Shock Wave Therapy for Lateral Hip Pain, Caused by Tendon Pathology

Study Overview
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Brief Summary
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The aim of this randomized controlled study is to investigate if focal shock wave is an effective treatment, with respect to hip pain and lower limb function, in a population affected by greater trochanteric pain syndrome with gluteal tendinopathy.

Official Title
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Focused Extracorporeal Shock Wave Therapy for Greater Trochanteric Pain Syndrome With Gluteal Tendinopathy: a Randomized Controlled Trial

Conditions
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Tendinopathy

Intervention / Treatment
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* Procedure: focused shock wave therapy
* Procedure: ultrasound therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: duration of lateral hip pain of six weeks or longer, normal passive hip range of movement (ROM), sonographic evidence of gluteal tendinopathy at their insertional site at the greater trochanter Exclusion Criteria: general contraindication to extracorporeal shock wave therapy (pacemaker, pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area), history of rheumatologic disease, previous fractures or surgery in the affected limb, full thickness tear of the gluteal tendons, osteoarthritis of the hip (with ROM limitation), clinical signs of lumbar radiculopathy, corticosteroid injections or other conservative therapies (except pharmacological pain treatments) since the onset of the current pain episode.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention:f-ESWT (focused shock wave therapy)<br>In the study-group, a device powered by a piezoelectric generator (PIEZOSON 100PLUS, Richard Wolf) was used . At the beginning of each treatment session, the enthesis of the gluteal tendons at the greater trochanter (at the anterior half of its lateral facet) was targeted through a non-inline sonographic focusing, using a linear probe (7.5-12 MHz) connected to an ultrasound scanner (ESAOTE MYLAB FIVE, Genova and Florence, Italy). All patients received 1800 pulses (frequency=4Hz) of an energy flux density of 0.15 mJ/mm2 once a week for three consecutive weeks. At the first treatment session, the energy flux density was gradually increased from 0.05 to 0.15 mJ/mm2 during the first 500 pulses. | Procedure: focused shock wave therapy<br> <br> |
| Active Comparator: Intervention:UST (ultrasound therapy)<br>In the control-group, we used a mono-frequency device (ROLAND, RT-20 series, frequency=1MHz). We treated an area of 5cm2, softly moving the US-probe around the most painful point of the greater trochanter at the clinical palpation. UST was supplied in a continuous modality, with an intensity of 1.5 W/cm2, for ten consecutive daily sessions of ten minutes each. | Procedure: ultrasound therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| p-NRS | Change from baseline p-NRS (pain-on-movement numeric rating scale) at 2 months and at 6 months. | Baseline, at two months, at six months | 
| LEFS score | Change from baseline LEFS (Lower extremity functional scale) total score at 2 months and at 6 months | Baseline, at two months, at six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shock waves, Greater trochanteric pain syndrome