720 participants in 2 patient groups, including a placebo group

intervention

Experimental group

Description:

rehabilitation + "active-dose" ESWT (extra-corporeal shockwave therapy)

Treatment:

Device: Extra-Corporeal Shockwave Therapy (ESWT)

Other: structured rehabilitation programme

control

Placebo Comparator group

Description:

rehabilitation + "placebo-dose" ESWT (extra-corporeal shockwave therapy)

Treatment:

Other: structured rehabilitation programme